Reminyl 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Galantamine hydrobromide

Available from:

Shire Pharmaceuticals Ltd

ATC code:

N06DA04

INN (International Name):

Galantamine hydrobromide

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000

Patient Information leaflet

Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER
REMINYL 4 MG TABLETS
REMINYL 8 MG TABLETS
REMINYL 12 MG TABLETS
galantamine
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 Reminyl is and what it is used for
2.
What you need to know before you take Reminyl
3.
How to take Reminyl
4.
Possible side effects
5.
How to store Reminyl
6.
Contents of the pack and other information
1.
WHAT REMINYL IS AND WHAT IT IS USED FOR
Reminyl contains the active substance ‘galantamine’, an
antidementia medicine. It is used in
adults to treat the symptoms of mild to moderately severe
Alzheimer’s disease, a type of dementia
that alters brain function.
Alzheimer’s disease causes increasing memory loss, confusion and
behavioural changes which
make it increasingly difficult to carry out normal daily activities.
These effects are thought to be
caused by a lack of ‘acetylcholine’, a substance responsible for
sending messages between brain
cells. Reminyl increases the amount of acetylcholine in the brain and
treats the signs of the
disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL
DO NOT TAKE REMINYL

if you are allergic to galantamine or to any of the other ingredients
of this medicine (listed
in section 6).

if you have severe liver or severe kidney disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Reminyl. This medicine
is only used in
Alzheimer’s disease, and is not recommended for other types of
memory loss or confusion.
SERIOUS SIDE EFFECTS
Page

Summary of Product characteristics

OBJECT 1
REMINYL TABLETS
Summary of Product Characteristics Updated 05-Jun-2017 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
Reminyl 4 mg Tablets
Reminyl 8 mg Tablets
Reminyl 12 mg Tablets
2. Qualitative and quantitative composition
Each 4 mg tablet contains 4 mg galantamine (as hydrobromide).
Each 8 mg tablet contains 8 mg galantamine (as hydrobromide).
Each 12 mg tablet contains 12 mg galantamine (as hydrobromide).
Excipients with known effect:
4 mg tablets: Lactose monohydrate 38.59 mg
8 mg tablets: Lactose monohydrate 77.18 mg
12 mg tablets: Lactose monohydrate 115.77 mg and orange yellow S
aluminium lake (E110) 0.45mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
4 mg tablet: Off-white, circular, biconvex tablets with the
inscription “JANSSEN” on one side and “G4”
on the other side
8 mg tablet: Pink, circular, biconvex tablets with the inscription
“JANSSEN” on one side and “G8” on the
other side
12 mg tablet: Orange-brown, circular, biconvex tablets with the
inscription “JANSSEN” on one side and
“G12” on the other side
4. Clinical particulars
4.1 Therapeutic indications
Reminyl is indicated for the symptomatic treatment of mild to
moderately severe dementia of the
Alzheimer type.
4.2 Posology and method of administration
Posology
_Adults/Elderly _
_Before start of treatment_
The diagnosis of probable Alzheimer type of dementia should be
adequately confirmed according to
current clinical guidelines (see section 4.4).
_Starting dose_
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4
weeks.
_Maintenance dose_
The tolerance and dosing of galantamine should be reassessed on a
regular basis, preferably within 3
months after start of treatment. Thereafter, the clinical benefit of
galantamine 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 therapeutic benefit is
favourable