TOPLEXIL 0,33MG / ML syrup without sugar dry cough 150ML

TOPLEXIL 0,33MG/ML SIROP S/S 150ML View larger

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Sanofi Aventis Sanofi Aventis

Toplexil sugar syrup is an antitussive drug without a prescription available in pharmacies to calm dry, irritated cough, especially when they occur in the evening or at night.

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For warnings, precautions for use and against-indications, please refer to the manual of Toplexil sugar syrup.

Description Toplexil sugar syrup

Toplexil sugar syrup is an antitussive drug without a prescription available in pharmacies to calm dry, irritated cough, especially when they occur in the evening or at night.
Attention is drawn, particularly among vehicle drivers and machine users, the drowsiness opportunities tied to the use of this drug, especially early in treatment: LEVEL 2

For adults and children over 2 years.

Composition of Toplexil sugar syrup

oxomemazine 0.033g

Excipients: glycerol, citric acid monohydrate, sodium citrate, caramel aroma compound, caramel (E 150), sucrose solution, purified water.

Contains sodium

Dosage and application advice

Adults and children over 40 kg (12 years): 10 ml per dose, 4 times a day

Children 13 to 20 kg (2-6 years): 5 ml per dose, 2 to 3 times per day

Children 20 to 30 kg (6-10 years): 10 ml per dose, 2 to 3 times per day

Children 30 to 40 kg (10-12 years): 10 ml per dose, 3 to 4 times per day

Repeat taken, if necessary, by spacing the minimum of 4 hours.

Cons-indications:

Children under 2 years, allergy to any component, urétroprostatiques disorders, acute glaucoma, a history of agranulocytosis, pregnancy, lactation, cough, certain medications (hyperprolactinemia: cabergoline, quinagolide). Avoid taking alcohol.

oral

Read the leaflet carefully.

Conditioning Toplexil syrup

a 150 ml bottle with measuring cup. Available in two models: With or without sugar.

Warnings about medications

Attention drug Toplexil sugar syrup is not a product like any other. Read the label of the drug Toplexil syrup without sugar before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the instructions for this drug Toplexil syrup without sugar on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug Toplexil sugar syrup.

VIDAL OF THE FAMILY

TOPLEXIL

Antitussive antihistamine

oxomemazine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

TOPLEXIL: syrup (caramel flavor); 150 ml bottle with measuring cup, graduated to 5 ml and 10 ml.
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TOPLEXIL without sugar: syrup (caramel flavor); 150 ml bottle with measuring cup, graduated to 5 ml and 10 ml.
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Laboratory Sanofi-Aventis France

COMPOSITION (summary)
p 5 ml p 5 ml
oxomemazine 1.65 mg 1.65 mg
Sucrose 3.7 g
Sodium 8.26 mg

INDICATIONS (summary)
This medication contains an antihistamine from the family of phenothiazines. It has antitussive and sedative properties .
It is used in the symptomatic treatment of dry coughs, especially those that occur at night.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medication is not suitable for the treatment of fatty cough, which is a normal defense mechanism of the body allowing the evacuation of the mucus present in the bronchi.
Cough is a symptom that can reveal many diseases ( allergies , heart disease, lung, digestive ...): 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 exposure to sunlight during treatment.
Avoid alcoholic beverages: increased risk of drowsiness.
This medication may induce somnolence, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using hazardous machines are not recommended, especially within hours of taking the medication.
DRUG INTERACTIONS (summary)
This medicinal product must not be combined with medicinal products containing cabergoline or quinagolide: the risk of their effects being nullified.
Tell your doctor or pharmacist if you are taking any other medicines that have atropine or sedative effects (tranquillizers, sleeping pills, some cough or pain medications containing opioids , antidepressants , neuroleptics, etc.).
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The effect of this medication during pregnancy is not well known: only your doctor can evaluate the possible risk of its use in your case.
In case of termination of pregnancy, monitoring of the newborn may be necessary.

Breastfeeding:
The data currently available do not indicate whether this drug passes into breast milk: as a precaution, it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication is taken preferably at the time of the cough, by spacing the catches of at least 4 hours. Evening catches should be preferred because of the risk of drowsiness.

Usual dosage:

  • Adult and child over 40 kg (over 12 years): 1 cup graduated to 10 ml, 4 times a day.
  • Child 30 to 40 kg (approximately 10 to 12 years): 1 cup graduated to 10 ml, 3 or 4 times a day.
  • Child of 20 to 30 kg (approximately 6 to 10 years): 1 cup graduated to 10 ml, 2 or 3 times a day.
  • Child 12 to 20 kg (approximately 2 to 6 years): 1 cup graduated to 5 ml, 2 or 3 times a day.
TIPS (summary)
If you are a smoker, continuing smoking affects the effectiveness of the treatment.
Simple measures, hot drinks and humidification of the ambient air, allow to calm the dry coughs.
This medicine should not be stored for more than 6 months after opening the bottle.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness.
Atropine effects: dry mouth, difficulty in accommodation , blocked urine, constipation, palpitations .
Orthostatic hypotension , dizziness .
Tremors, poor coordination of movements.
Agitation, confusion of ideas.
Allergic reaction , photosensitization .
Abnormal blood count .


GLOSSARY (summary)


accommodation
"Focus" of the eye, allowing clear vision close up. Presbyopia is the most common disorder of accommodation; some drugs such as atropine may cause passenger accommodation problems.


adenoma of the prostate
Increase in the volume of the prostate gland located under the bladder of man. This increase in volume is benign, has no relationship to cancer, but can interfere with the passage of urine into the urethra through the gland.
Symptoms that suggest the presence of a prostate adenoma are:
  • difficulty urinating (slowness, weakness of the spray);
  • the need to get up several times at night to urinate;
  • urges to urinate imperiously and difficult to control.
Some drugs, especially atropinics, may have the undesirable effect of aggravating the discomfort and may lead to a total blockage of the bladder evacuation. They are therefore contraindicated or should be used cautiously in men with the symptoms described above.


agranulocytosis
Disappearance of white blood cells. This serious condition prevents the body from reacting to infections. It is most often due to the toxicity of a drug on the bone marrow, where the blood cells are made.


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even 60o) is a better antiseptic than alcohol at 90o.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antidepressants
Medication that works against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, certain rebellious pain, enuresis, etc.
Depending on their mode of action and adverse effects, antidepressants are divided into different families: imipraminic antidepressants, serotonin reuptake inhibitors, selective or non-selective MAOIs. Finally, other antidepressants do not belong to any of these families, because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of moral suffering and the fight against inhibition which removes all will to action from the depressed. There may be a time lag between these two effects: moral suffering may persist, while the capacity for action reappears. During this short period, the risk of suicide in some depressed people can be increased. The physician takes it into account in its prescription (possible association with a tranquillizer) and it must imperatively be respected.


antihistamine
Medication that opposes different effects of histamine. Two main types exist: antihistamines type H1 (antiallergic) and antihistamines type H2 (gastric antiulcer). Some antihistamines of type H1 are sedative, others do not alter vigilance.


atropine
Medication with effects similar to those of atropine. Atropinics fight spasms and diarrhea. Adverse effects of atropinic drugs include: thickening of bronchial secretions, dry mouth and mucous membranes, constipation, risk of urine blockage and acute glaucoma in susceptible persons, accommodation disorders, abnormal sensitivity to light by dilation of the pupil. Taking several atropine medicines increases the risk of adverse effects. In the event of overdose or accidental ingestion, the following signs may also appear: red and warm skin, fever, acceleration of breathing, fall or, on the contrary, elevated blood pressure, agitation, hallucinations, poor coordination of movements. Emergency care should be given to your doctor or, if not available, call 15, 112 or an emergency medical service.
In addition to atropine and its derivatives, other drugs have atropine effects: imipraminic antidepressants, some antihistamines, antispasmodics, antiparkinsonian and neuroleptic.


epilepsy
A chronic seizure disorder associated with abnormal electrical activity of a group of brain cells. Its manifestations, varying in intensity, range from the sudden drop in attention (absences, or small evil) to loss of consciousness accompanied by abnormal muscle movements (convulsions, or great evil). Partial epilepsy, as its name implies, does not concern the whole body: the jerky movements only touch one or more muscle groups.


glaucoma
Disease characterized by increased pressure of the fluids contained in the eye (intraocular hypertension).
This general term covers two totally different affections:
  • Open angle glaucoma or chronic glaucoma is the most common; it is generally symptom-free, detected by the measurement of intraocular tension in the ophthalmologist. It does not cause acute seizures, and treatment relies primarily on beta-blocking eye drops. People with open-angle glaucoma should not use cortisone derivatives without prior ophthalmologic advice.
  • Closed-angle glaucoma or acute glaucoma is more rare. Between seizures, intraocular tension is normal. But the inadvertent use of atropine medicines (especially eye drops) causes an acute crisis of intraocular hypertension which can permanently damage the retina in a few hours. It is an ophthalmological emergency that is recognized by a brutally red eye, horribly painful, hard as a glass ball, and whose vision becomes blurred.
The angle in question in these two affections is the irido-corneal angle. It is indeed between the iris and the cornea that is located the system of evacuation of the liquids of the eye. A slightly open (closed) angle exposes a total obstruction of the evacuation system. This obstruction can occur when the iris is opened to the maximum (mydriasis) under the effect of an atropinic drug: the iris then comes to be attached to the cornea.
Contraindications for atropine medicines are limited to those who have already had closed-angle glaucoma or have been detected by an ophthalmologist. Those who suffer from chronic open angle glaucoma are not affected by these contraindications.


Orthostatic hypotension
Reduced blood pressure when changing from elongated to standing. Due mostly to drugs, orthostatic hypotension results in dizziness with risk of fall, especially in the elderly. These disturbances can be prevented by avoiding sudden changes of position: sit for a few moments at the edge of the bed before standing, slowly rising from a seat, keeping a support before moving.
Wearing compression stockings, which prevents blood from flowing back to the legs while standing, is also used to treat orthostatic hypotension.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


neuroleptics
Family of medicines used in the treatment of certain nervous disorders or various symptoms: digestive disorders, menopausal disorders, etc.


new born
Child less than one month old.


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leukocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


opiates
A chemical family that includes opium and its derivatives. In addition to drugs such as opium or heroin, the opiate family includes morphine (strong analgesic), codeine (antitussive and analgesic) and many other substances.


palpitations
Abnormal perception of irregular heartbeat.


photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


sedative
  • Quiets, calms down.
  • Medication belonging to different families: anxiolytics, hypnotics, analgesics, antitussives, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.


symptom
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 17/03/2017

Name of the medicinal product

TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium.

oxomemazine

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine by following the instructions in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after a few days.

Do not use this medication for children.

What is in this leaflet?

1. What is TOPLEXIL 0.33 mg / ml, NO SUGAR, oral solution sweetened with acesulfame potassium and in which cases it is used?

2. What should be known before taking TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium. ?

3. How to take TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium?

4. What are the possible side effects?

5. How to store TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium?

6. Package contents and other information.

1. WHAT IS TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: R06AD08 (R: Respiratory system).

TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium is an antitussive belonging to the family of antihistamines of phenothiazinic neuroleptic type. It is opposed to the effects of histamine especially on the bronchi. 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 TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium?

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Never take TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium:

· if you are allergic (hypersensitive) to the active substance (oxomemazine) or to any of the other ingredients of this medication mentioned in section 6.

· if you are allergic to a drug of the same family as TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium (antihistamines) used to treat allergies,

· do not give TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium to a child under 2 years,

· if you have already had a significant decrease in the level of certain white blood cells (granulocytes) in the blood (agranulocytosis),

· if you have difficulty urinating (disorders of prostatic origin or otherwise),

· if you have a risk of closed-angle glaucoma (high pressure inside the eye that may affect the eyesight),

· if you are taking a medication containing cabergoline or quinagolide (used to control excessive prolactin production) (see section "Other medicines").

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.

Warnings and Precautions

Take special care with TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium:

Special warnings

· If the cough persists despite the use of TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium, do not increase the doses.

Consult your doctor. Indeed, cough is a symptom that can have various origins: respiratory infections, bronchitis, flu, allergy, asthma, whooping cough, irritation, etc ...

In addition, tobacco use worsens or maintains cough.

· There are 2 types of coughs: dry coughs and greasy coughs. You should not treat an oily cough by using this medicine. Indeed, the fat cough is a natural means of defense necessary for the evacuation of bronchial secretions (mucus).

· If the cough becomes oily with congestion, sputum or fever, seek the advice of your doctor.

· Do not try to treat a fatty cough by combining this drug with a cough medicine.

· You should not expose yourself to sunlight or ultraviolet (UVA) rays during treatment.

· This medication should be used with caution due to the risk of drowsiness.

· Combination with other sedative medicines is not recommended (see section "Other medicines used or taken").

Precautions for use

Before taking this medicine, tell your doctor:

· If you have a chronic bronchial or lung disease with cough and sputum.

· If you have a chronic liver disease (severe hepatic impairment) or kidney (severe renal failure), your doctor will have to adjust the dose to your condition.

· If you have cardiovascular disease.

· If you suffer from epilepsy.

· If you are over 65 years of age (especially if you have chronic constipation, difficulty urinating due to increased prostate volume, hypotension, dizziness, or drowsiness).

· If the child suffers from asthma, gastroesophageal reflux.

During treatment, see your doctor:

If you have fever with or without signs of infection (angina, ...), pallor or sweating.

Contact your doctor before taking TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium.

Other medicines and TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium.

This medication contains an antitussive from the family of antihistamines, oxomemazine.

Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see section "Dosage").

You should never take TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium with medicines containing cabergoline or quinagolide (used to curb excessive prolactin production) (see section "Never take TOPLEXIL 0.33 mg / ml WITHOUT SUGAR, oral solution sweetened with acesulfame potassium ").

You should avoid taking medicines containing alcohol for the duration of the treatment.

You should wait at least 2 hours between taking TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium and taking gastrointestinal, antacid or charcoal dressings (used to relieve digestive disorders).

Many other medications may decrease alertness and cause drowsiness. Their combination with TOPLEXIL 0.33 mg / ml WITHOUT SUGAR, oral solution sweetened with acesulfame potassium can increase this effect. These include morphine derivatives (used for pain relief, as cough suppressants or for withdrawal from drug abuse), neuroleptics, benzodiazepines (anxiolytics), barbiturates, hypnotics (sleeping pills), antidepressants, sedative antihistamines, certain antihypertensives, and drugs containing baclofen and thalidomide.

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium with food and drink and alcohol

You should avoid drinking alcoholic beverages or taking a medication containing alcohol during your treatment.

Pregnancy and breast feeding

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.

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Sport

Not applicable.

Driving and using machines

This medication may cause drowsiness, especially at the beginning of treatment. It is not recommended to drive a vehicle or use a machine if you feel this effect. The risk of drowsiness is increased if you consume alcoholic beverages, medicines containing alcohol or other sedative drugs (see section "Other medicines and TOPLEXIL 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassic ").

TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium contains sodium and maltitol.

This medicine contains sodium. This medicinal product contains 8.26 mg sodium per 5 ml oral solution and 16.53 mg sodium per 10 ml oral solution. To be taken into account in patients controlling their sodium dietary intake.

The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).

3. HOW TO TAKE TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium?

This medication is reserved for adults and children over 2 years of age.

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

In adults and children over 40 kg (12 years): The usual dose is 10 ml of oral solution per dose, 4 times a day.

For children aged 2 to 12 years: the daily dose depends on the weight of your child:

· Children 13 to 20 kg (2 to 6 years): the dose is 5 ml of oral solution per dose, 2 to 3 times a day.

· Children 20 to 30 kg (6 to 10 years): the dose is 10 ml of solution per dose, 2 to 3 times a day.

· Children 30 to 40 kg (10 to 12 years): the dose is 10 ml of oral solution per dose, 3 to 4 times a day.

Frequency of Administration

Receptacles must be renewed only if necessary and spaced at least 4 hours apart.

This medication may cause drowsiness. It is preferable to take TOPLEXIL 0.33 mg / ml WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium in the evening.

Administration mode

This medication is taken orally. Use the supplied dosing cup in the box.

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 take more TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium you should:

Consult your doctor or doctor immediately.

TOPLEXIL overdose 0.33 mg / ml SUGAR-FREE, oral solution sweetened with acesulfame potassium may cause convulsions (especially in children), drowsiness , alertness, coma.

If you forget to take TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium:

Do not take a double dose to make up for the single dose you have forgotten to take;

If you stop taking TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium:

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?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

STOP TREATMENT AND IMMEDIATELY CONSULT A DOCTOR

· If you have signs of allergy to the medication such as:

o redness on the skin, eczema, purple spots on the skin (purpura),

o swelling of the face and / or neck may cause difficulty breathing and put you at risk (angioedema)

o malaise with severe drop in blood pressure (anaphylactic shock).

· If you experience an exaggerated reaction of the skin after exposure to the sun or UV.

· If you have a decrease in the number of certain blood cells: white blood cells (neutropenia, agranulocytosis), platelets (thrombocytopenia) or red blood cells (haemolytic anemia).

The following effects may also occur:

· Drowsiness, decreased vigilance especially at the beginning of treatment.

· Disorders of memory or concentration, dizziness.

· Difficulty coordinating movement, trembling.

· Confusion, hallucinations.

· Dry mouth, visual disturbances, difficulty urinating (urine retention), constipation, palpitations of the heart, significant drop in blood pressure during the transition to the standing position, sometimes responsible for dizziness and / or malaise (orthostatic hypotension).

More rarely, signs of excitement (agitation, nervousness, insomnia) may occur.

Declaration of side effects

If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package.

Store in the original package in order to protect from light.

Store at maximum 6 months after first opening the bottle.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What TOPLEXIL contains 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium.

· The active substance (s) is (are):

Oxomemazine ................................................. .................................................. ...................... 0.033 g

For 100 ml oral solution

· The other component (s) is (are):

Sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, flavor caramel compound (mainly heliotropin (piperonal), vanilla, propylene glycol, alcohol, maltol, water), liquid maltitol, acesulfame potassium, purified water.

What is TOPLEXIL 0.33 mg / ml, WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and contents of the pack

This medication is in the form of a drinkable solution in 150 ml, 200 ml or 250 ml flasks with a measuring cup (polypropylene).

Not all pack sizes may be marketed.

Marketing Authorization Holder

SANOFI-AVENTIS FRANCE

82, AVENUE RASPAIL

94250 GENTILLY

Marketing Authorization Operator

SANOFI-AVENTIS FRANCE

82, AVENUE RASPAIL

94250 GENTILLY

Maker

A. NATTERMANN & CIE GMBH

NATTERMANN ALLEE 1

D-50829 COLOGNE

FABLIBADRESSE2

GERMANY

or

UNITHER LIQUID MANUFACTURING

1-3, ALLEE OF NESTE

31770 COLOMIERS

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

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