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NAUTAMINE Scored 20 TABLETS
Over-the-counter medication

NAUTAMINE Scored 20 TABLETS

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Nautamine tablet is indicated for adults and children over 2 years of age in the prevention and treatment of motion sickness.

NAUTAMINE prevention treatment of motion sickness 20 tablets

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

Description of Nautamine

Nautamine tablet is a drug indicated in adults and children over 2 years of age for the prevention and treatment of motion sickness.

Travel sickness gives rise to various manifestations, the intensity of which varies from person to person.
At first, the troubles felt can be :

  • a feeling of discomfort in the upper part of the belly (frequent sign);
  • nausea ;
  • in young children, disgust for food, crying, restlessness and / or yawning.

Other symptoms may occur :

  • pallor;
  • cold sweats;
  • hypersalivation;
  • vomitings ;
  • dizziness ;
  • faster breathing;
  • headaches ;
  • tiredness.

Composition

Di (acefylline) diphenhydramine: 90 mg per tablet.

Excipients: Hydrated colloidal silica, potato starch, magnesium stearate, indigotine (E132), microcrystalline cellulose, ethylcellulose.

Dosage of the drug Nautamine

Reserved for adults and children over 2 years old.

Child between 2 and 6 years: Crush the 1/4 or 1/2 tablets then pour the powder obtained in a glass of water. 1/2 crushed tablet per dose to be taken 1/2 hour before departure. Renew if necessary after 6 hours, without exceeding 4 half- crushed tablets per day.

Children between 6 and 12 years old: The tablets should be swallowed with a glass of water. 1 tablet to be taken 1/2 hour before departure. Renew if necessary after 6 hours, without exceeding 4 tablets per day.

Adults and children over 12 years of age: The tablets should be swallowed with a glass of water. 1 to 1.5 tablets to be taken 1/2 hour before departure. Renew if necessary after 6 hours, without exceeding 6 tablets per day.

Precautions for use

  • This Nautamine medication should generally not be used when breastfeeding
  • This over-the-counter medication should generally not be used during treatment with enoxacin.
  • In case of long-term liver or kidney disease, consult your doctor so that he can adjust the dosage.
  • Taking this medication requires medical advice in the elderly who are prone to constipation, dizziness or drowsiness, or who have prostate problems.
  • This drug can cause a strong drowsiness increased by alcohol: abstain from alcoholic drinks or drugs containing alcohol during the duration of the treatment.
  • This Nautamine medication contains an antihistamine, diphenydramine. Other drugs contain it. Do not combine them, so as not to exceed the maximum recommended dose.
  • It is possible to take this medicine during your pregnancy provided that it is for a short time (a few days) and at the recommended doses. Indeed, at the end of pregnancy, excessive use of this drug can lead to harmful effects in the newborn. Therefore, you should always seek the advice of your doctor before using it.
  • This nonprescription drug passes into breast milk. It is therefore not recommended for women who are breastfeeding.
  • Do not store above 30 ° C.
  • Do not exceed the expiration date.

Contraindications :

  • Child under 2 years of age due to the pharmaceutical form,
  • Certain forms of glaucoma (increased pressure inside the eye),
  • Difficulty urinating from prostatic or other sources,
  • Known allergy to antihistamines,
  • In case of breastfeeding,
  • In case of treatment with enoxacin.

Read the instructions before use.

Route of administration: Oral route

Conditioning

Box of 20 coated tablets

Drug warnings

Please note, the Nautamine medication is not a product like any other. Read the Nautamine medication leaflet carefully before ordering. 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 the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
  • Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on: 29/07/2016

Name of the medicinal product

NAUTAMINE, scored tablet

Di (acefylline) diphenhydramine

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 contact your doctor if you do not feel any improvement or if the symptoms worsen or persist.

What is in this leaflet?

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

2. What information should I take before taking NAUTAMINE tablet?

3. How to take NAUTAMINE, scored tablet?

4. What are the possible side effects?

5. How to store NAUTAMINE, scored tablet?

6. Package contents and other information.

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

Pharmacotherapeutic group

NAUTAMINE, scored tablet belongs to a family of medicines called antinaupathic.

Therapeutic indications

This medicine contains an antihistamine: diphenhydramine.

It is indicated in adults and children over 2 years in the prevention and treatment of motion sickness.

2. BEFORE YOU TAKE NAUTAMINE, scored tablet?

Do not take NAUTAMINE, scored tablet:

· in children under 2 years of age,

· if you are allergic to the active ingredient (diphenhydramine) or to any of the other ingredients of NAUTAMINE, scored tablet. You will find the list of components in section 6,

· if you are allergic to another antihistamine,

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

· if you have problems of prostatic origin (risk of blocking to urinate).

This medication MUST NOT BE GENERALLY USED unless your doctor tells you otherwise if you are breast-feeding.

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

Warnings and Precautions

Mi s es in g a rde s pe c ial s e

Crush the tablets before giving them to your child if he is less than 6 years old, as he could swallow it and stifle it.

Before taking this medication:

Check with your doctor if you have severe liver or kidney disease (severe liver or kidney failure): you can adjust the dose of NAUTAMINE, a scored tablet.

Taking this medication requires a MEDICAL ADVICE in the elderly :

· predisposed to dizziness, orthostatic hypotension (drop in blood pressure when going up), or drowsiness,

· suffering from constipation,

· with disorders of prostatic origin.

PREVENT YOUR DOCTOR before taking this antihistamine.

The occurrence of signs or symptoms suggestive of abuse or drug dependence of diphenhydramine should be carefully monitored.

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

Children and Youth

Not applicable.

Other medicines and NAUTAMINE, scored tablet

This medication contains an antihistamine, diphenhydramine.

Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended dose (see section 3 "HOW TO TAKE NAUTAMINE, tablet

scored? ").

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Avoid taking medication containing alcohol.

NAUTAMINE, scored tablet with food and beverages

NAUTAMINE, scored tablet can cause severe drowsiness accentuated by alcohol: Refrain from drinking alcoholic beverages during the course of treatment.

Pregnancy and breast feeding

Pregnancy

You may take this medication during pregnancy, provided it is for a short time (a few days) and at recommended doses.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

This drug passes into breast milk. Avoid using this medication if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Driving and using machines

Caution : The drowsiness and decreased vigilance caused by this medication can be very important. This is exacerbated by the use of alcoholic beverages or alcohol-containing medications.

3. HOW TO TAKE NAUTAMINE, scored tablet?

Always observe the conditions of use mentioned in this leaflet. Do not exceed the recommended dose. Cases of abuse with diphenhydramine have been reported.

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

The tablets are divisible: they can be cut in 2 equal parts.

Adult and child over 12 years:

The tablets should be swallowed with a glass of water (oral).

The usual dose is 1 to 1.5 tablets to take half an hour before departure. Replace the plug if necessary after 6 hours, without exceeding 6 tablets per day.

Children between 6 and 12 years:

The tablets should be swallowed with a glass of water (oral).

The usual dose is 1 tablet to take half an hour before departure. Replace the plug if necessary after 6 hours, without exceeding 4 tablets per day.

Children between 2 and 6 years:

Crush the half-tablets and then pour the powder obtained in a glass of water (oral).

The usual dose is 1 half-compressed crushed per take to take half an hour before departure. Replace the plug if necessary after 6 hours, without exceeding 4 crushed half-tablets per day.

If you or your child have taken more NAUTAMINE, scored tablet than you should: Consult your doctor immediately or medical emergencies.

If you forget to take NAUTAMINE, scored tablet:

Not applicable.

If you stop taking NAUTAMINE, scored tablet:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

· Some side effects require STOPPING IMMEDIATELY TREATMENT AND WARNING A PHYSICIAN

o Allergic reactions:

§ redness of skin (erythema), eczema, small red spots (purpura), red patches on the skin that itch (urticaria),

§ abrupt swelling of the face and neck, which may cause difficulty breathing (angioedema)

§ sudden discomfort with a significant drop in blood pressure that can put your life at risk (anaphylactic shock),

o abnormalities seen during a blood test:

§ decrease in the number of white blood cells (leucopenia, neutropenia) which may be manifested by the appearance or the recrudescence of a fever accompanied or not by signs of infections.

§ abnormal decrease in platelet count, which may result in nosebleeds or gums (thrombocytopenia),

§ decreased number of red blood cells (hemolytic anemia) that may manifest as pallor, shortness of breath, with or without fever, pain in the joints, abdomen, jaundice, or discomfort.

· Other side effects may include:

o sedation or somnolence ,

o confusion, hallucinations,

o impaired balance, dizziness, decreased memory or concentration (more common in the elderly),

o difficulty in coordinating its movements,

o tremors,

o dryness of the mucous membranes,

o drying of the lactated secretion,

o urinary blockage,

o constipation,

o palpitations, drop in blood pressure when going to standing (orthostatic hypotension),

o blurred vision (accommodation disorders, mydriasis).

· More rarely signs of excitement: agitation, nervousness, insomnia.

· Cases of abuse and drug dependence with diphenhydramine have been reported.

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 NAUTAMINE, scored tablet?

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 carton. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 30 ° C.

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 NAUTAMINE contains, breakable tablet

· The active substance is:

Di (acefylline) diphenhydramine ............................................. .............................................. 90 mg

For a scored tablet.

· The other components are : hydrated colloidal silica, potato starch, magnesium stearate, indigotin (E 132), microcrystalline cellulose, ethylcellulose.

What is NAUTAMINE, scored tablet and contents of the pack

This medication is in the form of a scored tablet. One box contains 20 tablets.

Marketing Authorization Holder

SANOFI AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Marketing Authorization Operator

SANOFI AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Maker

DELPHARM DIJON

6 BOULEVARD OF EUROPE

21800 QUETIGNY

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

Not applicable.

VIDAL OF THE FAMILY

NAUTAMINE

antiemetic

diphenhydramine

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

PRESENTATIONS (summary)

NAUTAMINE: scored tablet (blue); box of 20.
-

Laboratory Sanofi-Aventis France

COMPOSITION (summary)
p cp
Diphenhydramine di-acefylline 90 mg

INDICATIONS (summary)
This medication belongs to the family of H1 type antihistamines . It also has sedative and atropine effects which explain certain precautions of use.
It is used to prevent and treat motion sickness.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • risk of closed-angle glaucoma ,
  • risk of urine retention,
  • child under 2 years of age.
WARNING (Contents)
Precautions are necessary in patients with severe hepatic impairment or renal insufficiency and in the elderly, especially in cases of chronic constipation, prostate adenoma , tendency to dizziness or drops in tension.
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)
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 :
Use of this medication during pregnancy is possible, provided that the recommended dosage is followed. However, its use in the days prior to delivery should be reported to the physician; in fact, special surveillance of the newborn may be necessary.

Breastfeeding:
This drug passes into breast milk; do not use or reuse without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication should be taken with a little water, half an hour before departure. The catch may be renewed during the trip, within 6 hours.
For children under 6, tablets should be crushed before being swallowed.

Usual dosage:

  • Adult and child over 12 years: 1 tablet or 1 and a half tablets, to be renewed if necessary, without exceeding 6 tablets per day.
  • Child 6 to 12 years: 1 tablet, to be renewed if necessary, without exceeding 4 tablets per day.
  • Child 2 to 6 years: ½ tablet, to be renewed if necessary, without exceeding 4 half-tablets per day.
TIPS (summary)
There are simple and often effective measures to prevent motion sickness:
  • sleep well on the eve of the trip;
  • eat lightly but regularly during the ride;
  • avoid coffee, alcoholic or soft drinks;
  • privilege certain places: in front by coach, at the level of the wings by plane, on the bridge in the center by boat.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness.
Atropine effects: dry mouth, difficulty in accommodation , blocked urine, constipation, palpitations .
Orthostatic hypotension , dizziness , tremors, restlessness.
Allergic reaction .
Abnormal blood count .
Drowsiness.
Atropine effects: dry mouth, difficulty in accommodation , blocked urine, constipation, palpitations .
Orthostatic hypotension .
Dizziness , impaired balance, decreased concentration, usually in the elderly.
Tremors, confusion of ideas, hallucinations; more rarely, restlessness, nervousness, insomnia.
Allergic reaction .
Abnormal blood count .
Cases of abuse, misuse and dependency have been observed, especially among adolescents.


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.


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 at 60o) is a better antiseptic than alcohol at 90o.


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.


addiction
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.


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.


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 up, slowly rising from a seat with 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.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


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.


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.


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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