Oxomemazine 0.33 mg/ml sugar-free syrup from Mylan is used for the symptomatic treatment of dry coughs, especially those that occur at night. OXOMEMAZINE Mylan 0.33 mg/ml WITHOUT SUGAR is an oral solution sweetened with acesulfame potassium.
For warnings, precautions for use and contraindications, please consult the instructions for use.
This medication contains an antihistamine from the phenothiazine family. It has antitussive and sedative properties.
It is used in the symptomatic treatment of dry coughs, especially those that occur at night.
This medicine is not suitable for the treatment of wet cough, which is a normal defense mechanism of the body allowing the evacuation of mucus present in the bronchi.
Cough is a symptom that can reveal many diseases (allergy, heart, lung, digestive disease.): consult your doctor if it persists for more than a few days.
Precautions are necessary in case of heart disease, epilepsy, hepatic insufficiency, renal insufficiency and in the elderly, especially in case of chronic constipation, prostate adenoma, tendency to dizziness or drops Of voltage.
Oxomemazine, like other drugs in the phenothiazine family, is likely to cause photosensitization reactions; avoid sun exposure during treatment.
Avoid alcoholic beverages: increased risk of drowsiness.
This medication can induce drowsiness, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using dangerous machinery is not recommended, especially in the hours after taking the drug.
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.
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 oral solution 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 because of the sedative effect, especially at the start of treatment, of oxomemazine.
Glycerol, maltitol (E965), acesulfame potassium, citric acid monohydrate, sodium citrate, sodium benzoate (E211), caramel flavor*, purified water.
*contains in particular propylene glycol, vanillin, 3-hydroxybutanone (acetylmethylcarbinol).
This medication is CONTRAINDICATED in the following cases :
Special warnings
This medicine contains maltitol (E965). Its use is not recommended in patients with fructose intolerance (rare hereditary disease).
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.
The intake of alcoholic beverages or drugs containing alcohol is strongly discouraged for the duration of the 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.
Bottle of Oxomemazine of 0.33 mg/ml Sugar-free syrup (+ measuring cup) of 150 ml
Opiate derivatives: essential They inhibit the cough centre.
Codeine (Eucalyptine syrup, Pulmoserum.), codeethylin (Vegetoserum.) and noscapine (Tussisedal.) reduce respiratory activity (depressants).
Dextromethorphan (Dexir, Drill dry cough, Humex Dry cough, Nodex dry cough syrup-sachets, Vicks dry cough lozenges.) is a weak respiratory depressant at conventional therapeutic doses.
All opiate derivatives are contraindicated in case of breastfeeding, respiratory failure, asthma and association with MAOIs (Moclamine, Marsilid). All are contraindicated during pregnancy, except dextromethorphan for occasional use. In the elderly, prefer dextromethorphan.
Antihistamines for allergic coughs They are recommended to calm coughs with an allergic component (Calmixene, Toplexil, Humex dry cough oxomemazine.). They are contraindicated in cases of angle-closure glaucoma, urethroprostatic obstruction, in combination with CNS depressants (antidepressants, clonidine, hypnotics, neuroleptics, anxiolitics), in case of pregnancy and breastfeeding. Spasmolytics to fight against hacking coughs Pentoxyverine (Toclase dry cough, Codotussyl dry cough.) is a spasmolytic specially adapted for hacking coughs.
Pentoxyverine is contraindicated in cases of angle-closure glaucoma, urethroprostatic obstruction, asthma, respiratory failure, in children under 15 years of age and in cases of pregnancy and breastfeeding. In children From 6 to 15 years old In children over 6 years old (minimum weight of 20 kg), treatment of dry cough is possible with dextromethorphan (Dexir child, Drill dry cough child.) or antihistamine (Toplexil .).
The treatment should not exceed 4 or 5 days. Dextromethorphan is contraindicated in asthmatic coughs. From 2 to 6 years old Avoid self-medication; possible use of antihistamine (Toplexil) for 48 hours. Under two years No cough suppressants. Washing of the nose, ventilation of the room, total eviction of tobacco are recommended.
Attention, the drug is not a product like the others. Read the medication leaflet carefully 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 - Last updated: 05/11/2012
OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium
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 SUGAR-FREE, oral solution sweetened with acesulfame potassium AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium?
3. HOW TO TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OXOMEMAZINE BIOGARAN 0.33 mg / ml WITHOUT SUGAR, oral solution sweetened with acesulfame potassium?
6. ADDITIONAL INFORMATION
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.
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.
Do not take this medication:
· in infants (less than 2 years of age),
· if you are allergic (hypersensitive) to any of the components ( see list in section 6 "Additional information" ), including antihistamines (medicines used to treat certain allergies)
· 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).
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with this medicine:
Coughing is a symptom that can have various origins: respiratory infections, bronchitis, flu, allergy, asthma, pertussis (infectious disease), irritation, etc ...
Tobacco use worsens or maintains cough.
Consult your doctor if you develop a fever with or without signs of infection (angina ...), paleness or sweating.
Do not treat a fatty cough with this medication because 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.
An expectorant or mucolytic (bronchial fluid-thinning drugs) should not be combined.
In case of long-term liver or kidney disease , consult your doctor to adjust the dose.
Taking this medication requires medical advice:
· in the elderly:
o predisposed to constipation, dizziness or drowsiness,
o having prostate disorders;
· in children with asthma or gastro-oesophageal reflux (acid burns and ascents),
· in case of severe heart disease or epilepsy.
Tell your doctor before taking this antihistamine.
Refrain from taking alcoholic beverages or medication containing alcohol during this treatment.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
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 seek the advice of your doctor or 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 section "Dosage" ).
Combination with other sedative medicines is not recommended because of the increased risk of sedation.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Food and drinks
Do not take alcoholic beverages or medication containing alcohol during this treatment.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication should not be used, unless otherwise advised 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 (tranquilizing) 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 maltitol (E965).
Not applicable.
Oral use.
Reserved for adults and children over 2 years of age.
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 weight of your child, either as an indication:
· Child 13 to 20 kg (2 to 6 years): 5 ml per dose, 2 to 3 times a day, comply with the advice of the doctor,
· 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
Replace the plugs, if necessary, by spacing them at least 4 hours.
Due to the sedative effect, especially at the beginning of treatment, oxomemazine should be preferred.
Duration of treatment
Treatment should be short (a few days) and limited to coughing times.
If your cough persists, seek advice from your doctor.
If you think the effect of this medicine is too strong or too weak:
Consult your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you take more of this medication than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take this medicine:
Do not take a double dose to make up for a missed dose.
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium is likely to have undesirable effects, although not everyone is subject to it.
Stop treatment immediately and tell your doctor if you:
· Allergic reactions of type:
o rash (erythema, eczema, purpura, urticaria),
o angioedema (urticaria with sudden swelling of the face and neck, which can cause respiratory discomfort),
o anaphylactic shock,
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.
In more frequent cases:
· 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 of urine,
· Constipation,
· palpitations,
· Low blood pressure.
In more rare cases:
· Signs of excitement (agitation, nervousness, insomnia).
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.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Before opening: no special precautions for storage.
After opening: the oral solution is kept for 6 months 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 SUGAR-FREE, oral solution sweetened with acesulfame potassium?
The active substance is:
Oxomemazine ................................................. .................................................. .............................. 0.033 g
For 100 ml of oral solution.
The other components are:
Glycerol, maltitol (E965), acesulfame potassium, citric acid monohydrate, sodium citrate, sodium benzoate (E211), caramel flavor *, purified water.
* contains in particular propylene glycol, vanillin, 3-hydroxybutanone (acetylmethylcarbinol).
Pharmaceutical form and content
What is OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium and contents of the pack?
This medication is in the form of a drinkable solution in a 150 ml bottle (brown glass).
BIOGARAN LABORATORIES
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
BIOGARAN LABORATORIES
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
H2 PHARMA
21, RUE JACQUES TATI
ZA THE CROIX BONNET
78390 BOIS D'ARCY
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: