Doliprane Liquiz 300 mg sugar-free paracetamol 12 sachets

1. WHAT IS DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

DOLIPRANELIQUIZ 300 mg SUGAR-FREE contains paracetamol. Paracetamol is an analgesic (pain reliever) and an antipyretic (fever reducer).

Therapeutic indications

Paracetamol is indicated for pain and/or fever, such as headaches, flu, toothache, aches and pains, painful menstruation.

This presentation is reserved for children from 16 to 48 kg (approx. 4 to 15 years). Read the Dosage section carefully.

For children of different weights, there are other paracetamol presentations with more suitable dosages. Ask your doctor or pharmacist for advice.

2. WHAT DO I NEED TO KNOW BEFORE TAKING DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?

List of information you need to know before taking this medicine

Not applicable.

Contraindications

Never give DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol:

-ifyour child is allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine, as listed in section 6.

-ifyour child has severe liver disease,

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Special warnings

In case of overdose, or if you take too much by mistake, consult your doctor immediately.

precautions for use

-If pain persists for more than 5 days or fever for more than 3 days, or in the event of insufficient efficacy or any other sign, do not continue treatment without consulting your doctor.

-Before starting treatment with this medicine, check that you or your child are not taking any other medicines containing paracetamol.

in the event of malnutrition or dehydration, DOLIPRANELIQUIZ 300 mg SUGAR-FREE should be used with caution.

-Tell your doctor if you have liver or kidney disease, or alcohol abuse.

-Tell your doctor if you or your child are taking other medicines containing paracetamol.

-This medicine contains sugars (sorbitol and liquid maltitol). Its use is not recommended in patients with fructose intolerance (a rare hereditary disease)

-If your doctor has already told you that your child is intolerant to certain sugars, contact him/her before giving this medicine.

-This medicine contains an azoic coloring agent (azorubin E122) and may cause allergic reactions.

-This medicine contains ethyl methyl propyl hydroxybenzoate (NIPASEPT) and may cause allergic reactions.

-In the event of viral hepatitis, stop treatment and consult your doctor.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other drugs

Other drugs and DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol

Do not combine this medicine with sulfosodium catioresin (an active substance used in cases of hyperkalemia, an excess of potassium in the blood): the combination may lead to a risk of colonic necrosis, which could be fatal.

If your child is taking an oral anticoagulant, DOLIPRANELIQUIZ 300 mg SUGAR-FREE at the maximum recommended dose for more than 4 days requires closer monitoring of INR. In this case, consult your doctor.

If your doctor prescribes a uric acid or blood sugar test, tell your doctor that you or your child are taking this medicine.

Tell your doctor or pharmacist if you or your child has recently taken any other medication, including over-the-counter medicines.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and breast-feeding

Pregnancy and breast-feeding

Paracetamol may be used during pregnancy and while breast-feeding under normal conditions of use.

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

Sportsmen

Not applicable.

Effects on ability to drive vehicles or use machines

Not applicable.

List of excipients

DOLIPRANELIQUIZ 300 mg SUGAR-FREE contains sorbitol, liquid maltitol, azorubin (E122), ethyl, methyl and propyl hydroxybenzoate (NIPASEPT).

3. HOW TO TAKE DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?

Instructions for proper use

Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

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

Dosage

This presentation is reserved for children weighing between 16 and 48 kg (approximately 4 to 15 years).

For children of other weights, there are other paracetamol presentations with more suitable dosages: ask your doctor or pharmacist for advice.

Paracetamol dosage depends on the child's weight; ages are given for information only.

If you don't know your child's weight, weigh him/her to determine the most appropriate dose.

Paracetamol is available in a wide range of dosages, enabling treatment to be adapted to each child's weight.

The recommended daily dose of paracetamol depends on the child's weight: approximately 60mg/kg/day daydivided into 4 or 6 doses, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

The usual dosage is :

For children weighing 16 to 24 kg (approx. 4 to 9 years), the dose is 1 sachet per dose, repeated if necessary after 6 hours, not to exceed 4 sachets per day.

For children weighing 25 to 30 kg (approx. 8 to 11 years), the dose is 1 sachet per dose, repeated if necessary after 4 hours, but not exceeding 6 sachets per day.

For children weighing 31 to 48 kg (approx. 10 to 15 years): 2 sachets per dose, repeated if necessary after 6 hours, but not exceeding 8 sachets per day.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

If you feel that the effect of DOLIPRANELIQUIZ 300 mg SUGAR-FREE is too strong or too weak, consult your doctor or pharmacist

Method and route of administration

Oral administration.

The suspension may be drunk neat or diluted in a small quantity of beverage (e.g. water, milk, fruit juice).

In addition, if your child has a fever of over 38.5°C, you can improve the effectiveness of treatment by taking the following measures:

-discover your child,

-make him drink,

-do not leave your child in a hot place.

Frequency of administration

Regular doses help prevent pain and fever from returning: "see Dosage" section.

In childrentake at regular intervals, including at night. The frequency of administration depends on the child's weight: see Dosage section.

In case of severe kidney disease (severe renal failure), you should wait at least 8 hours between each dose.

If you feel that the effect of DOLIPRANELIQUIZ 300 mg SUGAR-FREE is too strong or too weak, consult your doctor or pharmacist.

Duration of treatment

Stop treatment and consult your doctor immediately:

-ifpain persists for more than 5 days or fever lasts for more than 3 days,

-ifpain or fever worsens

-orif new symptoms appear.

Symptoms and instructions in case of overdose

If you have taken or given your child more DOLIPRANELIQUIZ 300 mg SUGAR-FREE than you should have:

Consult immediately your doctor or seek medical attention immediately.

Overdose can be fatal in young children, the elderly and in certain situations (liver disease, alcoholism, chronic malnutrition).

Within the first 24 hours, the main symptoms of intoxication are vomiting, abdominal pain and paleness.

Instructions in case of missed dose(s)

If you forget to take or to give your child DOLIPRANELIQUIZ 300 mg SUGAR-FREE :

Do not give a double dose to make up for the one you missed.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of undesirable effects

As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.

-In rare cases, a skin rash or redness may occur, or an allergic reaction may manifest itself as sudden swelling of the face and neck, or sudden malaise with a drop in blood pressure. Treatment must be stopped immediately, your doctor must be informed and you must never take paracetamol-containing drugs again.

-In exceptional cases, biological changes requiring a blood test may be observed: liver function disorders, abnormally low levels of certain white blood cells or blood cells such as platelets, which may lead to nose or gum bleeding. In this case, consult a doctor.

Reporting side effects

If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance

By reporting adverse reactions, you help to provide more information on drug safety.

5. HOW TO USE DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?

Keep out of sight and reach of children.

Expiration date

Do not use this medicine after the expiration date indicated on the box.

Storage conditions

Store at temperatures not exceeding 30°C.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol, contains

The active substance is :

Paracetamol .......................................................................................................................... 300 mg

For one 12.5 ml sachet.

Other ingredients include :

Malic acid, xanthan gum, liquid maltitol (LYCASIN), 70 percent crystallizable sorbitol, sorbitol, citric acid anhydrous, ethyl, methyl, propyl hydroxybenzoate (NIPASEPT), azorubin, strawberry flavour*, purified water(see section 2, "DOLIPRANELIQUIZ 300 mg SUGAR-FREE contains").

*Composition of strawberry flavour: natural flavouring substances, natural flavouring substances, propylene glycol, benzyl alcohol, ethyl maltol, maltol.

Pharmaceutical form and contents

Aspect of DOLIPRANELIQUIZ 300 mg SUGAR-FREE, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol and contents of packaging

This medicine is available as a drinkable suspension in 12.5 ml sachets.

Boxes of 12 or 100 sachets

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

Marketing authorization holder and manufacturer

Holder

SANOFI-AVENTIS FRANCE

1-13, BOULEVARD ROMAIN ROLLAND

75014 PARIS