NOTICE
ANSM - Updated on : 02/09/2024
Product name
OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup
Oxomemazine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. 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 after a few days.
What does this leaflet contain?
1. What is OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup and what is it used for?
2. What do I need to know before taking OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
3. How do I take OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
4. What are the possible side effects?
5. How to store OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
6. Package contents and other information.
1. WHAT IS OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIHISTAMINES FOR SYSTEMIC USE, ATC code: R06AD08.
OXOMEMAZINE BIOGARAN is a cough suppressant belonging to the phenothiazine neuroleptic antihistamine family. It counteracts the effects of histamine, notably on the bronchi. It is recommended for soothing dry coughs and coughs of irritation in adults and children over 2 years of age, particularly when they occur in the evening or at night.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
Never take OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup:
- if you are allergic to loxomemazine or to any of the other components of this medicine listed in section 6;
- if you are allergic to any drug in the same family as OXOMEMAZINE BIOGARAN (antihistamines) used to treat allergies;
- do not give OXOMEMAZINE BIOGARAN to children under 2 years of age;
- if you have ever had a significant decrease in the number of certain white blood cells (granulocytes) in the blood (agranulocytosis);
- if you have difficulty in urinating (prostatic or other disorders);
- if you are at risk of developing angle-closure glaucoma (high pressure inside the eye that can affect vision);
- if you are taking medication containing cabergoline or quinagolide (used to curb excessive prolactin production) (see "Other drugs and OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup").
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using OXOMEMAZINE BIOGARAN.
- If your cough persists despite taking OXOMEMAZINE BIOGARAN, do not increase the dose. Consult your doctor. Coughing is a symptom that can have various origins: respiratory infections, bronchitis, flu, allergy, asthma, whooping cough, irritation, etc. In addition, smoking aggravates coughing. Smoking also aggravates or maintains coughing.
- There are 2 types of cough: dry and oily. You should not treat a wet cough with this medication. In fact, a wet cough is a natural defence mechanism for the evacuation of bronchial secretions (mucus);
- If your cough becomes oily, with congestion, sputum or fever, ask your doctor for advice;
- Do not try to treat a wet cough by combining this drug with a wet cough medication;
- Cases of abuse and dependence have been reported with loxomemazine. Be alert to any signs of abuse or dependence on this treatment.
- Do not expose to sunlight or ultraviolet light (UVA) during treatment;
- This drug should be used with caution because of the risk of drowsiness;
- Combination with other sedative drugs is not recommended (see "Other drugs and OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup").
Before taking this medicine, tell your doctor:
- if you have chronic bronchial or lung disease with coughing and sputum production;
- if you have chronic liver disease (severe hepatic insufficiency) or kidney disease (severe renal insufficiency), your doctor will need to adapt the dose to your condition;
- if you have cardiovascular disease;
- if you suffer from seizures;
- if you are over 65 (particularly in cases of chronic constipation, difficulty in urinating due to prostate enlargement, hypotension, dizziness or drowsiness);
- if your child suffers from asthma or gastro-sophageal reflux disease.
During treatment, consult your doctor:
if you have a fever with or without signs of infection (angina), paleness or sweating.
Children and adolescents
Not applicable.
Other drugs and OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine contains a cough suppressant of the antihistamine family, loxomemazine.
Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see "Dosage").
You should never take OXOMEMAZINE BIOGARAN with medicines containing cabergoline or quinagolide (used to slow excessive prolactin production) (see "Never take OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup").
You must avoid taking medicines containing alcohol throughout treatment.
You must wait at least 2 hours between taking OXOMEMAZINE BIOGARAN and taking gastrointestinal dressings, antacids or charcoal (used to relieve digestive disorders).
Many other drugs can reduce alertness and cause drowsiness. Their association with OXOMEMAZINE BIOGARAN may increase this effect. These include morphine derivatives (used for pain relief, as cough suppressants or in drug withdrawal), neuroleptics, benzodiazepines (anxiolytics), benzodiazepines (antidepressants), benzodiazepines (antidepressants) and benzodiazepines (antidepressants).pines (anxiolytics), barbiturates, hypnotics (sleeping pills), antidepressants, sedative antihistamines, certain antihypertensives and drugs containing baclofen and thalidomide.
OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup with food, drink and alcohol
Avoid consuming alcoholic beverages or taking medicines containing alcohol during treatment.
Pregnancy and breast-feeding
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.
Pregnancy
Unless your doctor advises otherwise, this medicine should not be used during the first trimester of pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as soon as possible, as only he/she will be able to adapt the treatment to your condition.
At the end of pregnancy, taking too much of this medicine may have harmful effects on the newborn. Therefore, always seek your doctor's advice before use, and never exceed the recommended dose and duration of treatment.
Breast-feeding
This drug passes into breast milk. Because of its pronounced sedative properties, it should not be taken while breast-feeding.
Driving vehicles and using machines
This drug may cause drowsiness, especially at the start of treatment. It is not recommended to drive a vehicle or operate machinery if you experience this effect. The risk of drowsiness is increased if you consume alcoholic beverages, medicines containing alcohol or other sedative drugs (see "Other drugs and OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup").
OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup contains sucrose, sodium benzoate (E211) and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
This medicine contains 7.3 g of sucrose per 10 mL of syrup. This should be taken into account in patients with diabetes mellitus.
This medicine contains 3 mg sodium benzoate per mL syrup, i.e. 15 mg per 5 mL dose and 30 mg per 10 mL dose. Sodium benzoate may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
This medicine contains less than 1 mmol (23 mg) sodium per 10 mL dose of syrup, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
This medicine is intended for adults and children over 2 years of age.
In adults and children over 40 kg (12 years): the usual dose is 10 mL syrup per dose, 4 times a day.
For children aged 2 to 12: the daily dose depends on your child's weight:
- children from 13 to 20 kg (i.e. 2 to 6 years): the dose is 5 mL syrup per dose, 2 to 3 times a day;
- children from 20 to 30 kg (6 to 10 years): the dose is 10 mL of syrup per dose, 2 to 3 times a day;
- children 30 to 40 kg (10 to 12 years): 10 mL syrup per dose, 3 to 4 times a day.
Frequency of administration
Repeat doses should be taken only when necessary, and at least 4 hours apart.
This drug may cause drowsiness. It is preferable to take OXOMEMAZINE BIOGARAN in the evening.
Method of administration
OXOMEMAZINE BIOGARAN is to be taken orally. Use the measuring cup supplied in the box.
Duration of treatment
Without a doctor's prescription, the duration of treatment should not exceed 5 days.
If your cough persists after 5 days, if there is no improvement or if other symptoms appear, ask your doctor for advice.
Treatment should be limited to the time when the cough occurs.
If you have taken more OXOMEMAZINE BIOGARAN 0.33 mg/mL syrup than you should have
Consult your doctor or emergency physician immediately.
An overdose of OXOMEMAZINE BIOGARAN may cause convulsions (especially in children), drowsiness, impaired alertness or coma.
If you forget to take OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup
Do not take a double dose to make up for the one you forgot to take.
If you stop taking OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not always occur in everyone.
STOP TREATMENT AND CONSULT A DOCTOR IMMEDIATELY
- If you develop any signs of allergy to the drug, such as :
o redness of the skin, eczema, purple patches on the skin (purpura) ;
o urticaria ;
o edema, sudden swelling of the face and/or neck that may make it difficult to breathe and put you at risk (angioedema);
o sudden malaise with a significant drop in blood pressure (anaphylactic shock).
- If you experience an exaggerated skin reaction after exposure to sunlight or UV rays;
- If you experience a reduction in the number of certain blood cells: white blood cells (neutropenia, agranulocytosis), platelets (thrombocytopenia) or red blood cells (hemolytic anemia).
The following effects may also occur
- drowsiness, reduced alertness, especially at the start of treatment ;
- memory or concentration problems, dizziness ;
- difficulty in coordinating movements, tremors;
- confusion, hallucinations;
- dry mouth, visual disturbances, difficulty in urinating (urine retention), constipation, heart palpitations, significant drop in blood pressure when standing, sometimes leading to dizziness and/or malaise (orthostatic hypotension).
More rarely: signs of excitement (agitation, nervousness, insomnia) may occur.
Undetermined frequency:
- abuse, dependence (see section 2. "What do you need to know before taking OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup? ") ;
- eosinophilia, which is an increase in the number of deosinophils (a type of white blood cell), seen on blood tests;
- thrombocytopenia, which is a decrease in the number of platelets (the blood cells that help clotting), seen in blood tests and which can lead to bleeding and bruising of the skin (thrombocytopenic purpura).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 Centres.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE OXOMEMAZINE BIOGARAN 0.33 mg/mL, syrup?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Before opening: no special storage precautions are required.
After opening: store at a temperature not exceeding 25°C.
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. CONTENTS AND OTHER INFORMATION
What OXOMEMAZINE BIOGARAN 0.33 mg/mL syrup contains
- The active substance is :
Oxomemazine................................................................................................................ 0.033 g
per 100 mL syrup.
- Other components are :
Sodium benzoate (E211), glycerol, citric acid monohydrate, sodium citrate, caramel flavor, caramel color (E150c), sucrose, purified water.
What OXOMEMAZINE BIOGARAN 0.33 mg/mL syrup is and what it contains
This medicine is available as a syrup. 150 mL bottle.
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
H2 PHARMA
ZAC LA CROIX BONNET
21 RUE JACQUES TATI
78390 BOIS D'ARCY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.