REMINYL XL 16MG PROLONGED RELEASE CAPSULES

Active substance: GALANTAMINE HYDROBROMIDE

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CUSTOMER: Waymade

REF:

PRODUCT:

Reminyl 8mg 16mg 24mg

ARTWORKER:

6464/2894 2895 2896E

DATE OF PROOF: 24/09/13

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DATE:

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PROOF HISTORY:
v.1 - waymade -24/09/13

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Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JUNE 2013
REPORTING SIDE EFFECTS

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5. How to store Reminyl XL
Keep out of the sight and reach of children.
Do not store above 30˚C.
Do not use after the expiry date which is stated on the carton and blister foil after the letters EXP. The expiry
date refers to the last day of that month.
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.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist who will advise you what to do.

6. Further information
What Reminyl XL contains:
The active substance is galantamine hydrobromide.
Reminyl XL 8 mg prolonged release capsules contain 8 mg of the active ingredient galantamine (as the
hydrobromide).
Reminyl XL 16 mg prolonged release capsules contain 16 mg of the active ingredient galantamine (as the
hydrobromide).
Reminyl XL 24 mg prolonged release capsules contain 24 mg of the active ingredient galantamine (as the
hydrobromide).
The other ingredients are:
Pellets: diethyl phthalate, ethylcellulose, hypromellose, macrogol 400, maize starch and sucrose (sugar).
Capsule shell: gelatin and titanium dioxide (E171).
Reminyl XL 16 mg prolonged release capsules also contain red ferric oxide (E172).
Reminyl XL 24 mg prolonged release capsules also contain red ferric oxide (E172) and yellow ferric oxide
(E172).
Printing ink: benzoic acid (E210), black ferric oxide (E172), dimethyl siloxane, glyceride, lecithin (soya)
(E322), methylcellulose, macrogol, macrogol stearate, shellac, sorbic acid and xanthan gum.
What Reminyl XL looks like and contents of the pack
Reminyl XL prolonged-release capsules, hard, are available in three strengths, each of which can be
recognised by its colour and lettering:
Reminyl XL 8 mg prolonged release capsules: White, opaque, hard capsules with the inscription ‘G8’,
containing white to off-white pellets.
Reminyl XL 16 mg prolonged release capsules: Pink, opaque, hard capsules with the inscription ‘G16’,
containing white to off-white pellets.
Reminyl XL 24 mg prolonged release capsules: Caramel, opaque, hard capsules with the inscription ‘G24’,
containing white to off-white pellets.
Reminyl XL prolonged release capsules are available in blister packs of 28 capsules.
POM

PL No: 06464/2894 Reminyl XL 8 mg prolonged release capsules
PL No: 06464/2895 Reminyl XL 16 mg prolonged release capsules
PL No: 06464/2896 Reminyl XL 24 mg prolonged release capsules

These products are manufactured by Janssen-Cilag S.p.A, Via C. Janssen, 04010 Borgo, San Michele,
Latina, Italy and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

REMINYL® XL 8mg PROLONGED RELEASE CAPSULES
REMINYL® XL 16mg PROLONGED RELEASE CAPSULES
REMINYL® XL 24mg PROLONGED RELEASE CAPSULES
(Galantamine Hydrobromide)
Patient Information Leaflet
This product is available as all of the above names, 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. What Reminyl XL is and what it is used for
2. Before you take Reminyl XL
3. How to take Reminyl XL
4. Possible side effects
5. How to store Reminyl XL
6. Further information

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

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.

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 are in Scotland, further information, advice and support is available from the 24 hour Dementia Helpline
on 0808 808 3000.

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

Leaflet revision and issue date (Ref.) 24.09.2013
Reminyl is a registered trademark of Shire Pharmaceutical Development Ltd.
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 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.

Your doctor will then decide whether treatment with Reminyl XL is suitable for you or if the dose needs to be
changed.
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.

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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

REF:

PRODUCT:

Reminyl 8mg 16mg 24mg

ARTWORKER:

6464/2894 2895 2896E

DATE OF PROOF: 24/09/13

CODE:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade -24/09/13

TVT CHECKED

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JUNE 2013
REPORTING SIDE EFFECTS

Pg 2

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 heartbeat, your doctor may consider an electrocardiogram (ECG).
If you need an operation which requires a general anaesthetic, you should inform the doctor that you are
taking Reminyl XL.
If you have any questions, speak to your doctor or pharmacist for advice.

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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.

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.

Children
Reminyl XL is not recommended for children.

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 breastfeed while you are taking Reminyl XL.

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.

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 prolonged-release 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: 8 mg, 16 mg and 24 mg. 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.

The treatment is started with the 8 mg capsule taken once daily. After 4 weeks of treatment, the
dose is increased.

2.

You would then take the 16 mg capsule once daily. After another 4 weeks of treatment at the
earliest, your doctor may decide to increase the dose again.

3.

You would then take the 24 mg 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.
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 8 mg capsule once daily in
the morning.
• If you have moderate liver or kidney disease, treatment is started with the 8 mg capsule once
every other day in the morning. After one week, begin taking the 8 mg capsule once daily in the
morning. Do not take more than 16 mg 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.

4. Possible side effects

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

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.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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