In this manual :
1. WHAT IS DONORMYL 15 mg, scored film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT DO I HAVE TO 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
For occasional insomnia in adults.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DONORMYL 15 mg, scored film-coated tablet?
List of information you should know before taking DONORMYL
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.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with DONORMYL 15 mg, scored film-coated tablet:
Special warnings
Insomnia can have a variety of causes, and does not necessarily require medication.
This drug should be used with caution in the elderly, due to the risk of drowsiness and/or dizziness, which can 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 cases of galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic disorders).
Like any hypnotic or sedative, doxylamine succinate may aggravate pre-existing sleep apnea syndrome (pauses in breathing during sleep).
Precautions for use
Do not drink alcohol during treatment.
Tell your doctor if you are pregnant.
In the event of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he/she can adjust the dosage.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medicines
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This medicine contains an antihistamine, 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 medication, including over-the-counter products.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy
Under normal conditions of use, this product may be used during pregnancy. However, always seek your doctor's advice before use, and never exceed the recommended dose.
Breast-feeding
This drug may be excreted in breast milk. In view of its sedative or stimulant properties, which may 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 ability to drive vehicles or use machines
Driving vehicles and using machines
Please note 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.
Insufficient sleep increases the risk of reduced alertness.
List of excipients: 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
FOR ADULTS ONLY.
The recommended dosage is ½ to 1 tablet per day for adults.
In adults, the dosage may be increased to 2 tablets per day if necessary.
In elderly patients and patients with impaired renal or hepatic function, the lower dosage is recommended.
Method and route of administration
Take by mouth.
Swallow the tablet with a little water.
Frequency of administration
Take once a day, in the evening, 15 to 30 minutes before bedtime.
Duration of treatment
Treatment lasts from 2 to 5 days.
Do not exceed 5 days' treatment without your doctor's advice.
Symptoms and instructions in case of overdose
If you have taken more DONORMYL 15 mg, scored film-coated tablet than you should have:
Tell a doctor immediately.
Instructions in case of missed dose(s)
If you forget to take DONORMYL 15 mg, scored film-coated tablet:
Do not take a double dose to make up for the one 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 undesirable 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 CONSERVE 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 expiration date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete 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 contents
What is DONORMYL 15 mg, scored film-coated tablet and what does it contain?
This medicine comes in the form of a scored film-coated tablet. Box of 10 tablets.
Name and address of the marketing authorization holder and of the manufacturing authorization 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
Drug names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this drug is available on the Afssaps (France) website.
Information reserved for healthcare professionals
Not applicable.
Not applicable.
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