Biomentin

Package Leaflet: Information for the Patient

Biomentin

10 mg, coated tablets

Biomentin

20 mg, coated tablets

Memantine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Biomentin and what is it used for
• 2. Important information before taking Biomentin
• 3. How to take Biomentin
• 4. Possible side effects
• 5. How to store Biomentin
• 6. Contents of the pack and other information

1. What is Biomentin and what is it used for

What is Biomentin

Biomentin belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses
(signals) that carry information in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors,
which are involved in the transmission of nerve signals important for the learning process and for memory processes.
Biomentin belongs to a group of medicines called NMDA receptor antagonists (these are compounds that block the stimulation
of these receptors). By affecting NMDA receptors, Biomentin improves the transmission of nerve impulses and facilitates memory.

What is Biomentin used for

Biomentin is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Biomentin

When not to take Biomentin

Warnings and precautions

Before starting treatment with Biomentin, discuss it with your doctor or pharmacist:

In these situations, treatment with Biomentin should be carried out under the close supervision of the attending physician,
who should regularly assess the effects of the therapy.
If memantine is used in patients with impaired renal function (kidney problems), the attending physician should closely monitor renal function
and, if necessary, adjust the dosage of the medicine.
It is recommended to avoid taking medicines such as: amantadine (used to treat Parkinson's disease), ketamine (a general anesthetic)
and dextromethorphan (an antitussive) and other NMDA receptor antagonists.

Children and adolescents

Biomentin is not recommended for children and adolescents under 18 years of age.

Biomentin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, the use of Biomentin may affect the action of the following medicines (and may require a change in their dosage by the doctor):

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen (muscle relaxants);
• cimetidine, ranitidine (medicines used for stomach ulcers, heartburn, and indigestion), procainamide, quinidine (medicines used for heart rhythm disorders), quinine (a medicine used for malaria), nicotine (used to treat tobacco addiction);
• hydrochlorothiazide (and all medicines containing hydrochlorothiazide) - a medicine used for high blood pressure;
• anticholinergic agents (substances used to treat movement disorders or intestinal cramps);
• antiepileptic drugs (substances used to prevent and stop seizures);
• barbiturates (substances used mainly as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants (e.g., warfarin) - blood thinners.

In the event of hospitalization, inform your doctor that you are taking Biomentin.

Biomentin with food and drink

Tell your doctor if you have recently changed your diet (e.g., switched to a strict vegetarian diet) or have been diagnosed with renal tubular acidosis (RTA; excessive blood acidification due to impaired kidney function)
or severe urinary tract infections (structures through which urine passes). In such cases, it may be necessary to adjust the dosage of the medicine by the doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Biomentin should not be used during pregnancy.
Women taking Biomentin should not breastfeed.

Driving and using machines

Your doctor should inform you whether your illness allows you to drive and use machines safely.
Biomentin may adversely affect your reaction speed, making it inadvisable to drive or operate machinery.
Biomentin contains lactose(a sugar found in milk). If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking Biomentin.
Biomentin contains sodium.This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which means that the medicine is considered "sodium-free".

3. How to take Biomentin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Biomentin 10 mg
The recommended dose of Biomentin for adults and the elderly is 20 mg once a day (two 10 mg tablets). To minimize the risk of side effects, the dose should be increased gradually, according to the following scheme:

• 1. week: half a 10 mg tablet once a day
• 2. week: one 10 mg tablet once a day
• 3. week: one and a half 10 mg tablets once a day
• 4. week and subsequent: two 10 mg tablets once a day

Biomentin 20 mg
Biomentin 20 mg is recommended only as a maintenance dose and may be used in adults and the elderly from the beginning of the fourth week of treatment. In this case, one 20 mg tablet should be taken once a day.

Dosage in patients with renal impairment

In patients with impaired renal function, the dose is determined by the doctor, depending on the patient's condition. In such cases, regular monitoring of renal function is necessary, at intervals specified by the doctor.

Dosage in patients with hepatic impairment

In patients with mild or moderate hepatic impairment, no dose adjustment is necessary. The use of Biomentin is not recommended in patients with severe hepatic impairment.

Use in children and adolescents

The safety and efficacy of memantine in children and adolescents have not been established. The use of Biomentin in children and adolescents under 18 years of age is not recommended.

Method of administration

Biomentin should be taken orally, once a day. To ensure the effectiveness of the treatment, the medicine should be taken regularly, at the same time every day. The coated tablets should be swallowed and washed down with water. The tablets can be taken with or without food.
The tablet can be divided into two equal doses.

Duration of treatment

Treatment should be continued for as long as the medicine produces positive therapeutic effects and no unacceptable side effects occur. The course of treatment should be regularly assessed by the doctor.

Overdose of Biomentin

Generally, taking too much Biomentin does not pose a risk to health. However, intensified side effects may occur, as described in section 4. "Possible side effects".
In the event of significant overdose of Biomentin, contact your doctor or another doctor, as appropriate treatment may be necessary.

Missed dose of Biomentin

Do not take a double dose to make up for a missed dose.
If you forget to take a dose of Biomentin, take the next dose at the usual time.

Stopping treatment with Biomentin

If you have any further 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 everybody gets them.
The observed side effects are usually mild to moderate.
The observed side effects are listed according to their frequency:

• Common (occurring in 1 to 10 out of 100 patients):

• Headache, drowsiness, constipation, increased liver enzyme activity, dizziness, balance disorders, shallow breathing, high blood pressure, hypersensitivity (allergy) to the medicine.

Uncommon (occurring in 1 to 10 out of 1,000 patients):

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

Rare (occurring in 1 to 10 out of 10,000 patients):

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

In the course of Alzheimer's disease, depression, suicidal thoughts, and suicides are also common. These events have also been observed in patients treated with memantine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Biomentin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP:". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Biomentin contains

• The active substance is memantine hydrochloride.

Biomentin 10 mg
Each coated tablet contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg of memantine).
Biomentin 20 mg
Each coated tablet contains 20 mg of memantine hydrochloride (equivalent to 16.62 mg of memantine).

• The other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, talc, magnesium stearate.
Coating: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%; sodium lauryl sulfate, polysorbate 80, talc, triacetin, simethicone.

What Biomentin looks like and contents of the pack

Biomentin is a white, round, biconvex, coated tablet with a dividing line on one side. The tablet can be divided into two equal doses.
Biomentin is available in packs of:
Biomentin, 10 mg
14, 28, 30, 56, 60, or 90 coated tablets.
Biomentin, 20 mg
7, 10, 14, 28, 30, 56, 60, or 90 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
biofarm@biofarm.pl

Date of last revision of the leaflet: