NOTICE
ANSM - Updated on : 04/06/2024
Product name
OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique
Oxomemazine
Sidebar
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 any advice or information you may need.
- 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 OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique and what is it used for?
2. What do I need to know before taking OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique?
3. How do I take OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique?
4. What are the possible side effects?
5. How to store OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique?
6. Package contents and other information.
1. WHAT IS OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTIHISTAMINES FOR SYSTEMIC USE - ATC code: R06AD08 (R: Respiratory system).
This medicine contains the antihistamine loxomemazine. 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 CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique?
Never take OXOMEMAZINE CLARIX 0.33 mg/ml, solution édulable édulcorée à lacésulfame potassique :
- in infants (under 2 years of age),
- if you are allergic (hypersensitive) to any of the constituents (see list in section 6 "Package contents and other information"), and in particular to antihistamines (drugs used in the treatment of certain allergies),
- if you have a history of agranulocytosis (severe drop in white blood cells),
- if you have difficulty in urinating, whether of prostatic or other origin,
- if you have certain forms of glaucoma (increased pressure inside the eye).
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Coughing is a symptom that may have various origins: respiratory infections, bronchitis, flu, allergy, asthma, whooping cough (infectious disease), irritation, etc.
Smoking aggravates or maintains coughing.
Consult your doctor in the event of the appearance or persistence of a fever, whether or not accompanied by signs of infection (angina), paleness or sweating.
Do not treat an oily cough with this medicine, as coughing is a natural defence mechanism to clear bronchial secretions.
If the cough becomes oily, accompanied by congestion, sputum or fever, seek medical advice.
In the case of chronic (long-term) bronchial or lung disease accompanied by coughing up sputum, medical advice is essential.
Do not combine with expectorants or mucolytics (drugs that thin bronchial secretions).
Cases of abuse and dependence have been reported with loxomemazine. Be alert to any signs of abuse or dependence on this treatment.
In the event of long-term liver or kidney disease, consult your doctor so that the dose can be adjusted.
Medical advice is required before taking this medicine:
- in the elderly:
o predisposed to constipation, dizziness or drowsiness,
o with prostate disorders;
- in children with asthma or gastro-sophageal reflux disease (burns and acid reflux),
- in cases of serious heart disease or epilepsy.
Tell your doctor before taking this antihistamine.
Do not take alcoholic beverages or any medication containing alcohol during treatment.
Do not expose yourself to sunlight or UVA rays during treatment.
This medication should be used with caution, as it may cause sedation. Combination with other sedative drugs is not recommended (see "Other drugs and OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique ").
If in doubt, ask your doctor or pharmacist for advice.
Children and teenagers
Not applicable.
Other medicinal products and OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique
This medicine contains the antihistamine loxomemazine. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see "Dosage").
Combination with other sedative drugs is not recommended, as it may increase the sedative effect of this drug.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if obtained without a prescription.
OXOMEMAZINE CLARIX 0.33 mg/ml, drinking solution sweetened with potassium sulfate with food, drink and alcohol
Do not take alcoholic beverages or any medication containing alcohol during this treatment.
Pregnancy and breast-feeding
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 immediately: 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 or duration of treatment.
Breast-feeding
This medicine passes into breast milk. Because of its pronounced sedative (tranquilizing) properties, it should not be taken while 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.
Driving vehicles and using machines
Drivers and users of machinery in particular should be aware of the possibility of drowsiness associated with the use of this drug, especially at the start of treatment.
This phenomenon is accentuated by the consumption of alcoholic beverages or medication containing alcohol.
OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique contains maltitol (E 965), sodium benzoate (E 211), propylene glycol (E 1520) and sodium.
This medicine contains 4.2 g of maltitol (E 965) per 5 ml dose of oral solution and 8.4 g of maltitol per 10 ml dose of oral solution, which may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol. If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 15 mg sodium benzoate (E 211) per 5 ml dose and 30 mg sodium benzoate (E 211) per 10 ml dose, equivalent to 3 mg/ml.
This drug contains up to 10 mg propylene glycol per 5-ml dose and up to 20 mg propylene glycol per 10-ml dose, equivalent to 2 mg/ml.
This drug contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially "sodium-free".
3. HOW TO TAKE OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with sucrose?
Method of administration
Oral administration.
For adults and children over 2 years of age.
Use the measuring cup.
Dosage
Adults and children over 40 kg (12 years): 10 ml per dose, 4 times a day.
For children: daily dosage depends on your child's weight:
- Children from 13 to 20 kg (i.e. 2 to 6 years): 5 ml per dose, 2 to 3 times a day, according to your doctor's advice,
- Children 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3 times a day,
- Children 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4 times a day.
Frequency of administration
Repeat doses as needed, at least 4 hours apart.
Due to the sedative effect of oxomemazine, especially at the start of treatment, evening doses are preferable.
Duration of treatment
Treatment should be short (a few days) and limited to the times when coughing occurs.
If your cough persists, ask your doctor for advice.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
If you have taken more OXOMEMAZINE CLARIX 0.33 mg/ml, drinking solution sweetened with lacésulfame potassique than you should have :
Consult your doctor or pharmacist immediately.
If you forget to take OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique :
Not applicable.
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.
Stop treatment immediately and tell your doctor if you experience any of the following:
- Allergic reactions such as :
o skin rash (erythema, eczema, purpura, urticaria),
o angioedema (hives with sudden swelling of the face and neck, which may cause breathing difficulties),
o anaphylactic shock,
o Sensitization of the skin under the effect of sunlight.
- Significant drop inwhite blood cells, which may be manifested by the onset or recurrence of fever, with or without signs of infection.
- Abnormal decrease in platelets in the blood, which may lead to bleeding from the nose or gums.
In more frequent cases :
- Drowsiness, reduced alertness, more marked at the start of treatment,
- Impaired memory or concentration, dizziness,
- Motor incoordination, tremors,
- confusion, hallucinations,
- Dry mouth,
- Visual disturbances,
- Urine retention,
- Constipation,
- Palpitations,
- Lowblood pressure.
In rarer cases:
- Signs of excitement (restlessness, nervousness, insomnia).
And with undetermined frequency:
- Abuse, dependence (see section 2: "What you should know before taking OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique").
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: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE OXOMEMAZINE CLARIX 0.33 mg/ml, drinkable solution sweetened with potassium sulfate?
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.
After opening: the oral solution can be stored for 6 months at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or with 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 CLARIX 0.33 mg/ml, drinkable solution sweetened with lacésulfame potassique, contains
- The active substance is :
Oxomemazine................................................................................................................ 0.033 g
per 100 ml drinking solution.
- The other components are : Glycerol, maltitol (E965), acesulfame potassium, citric acid monohydrate, sodium citrate, sodium benzoate (E211), caramel* flavoring, purified water.
*Contains propylene glycol, vanillin, 3-hydroxybutanone (acetylmethylcarbinol).
What is OXOMEMAZINE CLARIX 0.33 mg/ml, solution buvable édulcorée à lacésulfame potassique and what does it contain?
This medicine comes in the form of an oral solution in a 150 ml bottle (brown glass).
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
H2 PHARMA
Z.A. 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
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.