Kinetin Cream

Pronunciation: KIN-uh-tin
Generic Name: Kinetin
Brand Name: Kinerase

Kinetin Cream is used for:

Moisturizing skin, improving skin texture, reducing the appearance of freckles and brown spots, and reducing the look of fine lines and wrinkles caused by skin aging or sun damage. It may also be used to moisturize skin after certain procedures (eg, chemical peels, laser resurfacing) or to treat sensitive skin caused by rosacea, eczema, or dermatitis. It may also be used for other conditions as determined by your doctor.

Kinetin Cream is a moisturizing agent. It works by moisturizing the skin.

Do NOT use Kinetin Cream if:

• you are allergic to any ingredient in Kinetin Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kinetin Cream:

Some medical conditions may interact with Kinetin Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Kinetin Cream. However, no specific interactions with Kinetin Cream are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kinetin Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kinetin Cream:

Use Kinetin Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Kinetin Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Kinetin Cream refilled.


• Wash the affected area with a mild facial cleanser. Apply a dime-sized amount of medicine to the area to be treated as directed. Rub the medicine in until evenly distributed.


• Kinetin Cream is for external use only. Avoid getting Kinetin Cream in your eyes. If you get Kinetin Cream in your eyes, rinse immediately with cool tap water.


• Do not cover with a dressing unless directed to do so by your doctor.


• Wash your hands immediately after using Kinetin Cream.


• Sunscreen or makeup may be applied immediately after using Kinetin Cream.


• If you miss a dose of Kinetin Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Kinetin Cream.

Important safety information:

• Check with your doctor after using Kinetin Cream for 3 months to determine improvement in your skin appearance.


• Kinetin Cream does not make your skin sensitive to sunlight. However, if you are going outdoors it is recommended that you wear protective clothing and apply sunscreen with a minimum SPF 15 to prevent further sun damage to your skin.


• Kinetin Cream may be harmful if swallowed. If you may have taken Kinetin Cream by mouth, contact your local poison control center or emergency room immediately.


• Use Kinetin Cream with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Kinetin Cream, discuss with your doctor the benefits and risks of using Kinetin Cream during pregnancy. It is unknown if Kinetin Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Kinetin Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Kinetin Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Kinetin Cream:

Store Kinetin Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Kinetin Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Kinetin Cream, please talk with your doctor, pharmacist, or other health care provider.


• Kinetin Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Kinetin Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Kinetin resources

• Kinetin Use in Pregnancy & Breastfeeding
• Kinetin Support Group
• 8 Reviews for Kinetin - Add your own review/rating

Compare Kinetin with other medications

• Dry Skin

Gee's Linctus BP (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Gee's Linctus BP or Opiate Squill Linctus BP

2. Qualitative And Quantitative Composition

Opium Tincture 0.083ml per 5ml.

Squill Oxymel 1.667ml per 5ml.

For excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

A straw coloured to light brown opalescent or turbid liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of the symptoms of coughs.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults and children over 12 years: 5ml.

Children under 12 years: Not recommended.

The elderly: Use with care, not exceeding the recommended adult dose.

Dosage schedule

The dose may be repeated after 4 hours if required but not more than 4 doses in any 24 hours.

If symptoms persist for more than 7 days consult a doctor.

4.3 Contraindications

Contraindicated in patients with known hypersensitivity to any of the ingredients. Also contraindicated in patients with cardiac disorders and in impaired hepatic or renal function.

Contraindicated in cases of moderate to severe respiratory depression, alcoholism, head injuries and conditions in which intracranial pressure is raised, also in acute asthma, and heart failure secondary to chronic lung disease.

Contraindicated in patients receiving treatment with monoamine oxidase inhibitors or within 14 days of stopping such treatment.

4.4 Special Warnings And Precautions For Use

The linctus should be given with caution to patients with: hypothyroidism, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, prostatic hypertrophy, shock, myasthenia gravis, hypotension, the elderly and patients with general debilitation. Reduced doses may be required in these conditions.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Warnings to appear on labels:

Do not exceed the stated dose.

Recommended diluent: syrup BP

Keep out of the reach and sight of children.

If symptoms persist for more than 7 days consult a doctor.

Do not take if allergic to any of the ingredients, have heart, liver or kidney disease, or breathing difficulty or suffer from alcoholism or raised pressure in the head.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The linctus should not be taken by patients receiving monoamine-oxidase inhibitors or within 14 days of stopping such treatment.

Narcotic analgesics cause delayed absorption of mexiletine, they also cause potentiation of the effects of hypnotics and anxiolytics and other CNS depressants. They have opposing effects on gastro-intestinal activity to domperidone and metoclopramide. Toxicity of squill glycosides may be increased when given in combination with thiazides or loop diuretics, as these cause hypokalaemia and hypomagnesaemia which may lead to cardiac arrhythmias.

Hypokalaemia may result from simultaneous treatment with corticosteroids, amphotericin, sodium polystyrene sulphonate and carbenoxolone.

Absorption may be affected by intestinal absorptive agents and antacids including metoclopramide and propantheline. Simultaneous administration of spironolactone, phenobarbital or rifampicin may reduce renal excretion.

4.6 Pregnancy And Lactation

Should be used with caution if at all during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

At the recommended dose the linctus is unlikely to cause drowsiness, however, if affected do not drive or operate machinery.

4.8 Undesirable Effects

Narcotic analgesics may cause nausea, vomiting, constipation, drowsiness, confusion. Larger doses may cause respiratory depression, difficulty with micturition, urticaria, pruritis, flushing and hypotension. Tolerance gradually develops with long term use although not constipation, and dependence is liable to be caused. Squill contains cardiac glycosides and may cause nausea, vomiting and anorexia, diarrhoea and abdominal pain may also occur.

4.9 Overdose

Signs of morphine overdosage include pin-point pupils, depressed respiration, circulatory failure, pulmonary oedema, convulsions, renal failure and coma. Gastric lavage should be performed as soon as possible after ingestion, and intensive supportive therapy carried out. Naloxone may be given as an antidote (initially 0.8 – 2.0 mg, to a maximum of 10mg, by intravenous injection).

Common symptoms of digoxin overdosage are headache, facial pain, fatigue, weakness, dizziness, drowsiness, disorientation, mental confusion, bad dreams and more rarely delirium, acute psychoses, and hallucinations. Visual disturbances including blurred and misted vision may occur. Colour vision may be affected with objects appearing yellow or occasionally green, red, brown, blue or white. Convulsions have been reported.

Large doses of squill produce nausea, vomiting and diarrhoea, it has a digitalis-like effect on the heart. Supraventricular or ventricular arrhythmias and defects of conduction may be an early indication of excessive dosage.

Treatment of acute digoxin poisoning consists of emptying the stomach by emesis or aspiration and lavage. Activated charcoal may be given. Cardiac toxicity should be treated under ECG control and serum electrolytes should be monitored. Anti-arrhythmic treatment may be necessary and should be determined by the specific arrhythmia present. Atropine may be given intravenously to control bradycardia, and in patients with heart block; cardiac pacing may be necessary if atropine is not effective. Colestyramine or colestipol may be of use in increasing the elimination of cardiac glycosides.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

R05F A02 – Cough suppressants and expectorants, combinations – opium derivatives and expectorants

Morphine and other related opioids are effective for the suppression of cough. They depress the cough reflex, at least in part by a direct effect on a cough centre in the medulla.

Squill has an irritant effect on the gastric mucosa, it has a reflex expectorant action.

5.2 Pharmacokinetic Properties

Opioids are readily absorbed from the gastrointestinal tract. The major pathway for detoxification of morphine is conjugation with glucuronic acid. Small amounts of free morphine and larger amounts of conjugated morphine are excreted in the urine, accounting for most of the administered drug. 90% of total excretion occurs during the first day, however, traces may be detectable in the urine for over 48 hours. The major route of elimination of the metabolites is by glomerular filtration. 7 – 10% of administered morphine eventually appears in the faeces, this comes mostly from the bile as conjugated morphine.

Enterohepatic circulation of morphine and morphine glucuronide occurs, this accounts for the presence of morphine in the urine several days after the last dose.

Squill glycosides are poorly absorbed from the gastrointestinal tract, they are of short acting duration and are not cumulative. The drug promotes mild gastric irritation, causing a reflex secretion from the bronchioles.

5.3 Preclinical Safety Data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Anise oil

Benzoic Acid

Camphor

Ethanol (96%)

Purified Water

Tolu flavour solution

Syrup

6.2 Incompatibilities

No major incompatibilities known.

6.3 Shelf Life

100ml	36 months unopened.
200ml:	36 months unopened.
500ml:	36 months unopened.
2000ml:	36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

100ml:	amber glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner
200ml:	amber glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner
500ml:	amber glass bottle and plastic cap with liner or white 28mm cap with tamper evident band and EPE Saranex liner.
2000ml:	polythene bottle and plastic cap with liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0034

9. Date Of First Authorisation/Renewal Of The Authorisation

24.03.94

10. Date Of Revision Of The Text

August 2004

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable

Timodine

TIMODINE

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING ASK YOUR PHARMACIST OR DOCTOR.

What Is Timodine?

Timodine is a pale yellow cream which is applied thinly to the inflamed skin. It contains an antifungal agent, a corticosteroid, an antiseptic and a water-repellent.

Each tube of Timodine contains 30 g.

The active ingredients are nystatin BP 100,000 IU/g, hydrocortisone Ph Eur 0.5% w/w, dimeticone 350 BP 10% w/w and benzalkonium chloride solution BP 0.2% w/w.

The other ingredients are butylated hydroxyanisole, cetostearyl alcohol, cellulose nitrate, dibutyl phthalate, glyceryl monostearate, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbic acid, stearic acid, sodium metabisulphite and water.

Marketing Authorisation Holder:

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

Manufacturer:

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

What Is Timodine Used For?

Timodine is a medicine to treat inflamed skin conditions, particularly where infection by a germ called Candida albicans can occur.

Where two folds of skin rub together, chafing can occur, leading to a sore inflamed area of skin. This particularly happens in places such as the groin or under the breasts where frequent sweating occurs. This combination of irritated skin and wetness is called intertrigo. The same condition happens under babies’ nappies when it is known as nappy rash. In both intertrigo and nappy rash the inflamed skin is easily infected by germs, in particular a fungus called Candida albicans.

Timodine is specially formulated to ease the soreness and treat the infections in intertrigo and inflamed nappy rash.

• Nystatin kills Candida albicans.


• Hydrocortisone reduces the pain and soreness.


• Dimeticone stops wetting and chafing.


• Benzalkonium chloride kills bacteria.

Timodine can also be used to treat the following conditions when there is infection with Candida albicans:

• Eczema.


• “Housewives’ hands”, a skin irritation caused by chemicals such as washing powders.


• Seborrhoeic dermatitis: inflammation of the scalp with excessive amounts of dandruff scales and oily secretions.


• Pruritis ani and vulvae: irritation of the external area around the anus and the vagina.

Before Using Timodine

As with all medicines, Timodine may not be suitable for everybody:

• Do not use this medicine if you are allergic to the product or any of its ingredients.


• You should ask your doctor before using Timodine if you are pregnant.


• Avoid prolonged exposure on the face and keep away from eyes.

How To Use Timodine

For intertrigo, seborrhoeic dermatitis and “housewives’ hands”

Apply a thin layer of Timodine to the sore area and rub into the skin gently until the cream disappears. The treatment should be repeated three times a day until the skin is healed.

For severe nappy rash

Remove the soiled nappy, then clean and dry your baby’s skin. Rub a thin layer of Timodine into the sore areas until the cream disappears. The treatment should be repeated after every napkin change.

• Do not use Timodine for more than seven days unless your doctor tells you to. Once the infection has cleared up, use a barrier cream instead of Timodine.

In the case of a missed dose, simply apply when the next dose is due. In the case of accidental ingestion, seek medical advice.

How Much To Use

A finger-tip length of cream should be enough for each inflamed area.

What Side-Effects May Occur?

Tell your doctor or pharmacist if any side-effects occur after use of this product.

Storage

Keep all medicines away from children. Do not use after the expiry date shown on the pack.

Keep Timodine below 15°C.

Further Information

You may find a yellow stain on terry cotton nappies after using Timodine. This will disappear after soaking in bleach or nappy bucket solution followed by rinsing and normal washing.

Timodine is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

Leaflet last revised March 2010.

xxxxxx

UK 002

Promethazine Tablets

Pronunciation: proe-METH-a-zeen
Generic Name: Promethazine
Brand Name: Phenergan

Promethazine should not be used in children younger than 2 years old. Potentially fatal side effects (eg, difficult or slowed breathing, drowsiness leading to coma) may occur in this age group when taking Promethazine.

Caution should be used when using Promethazine in children 2 years old and older. The lowest possible dose should be used in this age group, and it should not be used with other medicines that cause slowed breathing.

Promethazine is used for:

Relieving allergy symptoms, including hives or runny nose. It is used to prevent and control nausea and vomiting during and after surgery. It is also used to help produce light sleep; prevent and treat motion sickness; or treat pain after surgery, in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Promethazine is a phenothiazine antihistamine. It works by blocking the sites where histamine acts.

Do NOT use Promethazine if:

• you are allergic to any ingredient in Promethazine


• you have severe central nervous system depression or are in a coma


• you are also taking astemizole, cisapride, terfenadine, or tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Promethazine:

Some medical conditions may interact with Promethazine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have nervous system problems, bone marrow depression, heart problems, a blood disease, glaucoma, increased eye pressure, low blood pressure, liver problems, prostate problems, Parkinson disease, seizures, or Reye syndrome


• if you regularly consume large amounts of alcohol

Some MEDICINES MAY INTERACT with Promethazine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Charcoal or lithium because they may decrease Promethazine's effectiveness


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), astemizole, cisapride, general anesthetics (eg, thiopental), methyldopa, terfenadine, or tramadol because side effects, such as low blood pressure and seizures, may occur


• ACE inhibitors (eg, enalapril), haloperidol, lithium, meperidine, metrizamide, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), naltrexone, polypeptide antibiotics (eg, actinomycin), or trazodone because the risk of their side effects may be increased by Promethazine


• Bromocriptine, epinephrine, levodopa, or pergolide because their effectiveness may be decreased by Promethazine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Promethazine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Promethazine:

Use Promethazine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Promethazine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you are using Promethazine for motion sickness, take a dose at least 30 to 60 minutes before you begin traveling.


• If you miss a dose of Promethazine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Promethazine.

Important safety information:

• Promethazine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Promethazine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Promethazine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Promethazine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Promethazine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Promethazine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Use Promethazine with extreme caution in the ELDERLY; they may be more sensitive to its effects.


• Promethazine should not be used in CHILDREN younger than 2 years old. Serious, and sometimes fatal, side effects (difficult or slowed breathing, drowsiness leading to coma) have occurred when Promethazine has been used in children in this age group.


• Promethazine should be used with extreme caution in CHILDREN 2 years old or older. The lowest effective dose should be used in children 2 years old or older.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promethazine while you are pregnant. Promethazine is found in breast milk. If you are or will be breast-feeding while you use Promethazine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Promethazine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Promethazine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include convulsions; dry mouth; flushing; hallucinations; loss of consciousness; nightmares; seizures; shortness of breath; trouble breathing; unusual drowsiness or restlessness.

Proper storage of Promethazine:

Store Promethazine at room temperature, between 68 to 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Promethazine out of the reach of children and away from pets.

General information:

• If you have any questions about Promethazine, please talk with your doctor, pharmacist, or other health care provider.


• Promethazine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Promethazine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Promethazine resources

• Promethazine Side Effects (in more detail)
• Promethazine Dosage
• Promethazine Use in Pregnancy & Breastfeeding
• Drug Images
• Promethazine Drug Interactions
• Promethazine Support Group
• 67 Reviews for Promethazine - Add your own review/rating

Compare Promethazine with other medications

• Allergic Reactions
• Anaphylaxis
• Hay Fever
• Light Sedation
• Motion Sickness
• Nausea/Vomiting
• Opiate Adjunct
• Sedation
• Urticaria
• Vertigo

Hydromol Cream (Alliance Pharmaceuticals)

1. Name Of The Medicinal Product

Hydromol Cream.

2. Qualitative And Quantitative Composition

Sodium Pyrrolidone Carboxylate 2.5%.

Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol.

For full list of excipients see Section 6.1.

3. Pharmaceutical Form

Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.

4. Clinical Particulars

4.1 Therapeutic Indications

Any condition in which “dry skin” is a feature, including all forms of dermatitis/eczema and all degrees of ichthyosis and senile pruritus.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required.

Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

4.3 Contraindications

There are no contra-indications except true hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The formulation is not designed for use as a diluent.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Hydromol Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely a non serious allergic type reaction may be experienced, e.g. rash.

4.9 Overdose

Not applicable. Hydromol Cream is for topical use only.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.

5.2 Pharmacokinetic Properties

Sodium pyrrolidone carboxylate positively aids the hydration of skin.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid Paraffin

Isopropyl Myristate

Sodium Lactate

Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol)

Myristyl Myristate

Cetomacrogol 1000

Hydroxybenzoates (Parabens)

Phenoxyethanol

Purified Water.

6.2 Incompatibilities

Not applicable. Hydromol Cream is for topical use only.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Hydromol Cream should be stored in a dry place avoiding extremes of temperature ie not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Hydromol Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd., Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB.

8. Marketing Authorisation Number(S)

PL 16853/0089.

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st October 2004.

10. Date Of Revision Of The Text

20^th March 2009

NasalCrom Solution

Pronunciation: KROE-moe-lin
Generic Name: Cromolyn
Brand Name: Examples include Nasal Allergy Control and NasalCrom

NasalCrom Solution is used for:

Preventing and relieving symptoms of hay fever and allergies, including runny/itchy nose, sneezing, and nasal congestion. It may be used alone or with other allergy medications.

NasalCrom Solution is a mast cell stabilizer. It works by stabilizing mast cells and preventing them from releasing their irritating chemicals.

Do NOT use NasalCrom Solution if:

• you are allergic to any ingredient in NasalCrom Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using NasalCrom Solution:

Some medical conditions may interact with NasalCrom Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems

Some MEDICINES MAY INTERACT with NasalCrom Solution. However, no specific interactions with NasalCrom Solution are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if NasalCrom Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use NasalCrom Solution:

Use NasalCrom Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Blow your nose before using NasalCrom Solution.


• Hold the pump with your thumb at the bottom and the nozzle between your fingers. If this is your first time using the pump, or if you have not used the pump for several days, spray into the air until you see a fine mist.


• Insert the nozzle into your nostril and spray upward one time while breathing in through the nose. Repeat in the other nostril.


• To keep the pump clean, wipe the nozzle and replace the cap and safety clip provided.


• For best results, start using NasalCrom Solution 1 week before contact with the cause of your allergies.


• If you miss a dose of NasalCrom Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use NasalCrom Solution.

Important safety information:

• NasalCrom Solution may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to NasalCrom Solution


• Several days to a few weeks may pass before you feel the full benefit of NasalCrom Solution.


• NasalCrom Solution is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using NasalCrom Solution during pregnancy. It is unknown if NasalCrom Solution is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of NasalCrom Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in the mouth; drowsiness; headache; irritated or burning sensation in the nose; sneezing.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: NasalCrom side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. NasalCrom Solution may be harmful if swallowed.

Proper storage of NasalCrom Solution:

Store NasalCrom Solution at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep NasalCrom Solution out of the reach of children and away from pets.

General information:

• If you have any questions about NasalCrom Solution, please talk with your doctor, pharmacist, or other health care provider.


• NasalCrom Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about NasalCrom Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More NasalCrom resources

• NasalCrom Side Effects (in more detail)
• NasalCrom Use in Pregnancy & Breastfeeding
• NasalCrom Support Group
• 0 Reviews for NasalCrom - Add your own review/rating

Compare NasalCrom with other medications

• Hay Fever

Contac 12 Hour

Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)

Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R

What is Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Chlorpheniramine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take chlorpheniramine and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Take chlorpheniramine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

Contac 12 Hour (chlorpheniramine and phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Contac 12 Hour resources

• Contac 12 Hour Drug Interactions
• 1 Review for Contac2 Hour - Add your own review/rating

• Triaminic Consumer Overview

Compare Contac 12 Hour with other medications

• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.