Order Oxomemazine syrup 0.33 mg / ml from Mylan in pharmacies, a non-prescription drug used in the symptomatic treatment of dry coughs, especially those that occur at night, nocturnal.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Antihistamine antitussive medicine used for dry coughs at night that prevent sleep.
The cough is a reflex of sudden and forced expiration of air, which must make it possible to "clean" the respiratory tract. Unlike the so-called wet cough, the dry cough does not produce sputum (it is non-productive). This is most often an irritating cough.
Non-prescription medicine indicated for the symptomatic treatment of bothersome non-productive coughs, in particular predominantly nocturnal.
Allergic cough and asthma also lead to chronic coughs. Asthma is a common cause of chronic cough in children and adults. It affects 15 to 50% of chronic coughs depending on age. In some people with mild asthma, cough is the only symptom. Often, it is nocturnal or morning. In children, this cough may be present for many years before asthma develops.
In itself, dry cough is not a disease. It is a symptom of various pathologies, the first of which are infections, especially viral ones: colds, flu and bronchitis. But also sinusitis or chronic rhinitis: “there are then formed in the nose some secretions charged with infectious agents which, during the night, descend into the bronchi and irritate them. When you wake up in the morning, you start coughing,” explains the pulmonologist.
We advise you in alternative treatment of natural food supplements to fight effectively against coughs , sore throats and flu-like states .
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.
Dry cough is a very common reason for medical consultation. It is not a disease, but a symptom, which is banal in itself but can have multiple causes.
Oral route. Use the measuring cup.
In adults and children over 40 kg (i.e. 12 years):
10 ml per dose, 4 times a day.
In children:
The daily dosage depends on the weight of the child (1 ml of syrup per kg of body weight and per day), either as an indication:
The catches are to be renewed if necessary and spaced at least 4 hours apart.
Evening intake should be preferred (medication to be taken in the evening or at night) because of the sedative effect, especially at the start of treatment, of oxomemazine.
p 5ml | p 5ml | |
Oxomemazine | 1.65mg | 1.65mg |
Sucrose | 3.7g |
This non-prescription medication is CONTRAINDICATED in the following cases:
hypersensitivity to one of the constituents, and in particular to antihistamines,
- due to the presence of oxomemazine:
The interactions mentioned are related to the presence of oxomemazine.
Combinations not recommended
+ Alcohol
Enhancement by alcohol of the sedative effect of H1 antihistamines. Impaired alertness can make driving vehicles and using machines dangerous.
Avoid taking alcoholic beverages and medicines containing alcohol.
Other non-prescription sedative drugs
Potentiation of the sedative effect of H1 antihistamines.
+ Sultopride
Increased risk of ventricular arrhythmias, in particular torsade de pointes, by the addition of electrophysiological effects.
Associations to consider
+ Other central nervous system depressants
(Sedative antidepressants, barbiturates, benzodiazepines, clonidine and related drugs, hypnotics, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, anxiolytics):
Increase in central depression. Impaired alertness can make driving vehicles and using machines dangerous.
+ Atropine and other atropine substances
(Imipramine antidepressants, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics):
Addition of atropine adverse effects such as urinary retention, constipation, dry mouth.
Precautions for use
RELATED TO THE PRESENCE OF OXOMEMAZINE:
Insofar as phenothiazines have been considered as hypothetical risk factors in the occurrence of sudden infant death syndrome, oxomemazine should not be used in children under 2 years of age.
Surveillance (clinical and possibly electrical) must be reinforced in epileptics because of the possibility of lowering the epileptogenic threshold.
Oxomemazine should be used with caution :
When used in children, bronchial asthma or gastroesophageal reflux should be ruled out before using oxomemazine as an antitussive.
Taking alcoholic beverages or drugs containing alcohol (see section Interactions with other drugs and other forms of interaction ) is strongly discouraged for the duration of treatment.
Given the photosensitizing effect of phenothiazines, it is preferable not to expose yourself to the sun during treatment.
H1 antihistamines should be used with caution due to the risk of sedation. The combination with other sedative drugs should be discouraged (see section Interactions with other drugs and other forms of interaction ).
The pharmacological characteristics of the oxomemazine molecule are at the origin of adverse effects of unequal intensity and related or not to the dose (see section Pharmacodynamic properties ):
Autonomic effects
Sensitization reactions
Hematological disorders
150ml syrup
To soothe your sore throat, it is also advisable to:
In addition, it is absolutely necessary to avoid the consumption of alcohol; avoid smoking tobacco or staying in smoky rooms; avoid air conditioners that deliver cold air and dry out the mucous membranes.
Please note that the drug Oxomemazine Mylan Night Cough 150ML is not a product like the others. Carefully read the non-prescription medication leaflet before ordering it. Do not leave medicines within the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 31/10/2012
OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup
oxomemazine
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
· If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this notice :
1. WHAT IS OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
3. HOW TO TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
6. ADDITIONAL INFORMATION
1. WHAT IS OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup AND WHAT IT IS USED FOR?
This medicine contains an antihistamine, oxomemazine.
It is recommended to calm dry coughs and coughs of irritation in adults and children over 2 years of age, especially when they occur in the evening or at night.
2. BEFORE YOU TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Never take OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup in the following cases:
· in infants (less than 2 years of age),
· allergy known to any of the constituents, and in particular to antihistamines,
· if you have a history of agranulocytosis (significant decrease in white blood cells),
· if you have difficulty passing urine of prostatic or other origin,
· if you have some forms of glaucoma (increased pressure inside the eye).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup:
Special warnings
Coughing is a symptom that can have various origins: respiratory infections, bronchitis, flu, allergy, asthma, whooping cough, irritation, etc ...
In addition, tobacco consumption worsens or maintains cough.
If a fever occurs or persists, accompanied or not by signs of infection (angina ...), pallor or sweating, it will be necessary to consult your doctor.
Do not use this medicine for a cough. In this case, coughing is a natural defense necessary for the evacuation of bronchial secretions.
If the cough becomes oily, is accompanied by clutter, sputum, fever, ask the doctor for advice.
In the case of chronic (long-term) bronchial or lung disease accompanied by cough with sputum, medical advice is essential.
A bronchial fluid (expectorant, mucolytic) should not be combined.
Precautions for use
In case of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he can adapt the dosage.
Taking this medication requires a MEDICAL ADVICE
· in the elderly:
o predisposed to constipation, dizziness or drowsiness,
o having prostate disorders;
· in children with asthma or gastroesophageal reflux disease,
· in case of severe heart disease, epilepsy.
PREVENT YOUR DOCTOR before taking this antihistamine.
Refrain from taking alcoholic beverages or medication containing alcohol during this treatment.
Use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicinal product contains 3.7 g sucrose per 5 ml intake and 7.3 g in 10 ml intake, which must be taken into account in the daily diet in the case of a diet low in sugar or diabetes.
Do not expose yourself to sunlight or UVA during treatment.
This medication should be used with caution due to the risk of sedation. Combination with other sedative medicinal products is not recommended ( see section "Other medicinal products and other medicinal products" ).
IN CASE OF DOUBT, DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
This medicine contains an antihistamine, oxomemazine. Other medicines contain it. Do not combine them, in order not to exceed the recommended daily dose ( see "Dosage" ). |
Combination with other sedative medicines is not recommended because of the increased risk of sedation.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Refrain from taking alcoholic beverages or medication containing alcohol during treatment.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication SHOULD NOT BE USED, unless otherwise directed by your doctor, during the first trimester of pregnancy.
If you discover that you are pregnant during treatment, consult your doctor promptly: he alone will be able to adapt the treatment to your condition.
At the end of pregnancy, abuse of this drug may cause adverse effects in the newborn. Therefore, always seek the advice of your doctor before using it and never exceed the recommended dose and duration of treatment.
feeding
This drug passes into breast milk. Due to its pronounced sedative properties, its intake should be avoided in case of breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
Attention is drawn to the possibilities of somnolence associated with the use of this medication, especially at the beginning of treatment, especially among vehicle drivers and machine users.
This phenomenon is accentuated by the use of alcoholic beverages or medicines containing alcohol.
List of excipients with known effect
Important information about some of the ingredients of this medication:
This medicine contains sucrose .
3. HOW TO TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
Not applicable.
ORAL WAY.
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.
Use the measuring cup.
Dosage
In adults and children over 40 kg (12 years): 10 ml per dose, 4 times a day.
In children:
The daily dosage depends on the child's weight (1 ml of syrup per kg of body weight per day) or as an indication:
· Child 13 to 20 kg (2 to 6 years): 5 ml per dose, 2 to 3 times daily,
· Child 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3 times daily,
· Child 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4 times a day.
Frequency of Administration
Receptacles must be renewed if necessary and spaced at least 4 hours apart.
Due to the sedative effect, especially at the beginning of treatment, oxomemazine should be preferred.
Duration of the treatment
Treatment should be short (a few days) and limited to coughing times.
If your cough persists, seek advice from your doctor.
If you feel that the effect of OXOMEMAZINE BIOGARAN, syrup is too strong or too weak:
Consult your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you take more OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup:
Do not take a double dose to make up for a missed dose.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup is likely to have undesirable effects, although not everyone is subject to it.
Some effects require STOPPING IMMEDIATELY TREATMENT AND WARNING YOUR DOCTOR:
· Allergic reactions of type:
o rash (erythema, eczema, purpura, urticaria),
o angioedema (urticaria with abrupt swelling of the face and neck which can cause respiratory discomfort),
o anaphylactic shock (violent allergic reaction endangering vital organs),
o phenomena of sensitization of the skin under the effect of the sun.
· Significant decrease in white blood cells in the blood, which may be manifested by the onset or recurrence of fever with or without signs of infection.
· Abnormal decrease in platelets in the blood that may result in nosebleeds or gums.
Others are more frequent:
· Drowsiness, decreased vigilance, more marked at the beginning of treatment,
· Disorders of memory or concentration, dizziness,
· Motor incoordination, tremors,
· Confusion, hallucinations,
· Dryness of the mouth,
· Visual impairment,
· Retention (accumulation) of urine,
· Constipation,
· palpitations,
· Low blood pressure.
More rarely,
· signs of excitement (agitation, nervousness, insomnia) may occur.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
Keep out of the reach and sight of children.
Do not use OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup after the expiry date which is stated on the carton or bottle after EXP. The expiry date refers to the last day of the month.
Before opening: no special precautions for storage.
After opening: Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Full list of active substances and excipients
What contains OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup?
The active substance is:
Oxomemazine ................................................. .................................................. .............................. 0.033 g
For 100 ml of syrup.
The other components are:
Sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel flavor *, caramel color (E150c), sucrose, purified water.
* Composition of caramel flavor: vanillin, ethylvanillin, benzaldehyde and propylene glycol.
Pharmaceutical form and content
What is OXOMEMAZINE BIOGARAN 0.33 mg / ml, syrup and contents of the pack?
This medication is in the form of a syrup. Bottle of 150 ml.
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
BIOGARAN LABORATORIES
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
H2 PHARMA
ZAC LA CROIX BONNET
21 RUE JACQUES TATI
78390 BOIS D'ARCY
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Antitussive antihistamine
This medication is a generic of TOPLEXIL
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
OXOMÉMAZINE BIOGARAN: syrup (caramel flavor); 150 ml bottle with measuring cup.
Refunded at 15%. - price: 1,84 euro (s).
OXOMÉMAZINE BIOGARAN without sugar: oral solution (caramel flavoring); 150 ml bottle with measuring cup.
Refunded at 15%. - price: 1,84 euro (s).
Biogaran Laboratory
p 5 ml | p 5 ml | |
oxomemazine | 1.65 mg | 1.65 mg |
Sucrose | 3.7 g |
Usual dosage: