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ALZHOK 10 MG SOLUBLE TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the user

Alzhok 10 mg soluble 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 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 Alzhok is and what it is used for
2. What you need to know before you take
Alzhok
3. How to take Alzhok
4. Possible side effects
5. How to store Alzhok
6. Contents of the pack and other
information
1. What Alzhok is and what it is used for
Alzhok 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.
Alzhok belong to a group of medicines
called NMDA-receptor antagonists. Alzhok
act on these NMDA-receptors improving
the transmission of nerve signals and the
memory.
Alzhok is used for the treatment of patients
with moderate to severe Alzheimer’s disease
in adults.
2. What you need to know before you take
Alzhok

Do not take Alzhok
- If you are allergic to memantine
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
Warning and precautions
Talk to your doctor or pharmacist before
taking Alzhok:
- 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 your treatment should be
carefully supervised, and the clinical benefit
of Alzhok assessed 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
Alzhok is not recommended for children and
adolescents under the age of 18 years.
Other medicines and Alzhok
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

In particular, Alzhok may change the effects
of the following medicines and their dose
may need to be adjusted by your doctor:
- amantadine (substance used in the
treatment of Parkinson’s disease)
- ketamine (an anaesthetic)
- dextromethorphan (substance used to treat
coughs)
- dantrolene (substance used as a muscle
relaxant)
- baclofen (substance used to relieve
muscle spasms occurring in various
illnesses such as cerebral palsy and
multiple sclerosis)
- cimetidine, ranitidine (substances used in
the treatment of indigestion, heartburn
and gastric ulcers)
- procainamide, quinidine (substances used
to treat irregular heartbeats)
- quinine (substance used to treat night time
leg cramps)
- nicotine (substance used to help you stop
smoking)
- hydrochlorothiazide (or any combination
with hydrochlorothiazide – substances
used in the treatment of water retention
and high blood pressure)
- 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 (such as L-dopa
and bromocriptine which are used in
Parkinson’s disease to stimulate your
nerve cells)
- neuroleptics (substances used in the
treatment of mental health disorders)
- oral anticoagulants (such as warfarin used
to thin the blood)
If you go into hospital, let your doctor know
that you are taking Alzhok.
Alzhok with food, drink and alcohol
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.
Pregnancy
The use of this medicine in pregnant women
is not recommended.
Breast-feeding
Women taking this medicine 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, Alzhok may change your
reactivity, making driving or operating
machinery inappropriate.
3. How to take Alzhok

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended treatment dose of 20 mg
per day is achieved by a gradual increase
of Alzhok 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

One 5 mg tablet

week 3

One 15 mg tablet

week 2
week 4 and beyond

One 10 mg tablet
One 20 mg tablet

The usual starting dose is one 5 mg tablet
once a day for the first week. This is
increased to one 10 mg tablet once a day in
the second week and to one 15 mg tablet
once a day in the third week. From the fourth
week on, the usual dose is 20 mg once a day
(two tablets of 10 mg or 1 tablet of 20 mg).
Dosage in patients with impaired kidney
function
If you have impaired (poor) 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
• This medicine should be administered
orally (by mouth) once a day.
• To benefit from your medicine you should
take it regularly every day at the same
time of the day.
• The tablets can be taken with or without
food.
• The tablets are best taken dissolved in a
glass of water, however, they can also be
taken whole, with a drink of water.
• Dissolve the tablet, that your doctor has
told you to take, in a glass of water, and
then drink all of it immediately.
• Do not leave your drink where someone
else may drink it as your medicine could
harm them.
Duration of treatment
Continue to take this medicine as long as it is
of benefit to you. Your doctor should assess
your treatment on a regular basis.
If you take more Alzhok than you should
- In general, taking more Alzhok than you
have been prescribed 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 Alzhok,
contact your doctor or get medical
advice, as you may need medical
attention.
If you forget to take Alzhok
- If you find you have forgotten to take
your dose of Alzhok, 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.
Alzheimer’s disease has been associated with
depression, suicidal thoughts and suicide.
These problems have been experienced by
patients being treated with Alzhok.
Common (may affect up to 1 in 10 people):
• Headache.
• Sleepiness.
• Constipation.
• Elevated liver function test results.
• Dizziness, problems with your balance.
• Shortness of breath.
• High blood pressure.
• Drug hypersensitivity.
Uncommon (may affect up to 1 in 100
people):
• Tiredness.
• Fungal infections.
• Confusion.
• Hallucinations.
• Being sick (vomiting).
• Abnormal gait.
• Heart failure.
• Blood clots in your veins (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).
• Psychotic reactions.
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 national reporting system. By reporting
side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal
5. How to store Alzhok
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.
This medicinal product does not require any
special temperature storage conditions.
Store in the original package in order to
protect from moisture.
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 Alzhok contain
- The active substance is memantine
hydrochloride. Each soluble tablet
contains 10 mg memantine hydrochloride
equivalent to 8.31 mg memantine.
- The other ingredients are:
Disodium Hydrogen Citrate
Citric Acid Anhydrous
Mannitol
Sodium Bicarbonate
Sodium Benzoate
Macrogol 6000 (PEG 6000)
Quinoline Yellow (E 104)
Patent Blue V (E 131)
What Alzhok look like and contents of the
pack
Memantine hydrochloride soluble tablets
10 mg are green-coloured, oblong, biconvex
tablets, with length of 11.0 mm ± 0.3 mm
and width of 5.30 mm – 5.90 mm, packed in
PA/Al/PVC/Al blisters. Each blister contains
7 tablets. The colour of the blister is green.
Pack size of 28 tablets i.e. four blisters of 7
tablets.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex, HA3 0BU
United Kingdom
Manufacturer
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka, Paiania,
Attiki, TK 19002, Greece.
Marketed and Distributed By
Quantum Pharmaceuticals
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
United Kingdom
This leaflet was last revised in March 2017

PRODUCT:

Amends:

Alzhok (Memantine hydro. )
10 mg soluble tablets ALL UK &
MALTA

Cutter Guide
Black

Times New Roman ALL 9 pts
body copy (min)

Approval:

2
2.3.17

Internal proof approval
Signed (digitally)

GM626
Artwork Signoff(digitally):

14.12.16
Leaflet (PIL)
135 x 360 mm

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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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