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MEMANTINE HYDROCHLORIDE ZENTIVA 20MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the patient
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Memantine hydrochloride 10 mg film-coated tablets
Memantine hydrochloride 20 mg film-coated tablets
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.
What is in this leaflet:
1. What memantine hydrochloride is and what it is used for
2. What you need to know before you take memantine hydrochloride
3. How to take memantine hydrochloride
4. Possible side effects
5. How to store memantine hydrochloride
6. Contents of the pack and other information

The name of your medicine is Memantine
Hydrochloride Film-Coated Tablets (referred to as
memantine hydrchloride throughout this leaflet).
Memantine hydrochloride is used for the treatment of
patients with moderate to severe Alzheimer’s disease.
Memantine hydrochloride 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 hydrochloride belongs to a group of
medicines called (NMDA)-receptor antagonists.
Memantine hydrochloride acts on these
(NMDA)-receptors improving the transmission of
nerve signals and the memory.
2. What you need to know before you take
memantine hydrochloride

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Do not take memantine hydrochloride
- if you are allergic to memantine hydrochloride or
any of the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
memantine hydrochloride
- 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
hydrochloride reassessed by your doctor on a regular
basis.
You should inform your doctor 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 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.

Children and adolescents
Memantine hydrochloride is not recommended for
children and adolescents under the age of 18 years.
Other medicines and memantine hydrochloride
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular, memantine hydrochloride 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 hydrochloride.
Memantine hydrochloride with food, drink and
alcohol
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), as
your doctor may need to adjust the dose of your
medicine.
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
or pharmacist for advice before taking this medicine.
The use of memantine hydrochloride in pregnant
women is not recommended.
Women taking this medicine 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 hydrochloride may change your reactivity,
making driving or operating machinery inappropriate.
Memantine Hydrochloride Film-Coated Tablets
contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before
taking this medicine.
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1. What memantine hydrochloride is and what it is
used for

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3. How to take memantine hydrochloride

Dosage
The recommended dose of memantine hydrochloride
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 (5 mg)
one 10 mg tablet (10 mg)
one and a half 10 mg tablet (15 mg)
two 10 mg tablets once a day or one
20 mg tablet (20 mg)

Reporting of side effects
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 Yellow card Scheme at:
www.mhra.gov.uk/yellowcard.

The usual starting dose is a half of 10 mg tablet once a
day (1 × 5 mg) for the first week. This is increased to 
one 10 mg tablet once a day (1 × 10 mg) in the
second week and to one and a half 10 mg tablet once
a day (1 × 15 mg) in the third week. From the fourth
week on, the usual dose is two 10 mg tablets or one
20 mg tablet once a day (1 × 20 mg).

By reporting side effects you can help provide more
information on the safety of this medicine.

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.

Do not use this medicine after the expiry date which
is stated on the carton after (EXP). The expiry date
refers to the last day of that month.

Duration of treatment
Continue to take memantine hydrochloride as long as
it is of benefit to you. Your doctor should assess your
treatment on a regular basis.
If you take more memantine hydrochloride than
you should
- In general, taking too much memantine
hydrochloride 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 this medicine contact
your doctor or get medical advice, as you may need
medical attention.
If you forget to take memantine hydrochloride
- If you find you have forgotten to take your dose of
memantine hydrochloride, 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, this medicine can cause side
effects, although not everybody gets them.

This medicinal product does not require any special
storage conditions.
Keep this medicine out of the sight and reach of children.

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.
6. Contents of the pack and other information
What Memantine Hydrochloride Film-Coated Tablets
contains
The active substance is memantine hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline
cellulose, silica colloidal anhydrous, talc, magnesium
stearate.
Tablet film-coating: hypromellose (E464), titanium
dioxide (E171), macrogol 400 (E1521).
What Memantine Hydrochloride Film-Coated Tablets
looks like and contents of the pack
Memantine hydrochloride 10mg film-coated tablets:
10 mg breakable film-coated tablets.
White to off-white, capsule shaped film coated tablets
with length approx. 11.1±0.2 mm and width
approx.5.1±0.2 mm, with break line on both sides.
Memantine hydrochloride 20mg film-coated tablets:
20mg breakable film-coated tablets.
White to off-white, capsule shaped film-coated tablets
with length approx.13.30±0.2 mm and width approx.
7.2±0.2 mm, having “SNAP TAB” score line on one side
and break line on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride 10 mg film-coated tablets:
PVC/Aluminium blister tablet container containing 14,
28, 30, 42, 45, 50, 56, 60, 84, 90, 98, 100 and 112 film
coated tablets.
Memantine hydrochloride 20 mg film-coated tablets:
PVC/Aluminium blister tablet container containing 14,
28, 30, 42, 45, 50, 56, 60, 84, 90, 98, 100 and 112 film
coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS,
UK
Manufacturer
Zentiva S.A., 50 Theodor Pallady Blvd., 032266,
Bucharest, Romania
This leaflet was last revised in
October 2013.

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170 x 290
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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.
Uncommon (may affect up to 1 in 100 people):
• Tiredness, fungal infections, confusion,
hallucinations, vomiting, abnormal gait, heart
failure and venous blood clotting
(thrombosis/thromboembolism).

5. How to store memantine hydrochloride

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Administration
Memantine hydrochloride 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.

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Alzheimer’s disease has been associated with
depression, suicidal ideation and suicide. These events
have been reported in patients treated with
memantine hydrochloride.

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Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Very rare (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.

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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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