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MEMANTINE 20 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Review - 4

P15xxxx
Memantine 10 mg film-coated tablets
Memantine 20 mg film-coated tablets
Memantine hydrochloride

TEMP

P15xxxx
Memantine 10 mg film-coated tablets
Memantine 20 mg film-coated tablets
Memantine hydrochloride

60 mm

TEMP

Pharmacode position can change as per
Supplier’s m/c requirement & additional small
pharma code may appear on the front/back panel

Memantine - UK - Leaflet

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

Package leaflet: Information for the user

Memantine 10 mg film-coated tablets
Memantine 20 mg 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, pharmacist or nurse.
• 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.







anticonvulsants (substances used to prevent and relieve seizures).

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).
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.

Memantine 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
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.

What Memantine is and what it is used for

Women taking Memantine should not breast-feed.

How does Memantine work

Driving and using machines

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 NMDA-receptor antagonists.
Memantine acts on these NMDA-receptors improving the transmission of nerve
signals and the memory.

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 or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

What is Memantine used for

Dosage
The recommended dose of Memantine for adults and elderly patients is 20 mg
once a day.

Memantine is used for the treatment of patients with moderate to severe
Alzheimer’s disease.

Do not take Memantine
• if you are allergic to memantine hydrochloride or any of the other ingredients
of this medicine (listed in section 6).

week 1
week 2
week 3
week 4 and beyond

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Memantine:

half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg tablet
two 10 mg tablets or one 20 mg tablet once a day

The usual starting dose is half a 10 mg tablet once a day (5 mg) for the first week.
This is increased to one 10 mg tablet once a day (10 mg) in the second week and
to 1 and a half 10 mg tablet once a day 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 (20 mg).

• 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).

At the beginning of treatment you will start by using 5 mg once a day. This dose
will be increased weekly by 5 mg until the recommended (maintenance) dose is
reached. The recommended maintenance dose is 20 mg once a day, which is
reached at the beginning of the 4th week.

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.

Dosage in patients with impaired kidney function

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.

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 is not recommended for children and adolescents under the age of
18 years.

Memantine 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.

Administration

Other medicines and Memantine

The tablets can be taken with or without food.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Duration of treatment
Continue to take Memantine as long as it is of benefit to you. Your doctor should
assess your treatment on a regular basis.

5 mm

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5 mm

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In order to reduce the risk of side effects this dose is achieved gradually by the
following daily treatment scheme. For up-titration other tablet strengths are
available.

What you need to know before you take Memantine

10 mm

Black
5 mm

Size: 210 x 360 mm

2.

amantadine, ketamine, dextromethorphan.

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

What is in this leaflet:
1. What Memantine is and what it is used for
2. What you need to know before you take Memantine
3. How to take Memantine
4. Possible side effects
5. How to store Memantine
6. Contents of the pack and other information
1.







Memantine - UK - Leaflet

Review - 4

60 mm

If you take more Memantine than you should

Memantine tablets are available in clear PVC/PE/PVDC/Aluminium lidding foil
blisters.

• 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.

Blister pack:
10 mg: 1, 10, 28, 30, 50, 56, 98, 100 and 112 tablets
20 mg: 10, 28, 30, 42, 56 and 98 tablets
Not all pack sizes may be marketed.

If you forget to take Memantine

Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay,
Dublin 2,
Ireland.

• If you find you have forgotten to take your dose of Memantine, 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,
pharmacist or nurse.
4.

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
In general, the observed side effects are mild to moderate.

This leaflet was last revised in 09/2014

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).
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.
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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
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: 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

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, label
and the blister after EXP. The expiry date refers to the last day of that month.

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Font size: 9 pt.

This medicinal product does not require any special storage conditions.
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

The active substance is memantine hydrochloride. Each tablet contains 10 mg
/20 mg of memantine hydrochloride equivalent to 8.31 mg /16.62 mg Memantine.
The other ingredients are:
Tablet core: Silica colloidal anhydrous, cellulose, microcrystalline, silicified
microcrystalline cellulose, sodium starch glycolate, talc, sodium stearyl fumarate.
Tablet film-coat: Hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron
oxide yellow (E 172) for 20 mg, iron oxide red (E 172) for 20 mg.
What Memantine looks like and contents of the pack
Film-coated tablet.

Size: 210 x 360 mm

Memantine 10 mg film-coated tablets:
White to off-white, centrally tapered oblong, biconvex, film-coated tablets with a
single break line on both sides and debossed with ‘Z’ and ‘03’ on either side of
break line on one side and plain on other side. The tablet can be divided in equal
doses.
Memantine 20 mg film-coated tablets:
Pale-red to grey-red, oval oblong, film-coated tablets debossed with ‘Z’ on one
side arid ‘06’ on other side.

5 mm

Outer line not to be printed.
5 mm

10 mm

Black
5 mm

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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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