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MEMANTINE HYDROCHLORIDE LUPIN 5MG + 10MG + 15MG+ 20MG FILM-COATED TABLETS

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

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55 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Memantine hydrochloride Lupin 5mg + 10mg + 15mg + 20mg
film-coated tablets, titration pack
Memantine hydrochloride

251628

40 mm

40 mm

Memantine hydrochloride Lupin
5mg + 10mg + 15mg + 20mg
film-coated tablets, titration pack

4247

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 NMDAreceptors 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 treatment dose of 20 mg per day is achieved by a gradual
increase of the Memantine dose during the first 3 weeks of treatment. The
treatment scheme is also indicated on the treatment initiation pack. Take one
tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (white to off-white, capsule shaped) for 7
days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (white to off-white, oval shaped) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (mustard coloured, oval shaped) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet per day (brownish pink coloured, oval shaped) for 7
days.
week 1
week 2
week 3 )
week 4 and beyond

5 mg tablet
10 mg tablet
15 mg tablet
20 mg tablet

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 medicines 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, filmcoated tablets, debossed with “10” on one side and breakline on the other
side.
Memantine 15mg tablets are mustard yellow coloured, oval shaped, filmcoated tablets, debossed with “15” on one side and plain on the other side.
Memantine 20mg tablets are brownish pink coloured, oval shaped, filmcoated 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 film-coated tablets in PVC/Al blisters
with 7 film-coated tablets of 5mg, 7 film-coated tablets of 10mg, 7 filmcoated 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 revised in April 2017.
Code No. GO/DRUGS/654

ID#: 251628

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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