MEMANTINE RATIOPHARM 5 mg + 10 mg + 15 mg + 20 mg FILM-COATED TABLETS
How to use MEMANTINE RATIOPHARM 5 mg + 10 mg + 15 mg + 20 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Patient Information Leaflet
Memantina ratiopharm 5mgfilm-coated tablets EFG
Memantina ratiopharm 10mgfilm-coated tablets EFG
Memantina ratiopharm 15mgfilm-coated tablets EFG
Memantina ratiopharm 20mg film-coated tablets EFG
Memantine hydrochloride
Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What Memantina ratiopharm is and what it is used for
- What you need to know before you take Memantina ratiopharm
- How to take Memantina ratiopharm
- Possible side effects
- Storage of Memantina ratiopharm
- Contents of the pack and other information
1. What Memantina ratiopharm is and what it is used for
How it worksMemantina ratiopharm
Memantina ratiopharm belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of important nerve signals in learning and memory. Memantina ratiopharm belongs to a group of medicines called NMDA receptor antagonists. Memantina ratiopharm acts on these receptors, improving the transmission of nerve signals and memory.
What it is used forMemantina ratiopharm
Memantina ratiopharm is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before you take Memantina ratiopharm
Do not takeMemantina ratiopharm:
- if you are allergic to memantine hydrochloride, peanuts or soy or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Memantina ratiopharm:
- if you have a history of epileptic seizures.
- if you have recently had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled hypertension (high blood pressure).
In these situations, treatment should be carefully supervised and your doctor should regularly reassess the clinical benefit of Memantina ratiopharm.
If you have renal insufficiency (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.
The use of memantine should be avoided with other medicines such as
- amantadine (for the treatment of Parkinson's disease),
- ketamine (a medicine usually used as an anesthetic),
- dextromethorphan (a medicine for the treatment of cough) and
- other NMDA antagonists.
Children and adolescents
Memantina ratiopharm is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Memantina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, the administration of Memantina ratiopharm may produce changes in the effects of the following medicines, so your doctor may need to adjust the dose:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
- hydrochlorothiazide (or any combination with hydrochlorothiazide)
- anticholinergics (substances usually used to treat movement disorders or intestinal spasms)
- anticonvulsants (substances used to prevent and eliminate convulsions)
- barbiturates (substances usually used to induce sleep)
- dopaminergic agonists (substances such as L-dopa, bromocriptine)
- neuroleptics (substances used in the treatment of mental illnesses)
- oral anticoagulants
If you are hospitalized, inform your doctor that you are taking Memantina ratiopharm.
Taking Memantina ratiopharm with food and drinks
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urinary tract), as your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of memantine is not recommended in pregnant women.
Women taking Memantina ratiopharm should stop breastfeeding.
Driving and using machines
Your doctor will inform you if your illness allows you to drive and use machines safely.
Memantina ratiopharm may also alter your reaction ability, so driving or operating machinery may be inappropriate.
Memantina ratiopharm contains lactose and soy lecithin
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.
3. How to take Memantina ratiopharm
The Memantina ratiopharm starter pack should only be used at the beginning of treatment with Memantina ratiopharm.
Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Dosage
The recommended dose is 20 mg per day, which is achieved by gradual dose increments of Memantina ratiopharm during the first 3 weeks of treatment. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 9.6 x 4.54 mm, smooth on one side and with the number "5" embossed on the other) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 12.5 x 5.6 mm, with a break line on one side and with the number "10" embossed on the other) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 14.0 x 6.0 mm, smooth on one side and with the number "15" embossed on the other) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 15.6 x 8.0 mm, with a break line on one side and with the number "20" embossed on the other) for 7 days.
Week 1 | 5 mg tablet |
Week 2 | 10 mg tablet |
Week 3 | 15 mg tablet |
Week 4 and subsequent | 20 mg tablet once a day |
Maintenance dose
The recommended daily dose is 20 mg once a day. For continued treatment, consult your doctor.
Dosage for patients with renal insufficiency
If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantina ratiopharm should be taken orally once a day. To get the most out of your medication, you should take it every day and at the same time.
The tablets should be swallowed with a little water. The tablets can be taken with or without food.
Duration of treatment
Continue taking Memantina ratiopharm as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantina ratiopharm than you should
- Generally, taking an excessive amount of Memantina ratiopharm should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".
- If you take an overdose of Memantina ratiopharm, contact your doctor or seek medical advice, as you may need medical attention.
If you forget to take Memantina ratiopharm
- If you realize that you have forgotten to take your dose of Memantina ratiopharm, wait and take the next dose at the usual time.
- Do not take a double dose to make up for forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Memantina ratiopharm can cause side effects, although not everybody gets them.
In general, side effects are classified from mild to moderate.
Common (affects 1 to 10 of every 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (affects 1 to 10 of every 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.
Rare (affects less than 1 in every 10,000 patients):
- Seizures.
Frequency not known (frequency cannot be estimated from the available data):
- Pancreatitis, 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 memantine.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Memantina ratiopharm
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 pack after EXP. The expiry date refers to the last day of the month shown.
Do not store above 25°C.
Medicines should 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
Composition of Memantina ratiopharm
- The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg of memantine.
Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
Each film-coated tablet contains 15 mg of memantine hydrochloride, equivalent to 12.46 mg of memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
- The other ingredients are:
Core of the tablet
Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), anhydrous lactose, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Coating
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soy lecithin (E 322), xanthan gum (E 415).
Appearance of the product and pack contents
The 5 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (9.6 x 4.54 mm), smooth on one side and with the number "5" embossed on the other.
The 10 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (12.5 x 5.6 mm), with a break line on one side and with the number "10" embossed on the other.
The 15 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (14.0 x 6.0 mm), smooth on one side and with the number "15" embossed on the other.
The 20 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (15.6 x 8.0 mm), with a break line on one side and with the number "20" embossed on the other.
Memantina ratiopharm is available in packs of 28 (7 + 7 + 7 + 7) film-coated tablets.
Marketing authorisation holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
HBM Pharma s.r.o.
Slabinská 30, 03680 Martin
Slovakia
You can request more information about this medicine from the local representative of the marketing authorisation holder:
Belgium Teva Pharma Belgium N.V./S.A./AG Tel: +32 3 820 73 73 | Lithuania UAB “Sicor Biotech” Tel: +370 5 266 0203 |
Bulgaria ?????????????? Te?: +359 2 489 95 82 | Luxembourg ratiopharm GmbH Germany Tel: +49 731 402 02 |
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 | Hungary Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00 |
Denmark Teva Denmark A/S Tlf: +45 44 98 55 11 | Malta Teva Pharmaceuticals Ireland Ireland Tel: +353 51 321 740 |
Germany ratiopharm GmbH Tel: +49 731 402 02 | Netherlands Teva Nederland B.V. Tel: +31 800 0228 400 |
Estonia UAB “Sicor Biotech” Eesti filial Tel: +372 661 0801 | Norway ratiopharm AS Tlf: +47 66 77 55 90 |
Greece Teva ???????.?.?.? ?????: +30 210 72 79 099 | Austria ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 0 |
Spain ratiopharm España, S.A. Tel: +34 91 567 29 70 | Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00 |
France Teva Santé Tél: +33 1 55 91 78 00 | Portugal ratiopharm, Comércio e Indústria de Produtos Farmacêuticos, Lda Tel: +351 21 476 75 50 |
Croatia Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000 | Romania Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24 |
Ireland Teva Pharmaceuticals Ireland Tel: +353 51 321740 | Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390 |
Iceland Medical ehf. Sími: +354 534 3500 | Slovakia TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11 |
Italy Teva Italia S.r.l. Tel: +39 02 89 17 98 1 | Finland ratiopharm Oy Puh/Tel: +358 20 180 5900 |
Cyprus Teva ???????.?.?.?, ??????? ?????: +30 210 72 79 099 | Sweden Teva Sweden AB Tel: +46 42 12 11 00 |
Latvia UAB “Sicor Biotech” filiale Latvija Tel: +371 673 23 666 | United Kingdom Teva UK Limited Tel: +44 1977 628500 |
Date of last revision of this leaflet:<{MM/AAAA}><{month AAAA}>
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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