Mylan's Oxomemazine 0.33 mg/mL sugar-free syrupis used for the symptomatic treatment of dry coughs, particularly those that occur at night. OXOMEMAZINE Mylan 0.33 mg/mL SUGAR-FREE is an oral solution sweetened with acesulfame potassium.
For warnings, precautions, and contraindications, please refer to the package insert.
OXOMEMAZINE Mylan 0.33 mg SUGAR-FREE 150 mL: This medication contains an antihistamine from the phenothiazine class. It has antitussive and sedative properties.
It is used for the symptomatic treatment of dry coughs, particularly those that occur at night.
A sugar-containing syrup formulation is available if you do not consume sweeteners.
This medication is not suitable for treating a productive cough, which is a normal defense mechanism of the body that helps clear mucus from the bronchi.
A cough is a symptom that may indicate many different conditions (allergies, heart disease, lung disease, digestive disorders, etc.): consult your doctor if it persists for more than a few days.
Precautions are necessary in cases of heart disease, epilepsy, liver failure, kidney failure, and in the elderly—particularly in cases of chronic constipation, prostate adenoma, or a tendency toward dizziness or low blood pressure.
Oxomemazine, like other drugs in the phenothiazine class, may cause photosensitivity reactions; avoid sun exposure during treatment.
Avoid alcoholic beverages: they increase the risk of drowsiness.
This medication may cause drowsiness, which can be severe in some people. This drowsiness may be exacerbated by alcohol or other sedative medications. Driving and operating hazardous machinery are not recommended, especially in the hours following administration of the medication.
FOR ADULTS AND CHILDREN OVER 2 YEARS OF AGE ONLY.
For oral use.
Use the measuring cup.
For adults and children weighing more than 40 kg (or aged 12 years and older):
10 mL per dose, 4 times a day.
For children:
The daily dose depends on the child’s weight (1 mL of oral solution per kg of body weight per day); as a general guideline:
Doses should be repeated as needed, with at least a 4-hour interval between doses.
It is recommended to take doses in the evening due to the sedative effect of oxomemazine, especially at the start of treatment.
Glycerol, maltitol (E965), acesulfame potassium, citric acid monohydrate, sodium citrate, sodium benzoate (E211), caramel flavoring*, purified water.
*Contains, among other ingredients, propylene glycol, vanillin, and 3-hydroxybutanone (acetylmethylcarbinol).
This medication is CONTRAINDICATED in the following cases:
Special Warnings
This medication contains maltitol (E965). Its use is not recommended in patients with fructose intolerance (a rare hereditary disorder).
RISKS ASSOCIATED WITH OXOMEMAZINE:
Since phenothiazines have been considered potential risk factors for sudden infant death syndrome, oxomemazine should not be used in children under 2 years of age.
Monitoring (clinical and, if necessary, electroencephalographic) should be intensified in patients with epilepsy due to the possibility of a lowered seizure threshold.
Oxomemazine should be used with caution:
When used in children, bronchial asthma or gastroesophageal reflux must be ruled out before using oxomemazine as a cough suppressant.
Consumption of alcoholic beverages or medications containing alcohol is strongly discouraged during treatment.
Given the photosensitizing effect of phenothiazines, it is best to avoid sun exposure during treatment.
H1 antihistamines should be used with caution due to the risk of sedation. Combining this medication with other sedative medications is not recommended.
Bottle of Oxomemazine 0.33 mg/mL Sugar-Free Syrup (+ measuring cup) 150 mL
Opioid derivatives: essential They inhibit the cough center.
Codeine (Eucalyptine syrup, Pulmosérum), codeethyline (Végétosérum), and noscapine (Tussisédal) reduce respiratory activity (depressants).
Dextromethorphan (Dexir, Drill Dry Cough, Humex Dry Cough, Nodex Dry Cough Syrup Sachets, Vicks Dry Cough Lozenges) has minimal respiratory depressant effects at standard therapeutic doses.
All opioid derivatives are contraindicated during breastfeeding, in cases of respiratory failure or asthma, and when used in combination with MAOIs (Moclamine, Marsilid). All are contraindicated during pregnancy, except for dextromethorphan when used on an occasional basis. In the elderly, dextromethorphan is the preferred choice.
Antihistamines for allergic coughs They are recommended to relieve coughs with an allergic component (Calmixène, Toplexil, Humex for dry cough containing oxomemazine). They are contraindicated in cases of angle-closure glaucoma, urethral-prostatic obstruction, or when used in combination with CNS depressants (antidepressants, clonidine, hypnotics, neuroleptics, anxiolytics), and during pregnancy and breastfeeding. Antispasmodics for treating paroxysmal coughs Pentoxyverine (Toclase for dry cough, Codotussyl for dry cough) is an antispasmodic specifically indicated for paroxysmal coughs.
Pentoxyverine is contraindicated in cases of angle-closure glaucoma, urethral-prostatic obstruction, asthma, respiratory failure, in children under 15 years of age, and during pregnancy and breastfeeding. For children aged 6 to 15 years: For children over 6 years of age (weighing at least 20 kg), dry coughs can be treated with dextromethorphan (Dexir for Children, Drill for Children’s Dry Cough) or an antihistamine (Toplexil).
Treatment should not exceed 4 or 5 days. Dextromethorphan is contraindicated for asthma-related coughs. Ages 2 to 6: Avoid self-medication; an antihistamine (Toplexil) may be used for up to 48 hours. Under 2 years of age: No cough suppressants. Nasal irrigation, room ventilation, and complete avoidance of tobacco smoke are recommended.
Please note: Medications are not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 05/11/2012
Name of the medicinal product
OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium
oxomemazine
framed
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.
Review summary
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
1. WHAT IS OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medicine contains an antihistamine, oxomemazine.
Therapeutic indications
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 SUGAR-FREE, oral solution sweetened with acesulfame potassium?
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.
Cons-indications
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.
Sport
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).
3. HOW TO TAKE OXOMEMAZINE BIOGARAN 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Administration mode
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.
Risk of withdrawal syndrome
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.
5. HOW TO STORE OXOMEMAZINE BIOGARAN 0.33 mg / ml WITHOUT SUGAR, oral solution sweetened with acesulfame potassium?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
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.
6. ADDITIONAL INFORMATION
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).
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BIOGARAN LABORATORIES
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
exploiting
BIOGARAN LABORATORIES
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Maker
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.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
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:
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