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Doxylamine 15 mg Insomnie Occasionnelle Mylan 10 tablets
Over-the-counter medication

Doxylamine 15 mg Insomnie Occasionnelle Mylan 10 tablets

Brand : Mylan Viatris Mylan Viatris

DOXYLAMINE MYLAN 15mg Sommeil 10 tablets in our organic pharmacy, Give your opinion on the advice of use and dosage with our partner Verified opinions after your purchase.

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DOXYLAMINE MYLAN 15mg Sleep 10 tablets

Doxylamine is indicated foroccasional insomnia in adults.

Description of DOXYLAMINE MYLAN 15mg Sleep 10 tablets

Doxylamine succinate is an H1 antihistamine of the ethanolamine class with sedative and atropinic effects. It has been shown to reduce the time it takes to fall asleep and improve sleep duration and quality.

Directions for use and dosage

FOR ADULTS ONLY.

Dosage
The recommended dosage is 7.5 to 15 mg per day (i.e. ½ to 1 tablet per day). It may be increased to 30 mg per day (i.e. 2 tablets per day) if necessary.
For elderly patients and patients with impaired renal or hepatic function, a lower dosage is recommended.

Method of administration
Take orally.
Take once a day in the evening, 15 to 30 minutes before bedtime.

Duration of treatment
Treatment lasts from 2 to 5 days.
If insomnia persists for more than 5 days, treatment should be re-evaluated.

Give your opinion on the advice for use and dosage of DOXYLAMINE MYLAN 15mg Sommeil 10 tablets with our partner Verified opinions after your purchase.

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

During the night, the quantity of sleep is reduced by difficulties in falling asleep, nocturnal awakenings and waking up too early in the morning.

Sleep is experienced as light and unrestful. The next day is difficult, with complaints of fatigue, drowsiness and irritability, often accompanied by mood disorders.

There are various explanations for sleep disorders. Environmental factors (noise, heat, etc.), unhealthy lifestyles (too much activity in the evening, coffee or alcohol abuse), inadequate work schedules (night shifts or shift work), an associated organic disease that disrupts sleep (asthma, angina, peptic ulcer, gastro-oesophageal reflux disease, etc.) or the use of stimulant medications (theophylline, salbutamol, cortisone, beta-blockers ....) are often at the root of sleep disorders.

Composition of DOXYLAMINE MYLAN 15mg Sommeil 10 tablets

Doxylamine hydrogensuccinate...........................15 mg

Excipient : contains 76.90 mg lactose monohydrate.

Excipients

  • Core : Lactose monohydrate (note), Microcrystalline cellulose (E460), Croscarmellose sodium (E468), Magnesium stearate (E572)
  • Film coating : Hypromellose (E464), Talc (E553b), Titanium dioxide (E171), Macrogol 6000, Propylene glycol (E1520)

Precautions for use

Contraindicated in the following cases:

  • Hypersensitivity to doxylamine
  • History of acute glaucoma
  • Family history of acute glaucoma
  • Urethroprostatic disorders at risk of urinary retention
  • Children under 15 years of age

Not recommended in the following cases

  • Galactose intolerance
  • Glucose malabsorption syndrome
  • Galactose malabsorption syndrome
  • Lactase deficiency
  • Alcohol consumption
  • Breast-feeding

Warnings and precautions in the following cases :

  • Sleep apnea syndrome
  • Elderly patients
  • Renal insufficiency
  • Liver failure
  • Daytime sleepiness
  • Late pregnancy
  • Newborns of treated mothers

Presentation of DOXYLAMINE MYLAN 15mg Sleep

Doxylamine comes in a box containing 10 tablets.

Our advice and expert opinions

You can't sleep through the night again! You're prostrate in bed, eyes wide as an owl's: but how can you overcome a little insomnia?

The triggering of sleep mechanisms is linked to a particular behavior at bedtime. In the case of insomniacs, this behavior is disrupted. There are several ways to re-establish consistent sleep signals. Restoring a healthy lifestyle is an essential, but not sufficient, prerequisite for better sleep. Other solutions are also available.

For people with difficulty falling asleep

  • Valerian: 1 capsule in the evening with meals or at bedtime, from age 12. Reduces time to sleep and alertness.
  • Lemon balm: Helps improve sleep quality and relaxes. It can be taken as a fluid extract in the evening, combined with vervain (which lowers heart rate) and lime blossom (which lowers body temperature and increases the amount of water eliminated).
  • Passionflower: reduces the effect of anxiety on the body and acts as a natural anti-depressant. 1 capsule in the morning and 1 in the evening for 15 days.

To combat nocturnal agitation and early awakening

  • Eschscholtzia: also known as "California poppy". This plant helps to make sleep more peaceful and to induce REM sleep more rapidly.
  • It can be combined with passionflower or valerian. Two capsules at bedtime with a large glass of water are recommended.
  • For aromatherapy, we recommend Petitgrain Bigarade essential oil (as a vapour), lemon litsea essential oil (as a rub) or organic mandarin essential oil (as a vapour or on a handkerchief).

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated: 29/08/2017

Name of the drug

DOXYLAMINE EG LABO 15 mg, scored film-coated tablet

doxylamine

framed

You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.

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

· Talk to your pharmacist for any advice or information.

· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse after 5 days.

What does this booklet contain ?

1. What is DOXYLAMINE EG LABO 15 mg film-coated tablet scored and in what cases is it used?

2. What you need to know before taking DOXYLAMINE EG LABO 15 mg film-coated tablet scored?

3. How to take DOXYLAMINE EG LABO 15 mg film-coated tablet scored?

4. What are the possible side effects?

5. How to store DOXYLAMINE EG LABO 15 mg film-coated tablet scored?

6. Contents of the package and other information.

1. WHAT DOXYLAMINE EG LABO 15 mg, scored film-coated tablet AND WHAT IT IS USED FOR

Pharmacotherapeutic group - ATC code: R06AA09

This medicine is recommended in occasional insomnia in adults.

2. BEFORE YOU TAKE DOXYLAMINE EG LABO 15 mg film-coated tablets scored?

Do not take DOXYLAMINE EG LABO 15 mg film-coated tablets

· if you are allergic (hypersensitive) to the antihistamines, the active substance or any of the other ingredients of this medicine, listed in section 6;

· if you have a history of acute glaucoma (increased pressure inside the eye)

· if you have difficulty urinating in humans (of prostatic origin or other);

· if you are a child under 15 years old.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR

FROM YOUR PHARMACIST .

Warnings and precautions

Talk to your doctor or pharmacist before taking DOXYLAMINE EG LABO .

Insomnia can have various causes that do not necessarily require taking a drug.

This drug should be used with caution in the elderly, because of the risk of cognitive impairment, drowsiness, slow reactivity, and / or dizziness / dizziness that may cause falls (eg night-time ), with often serious consequences in this population.

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

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

The intake of alcohol is formally discouraged during the course of treatment.

Tell your doctor if you are pregnant.

If you have long-term liver or kidney disease, CHECK YOUR DOCTOR so that he can adjust the dosage.

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

Children

Not applicable.

Other medicines and DOXYLAMINE EG LABO 15 mg film-coated tablets

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

This medicine contains an antihistamine, doxylamine.

Other medicines contain it. Do not combine them so as not to exceed the maximum recommended dose (see Posology, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment).

This medicine should be avoided in combination with sodium oxybate.

TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SIGNALLY REPORT ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST.

DOXYLAMINE EG LABO 15 mg film-coated tablets scored with <,>

Not applicable.

Pregnancy <,> breastfeeding

Pregnancy

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

feeding

The passage of this medicine in breast milk is possible. Given its sedative or otherwise exciting properties that could affect your child (lethargy, decreased tone, or insomnia contrary), this drug is not recommended in case of breastfeeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Attention is drawn to daytime sleepiness and decreased alertness to the use of this medication.

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

If sleep time is insufficient, the risk of decreased alertness is further increased.

DOXYLAMINE EG LABO 15 mg, scored film-coated tablet contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DOXYLAMINE EG LABO 15 mg film-coated tablets scored?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

Dosage

RESERVED FOR THE ADULT.

The recommended dosage is ½ to 1 tablet per day in adults.

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

In the elderly, renal or hepatic impairment, the lowest dosage is recommended.

Method and route of administration

Oral way.

Swallow the tablet with a little water.

Frequency and timing at which the drug is to be administered

Only once a day, in the evening, 15 to 30 minutes before bedtime.

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 DOXYLAMINE EG LABO 15 mg film-coated tablet scored than you should

Immediately consult your doctor or pharmacist.

If you forget to take DOXYLAMINE EG LABO 15 mg, scored film-coated tablet

Do not take a double dose to make up for the dose you forgot to take.

Take the next dose at the usual time.

If you stop taking DOXYLAMINE EG LABO 15 mg, scored film-coated tablet

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

· daytime sleepiness;

· constipation;

· urinary retention ;

· dry mouth;

· confusion ;

· rhabdomyolysis (severe damage to the muscles);

· increased blood creatine phosphokinase (CPK);

· visual disturbances (accommodation disturbances, blurred vision, hallucinations, visual impairment);

· heart palpitations.

In addition, first-generation H1 antihistamines are known to cause sedation, cognitive impairment, and psychomotor performance disorders.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information about the safety of the medicine.

5. HOW TO STORE DOXYLAMINE EG LABO 15 mg film-coated tablets scored?

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

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

Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What DOXYLAMINE EG LABO contains 15 mg, scored film-coated tablet

· The active substance is:

Doxylamine Hydrogensuccinate ............................................... .............................. 15.00 mg

For a scored film-coated tablet

· The other excipient components are:

Core :

Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Pelting:

Hypromellose (E464), talc, titanium dioxide (E171), macrogol 6000, propylene glycol.

What DOXYLAMINE EG LABO 15 mg film-coated tablet scored and contents of the pack

Marketing Authorization Holder

EG LAB - LABORATORIES EUROGENERICS

THE QUINTET, BUILDING A

12 DANJOU STREET

92517 BOULOGNE BILLANCOURT CEDEX

Operator of the marketing authorization

EG LAB - LABORATORIES EUROGENERICS

THE QUINTET, BUILDING A

12 DANJOU STREET

92517 BOULOGNE BILLANCOURT CEDEX

Maker

BTT LABORATORIES

ZI DE KRAFFT

67150 ERSTEIN

Names of the drug in the member states of the European Economic Area

Not applicable.

The last date this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{YYYY month}.>

Other

The ANSM will reevaluate every year any new information on this medication and if necessary this leaflet will be updated.

VIDAL OF THE FAMILY

DOXYLAMINE EG LABO BOARD

Hypnotic

This medicine is a generic of DONORMYL.

. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

DOXYLAMINE EG LABO TIP 15 mg: scored tablet (white); box of 10.
Not refunded - Free price -

Laboratory EG Labo

COMPOSITION (summary)
p cp
Doxylamine hydrogen succinate 15 mg
Lactose 76.9mg

INDICATIONS (summary)
This medicine is a hypnotic (sleeping pill). It contains an antihistamine that has a sedative effect. It also has atropinic properties that explain some contraindications and some adverse effects.
It is used in the treatment of occasional insomnia.
CONTRAINDICATIONS (summary)
This medicine should not be used in the following cases:
ATTENTION (summary)
Some insomnia can translate a masked depression and justify a specific treatment.
Like any hypnotic or sedative treatment, this medication may aggravate the symptoms of sleep apnea.
This medicine has atropinic effects. It can cause acute glaucoma in predisposed people: red eye, hard and painful, with blurred vision. An emergency consultation with an ophthalmologist is necessary.
This hypnotic can be bought without a prescription. Nevertheless, it is recommended to take a medical advice before using it in cases of renal insufficiency, liver failure and in the elderly person: a reduction of the dosage may be necessary.
Sleeping pills expose a senior who is accustomed to getting up at night to risk falling at night.
Avoid alcoholic beverages: increased risk of drowsiness.
This medicine is a sleeping pill. Driving or using a dangerous machine within hours of taking it is of course contraindicated. The duration of the sedative effect, as well as its intensity, is very variable from one person to another. It is your responsibility to check, after the first shots, that the possible persistence of drowsiness upon waking is compatible with the continuation of your usual activities.
DRUG INTERACTIONS (summary)
Tell your doctor or pharmacist if you are taking any other medicine that has atropine or sedative effects (tranquilizers, sleeping pills, some cough or pain medicines containing opiates , antidepressants , neuroleptics ...).
PREGNANCY and BREASTFEEDING (summary)
Pregnancy :
This medicine can be used during pregnancy after medical advice. If taken at the end of pregnancy, monitoring of the newborn may be necessary.

Breastfeeding:
The available data do not allow to know if this drug passes into breast milk: it is not recommended during breastfeeding without medical advice.
DIRECTIONS AND DOSAGE (summary)
This medication should be taken 15 to 30 minutes before bedtime.

Usual dosage:

  • Adult: ½ to 1 tablet a day. The dosage can be increased 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 lifestyle, a moderate consumption of excitants (including alcoholic beverages) also make it possible to fight effectively against insomnia.
ADVERSE POSSIBLE EFFECTS (summary)
Drowsiness during the day.
Atropinic effects: disturbances of accommodation , constipation, dry mouth, palpitations .


LEXICON (summary)


accommodation
"Focus" of the eye, allowing close-up vision. Presbyopia is the most common accommodation disorder; certain medications such as atropine can cause transient accommodation disturbances.


prostate adenoma
Increase in the volume of the prostate gland located under the bladder of the man. This increase in volume is benign, has nothing to do with cancer, but may hinder the passage of urine in the canal (urethra) that passes through the gland.
The symptoms that suggest the presence of a prostate adenoma are:
  • Difficulty urinating (slow, weak jet)
  • the need to get up several times a night to urinate;
  • urges to urinate imperious and difficult to control.
Some drugs, especially atropine, may have the undesirable effect of aggravating the discomfort and may lead to a complete blockage of the evacuation of the bladder. They are therefore contraindicated or should be used with caution in men with the symptoms described above.


antecedent
Affection healed or still evolving. The antecedent can be personal or family. The antecedents are the story of a person's health.


antidepressants
Drug that acts against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, some rebel pain, enuresis, etc.
Depending on their mode of action and their adverse effects, antidepressants are divided into different families: imipramine antidepressants, serotonin reuptake inhibitors, MAOIs (selective or non-selective). 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 the moral suffering and the fight against the inhibition which removes any will of action to the depressed. Sometimes there is a discrepancy between these two effects: the moral suffering can persist, while the capacity for action reappears. During this short period, the suicidal risk present in some depressed may be increased. The doctor takes this into account when prescribing (possible association with a tranquilizer) and this must be respected.


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


atropine
Drug whose effects are close to those of atropine. Atropinics fight spasms and diarrhea. The adverse effects of atropinic agents are: thickening of bronchial secretions, dryness of the mouth and mucous membranes, constipation, risk of blockage of urine and acute glaucoma attack in susceptible persons, disturbances of accommodation, abnormal sensitivity to light by dilation of the pupil. Taking several atropine drugs increases the risk of side effects. In case of overdose or accidental ingestion, the following signs may also appear: red and hot skin, fever, acceleration of breathing, drop or, on the contrary, rise in blood pressure, agitation, hallucinations, poor coordination of movements. Tell your doctor urgently or, if not, call 15, 112 or an emergency medical service.
In addition to atropine and its derivatives, other drugs have atropine effects: imipramine antidepressants, some antihistamines, antispasmodics, antiparkinsonian and neuroleptics.


depression
Disease most often associating 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 the increase of the pressure of the liquids contained in the eye (intraocular hypertension).
This general term covers two completely different affections:
  • Open-angle glaucoma or chronic glaucoma is the most common; it is usually symptom free, detected by measurement of intraocular pressure in the ophthalmologist. It does not cause an acute attack, and the treatment is essentially based on beta-blocker eye drops. People with open-angle glaucoma should not use cortisone derivatives without prior ophthalmic advice.
  • Angle-closure glaucoma or acute glaucoma is more rare. Between seizures, intraocular tension is normal. But the inadvertent use of atropine drugs (especially eye drops) causes an acute attack of intraocular hypertension that can permanently damage the retina in a few hours. It is an ophthalmological emergency that can be recognized by a brutally red eye, horribly painful, hard as a glass ball, and whose vision becomes blurred.
The angle referred to in these two affections is the iridocorneal angle. It is indeed between the iris and the cornea that the liquid evacuation system of the eye is located. A slightly open angle (closed) exposes to a total obstruction of the evacuation system. This obstruction can occur when the iris is open to the maximum (mydriasis) under the effect of an atropine drug: the iris then sticks to the cornea.
The contraindications for atropine medications only apply to people who have had an angle-closure glaucoma attack, or for whom an ophthalmologist has detected this risk. Those with chronic open angle glaucoma are not affected by these contraindications.


hypnotic
Drug causing sleep.
Synonym: sleeping pill.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of certain wastes, 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 dispose of waste or drugs. Advanced renal failure does not necessarily result in a decrease in the amount of urine eliminated. Only a blood test and the determination of creatinine can reveal this disease.


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


opiates
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.


sedative
  • Soothing, calm.
  • Medicines belonging to different families: anxiolytics, hypnotics, analgesics, antitussives, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative may be responsible for drowsiness and increase the effects of alcohol.

used for :

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