NOTICE
ANSM - Updated on : 22/08/2021
Product name
PAXELADINE 0.2 PER CENT, syrup
Doxeladine citrate
Box
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
Always follow the directions in this leaflet or from your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is PAXELADINE 0.2 PER CENT, syrup and what is it used for?
2. What do I need to know before taking PAXELADINE 0.2 PER CENT, syrup?
3. How do I take PAXELADINE 0.2 PER CENT, syrup?
4. What are the possible side effects?
5. How do I keep PAXELADINE 0.2 PER CENT, syrup?
6. Package contents and other information.
1. WHAT IS PAXELADINE 0.2 PER CENT, syrup AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: contains the cough suppressant loxeladine.
This medicine is indicated for the relief of dry coughs and coughs of irritation in adults and children over 30 months and weighing more than 15 kg.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PAXELADINE 0.2 PER CENT, syrup?
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Never take PAXELADINE 0.2 PER CENT, syrup :
- if you are allergic to any of the ingredients.
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking PAXELADINE, Syrup.
Caution with PAXELADINE 0.2 PER CENT, syrup
- Do not use this medicine to treat a wet cough. In this case, coughing is a natural defence mechanism to clear bronchial secretions.
- If the cough becomes oily, accompanied by congestion, sputum or fever, ask your doctor for advice.
- In the case of chronic (long-term) bronchial or lung disease accompanied by coughing up sputum, medical advice is essential.
- This medicine is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
- In case of diabetes or low-sugar diet, please take into account the daily sugar content: 4.25 g per 5 ml dose and 2.125 g per 2.5 ml dose.
- This medicine contains 12 mg of ethanol in each 2.5 ml dose. A 12 mg dose of alcohol is less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine is unlikely to have any noticeable effect.
- It should not be combined with a drug that thins bronchial secretions (expectorant, mucolytic).
If in doubt, ask your doctor or pharmacist.
Children
Not applicable
Other medicines and PAXELADINE 0.2 PER CENT, syrup.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
PAXELADINE 0.2 PER CENT, syrup with food and drink
Not applicable.
Pregnancy and breast-feeding
The use of this drug should generally be avoided during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this product if you are breast-feeding.
Driving and using machines
Not applicable.
PAXELADINE 0.2 PER CENT, syrup contains sucrose (4.25 g per 5 ml dose and 2.125 g per 2.5 ml dose) and ethanol (24 mg per 5 ml dose and 12 mg per 2.5 ml dose).
3. HOW DO I TAKE PAXELADINE 0.2 PER CENT, syrup?
Always take this medicine exactly as instructed in this leaflet, or as advised by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
In the absence of efficacy, do not increase doses beyond those recommended, do not take another cough suppressant at the same time, but consult your doctor.
PAXELADINE must be administered orally and is intended for adults and children over 30 months and weighing more than 15 kg.
Use the 2.5 ml and 5 ml double-measuring spoon or the 2.5 ml and 5 ml measuring cup supplied with this syrup.
Children from 15 to 20 kg (i.e. 30 months to 6 years): 1 dose of 2.5 ml per dose, repeated after 4 hours if necessary, without exceeding 3 or 4 doses per day, depending on weight.
Children from 20 to 30 kg (i.e. 6 to 10 years): 1 dose of 5 ml per dose, to be repeated after 4 hours if necessary, without exceeding 2 or 3 doses per day, depending on weight.
Children 30 to 50 kg (i.e. 10 to 15 years): 1 dose of 5 ml per dose, repeated after 4 hours if necessary, without exceeding 3 to 5 doses per day, depending on weight.
Adults: 1 dose of 5 ml per dose, repeated after 4 hours if necessary, up to a maximum of 5 doses per day.
This medicine has been personally prescribed for a specific situation. It may not be suitable for other situations. Do not recommend it to others.
Method and route of administration
This drug is taken orally.
Duration of treatment
Treatment should be short (a few days) and limited to times when coughing occurs.
If you have used more PAXELADINE 0.2 PER CENT, syrup than you should have :
If you have taken more PAXELADINE 0.2 PER CENT, syrup than you should have and you experience side effects not mentioned in this leaflet, please contact your doctor.
If you forget to take PAXELADINE 0.2 PER CENT, syrup
Not applicable.
If you stop taking PAXELADINE 0.2 PER CENT, syrup
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not occur in everyone.
Cases of allergy (hypersensitivity) have occasionally been reported: rash, itching, swelling of the skin and tissues under the skin (angiodema or angioedema).
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE PAXELADINE 0.2 PER CENT, syrup?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box after EXP. The expiration date refers to the last day of that month.
After opening, the medicine can be stored for a maximum of 6 months.
No special storage conditions are required.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PAXELADINE 0.2 PER CENT, syrup contains
- The active substance is :
Doxeladine citrate................................................................................................................... 0.2 g
Per 100 ml syrup.
A 2.5 ml dose contains 5 mg doxeladine citrate.
A 5 ml dose contains 10 mg doxeladine citrate.
Other components are : Cocoa flavoring (containing ethanol (see section 2), sucrose (see section 2), potassium sorbate, purified water.
What PAXELADINE 0.2 PER CENT is and what it contains
This medicine takes the form of a clear, slightly yellow syrup. It is packaged in 100 ml or 125 ml bottles.
Marketing authorization holder
IPSEN CONSUMER HEALTHCARE
65 quai georges gorse
92100 boulogne-billancourt
Marketing authorization holder
IPSEN CONSUMER HEALTHCARE
65 quai georges gorse
92100 boulogne-billancourt
Manufacturer
BEAUFOUR IPSEN INDUSTRIE
RUE ETHE VIRTON
28100 DREUX
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is :
The last date on which this leaflet was revised: August 2021
Other
Not applicable.