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MEMANTINE HYDROCHLORIDE LUPIN 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Memantine hydrochloride 10 mg film-coated tablets
Memantine hydrochloride 20 mg film-coated tablets
Memantine hydrochloride 5mg + 10mg + 15mg + 20mg
film-coated tablets, titration pack
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. See section 4.
What is in this leaflet
1. What Memantine tablets are and what they are used for
2. What you need to know before you take Memantine tablets
3. How to take Memantine tablets
4. Possible side effects
5. How to store Memantine tablets
6. Contents of the pack and other information
1. What Memantine tablets are and what they are used for
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
NMDA-receptors improving the transmission of nerve signals
and the memory.
• Memantine tablets are used for the treatment of patients
with moderate to severe alzheimer’s disease.
2. What you need to know before you take Memantine tablets.
Do not take Memantine tablets:
- if you are allergic to memantine hydrochloride or any of
the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor or pharmacist before
taking Memantine tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine
tablets.
- you have a history of epileptic seizures
- 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 should be
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.
Other medicines and Memantine tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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.

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 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 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 this medicine exactly as your doctor has told you.
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.
The treatment scheme is also indicated on the treatment
initiation pack where you take one tablet per day.
week 1 (day 1-7)
half a 10 mg tablet (5mg)
week 2 (day 8-14)
one 10 mg tablet (10mg)
week 3 (day 15-21) one and a half 10 mg tablets (15mg)
week 4 and beyond two 10 mg tablets once a day (20mg)
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 tablets once a day
in the third week. From the fourth week on, the usual dose is 2
tablets once a day (1x 20 mg).
Maintenance dose
The recommended daily dose is 20mg 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 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.
The 10mg and 20mg tablet can be divided into equal doses.
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
- In general, taking too many 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, this medicine can cause side effects,
although not everybody gets them.
If you notice any effects such as seizures, suicidal ideation
and suicidal thoughts, speak to your doctor or pharmacist
immediately.
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 disorder, 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)

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 tablets.
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 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 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.
Do not store above 25oC. Protect from light. Store in the
original package.
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 tablets contains
- The active substance is memantine hydrochloride. Each
film-coated tablet contains either 5mg, 10mg, 15mg or
20mg memantine hydrochloride equivalent to 4.15mg,
8.31mg, 12.46mg or 16.62mg memantine.
- The other ingredients are microcrystalline cellulose,
silica, colloidal anhydrous, croscarmellose sodium,
talc, magnesium stearate all in the tablet core; and
hypromellose, macrogol 400 and titanium dioxide (E171)
all in the tablet coating.
- Additional for the 15mg tablets, Iron Oxide yellow (E172)
in the tablet coating.
- Additional for the 20mg tablets, Red Iron Oxide (E172) in
the tablet coating.
What Memantine tablets look like and contents of the pack
Memantine 5mg tablets are white to off white coloured, capsule
shaped, biconvex, film-coated tablets, debossed with “5” on
one side and plain on the other side.

Memantine 10mg tablets are white to off white coloured, oval
shaped, film-coated tablets, debossed with “10” on one side
and breakline on the other side.
Memantine 15mg tablets are mustard yellow coloured, oval
shaped, film-coated tablets, debossed with “15” on one side
and plain on the other side.
Memantine 20mg tablets are brownish pink coloured, oval
shaped, film-coated tablets, debossed with “20” on one side
and breakline on the other side
Memantine 10mg and 20mg tablets can be divided into equal
doses.
Contents of the pack
Memantine 10mg and 20mg film-coated tablets are available
in blister packs containing either 7, 10, 14 or 20 tablets per
blister strip.
Pack sizes of 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98,
98 x 1, 100, 100 x 1, 112, 840 (20 x 42), 980 (10 x 98) or 1000
(20 x 50) tablets are presented.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated
tablets are presented in unit dose blister.
Treatment initiation pack containing 5mg, 10mg, 15mg and
20mg tablets are available in blister packs contains 28 filmcoated tablets in PVC/Al blisters with 7 film-coated tablets of
5mg, 7 film-coated tablets of 10mg, 7 film-coated tablets of
15mg and 7 film-coated tablets of 20mg tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Ltd
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF, UK
The leaflet was last approved in September 2013.
Code No. GO/DRUGS/654

ID#: 233750

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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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