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Information For Patients: Reminyl (Galantamine Hydrobromide)
This leaflet
contains important information. Please read it carefully before taking
your medicine. If you are a carer and will be giving Reminyl to the person
you look after, it is also important that you read this leaflet on their
behalf. If you have any questions or concerns after reading the leaflet,
speak to your doctor or pharmacist.
WHAT IS REMINYL? The name of
this medicine is Reminyl. It contains the active ingredient galantamine
hydrobromide. Reminyl comes in 3 different strengths of tablets.
The tablets also contain the inactive
ingredients colloidal anhydrous silica, crospovidone, hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
propylene glycol, talc and titanium dioxide (E171).
The tablets contain the following
colouring agents: 4mg tablets: yellow ferric oxide (E172); 8 mg
tablets: red ferric oxide (E172); 12 mg tablets: red ferric oxide (E172)
and orange yellow S aluminium lake (E110).
Warning: The colouring E110 in
the 12mg tablets can cause an allergic reaction, like asthma, in some
people. An allergic reaction to E110 is more likely in people who are
allergic to aspirin (acetylsalicylic acid). Speak to your doctor for
advice before taking any tablets.
The 4 mg tablets come in packs of 14
tablets, the 8 mg tablets in packs of 14 or 56 and the 12 mg tablets in
packs of 56, 112 or 168.
The marketing authorisation for
Reminyl is held by Shire Pharmaceuticals Limited, East Anton, Andover,
Hampshire SP10 5RG, UK. The tablets are manufactured by Janssen-Cilag SpA,
Via C Janssen, Borgo San Michelle, 04010 Latina, Italy.
WHAT IS REMINYL FOR? Reminyl
is used to treat the symptoms of mild to moderately severe dementia of the
Alzheimer type, a disease that alters brain function. The
symptoms include progressive memory loss, increasing confusion and
behavioural changes. As a result, sufferers find it becomes more and more
difficult to carry out their normal daily activities. Symptoms of
dementia of the Alzheimer type are believed to be related to a lack of
acetylcholine, a substance responsible for sending messages between brain
cells. Reminyl works by increasing the amount of acetylcholine in the
brain and so improves the symptoms of the disease.
WHEN REMINYL SHOULD NOT BE
USED Reminyl should not be taken:
-
By people who have had an allergic
reaction to galantamine (Reminyl) or to any of the other ingredients.
Check the ingredients by reading the section above called 'What is
Reminyl'. An allergic reaction may be recognised as a rash, itching,
swollen face or lips, or shortness of breath.
- By people who have either severe liver or severe kidney disease.
- By people who have significant, combined liver and kidney
problems.
Speak to your doctor if you suffer from these
problems or have suffered from them in the past.
BEFORE TAKING
REMINYL Medicines are not always suitable for everyone. Do you have
any of the following conditions? Have you suffered from these in the past?
If the answer to any of these
questions is 'Yes', speak to your doctor for advice before any Reminyl is
taken. Your doctor will decide whether this medicine is suitable for
you. Your doctor may adjust the amount of medicine that you
take. If you are pregnant, trying to become pregnant or
breast-feeding, do not take any Reminyl before speaking to your doctor for
advice. If you need to have a general anaesthetic for an operation,
tell the doctor that Reminyl is being taken. Reminyl is not recommended
for children.
Driving or operating
machinery Reminyl, as well as the disease itself, can affect the
ability to drive or operate machinery. Please discuss this with your
doctor.
Other medicines Always tell
the doctor, nurse or pharmacist if any other medicines are being taken
because taking some medicines together can be harmful. Reminyl
should not be taken with other medicines that act the same way. If
medicines for diarrhoea, Parkinson's disease or asthma are taken, check
with your doctor to see if these affect Reminyl. Tell your doctor
if drugs for certain heart disorders or high blood pressure (e.g. digoxin
or the so-called beta-blockers) are being taken.
Your doctor may
prescribe a smaller dose of Reminyl if certain drugs are being taken at
the same time (for example certain antidepressants (such as paroxetine,
fluoxetine or fluvoxamine), quinidine (used for heart rhythm problems),
ketoconazole (an antifungal) or ritonavir (a treatment for HIV). If you
are not sure, speak to your doctor or pharmacist for advice.
HOW TO TAKE REMINYL Reminyl
should be taken by mouth. It should be taken twice a day, preferably with
morning and evening meals. Reminyl is usually started at a low dose.
Your doctor may then slowly increase the amount of Reminyl that you take
to find the most suitable dose for you. Treatment with Reminyl is
usually started at a dose of 4 mg taken twice daily. This dose will be
taken for at least four weeks. Your doctor will then increase the dose to
8mg taken twice daily. This dose will be taken for at least 4 weeks. If
your doctor decides to increase your dose again, you should take 12 mg
twice daily. What if a dose of Reminyl is forgotten? If
a dose is missed, the next dose should be taken as usual. Then continue as
before. If more than one dose has been missed, contact your doctor for
advice. Do not take 2 doses at the same time to make up for a
missed dose.
OVERDOSE If too much Reminyl
has been taken, contact a doctor or hospital straightaway. Take any
remaining tablets and the packaging with you.
AFTER TAKING THIS
MEDICINE If undesired effects such as nausea and vomiting occur,
they are mainly experienced early on in the treatment or when the dose is
increased. They tend to disappear gradually as the body gets used to the
treatment and generally will not last for more than a few days. If you are
experiencing these effects your doctor may recommend that you drink more
liquids and, if necessary, they may prescribe a medicine to stop you being
sick. Other possible side effects include: abdominal pain, diarrhoea,
indigestion, decreased appetite and weight loss. Also, headache,
dizziness, tiredness, sleepiness or sleeplessness and confusion might be
experienced as well as a runny or blocked nose, a urinary tract infection
and falling, sometimes resulting in injury. In very rare cases
trembling has occurred. A slow heartbeat or fainting has also been
reported. Should such symptoms be experienced, contact a doctor as medical
assistance might be necessary. Do not be alarmed by this list of
possible side effects. You may not have any of them. Tell your doctor
or pharmacist if you are worried or think that Reminyl is causing you any
problem.
HOW TO STORE REMINYL As with
all medicines, Reminyl should be kept in a safe place where children
cannot see or reach it. There are no special storage instructions for
Reminyl tablets. Medicines can be kept for a limited period only.
Therefore, do not use Reminyl after the date printed on the
packaging. Always return any leftover medicines to your
pharmacist.
Date of preparation: July 2000. Further
Information If you are a person with Alzheimer's Disease or are
caring for someone, and you are in England, Wales or Northern Ireland,
further information, advice and support is available from the
Alzheimer's Helpline 0843 300 0336 Monday - Friday 08.30 - 18.30. The
helpline is provided by the Alzheimer's Society, Gordon House, 10
Greencoat Place, London SW1P 1PH. Telephone: 0207 306 0606, Fax: 0207
306 0808, e-mail: mailto:info@alzheimers.org.uk
If
you are in Scotland, further information, advice and support is available
from the 24 hour Dementia Helpline on 0808 808 3000. The helpline is
provided by Alzheimer Scotland - Action on Dementia, 22 Drumsheugh
Gardens, Edinburgh EH3 7RN. Telephone (office) 0131 2431453, Fax 0131
2431450. Website address: http://www.alzscot.org/, email: mailto:alzheimer@alzscot.org
If
you live in the Republic of Ireland, further information, advice and
support is available from either:- Alzheimer Society of Ireland, Alzheimer
House, 43 Northumberland Avenue, Dun Laoughaire, Co. Dublin. Telephone: 01
284 6616. Fax: 01 284 6030. e-mail:mailto:Alzheim@aol.ie or Western
Alzheimer Foundation, Mount Street, Claremorris, Co. Mayo. Telephone:
094 624 80. Fax: 094 62560.
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