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ALZHOK 5 MG + 10 MG + 15 MG + 20 MG SOLUBLE TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE / MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the user

Alzhok 5 mg + 10 mg + 15 mg + 20 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-Daspartate (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 acts 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)

- n icotine (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 breastfeed.
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

The “Alzhok treatment initiation pack” is only to
be used for the beginning of the treatment with
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 the
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.
• This pack contains 4 different blisters.
• Each blister is a different colour and contains
either 5mg, 10mg, 15mg or 20mg strength
tablets, which is stated on the blister.
week 1

5 mg tablet

week 3

15 mg tablet Pink blister

week 2

Yellow blister

10 mg tablet Green blister

week 4 and 20 mg tablet Blue blister
beyond
• E
 ach week’s tablet has a different colour and
shape.
• To reduce the risk of side effects the
recommended starting dose is 5 mg per day,
which is stepwise increased over the first 3
weeks of treatment reaching the full strength
(20mg) in the fourth week.
• It is important that you take the tablets in the
correct order. The treatment scheme is also
shown on the treatment initiation pack.
• Take one tablet once a day as follows:
Week 1 (day 1-7):
Take one 5 mg soluble tablet once a day (bluecoloured, oblong, biconvex tablet with length of
8.0 mm ± 0.2 mm and width of 3.75 mm –
4.35 mm) for 7 days.

Week 2 (day 8-14):
Take one 10 mg soluble tablet once a day (greencoloured, oblong, biconvex tablet with length of
11 mm ± 0.3 mm and width of 5.30 mm –
5.90 mm ) for 7 days.
Week 3 (day 15-21):
Take one 15 mg soluble tablet once a day (greencoloured, round, biconvex tablet of diameter
8.7 mm ± 0.2 mm) for 7 days.
Week 4 (day 22-28):
Take one 20 mg soluble tablet once a day (bluecoloured round, flat tablet of diameter 11.0 mm ±
0.2 mm) for 7 days.
Maintenance dose (for the fourth week and after
this pack has been finished)
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 (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. Dependent on the strength
of the tablet (stated on the blister pack), each
soluble tablet contains:
5 mg of memantine hydrochloride equivalent
to 4.15 mg memantine
10 mg of memantine hydrochloride equivalent
to 8.31 mg memantine
15 mg of memantine hydrochloride equivalent
to 12.46 mg memantine

20 mg of memantine hydrochloride equivalent
to 16.62 mg memantine.
- The other ingredients are:
Disodium Hydrogen Citrate
Citric Acid Anhydrous
Mannitol
Sodium Bicarbonate
Sodium Benzoate
Macrogol6000 (PEG 6000)
Soluble tablets 5, 20 mg
Brilliant Blue FCF (E 133)
Soluble tablets 10, 15 mg
Quinoline Yellow (E 104) and Patent Blue V
(E 131)
What Alzhok look like and contents of the pack
Alzhok are supplied in packs of 28 tablets
containing 4 PA/Al/PVC/Al blisters. Each blister
contains 7 tablets. This treatment initiation pack
consists of 4 blisters of 4 different strengths
which is stated on the blister. One each of the
following:
• 7 tablets of 5 mg blue-coloured, oblong,
biconvex tablets with length of 8.0 mm ±
0.2 mm and width of 3.75 mm – 4.35 mm. The
colour of the blister is yellow.
• 7 tablets of 10 mg green-coloured, oblong,
biconvex tablets with length of 11 mm ±
0.3 mm and width of 5.30 mm – 5.90 mm. The
colour of the blister is green.
• 7 tablets of 15 mg green-coloured, round,
biconvex tablets of diameter 8.7 mm ±
0.2 mm. The colour of the blister is pink.
• 7 tablets of 20 mg blue-coloured round, flat
tablets of diameter 11.0 mm ± 0.2 mm. The
colour of the blister is blue.
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. )
Treatment Initiation Pack Leaflet
UK & MALTA

Cutter Guide
Black

Times New Roman ALL 9 pts
body copy (min)

Approval:

1

Internal proof approval
Signed (digitally)

GM626
Artwork Signoff(digitally):

2.3.17
Leaflet (PIL)
135 x 360 mm

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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