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Galzemic Xl 8mg Prolonged Release Capsules

Document: leaflet CREO PHARMA_PL 17277-0199 change

PACKAGE LEAFLET: INFORMATION FORTHE USER

GalzemicXL 8 mg prolonged-release capsules GalzemicXL 16 mg prolonged-release capsules GalzemicXL 24 mg prolonged-release capsules

Galantamine

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 Galzemic XL is and what it is used for

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

3.    How to take Galzemic XL

4.    Possible side effects

5.    How to store Galzemic XL

6.    Contents of the pack and other information

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

Galzemic 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 behavioural changes, which make it increasingly difficult to carry out normal daily activities. These effects are thought to be caused by a lack of'acetylcholine', a substance responsible for sending messages between brain cells. Galantamine increases the amount of acetylcholine in the brain and treats the signs of the disease.

2.    What you need to know before you take GalzemicXL Do not take Galzemic XL

•    If you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6).

•    Ifyou havesevere liverorsevere kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Galzemic 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

Galantamine can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Galzemic XL. See'Look out for serious side effects'in section 4.

Before you take GalzemicXL, your doctor needs to know if you have, or have had,anyofthefollowing:

•    liver or kidney problems

•    a heart condition (such as chest discomfort that is often brought on by physical activity, a 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 as epilepsy or Parkinson's disease)

•    a respiratory disease or infection that affects breathing (such as asthma, obstructive pulmonary disease or pneumonia)

•    problems passing urine.

Your doctor will decide if Galzemic XL is suitable for you, or if the dose needs to be changed.

Also tell your doctor ifyou recently had an operation on the stomach, intestines or bladder. Your doctor may decide that Galantamine is not suitable for you.

Galantamine can cause weight loss. Your doctor will check your weight regularly while you are taking Galzemic XL.

Children and adolescents

Galantamine is not recommended for children and adolescents.

Other medicines and Galzemic XL

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

Galzemic 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 muscle weakness)

•    pilocarpine (when taken by mouth for dry mouth or dry eyes).


Some medicines can lead to side effects more likely in people taking Galantamine. These include:

paroxetine orfluoxetine (antidepressants) quinidine (for uneven heart beat) ketoconazole (an antifungal) erythromycin (an antibiotic) ritonavir (for human immunodeficiency virus or'HIV'). non-steroidal anti-inflammatory painkillers (such as ibuprofen) which can increase the risk of ulcers

medicines taken for heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents). If you take medicines for an uneven heart-beat, your doctor may check your heart using an electrocardiogram (ECG).

Your doctor may give you a lower dose of Galzemic XL ifyou are taking any of these medicines.

Galantamine may affect some anaesthetics. Ifyou are going to have an operation under a general anaesthetic, tell the doctor that you are taking Galzemic XL, well in advance.

If you have any questions, talk to your doctor or pharmacist for advice. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not breastfeed while you are taking GalzemicXL.

Driving and using machines

Galantamine may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Galzemic XL affects you, do not drive or use any tools or machinery.

3. How to take Galzemic XL

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

If you are currently taking Galantamine immediate release tablets or oral solution and have been told byyourdoctorto switch to Galantamine prolonged-release capsules, read the instructions at the end of this section carefully.

How much to take

You will start treatment with Galzemic XL at a low dose. The recommended starting dose is 8 mg, taken once a day. Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you. The maximum dose is 24 mg, taken once a day.

Your doctor will explain what dose to start with and when the dose should be increased. Ifyou are not sure what to do, or find that the effect of Galzemic XL capsules 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 and to discuss how you are feeling.

Ifyou have liver or kidney problems, your doctor may give you a reduced dose of Galantamine, or may decide this medicine is not suitable for you. Switching from taking Galantamine immediate release tablets or oral solution to Galantamine prolonged release capsules

If you are currently taking Galantamine tablets or oral solution, your doctor may decide you should switch to Galantamine prolonged-release capsules. If this applies to you:

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

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

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


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How to take Galzemic XL

• Change in sense of taste

Galantamine capsules must be swallowed whole and NOT chewed or crushed.

• Daytime sleepiness

Take your dose of Galantamine once a day in the morning, with water or other

• Blurred vision

liguids. Try to take Galantamine with food.

• Ringing in the ears that does not go away (tinnitus)

Drink plenty of liguids while you are taking Galzemic XL, to keep yourself

• Low blood pressure

hydrated.

• Flushing

Ifyou take more Galzemic XL than you should

• Feeling the need to vomit (retch)

If you take too much Galzemic XL, contact a doctor or hospital straight away.

• Excessive sweating

Take along any remaining capsules and the packaging with you. The signs of

• Weak muscles

overdose may include: severe nausea and vomiting, weak muscles, slow heart

• Increased level of liver enzymes in the blood

beat, fits (seizures) and loss of consciousness.

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

Ifyou forget to take GalzemicXL

• Inflamed liver (hepatitis).

If you forget to take one dose, miss out the forgotten dose completely and take

Reporting of side effects

the next dose at the normal time.

If you get any side effects, talk to your doctor or pharmacist or nurse. This

Do not take a double dose to make up for a forgotten dose.

includes any possible side effects not listed in this leaflet. You can also report

If you forget to take more than one dose, contact your doctor.

side effects directly via the Yellow Card Scheme

Ifyou stop taking GalzemicXL

Website: www.mhra.gov.uk/yellowcard

Check with your doctor before you stop taking Galzemic XL. It is important to

By reporting side effects you can help provide more information on the safety

continue taking this medicine to treat your condition.

of this medicine.

If you have any further guestions on the use of this medicine, ask your doctor or pharmacist.

5. How to store Galzemic XL

4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.

Look out for serious side effects

Stop taking your medicine and see a doctor or go to your nearest emergency department immediately ifyou notice any of the following:

•    Skin reactions, including:

-    Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).

-    Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalized exanthematous pustulosis).

-    Rash that may blister, with spots that look like small targets.

These skin reactions are rare in people taking Galantamine (may affect up to 1 in 1,000 people).

•    Heart problems including changes in heart beat (such as a slow beat, extra beats) or palpitations (heart beat feels fast or uneven). Heart problems may show as an abnormal tracing on an 'electrocardiogram'(ECG), andean be common in people taking Galantamine (may affect up to 1 in 10 people)

•    Fits (seizures). These are uncommon in people taking Galantamine (may affect up to 1 in 100 people).

You must stop taking Galantamine and seek help immediately if you

notice any of the side effects listed above.

Other side effects:

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

•    Nausea and vomiting. These side effects are more likely to happen in the first few weeks of treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the medicine and generally only last for a few days. Ifyou have these effects, your doctor may recommend that you drink more liguids and may prescribe a medicine to stop you being sick.

Common side effects (may affect up to 1 in 10 people):

•    Decreased appetite; weight loss

•    Seeing, feeling, or hearing things that are not there (hallucinations)

•    Depression

•    Feeling dizzyorfainting

•    Muscle tremors or spasms

•    Headache

• Feeling very tired, weak or generally unwell

• Feeling very sleepy with low energy

•    High blood pressure

•    Stomach pain or discomfort

•    Diarrhoea

•    Indigestion

•    Falls

•    Wounds


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

•    Allergic reaction

•    Not enough water in the body (dehydration)

•    Tingling or numb feeling of the skin (pins and needles)


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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 after EXP.

The expiry date refers to the last day of that month.

This medicinal product does not reguire any special storage conditions.

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

6. Contents of the pack and other information

What GalzemicXL contains

The active substance is galantamine.

•    Galzemic XL 8 mg prolonged-release capsules contain 8 mg galantamine (as hydrobromide)

•    GalzemicXL 16 mg prolonged-release capsules contain 16 mg galantamine (as hydrobromide)

•    Galzemic XL 24 mg prolonged-release capsules contain 24 mg galantamine (as hydrobromide)

The other ingredients are:

Capsule contents: Cellulose microcrystalline, Hypromellose, Ethylcellulose and Magnesium stearate.

Capsule shell: Gelatin and Titanium dioxide (E171).

The 16 mg capsule also contains red iron oxide (E172).

The 24 mg capsule also contains Indigo carmine (E132), Erythrosin (E127),

Red Iron Oxide (E172) and Yellow iron oxide (E172).

What GalzemicXL looks like and contents of the pack

Galzemic XL prolonged-release capsules are available in three strengths, each of which can be recognised by its colour:

8 mg: Opague white size 2 hard gelatine capsules containing one round biconvex tablet

16 mg: Opague, flesh size 2 hard gelatine capsules containing two round biconvex tablets

24 mg: Opague orange size 2 hard gelatine capsules containing three round biconvex tablets Pack sizes:

7,28,30,56,84,90,98,250,500 capsules orwhite opague polyethylene high density container with screw cap with 100 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki Greece

Manufacturers

Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki Greece or

Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture,

Block No 5, Rodopi 69300, Greece Distributed by:

Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK


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