MEMANTINA DOC GENERICI

PACKAGE LEAFLET: INFORMATION FOR THE USER

MEMANTINA DOC Generici 10 mg film-coated tablets, 20 mg film-coated tablets

Medicinal product subject to medical prescription
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MEMANTINA DOC Generici is and what it is used for
2. What you need to know before taking MEMANTINA DOC Generici
3. How to take MEMANTINA DOC Generici
4. Possible side effects
5. How to store MEMANTINA DOC Generici
6. Contents of the pack and other information

1. What MEMANTINA DOC Generici is and what it is used for

How MEMANTINA DOC Generici works
MEMANTINA DOC Generici belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to impaired transmission of messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors involved in the transmission of nerve signals important for learning and memory. MEMANTINA DOC Generici belongs to a group of medicines known as NMDA receptor antagonists. MEMANTINA DOC Generici acts on these NMDA receptors, improving the transmission of nerve signals and memory.

What MEMANTINA DOC Generici is used for
MEMANTINA DOC Generici is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you should know before taking MEMANTINA DOC Generici

Do not take MEMANTINA DOC Generici

• if you are allergic (hypersensitive) to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking MEMANTINA DOC Generici

• if you have a history of epileptic seizures
• if you have recently had a myocardial infarction (heart attack) or if you suffer from congestive heart failure or uncontrolled high blood pressure. In these cases, treatment must be closely monitored and the clinical benefits of MEMANTINA DOC Generici should be regularly reassessed by your doctor.

If you have renal impairment (kidney problems), your doctor must carefully monitor renal function and, if necessary, adjust memantine dosage accordingly.
Avoid concomitant use of medicinal products such as amantadine (used to treat Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.

Children and adolescents
MEMANTINA DOC Generici is not recommended for children and adolescents under 18 years of age.

Other medicines and MEMANTINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of the following medicines may be altered by MEMANTINA DOC Generici, and dose adjustment may be necessary:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat epileptic seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental disorders)
• oral anticoagulants.

If you are admitted to hospital, inform medical staff that you are taking MEMANTINA DOC Generici.

MEMANTINA DOC Generici with food and drinks
Talk to your doctor if you have recently changed or plan to substantially change your diet (e.g. from a normal diet to a strictly vegetarian diet), or if you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the structure that carries urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy or breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of MEMANTINA DOC Generici in pregnant women is not recommended.
Women taking MEMANTINA DOC Generici must not breastfeed.

Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your condition.
Furthermore, MEMANTINA DOC Generici may affect your reaction time, making it inadvisable to drive vehicles or operate machinery.

MEMANTINA DOC Generici contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take MEMANTINA DOC Generici

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose of MEMANTINA DOC Generici for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually according to the following daily dosing schedule:
Week 1: Half a 10 mg tablet
Week 2: 10 mg
Week 3: One and a half 10 mg tablets
Week 4 and onwards: 20 mg

The recommended starting dose is 5 mg of memantine once daily during the first week. This dose is increased to 10 mg of memantine once daily in the second week, and to 15 mg of memantine once daily in the third week. From the fourth week onwards, the usual dose is 20 mg of memantine once daily.

MEMANTINA DOC Generici 10 mg film-coated tablets may be divided into equal doses.

Dosage in patients with reduced renal function
If you have reduced kidney function, your doctor may decide on a dosage regimen suitable for your condition. In such cases, regular monitoring of kidney function should be arranged by your doctor.

Administration
MEMANTINA DOC Generici should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Swallow the tablets with some water. The tablets may be taken with or without food.

Duration of treatment
Continue taking MEMANTINA DOC Generici for as long as you benefit from it. Your doctor will review your treatment at regular intervals.

If you take more MEMANTINA DOC Generici than you should

• In general, an overdose of MEMANTINA DOC Generici is not harmful. However, a greater number of symptoms described in section 4 "Possible side effects" may occur.
• In case of a significant overdose of MEMANTINA DOC Generici, contact your doctor, as medical intervention may be required.

If you forget to take MEMANTINA DOC Generici

• If you forget to take a dose, take the next dose at your usual scheduled time.
• Do not take a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In general, the side effects observed are mild to moderate.

Common (affects up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and venous blood clotting (thrombosis/thromboembolism).

Very rare (affects up to 1 in 10,000 people):

• Seizures.

Not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, inflammation of the liver (hepatitis), and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with MEMANTINA DOC Generici.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MEMANTINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MEMANTINA DOC Generici contains

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10/20 mg of memantine hydrochloride, equivalent to 48.31/16.62 mg of memantine.
• The other components are: Core of the film-coated tablet: microcrystalline cellulose, crospovidone Type A, talc, and magnesium stearate. Coating of the 10 mg film-coated tablets: (Opadry II White 33G28435): hypromellose 6cP, titanium dioxide (E171), monohydrate lactose, macrogol 3350, and triacetin. Coating of the 20 mg film-coated tablets: (Opadry II Pink 33G240000): hypromellose 6cP, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin, and red and yellow iron oxides (E172).

Description of the appearance of MEMANTINA DOC Generici and contents of the pack
MEMANTINA DOC Generici 10 mg: white, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm, with a break line and "M10" engraved on one side of the break line. The tablet can be divided into two equal parts.
MEMANTINA DOC Generici 20 mg: dark pink, oval-shaped, biconvex film-coated tablet, 12.6 mm x 7 mm, with "M20" engraved on one side.
Pack sizes
Film-coated tablets are available in blisters of 28 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici Srl, Via Turati, 40 - 20121 Milan, Italy.
Responsible manufacturer for batch release
Actavis Ltd, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Denmark Memantinhydrochlorid DOC Generici
Italy Memantina DOC Generici
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