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?
Pharmacotherapeutic class
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
List of information needed before taking the medicine
Not applicable.
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.
Precautions for use; special warnings
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.
Interactions with other medicines
Taking or using other medicines
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This medicine contains an antihistamine called doxylamine.
Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended dose (see Dosage).
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Talk to your doctor or pharmacist if you are taking or have recently taken any other medicine, including over-the-counter medicines.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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.
Not applicable.
Effects on the ability to drive or use machines
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 known effect
List of excipients with a notable effect: lactose.
3. HOW TO TAKE DONORMYL 15 mg, scored film-coated tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
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.
Symptoms and instructions in case of overdose
If you have taken more DONORMYL 15 mg film-coated tablets than you should have, contact your doctor immediately:
Tell a doctor immediately.
Instructions in case of missed doses
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.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of 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.
If necessary, warnings against certain visible signs of deterioration
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
Full list of active ingredients and excipients
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.
Pharmaceutical form and content
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.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
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
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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