1. WHAT IS DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ANTIHISTAMINES FOR SYSTEMIC USE
Therapeutic indications
This medicine is recommended for occasional insomnia in adults.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film coated tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Contraindications
Never take DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet in the following cases:
- known allergy to antihistamines,
- a history of acute glaucoma(increased pressure inside the eye),
- difficulty in urinating in men(prostatic or other),
- in children under 15 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Be careful with DOXYLAMINE SANDOZ CONSEIL 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.
Doxylamine hydrogen 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 the event of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he can adjust the dosage.
The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacistif youare taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and use of machines
Attention is drawn to the daytime drowsiness and reduced alertness associated with the use of this medicine.
Combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving a car or operating machinery.
If the sleep duration is insufficient, the risk of reduced alertness is further increased.
List of excipients with a known effect
Important information about some ingredients of DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet
This medicine contains lactose.
3. HOW TO TAKE DOXYLAMINE SANDOZ CONSEIL 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
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.
Symptoms and instructions in case of overdose
If you have taken more than DOXYLAMINE SANDOZ CONSEIL 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 DOXYLAMINE SANDOZ If you forget to take doxylamine sandoz 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, DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet is likely to have undesirable effects, although not everyone is subject to them.
- daytime drowsiness,
- 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 USE DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet
Keep out of sight and reach of children.
Expiry date
Do not use DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet after the expiry date stated on the box and tube after "EXP". The expiry date refers to the last day of that month.
Conditions of storage
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 protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What it contains DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet
The active substance is:
Doxylamine hydrogen succinate .............................................................................................. 15.00 mg
For one scored film-coated tablet.
The other components are:
Core :
Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film coating :
Hypromellose (E464), talc, titanium dioxide (E171), macrogol 6000, propylene glycol.
Pharmaceutical form and content
What is DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet and contents of the pack
This medicine is presented as a white to approximately white, oblong, biconvex, scored film-coated tablet with a break-off bar.
The tablet can be divided into equal doses.
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
sandoz
49 avenue georges pompidou
92593 levallois-perret cedex
Français
English
