COQUELUSEDAL CHILD 30 MONTHS 15 YEARS BOX OF 10 SUPPOSITORIES

1. WHAT IS COQUELUSEDAL CHILDREN, suppository AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

Antitussive combination

(R. Respiratory system)

Therapeutic indications

This medicine is used as an adjunct to the treatment of acute benign bronchial disorders in children from 30 months to 15 years of age.

The duration of treatment is limited to 3 days.

2. WHAT YOU SHOULD KNOW BEFORE USING COQUELUSEDAL CHILDREN, suppository

List of information needed before taking the medicine

Not applicable.

Contraindications

Never use COQUELUSEDAL CHILDREN, suppository in the following cases:

• Allergy to any of the constituents.
• Children under 30 months of age.
• Children with a history of epilepsy or febrile seizures.
• Children with a recent history of anorectal injury.

Due to the presence of terpene derivatives, this medicine is GENERALLY NOT recommended, unless otherwise advised by your doctor, when breastfeeding.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with COQUELUSEDAL CHILDREN, suppository:

Special warnings

This speciality contains niaouli which may cause, in excessive doses, neurological accidents such as convulsions in infants and children.

• Do not prolong the duration of treatment beyond 3 days because of

othe risk of accumulation of the terpene derivative (niaouli) in the body including the brain, and in particular risk of neurological disorders,

othe risk of irritation such as burning in the rectum.

• Do not exceed the recommended doses because of the increased risk of undesirable effects and disorders associated with overdose.
• As terpene derivatives are flammable, do not bring this product near a flame.

In case of fever, fatty or purulent sputum, or in case of chronic bronchial or lung disease, ask your doctor for advice.

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

Precautions for use

In case of a history of convulsions, ask your doctor for advice.

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

Interactions with other medicines

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is 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

Do not use this medicine during pregnancy and breastfeeding.

Ask your doctor or pharmacist for advice before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW TO USE COQUELUSEDAL CHILDREN, suppository

Instructions for proper use

Not applicable.

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

Dosage

For children from 30 months to 15 years of age.

1 to 2 suppositories per day.

THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN A SPECIFIC SITUATION:

• It may not be suitable for another case.
• Do not recommend it for another person.

Method of administration

Rectal route.

The choice of rectal route is determined solely by the convenience of administering the drug.

Frequency of administration

1 to 2 suppositories per day.

Duration of treatment

The duration of treatment is limited to 3 days.

The rectal route should be used for the shortest possible time due to the risk of local toxicity.

Symptoms and instructions in case of overdose

If you have used more COQUELUSEDAL CHILDREN, suppository than you should have:

Due to the presence of niaouli and if the recommended doses are not followed: risk of convulsions in children and infants.

Consult your doctor.

Instructions in case of omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, COQUELUSEDAL CHILDREN, suppository is likely to have undesirable effects, although not everyone is subject to them.

Local effects (irritation of the anus or rectum), related to the route of administration, may be observed. The longer the duration of use, the higher the rate of administration and the higher the dosage, the more frequent and intense they are.

• If the recommended dose is not observed, there is a risk of convulsions in infants.

DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

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

5. HOW TO USE COQUELUSEDAL CHILDREN, suppository?

Keep out of the reach and sight of children.

Expiry date

Do not use COQUELUSEDAL CHILDREN, suppository after the expiry date stated on the box.

Storage conditions

Store at a temperature not exceeding 25°C.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of the medicine in the sewer 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 COQUELUSEDAL CHILDREN, suppository contain?

The active substances are:

Niaouli essential oil .................................................................................................................. 20 mg

Grindelia soft hydroalcoholic extract ............................................................................................. 20 mg

Soft hydroalcoholic extract of gelsemium .......................................................................................... 10 mg

For one suppository.

Other components are:

Propylene glycol, solid hemi-synthetic glycerides (type Witepsol WS55).

Pharmaceutical form and content

What is COQUELUSEDAL CHILDREN, suppository and what does it contain?

This medicine is in the form of a suppository.

Box of 6, 8, 10 or 12.

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

Holder

LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE

181-183, RUE ANDRE KARMAN

BP 101

93303 AUBERVILLIERS CEDEX