Biomentin

Package leaflet: Information for the patient

Biomentin
10 mg, coated tablets
Biomentin
20 mg, coated tablets
Memantini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet:

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

1. What Biomentin is and what it is used for

What Biomentin is
Biomentin belongs to a group of medicines used to treat dementia.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses (signals) carrying information in the brain. In the brain there are so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in transmitting nerve signals important for learning and memory processes. Biomentin belongs to a group of medicines known as NMDA receptor antagonists (these are compounds that block the activation of these receptors). By acting on NMDA receptors, Biomentin improves the transmission of nerve impulses and enhances memory function.

What Biomentin is used for
Biomentin is used in the treatment of patients with moderate to severe Alzheimer's disease.

2. Important information before using Biomentin

When not to use Biomentin

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

Warnings and precautions
Before starting treatment with Biomentin, discuss this with the treating physician or
pharmacist:

• if the patient has previously experienced epileptic seizures;
• if the patient has recently had a myocardial infarction (heart attack) or suffers from congestive heart failure or uncontrolled hypertension (high blood pressure).

In the above situations, treatment with Biomentin should be carried out under strict supervision
of the treating physician, who should regularly assess the effects of the therapy.
If memantine is used in patients with impaired renal function (kidney problems),
the treating physician should closely monitor kidney function and, if necessary,
adjust the dosage of the medicine accordingly.
Concomitant use of the following medicines should be avoided: amantadine (used to treat
Parkinson's disease), ketamine (a general anaesthetic) and dextromethorphan (a cough suppressant),
as well as other medicines belonging to the NMDA antagonist group.
Children and adolescents
Biomentin is not recommended for use in children and adolescents under 18 years of age.
Biomentin and other medicines
Inform the treating physician or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient intends to take.
In particular, treatment with Biomentin may affect the action of the following
medicines (and may necessitate dosage adjustments by the treating physician):

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen (muscle relaxants acting on skeletal muscles);
• cimetidine, ranitidine (medicines used in peptic ulcer disease, heartburn and indigestion), procainamide, quinidine (medicines used in cardiac arrhythmias), quinine (a medicine used in malaria), nicotine (used in smoking cessation therapy);
• hydrochlorothiazide (and all medicines containing hydrochlorothiazide) – a medicine used in hypertension;
• anticholinergic agents (substances usually used in the treatment of movement disorders or intestinal spasms);
• anticonvulsant medicines (substances used to prevent and stop convulsive seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used in the treatment of psychiatric disorders);
• oral anticoagulants (e.g. warfarin) – blood-thinning medicines.

If hospitalization occurs, inform the physician that the patient is taking Biomentin.
Biomentin with food and drink
Inform the treating physician if the patient has recently made or plans to make
significant changes in dietary habits (e.g. switching from a normal diet to a strict
vegetarian diet), or if the patient has been diagnosed with renal tubular acidosis (RTA; excessive levels of acidic substances in the blood due to impaired kidney function) or severe urinary tract infection (structures through which urine flows). In such cases, dosage adjustment of the medicine by the treating physician may be necessary.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a physician or pharmacist before using this medicine.
Administration of Biomentin during pregnancy is not recommended.
Women taking Biomentin should not breastfeed.
Driving and operating machinery
The treating physician should inform the patient whether their condition allows them to safely
drive vehicles or operate machinery.
Biomentin may adversely affect reaction speed; therefore, driving
vehicles or operating machinery may be contraindicated.
Biomentin contains lactose (a sugar found in milk). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a physician before taking Biomentin.
Biomentin contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium in the maximum daily dose, meaning that the medicine is considered "sodium-free".

3. How to use Biomentin

This medicine should always be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist.
Dosage
Biomentin 10 mg
The recommended dose of Biomentin for adults and elderly patients is 20 mg once daily (two 10 mg tablets). To minimize the risk of adverse effects, the dose should be increased gradually according to the following schedule:

1. Week: half a 10 mg tablet once daily
2. Week: one 10 mg tablet once daily
3. Week: one and a half 10 mg tablets once daily
4. Week and onwards: two 10 mg tablets once daily

Biomentin 20 mg
Biomentin 20 mg is recommended exclusively as a maintenance dose and may be used in adults and elderly patients starting from the fourth week of treatment. One 20 mg tablet should be taken once daily.
Dosage in patients with renal impairment
Dosage in patients with impaired kidney function should be determined by the treating physician according to the patient's condition. In such cases, regular monitoring of kidney function at specified intervals, as recommended by the treating physician, is essential.
Dosage in patients with hepatic impairment
In patients with mild or moderate hepatic impairment, dosage adjustment is not required. Biomentin should not be used 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. Use of Biomentin in children and adolescents under 18 years of age is not recommended.
Method of administration
Biomentin should be taken orally once daily. For effective treatment, the medicine should be taken regularly at the same time each day. Film-coated tablets should be swallowed whole with water. The tablets may be taken with food or independently of meals.
The tablet may be divided into two equal doses.
Duration of treatment
Treatment should be continued as long as the medicine provides therapeutic benefits and no unacceptable adverse effects occur. The course of treatment should be regularly evaluated by the treating physician.
Use of a higher than recommended dose of Biomentin
Generally, taking an excessive dose of Biomentin does not pose a health risk. However, intensified symptoms described in section 4, "Possible adverse effects," may occur.
In case of significant overdose of Biomentin, contact the treating physician or another doctor, as specific treatment may become necessary.
Missed dose of Biomentin
Do not take a double dose to make up for a missed dose.
If a patient forgets to take a dose of Biomentin, the next dose should be taken at the usual time.
Discontinuation of Biomentin
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Observed adverse reactions are generally mild to moderate in severity.
Observed adverse reactions are listed below according to their frequency of occurrence:

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

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

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

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

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

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

Depression, suicidal thoughts, and suicide attempts occur frequently in the course of Alzheimer's disease. These events have also been observed in patients treated with memantine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Biomentin

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

6. Contents of the packaging and other information

What Biomentin contains

• The active substance is memantine hydrochloride.

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

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide
anhydrous, talc, magnesium stearate.
Tablet coating: polymethacrylic 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 packaging
Biomentin is a white, round, biconvex coated tablet with a score line on one side. The tablet can be divided into two equal doses.
Biomentin is available in the following pack sizes:
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 Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]