Donormyl Doxylamine 15mg 10 dry film-coated tablets

In this manual :

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING DONORMYL 15 mg, scored film-coated tablet

3. HOW DO I TAKE DONORMYL 15 mg, scored film-coated tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO CONSERVE DONORMYL 15 mg, scored film-coated tablet?

6. ADDITIONAL INFORMATION

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

ANTIHISTAMINES FOR SYSTEMIC USE

This medicine is recommended for occasional insomnia in adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING DONORMYL 15 mg, scored film-coated tablet

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Never take DONORMYL 15 mg, scored film-coated tablet in the following cases:

- known allergy to antihistamines,

- history of acute glaucoma(increased pressure inside the eye),

- difficulty in urinating in men(of prostatic or other origin),

- in children under 15 years of age.

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

Take caution with DONORMYL 15 mg, scored film-coated tablet:

Special Warnings

Insomnia may have various causes that do not necessarily require medication.

This drug should be used with caution in the elderly because of the risk of drowsiness and/or dizziness which may lead to falls (e.g., when getting up at night), often with serious consequences in this population.

Due to the presence of lactose, this drug 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, may aggravate pre-existing sleep apnea syndrome (pauses in breathing during sleep).

Precautions for use

Alcohol is not recommended during treatment.

Inform your doctor in case of pregnancy.

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 YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Taking or using other medicines

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicine, including over-the-counter medicines.

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Not applicable.

Pregnancy

This medicine, under normal conditions of use, may be used during pregnancy. However, always ask your doctor's advice before use and never exceed the recommended dose.

Breastfeeding

It is possible that this medicine is passed on in breast milk. Because of its sedative or stimulating properties, which could affect your child (lethargy, loss of energy, or insomnia), this medicine is not recommended for use during breastfeeding.

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

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Driving and Use of Machinery

Attention is drawn to the daytime drowsiness and reduced alertness associated with the use of this drug.

Combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving a car or operating machinery.

If you do not get enough sleep, the risk of reduced alertness is even greater.

List of excipients with a notable effect: lactose.

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

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Dosage

RESERVED FOR ADULTS.

The recommended dosage is ½ 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 patients, the lower dosage is recommended.

Mode and route of administration

Take by mouth.

Swallow the tablet with a little water.

Frequency of administration

One dose per 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 have taken more DONORMYL 15 mg film-coated tablets than you should have, contact your doctor immediately:

Tell a doctor immediately.

If you forget to take DONORMYL 15 mg scored film-coated tablets:

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

Take your next dose at the usual time.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, DONORMYL 15 mg, scored film-coated tablet is likely to have side effects, although not everyone is subject to them.

- daytime somnolence,

- constipation,

- dry mouth,

- visual disturbances (accommodation disorders),

- heart palpitations.

If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE DONORMYL 15 mg, scored film-coated tablet

Keep out of the reach and sight of children.

Do not use DONORMYL 15 mg, scored film-coated tablet after the expiry date stated on the box.

No special storage precautions.

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does DONORMYL 15 mg, scored film-coated tablet contain?

The active substance is:

Doxylamine succinate ............................................................................................................... 15.00 mg

For one scored film-coated tablet.

Other components are:

Lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol 6000, dye dispersion.

What is DONORMYL 15 mg, scored film-coated tablet and what does it contain?

This medicine is presented as a scored film-coated tablet. Box of 10 tablets.

Holder

UPSA CONSEIL

3, rue Joseph Monier

92500 Rueil-Malmaison

Operator

UPSA CONSEIL

3, rue Joseph Monier

BP 325

92506 RUEIL-MALMAISON CEDEX

or

Manufacturer

BRISTOL-MYERS SQUIBB

979 avenue des Pyrenees

47520 LE PASSAGE

or

BRISTOL-MYERS SQUIBB

304 avenue du Docteur Bru

47000 AGEN

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The last date on which this package insert was approved was {date}.

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Detailed information on this medicinal product is available on the website of Afssaps (France).

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