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AGYRAX Motion sickness Vertigo
Over-the-counter medication

AGYRAX Motion sickness Vertigo

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Reference : 3400933488383
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AGYRAX 25mg 15 Tablets is a medicine used in the symptomatic treatment of dizziness and the prevention and treatment of motion sickness .

Agyrax 25mg 15 tablets is a medicine for nausea, vomiting and dizziness

For warnings, precautions for use and contraindications, please consult the instructions for use of AGYRAX.

Agyrax 25mg 15 tablets is a medicine in the form of a scored tablet (15) based on Meclozine ( 25 mg ) indicated in the treatment of motion sickness and dizziness.

Description of Agyrax 25mg 15 tablets

Meclozine is a derivative of piperazine.
Dizziness, nausea and vomiting are not illnesses but symptoms indicating a dysfunction of the organism or an organ malfunction. Treatment of the cause depends on the underlying disease and may or may not require treatment.
The mechanism of anti-emetic action in motion sickness and vertigo of meclozine is not fully understood but probably related to its central anticholinergic activity and its depressive action on the central nervous system.

Indication of AGYRAX Travel sickness Vertigo

In adults :

  • Symptomatic treatment of the vertiginous crisis .
  • Prevention and treatment of motion sickness .

Directions for use and dosage of AGYRAX motion sickness Vertigo

Dizzying crisis :

  • 1 to 3 tablets per day to be taken before meals.
  • Swallow without chewing with a little water or other non-alcoholic drink.

Motion sickness :

  • The first dose should be taken 1 hour before the trip: 1 to 4 tablets per day.
  • Pediatric population: there are no data in children and adolescents.

Composition of agyrax tablets 25mg meclozine hydrochloride

Meclozine hydrochloride 25 mg
For a scored tablet.
Excipient : lactose.

Precaution for use

Pregnancy

  • Based on the available data, the use of meclozine hydrochloride is possible during pregnancy regardless of the term.
  • In case of treatment at the end of pregnancy, take into account the atropine and sedative properties of this molecule for the monitoring of the newborn.

Breast-feeding: It is not known whether meclozine hydrochloride passes into breast milk. Given the possibilities of sedation or paradoxical excitation of the newborn, this drug is not recommended in case of breast-feeding.

ATROPINIC DRUGS
It should be taken into account that atropine substances can add up their side effects and more easily lead to urinary retention, an acute outbreak of glaucoma, constipation, dry mouth, etc.
The various atropine drugs are represented by imipramine antidepressants, most atropine H1 antihistamines, anticholinergic antiparkinson drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics as well as clozapine.

SEDATIVE DRUGS
It should be taken into account that many drugs or substances can add up their depressant effects on the central nervous system and contribute to reducing vigilance. These are morphine derivatives (analgesics, cough suppressants and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (for example, meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepine , mianserin, mirtazapine, trimipramine), sedating H1 antihistamines, central antihypertensive drugs, baclofen and thalidomide.

Presentation of AGYRAX Car sickness Vertigo

Agyrax 25mg comes in the form of a box of 15 tablets.

Medication warnings

Attention, the drug AGYRAX is not a product like the others. Read the instructions for the medication carefully before ordering it. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

  • Please inform your online pharmacist of ongoing treatments in order to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.
  • Click here to find the instructions for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Advice from your pharmacist on motion sickness and dizziness

Do not confuse dizziness and discomfort

If the age-related instability appears gradually, the dizziness can appear more suddenly and is sometimes even treated urgently. They should not be confused with discomfort: vertigo is characterized by the sensation that the environment - the floor, the ceiling, objects - is moving around you or that your own body is moving in space - turning , swinging or falling. The great dizziness that causes nausea, vomiting and an inability to stand up should be taken care of during the day, in ENT or in the emergency room, especially if they are accompanied by hearing loss.

Travel sickness

Seasickness is very common. However, motion sickness can manifest itself in many other modes of transport than boats and ferries. In car, bus, plane or even train, the discomfort linked to motion sickness is the result of an inadequate response of the brain, linked to a contradiction between visual perception (information provided by the eyes) and the center of balance (information given by the vestibule, a balance organ located in the inner ear).
Dizziness, nausea, headache, cold sweating, drowsiness, hypersalivation, and rapid breathing are all symptoms of motion sickness that can lead to vomiting. These discomforts stop when the body gets used to the movement of the vehicle or when the latter stops.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 06/02/2017

Name of the medicinal product

AGYRAX, scored tablet

Meclozine Hydrochloride

framed

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

You should always take this medication exactly as prescribed 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 pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Review summary

What this leaflet contains:

1. What is AGYRAX, scored tablet and in which cases it is used?

2. What should be known before taking AGYRAX tablet scored?

3. How to take AGYRAX, scored tablet?

4. What are the possible side effects?

5. How to store AGYRAX, scored tablet?

6. Additional information.

1. WHAT IS AGYRAX, scored tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

This drug is recommended in adults:

· in the treatment of dizziness.

· in the prevention and treatment of motion sickness.

2. BEFORE YOU TAKE AGYRAX, scored tablet?

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

Never take AGYRAX, scored tablet:

This medicinal product should NOT be used in the following cases:

· Allergy known to meclozine or to any of the constituents of the product, or to a piperazine derivative

· Difficulties in urinating with prostatic origin

· Acute glaucoma (sudden increase in eye pressure)

· Hepatic insufficiency

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 AGYRAX, scored tablet:

Special warnings

Absorption of drinks or medications containing alcohol is not recommended for the duration of treatment.

The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

AGYRAX, scored tablet should be used with caution in the elderly and in patients with epilepsy.

Treatment with AGYRAX, scored tablet should be discontinued four days before allergic tests.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.

NEVER LEAVE TO CHILDREN.

Interaction with other medicines

Other medicines and AGYRAX, scored tablet

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

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy

This medication, under normal conditions of use, may be used during pregnancy. However, you should always seek the advice of your doctor before using it and never exceed the recommended dose.

feeding

The passage of this drug in breast milk is possible. Given its sedative or exciting properties that may affect your child (lethargy, decreased tone, or insomnia), this drug is not recommended in case of breast-feeding.

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

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

This medication may cause drowsiness and decreased alertness.

List of excipients with known effect

AGYRAX, scored tablet contains lactose.

3. HOW TO TAKE AGYRAX, scored tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage / Mode of Administration / Administration Frequency / Duration of Treatment

Dizzy Crisis

1 to 3 tablets per day to be taken before meals.

Swallow without chewing with a little water or other non-alcoholic beverage.

Travel sickness

The 1 st decision must be made 1 hour before the trip: 1 to 4 tablets per day.

IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.

Symptoms and Instructions for Overdose

Not applicable.

Instructions for omission of one or more doses

Not applicable.

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

They are related to the action of the drug on the central nervous system, the ingested dose and the individual sensitivity of each.

The most common side effects are drowsiness or sedation.

May also occur:

· Acceleration of the pulse, drop in blood pressure

· ringing of ears, dizziness

· abdominal pain, constipation, diarrhea,

· decreased or increased appetite

· headache, abnormal movements, fatigue, anxiety, euphoric mood, excitement, hallucinations, insomnia

· blurry vision

· urinary retention

· dryness of the mouth, throat and nose

· allergic reaction localized (rash) or generalized (anaphylactic shock)

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 AGYRAX, scored tablet?

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

Expiration date

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

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

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What AGYRAX contains: scored tablet:

· The active substance is:

Meclozine hydrochloride ............................................... ......................................... 25 mg

For a scored tablet.

· The other components are:

Lactose, corn starch, talc, polyvidone K 30, calcium stearate, anhydrous colloidal silica.

Pharmaceutical form and content

Aspect of AGYRAX, scored tablet and contents of the pack:

This medication is in the form of a scored tablet. Box of 15 or 60 tablets.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

Holder

TERALI PRODUCTS

23 RUE CHRISTOPHE PLANTIN

ZA THE HIGH LIMOUGERE

37230 FONDETTES

exploiting

TERALI PRODUCTS

23 RUE CHRISTOPHE PLANTIN

ZA THE HIGH LIMOUGERE

37230 FONDETTES

Maker

UCB PHARMA SA

CHEMIN DU FORIEST

1420 BRAINE L'ALLEUD

BELGIUM

or

DELPHARM EVREUX

5 RUE DU GUESCLIN

27000 EVREUX

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 notice was revised is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable.

Other

Not applicable.

VIDAL OF THE FAMILY

Agyrax

antihistamine

meclozine

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

PRESENTATIONS (summary)

AGYRAX: scored tablet (white); box of 15.
Refunded at 30%. - price: 1,78 euro (s).

Laboratory

COMPOSITION (summary)
p cp
Meclozine hydrochloride 25 mg
Lactose +

INDICATIONS (summary)
This medication belongs to the family of H1 type antihistamines . It has an antivertiginous and antiemetic action.
It is used in adults to treat symptoms of dizziness and to prevent and treat motion sickness.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medication is intended for the treatment of dizziness and not for disturbances of balance: talk to your doctor or pharmacist.
This antihistamine has atropinic effects. It can cause acute glaucoma in susceptible persons: red, hard and painful eyes, with blurred vision. An emergency consultation with an ophthalmologist is necessary.
Precautions are necessary in cases of epilepsy , pyloric stenosis , dementia, myasthenia gravis and the elderly.
Avoid alcoholic drinks during treatment: increased risk of drowsiness.
Conductor: This medication may be responsible for decreased vigilance, especially at the beginning of treatment.
DRUG INTERACTIONS (summary)
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 use of this medication is possible during pregnancy, provided that you respect the prescription of your doctor. Use in the days prior to delivery should be reported to the physician; special monitoring of the newborn may be necessary.

Breastfeeding:
The available data do not indicate whether this drug passes into breast milk: do not use it during breast feeding without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets should be swallowed without being chewed with a glass of water.

Usual dosage:

  • Adult :
    Dizziness: 1 tablet, 1 to 3 times a day, before meals.
    Sickness of transport: 1 to 4 tablets per day. The first catch is taken one hour before departure.
TIPS (summary)
There are simple and often effective measures to prevent motion sickness. For example :
  • sleep well on the eve of the trip;
  • eat lightly but regularly during the ride;
  • avoid coffee, alcoholic or soft drinks;
  • privilege certain places (at the front by coach, at the wings by plane, at the center of the bridge on a boat).
POSSIBLE ADVERSE EFFECTS (summary)
The most frequent: drowsiness, decreased vigilance.
Frequent: dry mouth.
Rarely: disorders of accommodation , nausea, vomiting.
Other side effects include palpitations, heartbeat, tinnitus, double vision, constipation, abdominal pain, diarrhea, fatigue, weakness, weight gain, increased or decreased appetite, dizziness , headaches, tingling, anxiety, excitement, hallucinations, insomnia, memory problems, disorientation, confusion of ideas, difficulty in urinating, dryness of the throat or nose, rash.


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 the 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.
Certain drugs, especially atropinic drugs, may have the undesirable effect of aggravating the discomfort and may lead to a total blockage of the evacuation of the bladder. They are therefore contraindicated or should be used cautiously in men with the symptoms described above.


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.


antihistamines
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.


épilpesie
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 frequent; 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 who have been detected by an ophthalmologist. Those who suffer from chronic open-angle glaucoma are not affected by these contraindications.


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.).


gravis
Disease of the muscles resulting in abnormal fatigability during exercise. There are more or less severe myasthenia gravis.


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


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.


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


stenosis
Shrinkage, for example of an artery.


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).

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