Memantine orion

Package leaflet: Information for the user

Memantine Orion, 10 mg coated tablets
Memantine Orion, 20 mg coated tablets
Memantine hydrochloride
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Memantine Orion is and what it is used for
2. What you need to know before you take 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 Memantine Orion is and what it is used for

Memantine Orion contains the active substance memantine hydrochloride. It belongs to a group of medicines called anti-dementia drugs.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses that carry information in the brain. In the brain there are receptors known as N-methyl-D-aspartate (NMDA) receptors, which are involved in transmitting nerve signals important for learning and memory processes.
Memantine Orion belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Memantine Orion improves the transmission of nerve impulses and memory.
Memantine Orion is used in the treatment of adult patients with moderate to severe Alzheimer's disease.

2. Important information before using Memantine Orion

When not to use Memantine Orion

• 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 Memantine Orion, discuss this with your doctor or pharmacist:

• if the patient has previously experienced epileptic seizures;
• if the patient has recently suffered a myocardial infarction (heart attack) or suffers from congestive heart failure or uncontrolled hypertension (high blood pressure). In the above situations, treatment should be carried out under strict medical supervision, with the doctor regularly assessing the clinical effects of therapy.

During administration of memantine to patients with renal impairment (kidney problems),
the treating physician should carefully monitor kidney function and, if necessary,
adjust the dosage of the medicine accordingly.
Concomitant use of the following drugs should be avoided: amantadine (used in the treatment of Parkinson's disease), ketamine (an anaesthetic), dextromethorphan (used to treat cough), as well as other drugs belonging to the group of NMDA antagonists.
Children and adolescents
It is not recommended to administer Memantine Orion to children and adolescents under 18 years of age.
Memantine Orion and other medicines
You must inform your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
In particular, treatment with Memantine Orion may lead to changes in the effects of, and may necessitate dose adjustments by the treating physician for the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic agents (substances usually used in the treatment of gastrointestinal motility disorders or intestinal spasms);
• anticonvulsant drugs (substances used to prevent or stop epileptic 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.

If hospitalised, you must inform the doctor that the patient is taking Memantine Orion.
Memantine Orion with food and drink
You should inform the treating physician if the patient has recently made or plans to make significant changes in diet (e.g. switching from a normal diet to a strict vegetarian diet), or if the patient has been diagnosed with renal tubular acidosis (excessive concentration of acidic substances in the blood caused by kidney dysfunction (impaired kidney function)) or severe urinary tract infections (structures through which urine passes). In the above cases, the treating physician may need to modify the dosage of the medicine.
Pregnancy and breastfeeding If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
It is not recommended to administer memantine to pregnant women.
Breastfeeding
Women taking Memantine Orion should not breastfeed.
Driving and operating machinery
The treating physician will advise the patient whether the disease allows him or her to drive or operate machinery safely. Memantine Orion may additionally affect reaction speed, making driving or operating machinery inadvisable.

3. How to use Memantine Orion

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantine Orion for adults and elderly patients is 20 mg once daily. To reduce the risk of adverse effects, the dose should be increased gradually according to the following schedule:
Week 1 (days 1-7):
Take half a 10 mg coated tablet (5 mg) daily for 7 days.
Week 2 (days 8-14):
Take one 10 mg coated tablet (10 mg) daily for 7 days.
Week 3 (days 15-21):
Take one and a half 10 mg coated tablets (15 mg) daily for 7 days.
From week 4 onwards (days 22-28 and onwards):
Take two 10 mg coated tablets (20 mg) or one 20 mg coated tablet daily for 7 days.

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

Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage of the medicinal product should be determined by the treating physician.
In such cases, continuous monitoring of kidney function at regular intervals, as directed by the treating physician, is necessary.

Method of administration
Memantine Orion tablets should be taken orally once daily. For effective treatment, the medicinal product should be taken regularly every day at the same time. Tablets should be swallowed with water.
The tablets may be taken with food or independently of meals.

Duration of treatment
Treatment should be continued as long as beneficial effects are observed. The treating physician should regularly assess the course of therapy.

Use of a higher than recommended dose of Memantine Orion

• In general, administration of an excessively high dose of Memantine Orion does not usually pose a health hazard. However, the symptoms described in section 4, "Possible side effects", may be intensified.
• In case of significant overdose of Memantine Orion, contact your treating physician or another doctor, as appropriate management may become necessary.

Missed dose of Memantine Orion

• If a patient forgets to take the medicinal product, they should take the next dose at the usual time.
• A double dose should not be taken to make up for the missed dose.

If you have any further doubts regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Generally observed side effects are mild to moderate in severity.

Common (may affect up to 1 in 10 people):

• Headache, somnolence, 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 (venous thrombosis/embolism).

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

• Seizures.

Unknown 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 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 side effects helps to provide more information on the safety of the 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 stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the specified month.
Store in the original packaging in order to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each 20 mg film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• Other components of the medicine are: microcrystalline cellulose, crospovidone (type B), colloidal anhydrous silica, talc, magnesium stearate, hypromellose 2910, macrogol 400, titanium dioxide (E 171).
• Additional colouring 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 film-coated tablets 10 mg are white to almost white, oval, biconvex film-coated tablets with bevelled edges, approximately 13.0 x 5.5 mm in size, embossed with "10" on one side and a division line on the other. The tablet can be divided into equal doses.
Memantine Orion film-coated tablets 20 mg are light red to grey-red, oval, biconvex film-coated tablets, approximately 15.3 x 6.2 mm in size, embossed with "20" on one side and smooth on the other.
Memantine Orion is available in blister packs (PVC/PVDC/Aluminium).
Pack sizes: 28, 30, 50, 56, 98 or 100 tablets in a cardboard box.

Marketing Authorisation 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

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]