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ZEEBRAL XL 8 mg, 16 mg AND 24 mg PROLONGED RELEASE CAPSULES, hard Galantamine

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 Zeebral XL is and what it is used for

2.    What you need to know before you take Zeebral XL

3.    How to take Zeebral XL

4.    Possible side effects

5.    How to store Zeebral XL

6.    Contents of the pack and other information

^ WHAT ZEEBRAL XL IS AND WHAT IT IS USED FOR

Zeebral XL is an anti-dementia medicine used to treat the symptoms of mild to moderately severe dementia ofthe 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. Zeebral 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.

You must talkto a doctor if you do not feel better or if you feel worse.

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEEBRAL XL

Do NOT take Zeebral XL

• Ifyou are allergic (hypersensitive) to galantamine or to any of the other ingredients ofthis medicine (listed in section 6) • Ifyou have severe liver and/or severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking galantamine. Zeebral 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 Zeebral XL ifyou suffer from or have suffered in the past from any ofthe following conditions: • liverorkidneyproblems

• 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 ofthe nervous system (like epilepsy or Parkinson's disease)

• a respiratory disease or infection that interferes with breathing (like asthma, obstructive pulmonary disease, or pneumonia)

• ifyou recently had an operation on the gut or bladder • ifyou have difficulties passing urine.

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

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

Other medicines and galantamine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Zeebral 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) iftaken by mouth.

Some medicines can affect the way Zeebral XL works, or 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 Zeebral XL if you are also taking any of the medicines listed above.

Some medicines can increase the number of side effects caused by Zeebral 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). Ifyou take medicines for an irregular heart-beat, your doctor may consider an electrocardiogram (ECG).

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

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

Zeebral XL with food and drink

Zeebral XL should be taken with food if possible.

Drink plenty of liquids during your treatment with Zeebral XL, to keep yourself hydrated.

See section 3 of this leaflet for full details about how to take this medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor of pharmacist for advice before taking this medicine. You should not breast-feed while you are taking Zeebral XL. Driving and using machines

Zeebral 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. Zeebral XL contains sucrose

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

^ HOW TO TAKE ZEEBRAL XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.

If you are currently taking galantamine tablets or oral solution and have been told by your doctor to switch to Zeebral XL prolonged release capsules, read the instructions at the end of this section carefully.

How to take Zeebral XL capsules Zeebral XL capsules should be swallowed whole, NOT chewed or crushed.They should be taken in the morning, with water or other liquids, and preferably with food.

Zeebral XL prolonged release capsules are available in 3 strengths: 8 mg, 16 mg and 24 mg. Zeebral XL is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Zeebral 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 Zeebral 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 Zeebral XL.

Liver or kidney disease

•    Ifyou have mild liver or kidney disease, treatment is started with the 8 mg capsule once daily in the morning

•    If you have moderate liver 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 moderate liver disease.

•    Ifyou have severe liver and/or kidney disease, do not take Zeebral XL.

How do I switch from taking galantamine tablets or oral solution to Zeebral XL prolonged release capsules?

If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Zeebral XL prolonged-release capsules.

•    Take your last dose of galantamine tablets or oral solution in the evening

•    The next morning, take your first dose of Zeebral XL prolonged-release capsules.

DO NOT take more than one capsule in a day. While you are taking once-daily Zeebral XL capsules, DO NOT take galantamine tablets or oral solution.

Use in Children and adolescents There is no use of Zeebral XL in children.

If you take more Zeebral XL than you should

If you take too much Zeebral 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 ofconsciousness. If you forget to take Zeebral XL

Ifyou 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. Ifyou forget to take more than one dose, you should contact your doctor. If you stop taking Zeebral XL

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

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4 | POSSIBLE SIDE EFFECTS

Like all medicines,this medicine can cause side effects,

although not everybody gets them. Some ofthese 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 ofyour lips, face, throat or tongue.

Side effects include:

Very common side effects (may affect more than 1 in 10

people):

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

Weight loss Decreased appetite Feeling faint Trembling Drowsiness

Stomach pain or discomfort Indigestion Muscles spasms High blood pressure General feeling ofdiscomfort Seeing, feeling or hearing things that are not real (hallucinations)

Feeling sad (depression).

Uncommon side effects (may affect up to 1 in 100 people):

•    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, prickling or numbness ofthe skin

•    Changeinthesenseoftaste

•    Excessive sleepiness

•    Fits

•    Blurredvision

•    Ringing or buzzing in the ears (tinnitus)

•    Feelingtheneedtovomit

•    Muscleweakness

•    Excessivewaterlossinthebody

•    Low blood pressure

•    Reddeningoftheface

•    Seeing or hearing things that are not real (visual or auditory hallucinations).

Rare side effects (may affect up to 1 in 1,000 people):

•    Inflammation ofthe liver (hepatitis).

Tell your doctor or pharmacist if you are worried or think that Zeebral XL is causing you a problem.

Ifany ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5 ) HOW TO STORE ZEEBRAL XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister or bottle after EXP The expiry date refers to the last day of that month. Discard the bottle 100 days after opening.

This medicinal product does not require and special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer in use.These measures will help protect the environment.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Zeebral XL contains

• The active substance is galantamine. Each prolonged-release capsule contains either 8 mg, 16 mg or 24 mg of galantamine (as galantamine hydrobromide).

• The other ingredients are

Capsule contents: sucrose, maize starch, hypromellose, macrogol 6000, ethylcellulose, triethyl citrate.

Capsule shell: titanium dioxide (E171), gelatin. 16 mg also contains: Quinoline yellow (E104), erythrosine (E127), 24 mg also contains: red iron oxide (E172), yellow iron oxide (E172). Ink: shellac glaze and iron oxide black (E172), propylene glycol.

What Zeebral XL looks like and contents of the pack

• Prolonged-release capsule, hard

• 8 mg: Hard gelatin capsule filled with white to off-white pellets, with a white cap and body imprinted 93

5532

• 16 mg: Hard gelatin capsule filled with white to off-white pellets, with a peach cap and body imprinted 93

5533

• 24 mg: Hard gelatin capsule filled with white to off-white pellets, with a light orange cap and body imprinted 93

5534

• 8 mg: Available in blister pack sizes of 1,14, 28, 30, (3 x 10), 56, 84 and 300 prolonged-release capsules, calendar packs of 14, 28, 56 and 84 prolonged-release capsules, and (50 x 1) hospital pack and bottle pack sizes of 30, 90 and 100 prolonged-release capsules.

16 mg: Available in blister pack sizes of 1, 28, 30, (3 x 10) 56, 84 and 300 prolonged-release capsules, calendar packs of 28, 56 and 84 prolonged-release capsules, and (50 x 1) hospital pack and bottle pack sizes of 30, 90 and 100 prolonged-release capsules.

24 mg: Available in blister pack sizes of1,14, 28, 30, (3 x 10), 56, 84 and 300 prolonged-release capsules, calendar packs of 14, 28, 56 and 84 prolonged-release capsules, and (50 x 1) hospital pack and bottle pack sizes of 30, 90 and 100 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG.

This leaflet was last revised in October 2013.

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