In this manual :
1. WHAT IS DOXYLAMINE MYLAN 15 mg, scored film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD 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
This medicine is recommended for occasional insomnia in adults.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOXYLAMINE MYLAN 15 mg, scored film-coated tablet
List of information needed 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 to urinate in men(of prostatic or other origin),
- 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 MYLAN 15 mg, scored film-coated tablet:
Special Warnings
Insomnia can have various causes that do not necessarily require medication.
This drug should be used with caution in elderly patients, due to the risk of drowsiness and/or dizziness which may lead to falls (e.g. when getting up at night), with often 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 diseases).
Doxylamine succinate, like any hypnotic or sedative, may aggravate pre-existing sleep apnea syndrome (pauses in breathing during sleep).
Precautions for use
Alcohol intake is strictly forbidden 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 drugs
Taking or using other medications
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This medication 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 medications.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication, under normal conditions of use, can be used during pregnancy. However, always ask your doctor's advice before using it and never exceed the recommended dose.
Breastfeeding
The passage of this drug in the breast milk is possible. Because of its sedative or exciting properties that could affect your child (lethargy, loss of energy, or insomnia), this medication is not recommended when 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 Machinery
Attention is drawn to the diurnal drowsiness and reduced vigilance associated with the use of this drug.
The association with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving or using machines.
If the duration of sleep is insufficient, the risk of reduced vigilance is further increased.
List of excipients with a known effect
List of excipients with a notorious effect: lactose.
3. HOW TO 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
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
Oral route.
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 DOXYLAMINE MYLAN 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 MYLAN 15 mg scored film-coated tablet
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, 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 USE 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.
Conditions of storage
No particular precautions for storage.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medication. This 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.
The other components are:
Lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol 6000, dye dispersion.
Pharmaceutical form and content
What is DOXYLAMINE MYLAN 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.
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