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MEMANTINE HYDROCHLORIDE ARCHIE SAMUEL 5 MG + 10 MG + 15 MG + 20 MG FILM-COATED TABLETS STARTER PACK

Active substance(s): MEMANTINE HYDROCHLORIDE

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Pharma code

Memantine hydrochloride
5 mg + 10 mg + 15 mg + 20 mg
Film-coated Tablets
Starter Pack
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.
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

1. What Memantine hydrochloride is and what it is used for
How does Memantine hydrochloride work
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.
What is Memantine hydrochloride used for
Memantine hydrochloride is used for the treatment of patients with moderate to
severe Alzheimer’s disease.

2. What you need to know before you take Memantine hydrochloride
Do NOT take Memantine hydrochloride:
• if you are allergic to memantine hydrochloride, peanut or soya 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.

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/using, have recently taken/used or
might take/use 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.

Memantine hydrochloride 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.
Women taking Memantine hydrochloride 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 contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal
product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not
take this medicinal product.

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

Package leaflet:
Information for the patient

Pharma code

The Memantine hydrochloride starter pack is only to be used for the beginning of
the treatment with Memantine hydrochloride.
Always take this medicine exactly as your doctor or pharmacist 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 hydrochloride dose during the first 3 weeks of
treatment. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (white, capsule shaped, biconvex, plain on one
side and embossed with “5” on the other side) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (white, capsule shaped, biconvex, with a break
score on one side and embossed with “10” on the other side) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (white, capsule shaped, biconvex, plain on one
side and embossed with “15” on the other side) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet once a day (white, capsule shaped, biconvex, with a break
score on one side and embossed with “20” on the other side) for 7 days.
week 1
week 2
week 3
week 4 and beyond

5 mg tablet
10 mg tablet
15 mg tablet
20 mg tablets once a day

Maintenance dose
The recommended daily dose is 20 mg 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.

Common (affects 1 to 10 users in 100):
• Headache, sleepiness, constipation, elevated liver function tests, dizziness,
balance disorders, shortness of breath, high blood pressure and drug
hypersensitivity.

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.

Uncommon (affects 1 to 10 users in 1,000):
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait,
heart failure and venous blood clotting (thrombosis/thromboembolism).

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 Memantine hydrochloride, 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 medicine, ask your doctor or
pharmacist.

4. 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.

Very Rare (affects less than 1 user in 10,000):
• 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 or pharmacist. This includes
any side effects not listed in this leaflet.

5. How to store Memantine hydrochloride
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 pack after EXP. The expiry date refers to the last day of that month.
HDPE bottles
Shelf life after first opening of the container: 6 months.
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
What Memantine hydrochloride contains
The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg or 10 mg or 15 mg or 20 mg of memantine
hydrochloride equivalent to 4.15 mg or 8.31 mg or 12.46 mg or 16.62 mg memantine.
The other ingredients are:
Tablet core
Cellulose microcrystalline, starch pregelatinised, lactose anhydrous, colloidal
anhydrous silica, magnesium stearate.
Coating
Polysorbate 80, polyvinyl alcohol, titanium dioxide, talc, soya lecithin, xanthan gum.
What Memantine hydrochloride looks like and contents of the pack
The 5 mg film-coated tablets are white, capsule shaped (9.6 x 4.54 mm), biconvex
tablets plain on one side and embossed with “5” on the other side.
The 10 mg film-coated tablets are white, capsule shaped (12.5 x 5.6 mm), biconvex
tablets with a break score on one side and embossed with “10” on the other side.
The 15 mg film-coated tablets are white, capsule shaped (14.0 x 6.0 mm), biconvex
tablets plain on one side and embossed with “15” on the other side.
The 20 mg film-coated tablets are white, capsule shaped (15.6 x 8.0 mm), biconvex
tablets with a break score on one side and embossed with “20” on the other side.
Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Film-coated Tablets
Starter Pack is available in packs with 28 (7 +7 +7 +7) film-coated tablets.
Marketing Authorisation Holder
Archie Samuel s.r.o., Slunná 16, 617 00 Brno, Czech Republic
Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen, Hungary
This leaflet was last revised in 04/2013
PL 35737/0010
Pharma code

3. How to take Memantine hydrochloride

10141-B
460 x160

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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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