Sedermyl Cream 35g tube
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  • Sedermyl Cream 35g tube

Sedermyl Cream 35g tube


€2.99

Indications: This medicine is recommended in case of itching, especially insect bites.

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In this manual :

1. WHAT IS SEDERMYL 0.75% cream AND WHAT IS IT USED FOR?

2. WHAT DO YOU NEED TO KNOW BEFORE USING SEDERMYL 0.75% cream?

3. HOW DO I USE SEDERMYL 0.75% cream?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE SEDERMYL 0.75% cream?

6. ADDITIONAL INFORMATION

1. WHAT IS SEDERMYL 0.75% Cream AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

This medicine is an antihistamine for topical use. It belongs to the class of dermatological medicines.

Therapeutic indications

This medicine is recommended in cases of itching, particularly insect bites.

2. WHAT DO YOU NEED TO KNOW BEFORE USING SEDERMYL 0.75% cream?

List of information needed before taking the medicine

SEDERMYL 0.75% cream is not a sunscreen.

SEDERMYL 0.75% cream should not be used as a skin care cream on healthy skin.

Contraindications

Never use SEDERMYL 0.75% cream in the following cases:

- history of allergy to antihistamines,

- infected or irritated skin lesions

- oozing skin lesions.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with SEDERMYL 0.75%, cream:

Do not apply over a large area, under an occlusive dressing, on injured skin or in premature babies or infants because of the risk of the active ingredient passing into the bloodstream.

Do not apply to mucous membranes.

This medicinal product contains cetostearyl alcohol and cetyl alcohol and may cause local skin reactions (for example: eczema).

This medicine contains propylene glycol and may cause skin irritation.

Itching is only a symptom which may have multiple causes requiring the advice of your doctor, especially in the event of persistent or worsening disorders.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other medicines

Taking or using other medicines

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

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

This medicine should be used with caution during pregnancy and breastfeeding. In general, you should seek the advice of your doctor or pharmacist before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Important information about some of the ingredients of SEDERMYL 0.75% cream

Cetostearyl alcohol, cetyl alcohol, propylene glycol.

3. HOW TO USE SEDERMYL 0.75% cream

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage

1 application 2 to 3 times daily.

Do not exceed 5 days of treatment.

For adults and children over 30 months of age only.

Mode and route of administration

Dermal route.

Duration of treatment

If the symptoms persist after 5 days of treatment, consult your doctor.

Symptoms and instructions in case of overdose

Not applicable.

Instructions in case of missed doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, SEDERMYL 0.75% cream may have side effects, although not everyone is susceptible:

- risk of allergy to isothipendyl or to any component of the cream.

- Very rare cases of photosensitisation (skin reaction to sunlight or UV light).

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE SEDERMYL 0.75% cream

Keep out of the reach and sight of children.

Expiry date

Do not use SEDERMYL 0.75% cream after the expiry date stated on the box or tube. The expiry date refers to the last day of the month.

Storage conditions

No special storage precautions.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does SEDERMYL 0.75% cream contain?

The active substance is:

Isothipendyl hydrochloride ................................................................................................................. 0.75 g

Per 100 g of cream.

The other components are:

Sodium acetate, emulsifier cetostearyl alcohol (type A) (Lanette N), oleic acid decylester (Cetiol V), cetyl alcohol, propylene glycol, purified water.

Pharmaceutical form and content

What is SEDERMYL 0.75% cream and what does it contain?

This medicine is in the form of a cream.

Tubes of 35 g and 60 g.

Not all presentations may be marketed.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

Operator

COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

Manufacturer

COOPERATION PHARMACEUTIQUE FRANCAISE

2 RUE DE LA SAUSSAIE

77310 SAINT FARGEAU PONTHIERRY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the package leaflet

The last date on which this package insert was approved was {date}.

MA under exceptional circumstances

Not applicable.

Internet information

Detailed information on this medicinal product is available on the Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

3400931890157

Specific References

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