Hydrocortisone Cream 1% w/w Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Hydrocortisone Cream 1% w/w Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 gram of the cream contains:
hydrocortisone…………..…………. 10 mg
(i.e. 1 %w/w)
Excipients……………………………..q.s.

Excipients with known effect

Each 1 gram of the cream contains 1 mg of chlorocresol (i.e. 0.1 %w/w) and 90 mg of cetomacrogol emulsifying wax (which contains cetostearyl).

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Cream for cutaneous use only.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.

4.2 Posology and method of administration

Posology

Use sparingly over a small area once/twice a day for a maximum period of one week. If the condition has not improved, or worsens, consult your doctor.

This product should not be recommended for use on children under 10 years of age without medical advice.

Method of administration

For cutaneous use.

4.3 Contraindications

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Use on the eyes and face, Ano-genital region, Broken or infected skin including cold sores, acne and athlete’s foot.

4.4 Special warnings and precautions for use

Remarks on indications

There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes.
Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systematic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.

Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy especially napkin eruption where the napkin can act as an occlusive dressing and increase absorption. In infants and children, courses of treatment should therefore not normally exceed 7 days.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and a systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to the face is undesirable.

Do not use under an occlusive dressing.

This medicinal product contains chlorocresol, which may cause allergic reactions.

This medicinal product also contains cetostearyl alcohol in the excipient cetomacrogol emulsifying wax, and may cause local skin reactions (e.g., contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

Breastfeeding

There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately.

Striae may occur especially in intertriginous areas.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Not applicable.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, weak (group I);

Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of Hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its anti-inflammatory activity.

5.2 Pharmacokinetic properties

Absorption: Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas, or under occlusive dressings.

Distribution: Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk

Metabolism: Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.

Elimination: Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.

5.3 Preclinical safety data

Adverse effects of Hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic side effects.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetomacrogol Emulsifying Wax, Chlorocresol, Liquid Paraffin, Macrogol, White Soft Paraffin, Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex end seal band in the crimp seal and a white plastic cap for reclosure after piercing membrane.

Pack Size: 15g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Any unused medicinal products or waste material should be disposed of in accordance with local requirements.

MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

HYDROCORTISONE CREAM
1%W/W
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hydrocortisone Acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

WHAT IS IN THIS LEAFLET

What Hydrocortisone Cream is and what it is used for
What you need to know before you take Hydrocortisone Cream
How to take Hydrocortisone Cream
Possible side effects
How to store Hydrocortisone Cream
Contents of the pack and other information
1. WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR

Hydrocortisone Cream is a smooth white cream for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Hydrocortisone Cream is used to reduce inflammation in a variety of inflammatory skin conditions, such as:

mild to moderate eczema
• dermatitis caused by irritants or allergens
• insect bite reactions

Hydrocortisone should not be confused with anabolic steroids, used by some body builders and taken as tablets or injections.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROCORTISONE CREAM

Do not use Hydrocortisone Cream:
• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
• if you have a bacterial infection (e.g. impetigo), viral infection (e.g. cold sores ‘herpes simplex’, chicken pox) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin.
• on your face or near your eyes, on the anal or genital region, or on broken skin.

Take special care with Hydrocortisone Cream
Hydrocortisone Cream is not suitable for use in the following:
• allergic skin reactions including temporary red or raised areas on your skin (short lived ‘wheal and flare’ reactions)
• conditions involving the deeper skin layers, such as granulomas
• psoriasis (long term scaly skin condition); only use this product on medical advice and with careful supervision by your doctor.

Do not cover the area with a plaster or dressing of any kind after application of Hydrocortisone Cream.

Take great care to apply the cream sparingly to the skin of infants or children, especially in the nappy area which can be covered for long periods. Covering the treated area can increase absorption. Treatment for infants must not exceed 7 days.

Do not apply the product to your face for long periods of time.

Other medicines and Hydrocortisone Cream

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. There is a very small risk of abnormalities in the unborn child if this product is used during pregnancy. If you are breast-feeding, do not apply the product to your chest area.

Hydrocortisone Cream contains chlorocresol and cetostearyl alcohol
• chlorocresol – may cause allergic reactions
• cetomacrogol emulsifying wax – which contains cetostearyl alcohol – may cause local skin reactions (e.g. contact dermatitis).

HOW TO TAKE HYDROCORTISONE CREAM

FOR EXTERNAL USE ONLY

Always use this medicine exactly as instructed in this leaflet. Check with your doctor or pharmacist if you are not sure.

Do not exceed the stated dose.

Not for use by children under 10 years of age without medical advice.

For application to the surface of the skin only:
1. Wash your hands thoroughly before use.
2. Apply the cream sparingly to the affected area, once or twice a day for a maximum of 7 days. Massage the cream gently into the affected area to help absorption into the skin.
3. Once applied, do not cover the area with a dressing or plaster.

If the condition has not improved after 7 days, or worsens, consult your doctor.

If you use more Hydrocortisone Cream than you should

If you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.

If you forget to use Hydrocortisone Cream

If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECT

Like all medicines, Hydrocortisone Cream can cause side effects, although not everybody gets them.

You may notice the following:
• rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop using Hydrocortisone Cream immediately.
• ‘stretch marks’ may appear, especially in skin folds such as the groin or armpits.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine

HOW TO STORE HYDROCORTISONE CREAM

Keep out of the sight and reach of children. Do not store above 25˚C. Store in the original package and keep the tube in the outer carton. Do not use Hydrocortisone Cream after the expiry date which is stated on the tube/carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

CONTENTS OF THE PACK AND FURTHER INFORMATION

What Hydrocortisone Cream contain
Each 1 gram of the cream contains:
hydrocortisone…………..…………. 10 mg
(i.e. 1 %w/w)
Excipients……………………………..q.s.

The other ingredients are Cetomacrogol Emulsifying Wax, chlorocresol, liquid paraffin, Macrogol 300, white soft paraffin and purified water

What Hydrocortisone Cream look like and contents of the pack
The product is a smooth, white cream and is available in aluminium tubes containing 15 g.