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MEMANTINE HYDROCHLORIDE 10MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE / MEMANTINE HYDROCHLORIDE / MEMANTINE HYDROCHLORIDE

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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
-

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 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 Tablets belongs to a group of medicines called
NMDA-receptor antagonists. Memantine Tablets acts on these NMDAreceptors 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.
2. BEFORE YOU TAKE MEMANTINE TABLETS
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

Taking Memantine Tablets with food and drink

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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 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.

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

Using other medicines

Your doctor will tell you whether your illness allows you to drive and to use
machines safely.

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.

Also, Memantine Tablets may change your reactivity, making driving or
operating machinery inappropriate.

In particular, Memantine Tablets may change the effects of the following
medicines and their dose may need to be adjusted by your doctor:

3. HOW TO TAKE MEMANTINE TABLETS

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.

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).

Other strengths and presentations of memantine are available.

Uncommon: may affect up to 1 in 100 people

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.

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

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.
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
-

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.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
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
·

Headache, sleepiness, constipation, elevated liver function tests,
dizziness, balance disorders, shortness of breath, high
blood pressure and drug hypersensitivity

·

Seizures

Not known: frequency cannot be estimated from the available data
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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 Tablets.
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
Keep out of the reach and sight of children.
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.

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).
This tablet can be divided into equal halves.
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
PL 34771/0159
This medicinal product is authorized in the member states of the EEA
under the following names:

6. FURTHER INFORMATION

Memantina Macleods
Memantin hydrochlorid Macleods 10 mg filmtabletten
Acomema
Memantina clorhidrato Macleods 10 mg comprimidos
recubiertos con película
United Kingdom: Memantine hydrochloride 10 mg film-coated tablets

What Memantine Tablets contains

This leaflet was last revised in {05/2017}.

This medicinal product does not require any special storage conditions.
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.

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.

Portugal:
Germany:
Italy:
Spain:

PM01684304

Administration

Tiredness, fungal infections, confusion, hallucinations, vomiting,
abnormal gait, heart failure and venous blood clotting (thrombosis/
thromboembolism)

Expand Transcript

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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