DOXYLAMINE 15MG SANDOZ 10 DRY FILM TABLETS

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

For occasional insomnia in adults.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet?

What you need to know before taking DOXYLAMINE SANDOZ CONSEIL

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,
• history of acute glaucoma(increased pressure inside the eye),
• difficulty in urinating in men(of prostatic or other origin),
• children under 15 years of age.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet:

Special warnings

Insomnia may have a variety of causes, not necessarily requiring 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.

Like any hypnotic or sedative, doxylamine hydrogensuccinate 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.

This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other drugs

Taking or using other medicines

If you are takingor have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

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.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Driving vehicles and using machines

Attention is drawn to the diurnal drowsiness and reduced vigilance 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

Important information on certain ingredients of DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet :

This medicine contains lactose.

3. HOW DO I 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

FOR ADULTS ONLY.

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 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 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 CONSEIL 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 CONSERVE DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet?

Keep out of sight and reach of children.

Expiration date

Do not use DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet after the expiration date stated on the box and tube after "EXP". The expiry date refers to the last day of that month.

Storage conditions

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 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 contents

What is DOXYLAMINE DOXYLAMINE SANDOZ CONSEIL 15 mg, scored film-coated tablet and contents of packaging

This medicine takes the form of 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 marketing authorization holder and manufacturing authorization holder responsible for batch release, if different

Holder

sandoz

49 avenue georges pompidou

92593 levallois-perret cedex