Valios 10mg orodispersible tablets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Memantine hydrochloride

Available from:

Dr Reddy's Laboratories (UK) Ltd

ATC code:

N06DX01

INN (International Name):

Memantine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 05036072006188

Patient Information leaflet

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 infarcti

Summary of Product characteristics

OBJECT 1
VALIOS 10MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 13-Apr-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Valios 10 mg Orodispersible Tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg memantine.
Excipients with known effect:
Each 10 mg tablet contains 12.5 mg lactose monohydrate and 2.5 mg
aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet
Light pink, round, flat, speckled tablets with beveled edges, with a
diameter of 9 mm and engraved with
“10“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of adult patients with moderate to severe Alzheimer's
disease.
4.2 Posology and method of administration
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of
Alzheimer's dementia.
Posology
Therapy should only be started if a caregiver is available who will
regularly monitor the intake of the
medicinal product by the patient. Diagnosis should be made according
to current guidelines. The
tolerance and dosing of memantine should be reassessed on a regular
basis, preferably within three
months after start of treatment. Thereafter, the clinical benefit of
memantine and the patient's tolerance of
treatment should be reassessed on a regular basis according to current
clinical guidelines. Maintenance
treatment can be continued for as long as a therapeutic benefit is
favourable and the patient tolerates
treatment with memantine. Discontinuation of memantine should be
considered when evidence of a
therapeutic effect is no longer present or if the patient does not
tolerate treatment.
_Adults:_
Dose titration
The maximum daily dose is 20 mg per day. In order to reduce the risk
of undesirable effects, the
maintenance dose is achieved by upward titration of 5 mg per week over
the first 3 weeks as follows:
Week 1 (day 1-7)
One 5 mg tablet per day for 7