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VALIOS 5 MG/10 MG/15 MG/20 MG ORODISPERSIBLE TABLETS (INITIATION PACK)

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Valios 10 mg Orodispersible Tablets
Valios 20 mg Orodispersible Tablets
Valios 5 mg/10 mg/15 mg/20 mg Orodispersible Tablets
(Initiation pack)
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 Valios is and what it is used for
2. What you need to know before you take Valios
3. How to take Valios
4. Possible side effects
5. How to store Valios
6. Contents of the pack and other information
1. What Valios is and what it is used for
Valios contains the active substance memantine
hydrochloride. It 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. Valios belongs to
a group of medicines called NMDA-receptor antagonists.
Valios acts on these NMDA-receptors improving the
transmission of nerve signals and the memory.
Valios is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2. What you need to know before you take Valios
Do not take Valios:
• if you are allergic to memantine hydrochloride or any of
the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Valios
• 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 Valios 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
Valios is not recommended for children and adolescents
under the age of 18 years.
Other medicines and Valios
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular, Valios 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 Valios.
Valios 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 tubular acidosis (RTA, an excess of acidforming 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.
Pregnancy
The use of memantine in pregnant women is not
recommended.
Breast-feeding
Women taking Valios 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, Valios may change
your reactivity, making driving or operating machinery
inappropriate.
Valios contains aspartame and lactose
Aspartame contains a source of phenylalanine which may be
harmful for people with phenylketonuria.
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Valios
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose of Valios for adults and older
people 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

Week 2

Week 3

Week 4 &
beyond

One 5 mg tablet per day for 7 days
(light pink, round, flat, speckled tablets
with bevelled edges, a diameter of 7 mm
and engraved with “5” on one side)
One 10 mg tablet per day for 7 days
(light pink, round, flat, speckled tablets
with bevelled edges, a diameter of 9 mm
and engraved with “10” on one side)
One 15 mg tablet per day for 7 days
(light pink, round, flat, speckled tablets
with bevelled edges, a diameter of
11 mm and engraved with “15” on one
side)
One 20 mg tablet per day
(light pink, round, flat, speckled tablets
with bevelled edges, a diameter of
12 mm and engraved with “20” on one
side)

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.
Administration
Valios 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 can be taken with or
without food.
Valios orodispersible tablets break easily, so you should
handle the tablets carefully. Do not handle the tablets with
wet hands as the tablets may break up.
• Hold the blister strip at the edges and separate one
blister cell from the rest of the strip by gently tearing
along the perforations around it.
• Carefully peel off the backing.
• Place the tablet on your tongue. The tablet will rapidly
disintegrate and can be swallowed without water.
Duration of treatment
Continue to take Valios as long as it is of benefit to you.
Your doctor should assess your treatment on a regular basis.
If you take more Valios than you should
• In general, taking too much Valios 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 Valios, contact your
doctor or get medical advice, as you may need medical
attention.
If you forget to take Valios
• If you find you have forgotten to take your dose of
Valios, 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, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

5. How to store Valios
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 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 Valios contains
The active substance is memantine hydrochloride.
Each 5 mg orodispersible tablet contains 5 mg memantine
hydrochloride equivalent to 4.15 mg memantine.
Each 10 mg orodispersible tablet contains 10 mg memantine
hydrochloride equivalent to 8.31 mg memantine.
Each 15 mg orodispersible tablet contains 15 mg memantine
hydrochloride equivalent to 12.46 mg memantine.
Each 20 mg orodispersible tablet contains 20 mg memantine
hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are polacrilin, sodium hydroxide (for
pH-adjustment), lactose monohydrate, cellulose,
microcrystalline, mannitol (E421), croscarmellose sodium,
aspartame (E951), silica, colloidal anhydrous, iron oxide red
(E172), flavour peppermint [containing Maltodextrin
(maize), Modified starch E1450 (waxy maize), Peppermint
oil (mentha arvensis)], magnesium stearate.
What Valios looks like and contents of the pack
Valios 5 mg orodispersible tablets are presented as light
pink round, flat, speckled tablets with bevelled edges, with a
diameter of 7 mm and engraved with “5” on one side.
Valios 10 mg orodispersible tablets are presented as light
pink, round, flat, speckled tablets with bevelled edges, with
a diameter of 9 mm and engraved with “10” on one side.
Valios 15 mg orodispersible tablets are presented as light
pink, round, flat, speckled tablets with bevelled edges, with
a diameter of 11 mm and engraved with “15” on one side.
Valios 20 mg orodispersible tablets are presented as light
pink, round, flat, speckled tablets with bevelled edges, with
a diameter of 12 mm and engraved with “20” on one side.

In general, the observed side effects are mild to moderate.

Valios orodispersible tablets are available in blister packs of
10 mg: 28 orodispersible tablets
20 mg: 28 orodispersible tablets

Common (may affect up to 1 in 10 people)
• Drug hypersensitivity, headache, sleepiness,
constipation, elevated liver function tests, dizziness,
balance disorders, shortness of breath and high blood
pressure

Initiation pack of 28 orodispersible tablets containing:
7 orodispersible tablets of 5 mg, 7 orodispersible tablets of
10 mg, 7 orodispersible tablets of 15 mg, 7 orodispersible
tablets of 20 mg

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)
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) and psychotic reactions

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95, 86156
Augsburg, Germany
This leaflet was last revised in 05/2015

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, website
www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this
medicine.

07MMDROD000UK00261

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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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