Memantine ratiopharm
memantine
memantine hydrochloride
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.
What Memantine ratiopharm is and what it is used for
What you need to know before you take Memantine ratiopharm
How to take Memantine ratiopharm
Possible side effects
How to store Memantine ratiopharm
Contents of the pack and other information
Memantine ratiopharm contains the active substance memantine hydrochloride. It belongs to a group
of medicines known as 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 transmitting nerve signals important in learning and memory. Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of
this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Memantine ratiopharm
if you have a history of epileptic seizures.
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine
ratiopharm reassessed by your doctor on a regular basis.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
The use of medicinal products called
amantadine (for the treatment of Parkinson’s disease),
ketamine (a substance generally used as an anaesthetic),
dextromethorphan (generally used to treat cough) and
other NMDA-antagonists
at the same time should be avoided.
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any
other medicines.
In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants
If you go into hospital, let your doctor know that you are taking Memantine ratiopharm.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
If you are pregnant or breast-feeding, 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 in pregnant women is not recommended. Women taking Memantine ratiopharm should not breast-feed.
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Memantine ratiopharm may change your reactivity, making driving or operating machinery
inappropriate.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day. In
order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
week 1 | half a 10 mg tablet |
week 2 | one 10 mg tablet |
week 3 | one and a half 10 mg tablets |
week 4 and beyond | two 10 mg tablets once a day |
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week on, the usual dose is two tablets once a day (1x 20 mg).
The tablet can be divided into equal doses.
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In
this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Memantine ratiopharm should be administered orally once a day. To benefit from your medicine you
should take it regularly every day at the same time of the day.
The tablets should be swallowed with some water. The tablets can be taken with or without food.
Continue to take Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess
your treatment on a regular basis.
In general, taking too much Memantine ratiopharm should not result in any harm to you. You may
experience increased symptoms as described in section 4. “Possible side effects”.
If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next
dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. In general, the observed side effects are mild to moderate.
Common (affects 1 to 10 users in 100):
Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Uncommon (affects 1 to 10 users in 1,000):
Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Very Rare (affects less than 1 user in 10,000):
Seizures
Not known (frequency cannot be estimated from the available data):
Inflammation of the pancreas, inflammation of the liver (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.
If you get 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.
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 the blister pack after EXP. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicinal product does not require any special storage conditions.
Shelf life after first opening of the container: 6 months
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is memantine hydrochloride.
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
The other ingredients are:
Tablet core
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), 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), soya lecithin (E 322), xanthan gum (E 415).
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film- coated tablets.
Not all pack sizes may be marketed.
ratiopharm GmbH Graf-Arco-Straße 3
89079 Ulm
Germany
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373
UAB Teva Baltics
Tel: +370 52660203
Тева Фарма ЕАД
Тел: +359 24899585
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Teva Gyógyszergyár Zrt.
Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U.
Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300
Teva Santé
Tél: +33 155917800
ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland
Tel: +44 2075407117
Pliva Ljubljana d.o.o.
Tel: +386 15890390
Alvogen ehf.
Sími: +354 5222900
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB
Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117