NOTICE
ANSM - Updated on : 31/10/2017
Product name
COMBANTRIN 125 mg/2.5 ml, drinkable suspension
Pyrantel
Box
Please read this leaflet carefully before taking this medicine as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. 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 COMBANTRIN 125 mg/2.5 ml, oral suspension and what is it used for?
2. What do I need to know before taking COMBANTRIN 125 mg/2.5 ml, oral suspension?
3. How do I take COMBANTRIN 125 mg/2.5 ml, Oral suspension?
4. What are the possible side effects?
5. How do I keep COMBANTRIN 125 mg/2.5 ml, Oral suspension?
6. Package contents and other information.
1. WHAT IS COMBANTRIN 125 mg/2.5 ml, Oral suspension AND WHAT IS IT USED FOR?
Pharmacotherapeutic class ANTIHEMINTIC (P: Parasitology)
This drug is an antiparasitic.
It is recommended for the treatment of parasites such as lascaridiosis, loxyurosis and lankylostomiasis.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING COMBANTRIN 125 mg/2.5 ml, oral suspension?
Never take COMBANTRIN 125 mg/2.5 ml, oral suspension :
- if you are allergic to pyrantel or any of the other ingredients listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking COMBANTRIN 125 mg/2.5 ml, oral suspension.
Use WITH CAUTION in case of liver disease.
Oxyurosis
To prevent reinfestation, practice rigorous hygiene: daily cleansing of the anal region, brushing of fingernails several times a day. Cut children's fingernails very short. Change underwear and nightwear regularly. Avoid scratching. Treat all family members at the same time, as infection is often accompanied by no symptoms.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Other medicines and COMBANTRIN 125 mg/2.5 ml, oral suspension
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Pregnancy and breast-feeding
Pregnancy
This medicine should be used during pregnancy only if necessary.
If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can decide whether or not to continue treatment.
Breast-feeding
As a precaution, avoid using this product while breast-feeding.
In general, always ask your doctor or pharmacist for advice before taking any medication during pregnancy or while breast-feeding.
COMBANTRIN 125 mg/2.5 ml, suspension buvable contains sodium benzoate, glycerol and sorbitol.
This medicine contains glycerol and may cause headaches and digestive disorders (diarrhoea).
Due to the presence of sorbitol, this medicine may cause mild digestive disorders (diarrhea). Calorific value 2.6 kcal/g sorbitol.
This medicine contains sorbitol. Not recommended for patients with fructose intolerance (rare hereditary diseases).
3. HOW DO I TAKE COMBANTRIN 125 mg/2.5 ml, oral suspension?
Dosage
FOR ADULTS AND CHILDREN OVER 12 KG ONLY
Oxyures
The usual dosage is 10 mg/kg to 12 mg/kg as a single dose in adults and children:
- in children: approximately ½ measuring spoon corresponding to the 2.5 ml graduation per 10 kg of weight.
- adults under 75 kg: approx. 3 measuring spoons.
- for adults over 75 kg: approx. 4 measuring spoons.
In the case of pinworm disease, observe strict hygiene measures and treat those around you as well.
To avoid reinfection, prescribe a 2nd dose 2 to 3 weeks after the initial dose.
Ascaridosis and Ankylostomiasis
Follow your doctor's prescription.
THIS MEDICINE HAS BEEN PERSONALLY PRESCRIBED FOR A SPECIFIC SITUATION:
- IT MAY NOT BE SUITABLE FOR OTHER SITUATIONS.
- DO NOT RECOMMEND IT TO ANYONE ELSE.
Method and route of administration
Oral route.
Duration of treatment
In the case ofxyurosis, treatment is given as a single dose. Repeat 3 weeks later.
Follow your doctor's recommendations in the case of Carcariasis andankylostomiasis.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Rarely:
-gastrointestinal disorders (nausea, vomiting, anorexia, diarrhea, abdominal pain).
-slight and transient increase in certain liver enzymes (transaminases).
Exceptional: headache, dizziness, fatigue, sleep disorders, skin rash.
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 - Website: www.ansm.sante.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW SHOULD COMBANTRIN 125 mg/2.5 ml beverages be used?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What COMBANTRIN 125 mg/2.5 ml, oral suspension contains
The active substance is :
Pyrantel (embonate of)...................................................................................................... 14.410 g
Quantity corresponding to PYRANTEL base........................................................................ 5,000 g
For 100 ml of oral suspension.
½ measuring spoon corresponds to the 2.5 ml graduation = 125 mg pyrantel
1 measuring spoon corresponds to the 5 ml graduation = 250 mg pyrantel
Other components are :
citric acid monohydrate, simeticone, sodium benzoate, caramel flavor, blackcurrant flavor, glycerol, soy lecithin, povidone, sorbitol 70 percent crystallizable, polysorbate, magnesium aluminum silicate, purified water.
What COMBANTRIN 125 mg/2.5 ml, oral suspension is and what it contains
This medicine comes in the form of a drinkable suspension.
Box of 1 x 15 ml bottle with 5 ml measuring spoon.
Marketing authorization holder
TEOFARMA S.R.L.
VIA F.LLI CERVI, 8
27010 VALLE SALIMBENE (PV)
ITALY
Marketing authorization holder
TEOFARMA S.R.L.
VIA F.LLI CERVI, 8
27010 VALLE SALIMBENE (PV)
ITALY
Manufacturer
TEOFARMA S.R.L.
VIALE CERTOSA, 8/A
27100 PAVIA
ITALY
Product names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
March 2012
Other
Detailed information on this drug is available on the ANSM (France) website.