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MEMANTINE HYDROCHLORIDE 10MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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2. BEFORE YOU TAKE MEMANTINE TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantine hydrochloride 10 mg film-coated
tablets
Read all of this leaflet carefully before you start taking this
medicine
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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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet
1.
2.
3.
4.
5.
6.

What Memantine Tablets are and what are they used for
Before you take Memantine Tablets
How to take Memantine Tablets
Possible side effects
How to store Memantine Tablets
Further information

1. WHAT MEMANTINE TABLETS IS AND WHAT IT IS
USED FOR
How does Memantine Tablets work
Memantine Tablets belongs to a group of medicines known as antidementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance of
message signals in the brain. The brain contains so-called N-methylD-aspartate (NMDA)-receptors that are involved in transmitting
nerve signals important in learning and memory. Memantine Tablets
belongs to a group of medicines called NMDA-receptor antagonists.
Memantine Tablets acts on these NMDA-receptors improving the
transmission of nerve signals and the memory.
What is Memantine Tablets used for
Memantine Tablets is used for the treatment of patients with
moderate to severe Alzheimer's disease.

Do not take Memantine Tablets
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if you are allergic (hypersensitive) to memantine or any of the other
ingredients of Memantine film-coated tablets (see section 6).

Take special care with Memantine Tablets
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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 Tablets 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 Tablets is not recommended for children and adolescents
under the age of 18 years.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
In particular, Memantine Tablets 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 Tablets.
Taking Memantine Tablets with food and drink
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Tell your doctor if you are pregnant or planning to become pregnant.
The use of memantine in pregnant women is not recommended.
Women taking Memantine Tablets 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 Tablets may change your reactivity, making
driving or operating machinery inappropriate.
3. HOW TO TAKE MEMANTINE TABLETS
Always take Memantine Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Memantine Tablets 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

half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg tablet
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 1 and a half tablet once a day in the third week. From the
fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).

vomiting, abnormal gait, heart failure and venous blood clotting
(thrombosis/thromboembolism)

Other strengths and presentations of memantine are available.
Dosage in patients with impaired kidney function

Very Rare: may affect up to 1 in 10,000 people
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Seizures

Not known: frequency cannot be estimated from the available data

Administration

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Memantine Tablets 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.

Alzheimer's disease has been associated with depression, suicidal
ideation and suicide. These events have been reported in patients
treated with Memantine Tablets.

Duration of treatment
Continue to take Memantine Tablets as long as it is of benefit to you.
Your doctor should assess your treatment on a regular basis.
If you take more Memantine Tablets than you should
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In general, taking too much Memantine Tablets 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 Tablets, contact your
doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine Tablets
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Inflammation of the pancreas, inflammation of the liver
(hepatitis) and psychotic reactions

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
http://www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.
5. HOW TO STORE MEMANTINE TABLETS

Do not use Memantine Tablets 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.
This medicinal product does not require any special storage
conditions.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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 to protect the environment.

4. POSSIBLE SIDE EFFECTS
6. FURTHER INFORMATION
Like all medicines, Memantine Tablets can cause side effects,
although not everybody gets them.
In general, the observed side effects are mild to moderate.
Common: may affect up to 1 in 10 people
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Headache, sleepiness, constipation, elevated liver function tests,
dizziness, balance disorders, shortness of breath, high blood
pressure and drug hypersensitivity

Uncommon: may affect up to 1 in 100 people
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Tiredness, fungal infections, confusion, hallucinations,

Memantine Tablets are available in blister packs of 28 tablets,
56 tablets, 98 tablets and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB, United Kingdom
Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom

Keep out of the reach and sight of children.

If you find you have forgotten to take your dose of Memantine
Tablets, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

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This tablet can be divided into equal halves.

What Memantine Tablets contains
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 Silicified microcrystalline cellulose,
Croscarmellose Sodium, Talc and Magnesium stearate, all in the
tablet core; and Hypromellose (E464), Titanium dioxide (E171) and
Macrogol 400, all in the tablet coating.

PL 34771/0159
This medicinal product is authorized in the member states of the
EEA under the following names:
Portugal:
Germany:

Memantina Macleods
Memantin hydrochlorid Macleods 10 mg
filmtabletten
Italy:
Memantina Macleods
Spain:
Memantina clorhidrato Macleods 10 mg
comprimidos recubiertos con película
United Kingdom: Memantine hydrochloride 10 mg film-coated
tablets
This leaflet was last revised in {02/2015}.

PM01684302

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.

What Memantine Tablets looks like and contents of the pack
Memantine Tablets are presented as white to off white, capsule
shape, film coated tablet debossed with 'CL 29' on one side and
breakline on both sides (approximate size 12.1 x 5.1mm).

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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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