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MEMANTINE HYDROCHLORIDE ARCHIE SAMUEL 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Memantine hydrochloride 10 mg
Film-coated Tablets
Package leaflet: Information for the patient

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:

Pharma code 332
First bar is 105mm from the top edge of the 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
If you go into hospital, let your doctor know that you are
taking Memantine hydrochloride.
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.

3

How to take 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 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

half a 10 mg tablet

week 2

one 10 mg tablet

week 3

one and a half 10 mg tablets

week 4 and beyond

two 10 mg tablets once a day

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 one and a half
tablets once a day in the third week. From the fourth week
on, the usual dose is two tablets once a day (1x 20 mg).
The tablet can be divided into equal doses.

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.
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.

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 10 mg memantine
Duration of treatment
Continue to take Memantine hydrochloride as long as it is hydrochloride equivalent to 8.31 mg memantine.
of benefit to you. Your doctor should assess your
The other ingredients are:
treatment on a regular basis.
Tablet core
Cellulose microcrystalline, starch pregelatinised, lactose
If you take more Memantine hydrochloride than you
anhydrous, colloidal anhydrous silica, magnesium
should
stearate.
• In general, taking too much Memantine hydrochloride
Coating
should not result in any harm to you. You may
experience increased symptoms as described in section Polysorbate 80, polyvinyl alcohol, titanium dioxide, talc,
soya lecithin, xanthan gum.
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.

What Memantine hydrochloride looks like and contents
of the pack
White to off-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.

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 Memantine hydrochloride is available in packs of 10, 14,
at the usual time.
21, 28, 30, 42, 50, 56, 98, 100 and 112 film-coated tablets.
• Do not take a double dose to make up for a forgotten
Not all pack sizes may be marketed.
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.
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

Marketing Authorisation Holder
Archie Samuel s.r.o.
Slunná 16, 617 00 Brno,
Czech Republic
Manufacturers
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex,
BN22 9AG, United Kingdom
This leaflet was last revised in 04/2015
PL 35737/0008

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

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.
Blister packs
Do not store above 25°C.
HDPE bottles
Shelf life after first opening of the container: 6 months.

15210-D

323 x 200

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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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