Medication Guide App

REMINYL XL 16MG CAPSULES

Active substance: GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

REMINYL® XL 16MG CAPSULES
(galantamine hydrobromide)
This medicine is available using the name Reminyl XL 16mg
Capsules but will be referred to as Reminyl XL throughout this
leaflet.

Read all of this leaflet carefully before you
start taking this medicine.

Keep this leaflet. You may need to read it again.
If you are a carer and will be giving Reminyl XL to the
person you look after, it is also important that you read this
leaflet on their behalf.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Reminyl XL is and what it is used for
Before you take Reminyl XL
How to take Reminyl XL
Possible side effects
How to store Reminyl XL
Further information

Taking other medicines

You should always tell the doctor, nurse or pharmacist if you are
taking or have recently taken any other medicines, including those
obtained without a prescription.
Reminyl XL should not be used with medicines that work in a
similar way, these include:
donepezil or rivastigmine (for Alzheimer’s disease)
ambenonium, neostigmine or pyridostigmine (for severe
muscular weakness)
pilocarpine (for dry mouth or dry eyes) if taken by mouth.
Some medicines can affect the way Reminyl XL works, or Reminyl
XL itself can reduce the effectiveness of other medicines taken at
the same time. These include:
paroxetine or fluoxetine (antidepressants)
quinidine (used for heart rhythm problems)
ketoconazole (antifungal)
erythromycin (antibiotic)
ritonavir (antiviral – HIV protease inhibitor).
Your doctor may prescribe a smaller dose of Reminyl XL if you are
also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused
by Reminyl XL, these include:
non-steroidal anti-inflammatory painkillers (e.g. ibuprofen)
which can increase the risk of ulcers
medicines taken for heart disorders or high blood pressure
(e.g. digoxin, amiodarone, atropine, beta-blockers, or
calcium channel blocking agents). If you take medicines for
an irregular heart-beat, your doctor may consider an
electrocardiogram (ECG).

1. What Reminyl XL is and what it is used for

If you need an operation which requires a general anaesthetic,
you should inform the doctor that you are taking Reminyl XL.

Reminyl XL is an antidementia medicine used to treat the
symptoms of mild to moderately severe dementia of the
Alzheimer type, a disease that alters brain function.

If you have any questions, speak to your doctor or pharmacist for
advice.

The symptoms of Alzheimer’s disease include increasing memory
loss, confusion and behavioural changes. As a result, it becomes
more and more difficult to carry out normal daily activities.
These symptoms are believed to be due to a lack of acetylcholine,
a substance responsible for sending messages between brain
cells. Reminyl XL increases the amount of acetylcholine in the
brain and so could improve the symptoms of the disease.
The capsules are made in a ‘prolonged-release’ form. This means
that they release the medicine more slowly.

2. Before you take Reminyl XL
Do not take Reminyl XL

If you are allergic (hypersensitive) to galantamine or to any
of the other ingredients listed in section 6 of this leaflet
If you have severe liver and/or severe kidney disease

Take special care with Reminyl XL

Reminyl XL should be used in Alzheimer’s disease and not other
forms of memory loss or confusion.
Medicines are not always suitable for everyone. Your doctor needs
to know before you take Reminyl XL if you suffer from or have
suffered in the past from any of the following conditions:
liver or kidney problems
a heart disorder (e.g. angina, heart attack, heart failure,
slow or irregular pulse)
electrolyte disturbances (e.g. decreased/increased blood
potassium levels)
peptic (stomach) ulcer disease
acute abdominal pain
a disorder of the nervous system (like epilepsy or
Parkinson's disease)
a respiratory disease or infection that interferes with
breathing (like asthma, obstructive pulmonary disease, or
pneumonia)
if you recently had an operation on the gut or bladder
if you have difficulties passing urine
If you need an operation which requires a general anaesthetic,
you should inform the doctor that you are taking Reminyl XL.
Your doctor will then decide whether treatment with Reminyl XL is
suitable for you or if the dose needs to be changed.

Taking Reminyl XL with food and drink

Reminyl XL should be taken with food if possible.
Drink plenty of liquids during your treatment with Reminyl XL, to
keep yourself hydrated. See section 3 of this leaflet for full details
about how to take this medicine.

Pregnancy and breast-feeding

Before taking Reminyl XL, speak to your doctor for advice if you
are pregnant, think you could be pregnant, or you are planning a
pregnancy.
You should not breast-feed while you are taking Reminyl XL.

Driving and using machines

Reminyl XL may cause dizziness or drowsiness, especially during
the first few weeks of treatment. If you experience these
symptoms, do not drive or use any tools or machinery.

Important information about some of the
ingredients of Reminyl XL

This product contains sucrose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Reminyl XL
Always take Reminyl XL exactly as your doctor has told you. You
should check with your doctor if you have any questions.
If you are currently taking Reminyl tablets or oral solution and
have been told by your doctor to switch to Reminyl XL prolongedrelease capsules, read the instructions at the end of this section
carefully.

How to take Reminyl XL capsules

Reminyl XL capsules should be swallowed whole, NOT chewed or
crushed. Reminyl XL should be taken in the morning, with water
or other liquids, and preferably with food.
Reminyl XL prolonged-release capsules are available in 3
strengths: 8mg, 16mg and 24mg. Reminyl XL is started at a low
dose. Your doctor may then tell you to slowly increase the dose
(strength) of Reminyl XL that you take to find the most suitable
dose for you.
1.
2.
3.

The treatment is started with the 8mg capsule taken once
daily. After 4 weeks of treatment, the dose is increased.
You would then take the 16mg capsule once daily. After
another 4 weeks of treatment at the earliest, your doctor
may decide to increase the dose again.
You would then take the 24mg capsule once daily.

Your doctor will explain what dose to start with and when the dose
should be increased. If you feel that the effect of Reminyl XL is
too strong or too weak, talk to your doctor or pharmacist.

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Your doctor will need to see you regularly to check that this
medicine is working for you and to discuss how you are feeling.
Your doctor will also check your weight regularly while you are
taking Reminyl XL.

Liver or kidney disease

If you have mild liver or kidney disease, treatment is started
with the 8mg capsule once daily in the morning.
If you have moderate liver or kidney disease, treatment is
started with the 8mg capsule once every other day in the
morning. After one week, begin taking the 8mg capsule once
daily in the morning. Do not take more than 16mg once
daily.
If you have severe liver and/or kidney disease, do not take
Reminyl XL.

If you take more Reminyl XL than you should

If you take too much Reminyl XL, contact a doctor or hospital
straight away. Take along any remaining capsules and the
packaging with you. Signs or symptoms of overdose may include,
among others: severe nausea, vomiting, muscle weakness, slow
heart beat, seizures and loss of consciousness.

If you forget to take Reminyl XL

If you forget to take one dose, miss out the forgotten dose
completely and take the next dose at the normal time.
Do not take a double dose to make up for a forgotten dose.
If you forget to take more than one dose, you should contact your
doctor.

If you stop taking Reminyl XL

You should consult your doctor before you stop taking Reminyl XL.
It is important to continue taking this medicine to treat your
condition.

How do I switch from taking Reminyl tablets or oral
solution to Reminyl XL prolonged-release capsules?
If you are currently taking Reminyl tablets or oral solution, your
doctor may decide to switch you to Reminyl XL prolonged-release
capsules.
Take your last dose of Reminyl tablets or oral solution in the
evening
The next morning, take your first dose of Reminyl XL
prolonged-release capsules.
DO NOT take more than one capsule in a day. While you are
taking once-daily Reminyl XL capsules, DO NOT take Reminyl
tablets or oral solution.

Children

Reminyl XL is not recommended for children.

4. Possible side effects
Like all medicines, Reminyl XL can cause side effects, although
not everybody gets them. Some of these effects may be due to
the disease itself.

Stop taking your medicine and see a doctor
immediately if you experience;

Heart problems including changes in heart beat (slow or
irregular)
Palpitations (pounding heart beat)
Conditions like blackout
An allergic reaction. The signs may include a rash,
swallowing or breathing problems, swelling of your lips, face,
throat or tongue

Side effects include:
Very Common: affects more than one user in 10.

Feeling sick and/or vomiting. If these undesired effects
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 have
these effects, your doctor may recommend that you drink
more liquids and, if necessary, may prescribe a medicine to
stop you being sick.

Common: affects 1 to 10 users in 100.

Weight loss
Loss of appetite
Decreased appetite
Slow heart beat
Feeling faint
Dizziness
Trembling
Headache
Drowsiness
Abnormally tired
Stomach pain or discomfort
Diarrhoea
Indigestion
Increased sweating
Muscle spasms
Falling
High blood pressure
Feeling weak
General feeling of discomfort
Seeing, feeling, or hearing things that are not real
(hallucinations)
Feeling sad (depression).

Uncommon: affects 1 to 10 users in 1000.

Increased liver enzymes in the blood (laboratory test result
that tells how well your liver is working)
Possible skipped heart beat
Disturbance in the mechanism of conducting impulses in the
heart
Sensation of abnormal heart beats (palpitations)
Tingling, pricking, or numbness of the skin
Change in the sense of taste
Excessive sleepiness
Fit (Seizures)
Blurred vision
Ringing or buzzing in the ears (tinnitus)
Feeling the need to vomit
Muscle weakness
Excessive water loss in the body
Low blood pressure
Reddening of the face
Allergic reaction.

Manufacturer

Manufacturer: Janssen-Cilag Spa, Latina, Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0484

POM

More 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 0845 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: 020 7306 0606, Fax: 020 7306 0808,
e-mail: 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 243 1453, Fax: 0131 243 1450,
email: alzheimer@alzscot.org.
If you live in the Republic of Ireland, further information, advice
and support is available from: The Alzheimer Society of Ireland,
Alzheimer House, 43 Northumberland Avenue, Dun Laoghaire,
Co. Dublin. Telephone: (01) 284 6616, Fax: (01) 284 6030,
e-mail: info@alzheimer.ie,
National Helpline (open Monday to Thursday 10am -4pm):
1 800 341 341 or Western Alzheimer Foundation, Mount Street,
Claremorris, Co. Mayo. Telephone: 094 624 80. Fax: 094 62560.
Reminyl® is a registered trademark of Shire Pharmaceutical
Development Limited.
Leaflet revision and issue date (Ref): 16.09.13

Rare side effects: affects 1 to 10 users in 10000.
Inflammation of the liver (hepatitis).

Tell your doctor or pharmacist if you are worried or think
that Reminyl XL is causing you a problem. If you notice any
side effects not listed in this leaflet, please tell your doctor.

5. How to store Reminyl XL
Do not store above 30°C.
Keep out of the sight and reach of children.
Do not use after the expiry date on the carton and blister labels.
The expiry date refers to the last day of that month.
Always return any leftover medicines to your pharmacist.
If your capsules appear to be discoloured or show any other signs
of deterioration, take them to your pharmacist who will advise
you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further information
What Reminyl XL contains:

Each prolonged-release capsule contains 16mg of the active
ingredient galantamine (as hydrobromide).
The other inactive ingredients are: diethyl phthalate,
ethylcellulose, hypromellose, macrogol, maize starch, sucrose,
gelatin, titanium dioxide (E171), red ferric oxide (E172) and
printing ink.

What Reminyl XL looks like and contents of the
pack

Reminyl XL are pink, opaque, hard capsules, printed in black with
‘G 16’, containing white to off-white pellets.
The capsules are available in calendar blister packs of
28 capsules.

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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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