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Benzal 15MG Doxylamine 10 scored tablets
Over-the-counter medication

Benzal 15MG Doxylamine 10 scored tablets

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Reference : 3400939535685
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Benzal 15MG 10 scored tablets doxylamine is used in the treatment of insomnia in adults. Contains Doxylamine IndicationsCe medicine is a hypnotic. This soporific contains an antihistamine which has a sedative effect. It also has antimuscarinic properties that explain some cons-indications and certain side effects.

LIDENE 15MG DOXYLAMINE 10 SHORT TABLETS

Warning: This is a medicine. Before use, read the instructions carefully. If in doubt, do not hesitate to contact your pharmacist.

Description of LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS

LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS is used to treat insomnia in adults . Contains Doxylamine. This medication is a hypnotic. This sleeping pill contains an antihistamine which has a sedative effect . It also has atropinic properties which explain certain contraindications and certain undesirable effects.

Using advice and opinion on LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS

The recommended dosage is 7.5 to 15 mg per day (½ to 1 tablet per day). It can be increased to 30 mg per day (i.e. 2 tablets per day) if necessary.

In the elderly, renal or hepatic insufficiency : it is recommended to reduce the dosage

Administration mode

  • Oral use.
  • A single dose per day in the evening, 15 to 30 minutes before bedtime.

Duration of the treatment

  • The duration of treatment is 2 to 5 days.
  • If insomnia persists for more than 5 days, treatment should be re-evaluated.

In case of recurrent sleep disorders , we advise you to take in addition the food supplement EuphytoseNuit, which contains melatonin and passionflower. this formula is more suitable for reducing the time to fall asleep .

Insomnia is the reduction in the usual duration of sleep and / or the achievement of quality of sleep with repercussions on the quality of the next day's waking.

During the night the amount of sleep is reduced by difficulty falling asleep, night awakenings, too early awakening in the morning.

Sleep is experienced as light and not restful. The next day is difficult with complaints of fatigue, drowsiness, irritability, and is often accompanied by mood disorders.

There are various explanations for sleep disorders. Environmental causes (noise, heat, etc.), lifestyle errors (activity too intense in the evening, coffee or alcohol abuse), an inadequate imposed rhythm (night or team work), organic illness associated disturbing sleep (asthma, angina, peptic ulcer, gastroesophageal reflux ...) or even taking exciting drugs (theophylline, salbutamol, cortisone, beta blockers ...) are often with origin of the troubles.

Learn more about psychophysiological insomnia

This type of sleep disorder accounts for 15 to 20% of insomnia. It is insomnia that appears without obvious cause. It generally follows insomnia, the cause of which can be identified: after a surgical intervention, the birth of a child, significant psychological stress, shift work ...
There is a negative conditioning to insomnia which results in a paradoxical activation of the awakening systems as soon as the person goes to bed. It results in fear of not sleeping, tension or anxiety at bedtime, spontaneous falling asleep when sleep is not wanted (in front of the TV ...), the impossibility of taking a nap to recover .

Composition of LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS  

Excipients: eudragit NE 30 D , hypromellose , macrogol 6000 , patent blue V , titanium dioxide , talc , sodium saccharin , aluminum hydroxide , microcrystalline cellulose , magnesium stearate
Excipient with known effect: lactose monohydrate

Precaution for use with LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS

  • Known hypersensitivity to antihistamines,
  • Personal or family history of acute glaucoma by closing the iridocorneal angle,
  • Urethroprostatic disorders at risk of urinary retention,
  • Child under 15 years old.

SUBJECT AGE, INSUFFICIENT RENAL OR HEPATIC:

There is an increase in plasma concentrations and a decrease in plasma clearance. It is recommended to decrease the dosage.

Presentation of LIDENE 15MG DOXYLAMINE 10 SHAKE TABLETS  

Box of 10 tablets

Drug warnings

Attention, the drug is not a product like the others. Read the package 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 - Last updated: 18/01/2017

Name of the medicinal product

LIDENE 15 mg film-coated tablet

Doxylamine succinate

framed

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

You should always use 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 experience no improvement or feel less well after 5 days.

Do not use this medication for children.

What is in this leaflet?

1. What is LIDENE 15 mg film-coated tablet and when it is used?

2. What should I watch for before taking LIDENE 15 mg film-coated tablet?

3. How to take LIDENE 15 mg film-coated tablet?

4. What are the possible side effects?

5. How to store LIDENE 15 mg film-coated tablet?

6. Package contents and other information.

1. WHAT IS LIDENE 15 mg film-coated, scored tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: ANTIHISTAMINIC FOR SYSTEMIC USE.

This medication is recommended in occasional insomnia in adults.

2. BEFORE YOU TAKE LIDENE 15 mg film-coated, scored tablet.

Do not take LIDENE 15 mg film-coated tablets in the following cases:

· Allergy known to antihistamines,

· Antecedent of acute glaucoma (increased pressure inside the eye),

· Difficulty in urinating in man (prostatic or other)

· In children under 15 years of age

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

Take special care with LIDENE 15 mg film-coated tablet:

Special warnings

Insomnia may have a variety of causes that do not necessarily require medication.

This medication should be used with caution in the elderly because of the risk of drowsiness and / or dizziness, which can lead to falls (eg in the case of a night-time rise), with often serious consequences in this population.

Due to the presence of lactose, this medication should not be used in patients with galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).

Doxylamine succinate, like any hypnotic or sedative, is likely to aggravate preexisting sleep apnea syndrome (breathing pauses during sleep).

Precautions for use

Drinking alcohol is formally discouraged during the treatment.

Tell your doctor if you are pregnant.

In case of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he can adapt the dosage.

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

Other medicines and LIDENE 15 mg film-coated tablet

This drug contains an antihistamine, doxylamine.

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

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

LIDENE 15 mg film-coated tablet with food and drink

Not applicable.

Pregnancy and breast feeding

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.

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

Sport

Not applicable.

Driving and using machines

Attention is drawn to the daytime sleepiness and decreased vigilance associated with the use of this medication.

The combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended for driving or using machines.

If the sleeping period is insufficient, the risk of decreasing alertness is further increased.

LIDENE 15 mg film-coated tablet contains:

Microcrystalline cellulose, lactose monohydrate, talc, dye dispersion, 30% polyacrylate dispersion, magnesium stearate.

Excipients with notable effects:

Lactose

3. HOW TO TAKE LIDENE 15 mg film-coated, scored tablet?

Dosage

RESERVED FOR ADULTS.

The recommended dosage is 1/2 to 1 tablet per day in adults.

In adults, the dosage may be increased to 2 tablets per day if necessary.

In the elderly, renal or hepatic insufficiency, the lowest dose is recommended.

Method and route of administration

Oral use.

Swallow the tablet with a little water.

Frequency of Administration

One dose per day, in the evening, 15 to 30 minutes before going to bed.

Duration of treatment

The duration of treatment is 2 to 5 days.

Do not exceed 5 days of treatment without the advice of your doctor.

If you take more LIDENE 15 mg film-coated tablet than you should:

Immediately notify a doctor.

If you forget to take LIDENE 15 mg film-coated tablet:

Do not take a double dose to make up for a missed dose.

Take the next dose at the usual time.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, LIDENE 15 mg film-coated tablet is likely to have side effects, although not everyone is subject to it:

· Diurnal somnolence,

· Constipation,

· Dry mouth,

· Visual disorders (accommodation disorders),

· Heart palpitations.

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 LIDENE 15 mg film-coated, scored tablet?

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

Do not use LIDENE 15 mg film-coated tablets after the expiry date which is stated on the carton.

Do not use this medication if you notice any signs of deterioration.

This medication should be stored at a temperature below 25 ° C and away from light.

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. PACKAGE CONTENTS AND OTHER INFORMATION

What LIDENE contains: 15 mg film-coated tablet

· The active substance is:

Doxylamine succinate ............................................... ................................................ 15.0 mg

· The other components are:

Microcrystalline cellulose, lactose monohydrate, talc, 30% polyacrylate dispersion, magnesium stearate, dye dispersion (talc, hypromellose, titanium dioxide, macrogol, saccharin sodium, aluminum indigo carmine lacquer, iron).

What is LIDENE 15 mg film-coated tablet and contents of the pack

Blue elongated film-coated tablet.

The tablet can be divided into two equal doses. Box of 10 tablets.

Marketing Authorization Holder

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

Marketing Authorization Operator

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

Maker

LIPHA

115 AVENUE LACASSAGNE

69003 LYON

or

EUROPHARTEC

1 RUE HENRI MATISSE

63370 LEMPDES

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:

December 2016

Other

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

VIDAL OF THE FAMILY

ylidene

Hypnotic

doxylamine

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

PRESENTATIONS (summary)

LIDENE 15 mg: scored tablet; box of 10.
-

French Pharmaceutical Cooperation Laboratory

COMPOSITION (summary)
p cp
Doxylamine succinate 15 mg
Lactose +

INDICATIONS (summary)
This medication is a hypnotic (sleeping pill). It contains an antihistamine that has a sedative effect. It also has atropinic properties which explain certain contraindications and some undesirable effects.
It is used in the treatment of insomnia.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
Some insomnia can translate a masked depression and justify a specific treatment.
This drug has atropine 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.
This drug exposes you to a risk of falling at night in the elderly person who has a habit of getting up at night.
Avoid alcoholic beverages: increased risk of drowsiness.
This medication is a sleeping pill. Driving or using a hazardous machine in the hours following its setting is of course contraindicated. The duration of the sedative effect, as well as its intensity, varies greatly from one person to another. It is up to you to check, after the first catches, that the possible persistence of a somnolence on awakening is compatible with the continuation of your usual activities.
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 :
This medication can be used during pregnancy, after medical advice. In case of termination of pregnancy, monitoring of the newborn may be necessary.

Breastfeeding:
The available data do not indicate whether this drug passes into breast milk: it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication should be taken 15 to 30 minutes before going to bed.

Usual dosage:

  • Adult: ½ to 2 tablets per day depending on individual sensitivity.
The duration of treatment is limited to 2 to 5 days without medical advice.
TIPS (summary)
Sleeping pills are not the only answer to sleep disorders. A better hygiene of life, a moderate consumption of stimulants (including alcoholic drinks) also make it possible to fight effectively against the insomnia.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness during the day.
Rarely, atropine effects: disorders of accommodation , constipation, dry mouth.


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.
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.


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 crisis 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.


depression
Disease usually associates a feeling of fatigue, uselessness, guilt, inability to perform daily tasks. Loss of appetite and sleep disorders are common. Suicidal impulses are one of the signs of severity of depression.


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.


hypnotic
Drug causing sleep.
Synonym: sleeping pill.


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.


sedative
  • 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.

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