Doxylamine 15mg Mylan Viatris 10 film-coated scored tablets

In this manual :

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

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

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

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

6. ADDITIONAL INFORMATION

1. WHAT IS DOXYLAMINE MYLAN 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 MYLAN 15 mg, scored film-coated tablet?

List of information required before taking the medicine

Not applicable.

Contraindications

Never take DOXYLAMINE MYLAN 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

Take special care with DOXYLAMINE MYLAN 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 elderly patients, 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

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.

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

List of excipients: lactose.

3. HOW DO I TAKE DOXYLAMINE MYLAN 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 DOXYLAMINE MYLAN 15 mg, scored film-coated tablet than you should have:

Seek medical advice immediately.

Instructions in case of missed dose(s)

If you forget to take DOXYLAMINE MYLAN 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 MYLAN 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 MYLAN 15 mg, scored film-coated tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use DOXYLAMINE MYLAN 15 mg, scored film-coated tablet after the expiration date stated on the box.

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 does DOXYLAMINE MYLAN 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 DOXYLAMINE MYLAN 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.