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MEMANTINE TORRENT 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the user
Memantine 10 mg film-coated tablets
Memantine 20mg film-coated tablets
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.

How does Memantine work
Memantine 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 belongs to a group of medicines called NMDAreceptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve
signals and the memory.
What is Memantine used for
Memantine is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine
Do not take Memantine
if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed
in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking Memantine:
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
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.
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.
Children and adolescents
Memantine is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine may change the effects of the following medicines and their dose may need to
be adjusted by your doctor:

-

If you take more Memantine than you should

In general, taking too much Memantine 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, contact your doctor or get medical advice, as you may
need medical attention.
If you forget to take Memantine
Do not take a double dose to make up for a forgotten dose. If you find you have forgotten to take your
dose of Memantine, wait and take your next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects

What Memantine is and what it is used for
What you need to know before you take Memantine
How to take Memantine
Possible side effects
How to store Memantine
Contents of the pack and other information

1. What Memantine is and what it is used for

-

Duration of treatment
Continue to take Memantine as long as it is of benefit to you. Do not stop taking the tablets unless told to
do so by your doctor. If you stop taking this medicine, the benefits of your treatment will gradually fade
away. Your doctor should assess your treatment on a regular basis.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the observed side effects are mild to moderate.
However, Alzheimer’s disease in itself has been associated with depression, suicidal ideation and suicide.
These events have been also reported in patients treated with Memantine. You must tell your doctor
immediately if you notice that you are depressed or have thoughts about harming yourself.
Common side effects (may affect up to 1 in 10 people):

Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
shortness of breath, high blood pressure and drug hypersensitivity
Uncommon side effects (may affect up to 1 in 100 people):

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and
venous blood clotting (thrombosis/thromboembolism)
Very Rare side effects (may affect up to 1 in 10,000 people):

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

Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.
5. How to store Memantine
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 after EXP. The
expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
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 to protect the environment.
6. Contents of the pack and other information
What Memantine contains
The active substance is memantine hydrochloride.
Each 10 mg film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg
memantine.
Each 20 mg film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg
memantine.
The other ingredients are microcrystalline cellulose, crospovidone (Type B), colloidal anhydrous
silica, talc, magnesium stearate, hypromellose, macrogol 400, titanium dioxide [E 171].
Additional colorants in the 20 mg coating are ferric oxide yellow [E 172] and ferric oxide red [E 172]
What Memantine looks like and contents of the pack
Memantine 10 mg film-coated tablets are white to off-white colored, oval shaped, approx. 13.0 x 5.5 mm,
biconvex, bevel edged, film coated tablets, debossed ‘10’ on one side and score line on other side. The
tablet can be divided into equal doses.
Memantine 20 mg film-coated tablets are pale red to grey red colored, oval shaped, approx. 15.3 x 6.2
mm, biconvex, bevel edged, film coated tablets, debossed ‘20’ on one side and plain on other side.
Memantine film-coated tablets are available in blister packs of 28, 30, 42, 50, 56, 98 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
Email: drugsafety@torrentpharma.co.uk

If you go into hospital, let your doctor know that you are taking Memantine.

This medicinal product is authorised in the Member States of the EEA under the following names:

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.

DE

The use of memantine in pregnant women is not recommended.
Women taking Memantine should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also,
Memantine may change your reactivity, making driving or operating machinery inappropriate.
3. How to take Memantine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure. Memantine can be taken with or without food.
Dosage
The recommended dose of Memantine for adults and elderly 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
week 2
week 3
week 4 and beyond

5 mg once a day
10 mg once a day
15 mg once a day
20 mg once a day

The usual starting dose is 5 mg once a day for the first week. This is increased to 10 mg once a day in the
second week and to 15 mg once a day in the third week. From the fourth week on, the usual dose is 20
mg once a day.
Maintenance dose
The recommended daily dose is 20 mg once a day.
For continuation of the treatment please consult your doctor.
Dosage in patients with impaired kidney function
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.
Method of administration
Memantine should be taken 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.

Memantin Heumann 10 mg Filmtabletten
Memantin Heumann 20 mg Filmtabletten
EL Memantin Torrent 10 mg επικαλυµµένα µε λεπτό υµένιο δισκία
Memantin Torrent 20 mg επικαλυµµένα µε λεπτό υµένιο δισκία
LT Memantinas Torrent 10 mg plėvele dengtos tabletės
Memantinas Torrent 20 mg plėvele dengtos tabletės
RO Memantina Torrent 10 mg comprimate filmate
Memantina Torrent 20 mg comprimate filmate
UK Memantine Torrent 10 mg Film-coated Tablets
Memantine Torrent 20 mg Film-coated Tablets
This leaflet was last revised in 02/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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