Package leaflet: Information for the user

Neogalzeim XL 8 mg prolonged-release capsules Neogalzeim XL 16 mg prolonged-release capsules Neogalzeim XL 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 Neogalzeim XL is and what it is used for

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

3.    How to take Neogalzeim XL

4.    Possible side effects

5.    How to store Neogalzeim XL

6.    Contents of the pack and other information

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

Neogalzeim 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. Neogalzeim XL increases the amount of acetylcholine in the brain and treats the signs of the disease.

The capsules are made in a 'prolonged-release' form. This means that they release the medicine slowly.

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

Do not take Neogalzeim XL

-    if you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6)

-    if you have severe liver or severe kidney disease Warnings and precautions

Talk to your doctor or pharmacist before taking Neogalzeim 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

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

Before you take Neogalzeim XL, your doctor needs to know if you have, or have had, any of the following:

•    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 Neogalzeim XL is suitable for you, or if the dose needs to be changed.

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

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

Children and adolescents

Neogalzeim XL is not recommended for children and adolescents.

Other medicines and Neogalzeim XL

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

Neogalzeim 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 (when taken by mouth for dry mouth or dry eyes)

Some medicines can make side effects more likely in people taking Neogalzeim XL. These include:

•    paroxetine or fluoxetine (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 Neogalzeim XL if you are taking some of these medicines.

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

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

If you are pregnant, 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 breast-feed while you are taking Neogalzeim XL.

Driving and using machines

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

Neogalzeim XL contains sucrose

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

3. How to take Neogalzeim XL

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

If you are currently taking galantamine immediate-release tablets or oral solution and have been told by your doctor to switch to Neogalzeim XL prolonged-release capsules, carefully read the instructions under 'Switching from taking galantamine tablets or oral solution to Neogalzeim XL prolonged release capsules' in this section. How much to take

You will start treatment with Neogalzeim XL at a low dose. The usual 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. If you are not sure what to do, or find the effect of Neogalzeim 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 and to discuss how you are feeling.

If you have liver or kidney problems, your doctor may give you a reduced dose of Neogalzeim XL, or may decide this medicine is not suitable for you.

Switching from taking galantamine immediate release tablets or oral solution to Neogalzeim XL prolonged-release capsules

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

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

How to take

Neogalzeim XL prolonged-release capsules must be swallowed whole and NOT chewed or crushed. Take your dose of Neogalzeim XL once a day in the morning, with water or other liquids. Try to take Neogalzeim XL with food.

Drink plenty of liquids while you are taking Neogalzeim XL to keep yourself hydrated.

If you take more Neogalzeim XL than you should

If you take too much Neogalzeim XL, contact a doctor or hospital straight away. Take any remaining capsules and the packaging with you. The signs of overdose may include:

•    severe nausea and vomiting

•    weak muscles, slow heart beat, fits (seizures) and loss of consciousness.

If you forget to take Neogalzeim 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, contact your doctor.

If you stop taking Neogalzeim XL

Check with your doctor before you stop taking Neogalzeim 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, ask your doctor or pharmacist.

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 Neogalzeim XL and see a doctor immediately if you notice any

of the following:

•    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), and can be common in people taking Neogalzeim XL (may affect up to 1 in 10 people).

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

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. If you have these effects, your doctor may recommend that you drink more liquids, 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 dizzy or fainting

•    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)

•    Change in sense of taste

•    Daytime sleepiness

•    Blurred vision

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

•    Low blood pressure

•    Flushing

•    Feeling the need to vomit (retch)

•    Excessive sweating

•    Weak muscles

•    Increased level of liver enzymes in the blood.

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

•    Inflamed liver (hepatitis)

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 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 Neogalzeim 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 foil after EXP The expiry date refers to the last day of that month.

This medicinal product does not require 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 Neogalzeim XL contains

-    The active substance(s) is galantamine.

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

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

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

-    The other ingredients are:

•    Granules: Povidone, ethylcellulose, diethylphtalate, magnesium stearate, sugar spheres

•    Capsule shell: 8 mg capsules contain gelatin, titanium dioxide (E171), iron oxide black (E172), iron oxide red (E172) and erythrosine (E127). 16 mg capsules contain gelatin, titanium dioxide (E171) and iron oxide red (E172). 24 mg capsules contain gelatin, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

What Neogalzeim XL looks like and contents of the pack

Neogalzeim XL prolonged-release capsules, hard are available in three strengths. Neogalzeim XL 8 mg prolonged release capsules opaque white; each capsule contains white pellets.

Neogalzeim XL 16 mg prolonged release capsules opaque flesh coloured; each capsule contains white pellets.

Neogalzeim XL 24 mg prolonged release capsules opaque caramel coloured; each capsule contains white pellets.

The 8 mg, 16 mg and 24 mg capsules are available in blister packs of 28.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Neopharma Ltd., 57 High Street, Odiham, Hook, RG29 1LF, UK

Manufacturer

Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero,

Modena, Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal - Galantamina Neopharma 8mg/16mg/24mg Capsula de libertagao prolongada

UK - Neogalzeim XL 8mg/16mg/24mg prolonged-release capsules This leaflet was last revised in April 2016

Client:	<[To be completed nationally]^
Leaflet:	PIL Neogalzeim XL 8-16-24 mg prolonged-release capsules 210x297.indd|
Color:	Black Dimensions:	210 x 297 mm
Font:	Helvetica Neue LT 9 pt Title: 22 pt	Subtitle: 9 pt
Leading:	3,81 mm (10.8 pt)	Page: 2