Consion XL 8mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Galantamine hydrobromide

Dostupno od:

Dr Reddy's Laboratories (UK) Ltd

ATC koda:

N06DA04

INN (International ime):

Galantamine hydrobromide

Doziranje:

8mg

Farmaceutski oblik:

Modified-release capsule

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04110000; GTIN: 05036072005693

Uputa o lijeku

WHAT IS IN THIS LEAFLET:
1.
What Consion XL is and what it is used for
2. What you need to know before you take
Consion XL
3. How to take Consion XL
4. Possible side effects
5. How to store Consion XL
6. Contents of the pack and other information
1. WHAT CONSION XL IS AND WHAT IT IS
USED FOR
Consion XL 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 behavioral changes which
make it increasingly difficult to carry out normal
daily activities.
These effects are thought to be caused bya lack of
‘acetylcholine’, a substance responsible for sending
messages between brain cells. Consion XL
increases the amount of acetylcholine in the brain
and treats the signs of the disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CONSION XL
DO NOT TAKE CONSION XL
•
If you are allergic to galantamine or 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
Consion XL.
This medicine is only used in Alzheimer’s disease,
and is not recommended for other types of
memory loss or confusion.
SERIOUS SIDE EFFECTS
Consion XL can cause serious skin reactions, heart
problems, fits (seizures). You must be aware of
these side effects while you are taking Consion XL.
See section 4.
BEFORE YOU TAKE CONSION XL, your doctor needs to
know if you have or have had any of the following:
•
liver or kidney problems
•
a heart disorder (such as chest discomfort that is
often brought on by physical activity, heart
attack, heart failure, slow or uneven heart beat)
•
changes in ‘electrolyte’ levels (naturally occurring
chemicals in the blood, such as potassium)
•
a peptic (stomach) ulcer
•
blockage of the stomach or intestines
•
a disorder of the nervous system (such

Svojstava lijeka

OBJECT 1
CONSION XL 8 MG PROLONGED-RELEASE CAPSULES,
HARD
Summary of Product Characteristics Updated 04-Apr-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Consion XL 8 mg prolonged-release capsules, hard
2. Qualitative and quantitative composition
Each 8 mg prolonged-release capsule contains 8 mg galantamine (as
hydrobromide).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release capsule, hard
Opaque white size 2 hard gelatin capsules containing one round
biconvex prolonged- release tablet of 8
mg
4. Clinical particulars
4.1 Therapeutic indications
Consion XL 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 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 and the patient tolerates
treatment with galantamine. Discontinuation of galantamine should be
considered when evidence of a
therapeutic effect is no longer present or if the patient does not
tolerate treatment.
The initial maintenance dose is 16 mg/day and patients should be
maintained on 16 mg/day for at least 4
weeks.
An increase to the maintenance dose of 24 mg/day should be considered
on an individual basis after
appropriate assessment including evaluation of clinical benefit and
tolerability.
In individual patients not showing an increased response or not
tolerating 24 mg/day,