Memantine Orion

Package Leaflet: Information for the User

Memantine Orion, 10 mg coated tablets

Memantine Orion, 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 package 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What is Memantine Orion and what is it used for

Memantine Orion contains the active substance memantine hydrochloride. It belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals that are important for learning and memory.
Memantine Orion belongs to a group of medicines called NMDA receptor antagonists.
Memantine Orion works by improving the transmission of nerve signals and memory.
Memantine Orion is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Memantine Orion

When not to take Memantine Orion

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

Warnings and precautions

Before taking Memantine Orion, discuss with your doctor or pharmacist:

• if you have ever had seizures (fits or convulsions);
• if you have recently experienced a heart attack (myocardial infarction) or have heart failure, or have uncontrolled high blood pressure. In these situations, treatment should be carried out under close medical supervision, with regular evaluation of the clinical effects of treatment.

During treatment with memantine, your doctor should regularly monitor your kidney function and, if necessary, adjust the dose of the medicine.
Avoid taking other medicines such as amantadine (for Parkinson's disease), ketamine (an anesthetic), dextromethorphan (for cough), and other NMDA receptor antagonists.

Children and adolescents

Do notgive Memantine Orion to children and adolescents under 18 years of age.

Memantine Orion with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.
In particular, taking Memantine Orion may affect the action of, and may require dose adjustment by your doctor, the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic agents (substances used to treat gastrointestinal disorders or their spasms);
• antiepileptic drugs (substances used to prevent and interrupt seizures);
• barbiturates (substances used mainly as sedatives);
• dopaminergic agonists (substances such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants.

If you are hospitalized, inform your doctor that you are taking Memantine Orion.

Memantine Orion with food and drink

Tell your doctor if you have recently changed your diet (e.g., switched from a normal diet to a strict vegetarian diet) or have been diagnosed with renal tubular acidosis (excessive concentration of acidic substances in the blood due to kidney dysfunction) or severe urinary tract infections (structures through which urine flows). In these cases, your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeedingIf you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do nottake memantine if you are pregnant.
Breastfeeding
Women taking Memantine Orion should not breastfeed.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive or use machines safely. Memantine Orion may also affect your reaction speed, making it inadvisable to drive or use machines.

3. How to take Memantine Orion

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

Dose

The recommended dose of Memantine Orion for adults and the elderly is 20 mg once daily. To reduce the risk of side effects, the dose of the medicine should be increased gradually, according to the following scheme:
Week 1 (days 1-7):
Take half a 10 mg coated tablet (5 mg) once daily for 7 days.
Week 2 (days 8-14):
Take one 10 mg coated tablet (10 mg) once daily for 7 days.
Week 3 (days 15-21):
Take one and a half 10 mg coated tablets (15 mg) once daily for 7 days.
From week 4 (days 22-28 and onwards):
Take two 10 mg coated tablets (20 mg) or one 20 mg coated tablet once daily for 7 days.

Maintenance dose

The recommended maintenance dose is 20 mg once daily.
To continue treatment, consult your doctor.

Dose in patients with renal impairment

In patients with impaired renal function, the dose of the medicine is determined by the doctor.
In such cases, regular monitoring of renal function is necessary, at intervals determined by the doctor.

Method of administration

Memantine Orion should be taken orally, once daily. To ensure the effectiveness of treatment, the medicine should be taken regularly, at the same time every day. The tablets should be swallowed with water.
The tablets can be taken with or without food.

Duration of treatment

Treatment should be continued as long as it is effective. Your doctor will regularly assess the effectiveness of treatment.

Overdose of Memantine Orion

• Generally, taking too much Memantine Orion does not pose a risk to health. However, increased symptoms as described in section 4 "Possible side effects" may occur.
• In case of significant overdose of Memantine Orion, contact your doctor or another doctor, as appropriate treatment may be necessary.

Missed dose of Memantine Orion

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

If you have any further questions about taking 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.
Generally, the observed side effects are mild to moderate.
Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, increased liver enzyme levels, dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 10,000 people):

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with Memantine Orion.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memantine Orion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Store in the original package to protect from light.
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 Memantine Orion contains

• The active substance is memantine hydrochloride. Each 10 mg coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each 20 mg coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients are: microcrystalline cellulose, crospovidone (type B), colloidal anhydrous silica, talc, magnesium stearate, hypromellose 2910, macrogol 400, titanium dioxide (E 171).
• The additional coloring agents in the coating of the 20 mg tablets are yellow iron oxide (E 172) and red iron oxide (E 172).

What Memantine Orion looks like and contents of the pack

Memantine Orion 10 mg coated tablets are white to almost white, oval, biconvex, film-coated tablets with a size of approximately 13.0 x 5.5 mm, with the imprint "10" on one side and a break line on the other side. The tablet can be divided into equal doses.
Memantine Orion 20 mg coated tablets are light red to reddish, oval, biconvex, film-coated tablets with a size of approximately 15.3 x 6.2 mm, with the imprint "20" on one side and a smooth surface on the other side.
Memantine Orion is available in blister packs (PVC/PVDC/Aluminum).
Pack sizes: 28, 30, 50, 56, 98, or 100 tablets in a cardboard box.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Manufacturer/Importer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: