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Document: leaflet CONSILIENT HEALTH (UK)_PL 01656-0131 change

• leaflet CONSILIENT HEALTH (UK)_PL 01656-0131
• leaflet MAH BRAND_PL 01656-0131

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1.    WHAT GALsYA XL is AND WHAT iT is

used for

Galsya XL contains the active substance 'galantamine' that is 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. Galsya 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 galsya xl

Do not take Galsya 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 Galsya 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

Galsya XL can cause serious skin reactions, heart problems, fits (seizures). You must be

aware of these side effects while you are taking Galsya XL. See 'Look out for serious side effects' in section 4.

Before you take Galsya 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, heart attack, heart failure, slow or uneven heart beat)

•    changes in 'electrolyte' levels (naturally occurring chemicals in the blood, such as potassium)

•    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 Galsya 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 Galsya XL is not suitable for you.

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

Children and adolescents

Galsya XL is not recommended for children and adolescents.

Other medicines and Galsya XL

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

Galsya 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 make side effects more likely in people taking Galsya 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 Galsya XL if you are also taking any of these medicines.

Galsya XL may affect some anaesthetics. If you are going to have an operation under a

general anaesthetic, tell the doctor that you are taking Galsya 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 for advice before taking this medicine.

You should not breastfeed while you are taking Galsya XL. Driving and using machines

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

3. HOW TO TAKE GALsYA XL

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

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

How much to take

You will start treatment with Galsya 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 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 Galsya 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 and to discuss how you are feeling.

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

switching from taking galantamine tablets or oral solution to Galsya XL capsules

If you are currently taking galantamine tablets or oral solution, your doctor may decide you

should switch to Galsya 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 Galsya XL prolonged-release capsule.

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

How to take Galsya XL

Galsya XL capsules must be swallowed whole, NOT chewed or crushed.

If you find the capsules difficult to swallow, you may empty the capsule and swallow the content whole - DO NOT chew or crush the contents.

Take your dose of Galsya XL once a day in the morning, with water or other liquids. Try to take Galsya XL with food. Drink plenty of liquids while you are taking Galsya XL, to keep yourself hydrated.

if you take more Galsya XL than you should

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

•    severe nausea and vomiting,

•    muscle weakness, slow heart beat, fits (seizures) and loss of consciousness.

if you forget to take Galsya 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 Galsya XL

You should consult your doctor before you stop taking Galsya 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 your medicine and see a doctor or go to your nearest emergency department immediately if you notice any of the following:

Skin reactions, including:

•    Severe rash with blisters and peeling of the 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), and can be common in people taking Galsya XL (may affect up to1 in 10 people).

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

You must stop taking Galsya XL and get help immediately if

you notice any of the side effects 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 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, may prescribe a medicine to stop you being sick.

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

•    Weight loss, decreased appetite

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

•    Depression

•    Feeling dizzy or fainting

•    Muscle tremor 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 the 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):

•    Inflammation of the 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: Yellow Card Scheme Website: 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 GALSYA 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 blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from moisture.

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 Galsya XL contains

•    The active substance is galantamine.

8 mg: Each prolonged-release capsule, hard contains 8 mg galantamine (as hydrobromide).

16 mg: Each prolonged-release capsule, hard contains 16 mg galantamine (as hydrobromide).

24 mg: Each prolonged-release capsule, hard contains 24 mg galantamine (as hydrobromide).

•    The other ingredients in the prolonged-release tablet core are sodium laurilsulfate, ammonio methacrylate copolymer (type B), hypromellose, carbomers, hydroxypropylcellulose, magnesium stearate and talc.

•    The other ingredients in the 8 mg capsule shell are gelatin, titanium dioxide (E171) and black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

•    The other ingredients in the 16 mg and 24 mg capsule shell are gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

What Galsya XL looks like and contents of the pack

8 mg: White capsules size 2 (capsule length: 17.6 - 18.4 mm) with G8 imprinted on the capsule's cap. Content of capsule is one white oval, prolonged-release tablet core.

16 mg: Pink capsules size 1 (capsule length: 19.0 - 19.8 mm) with G16 imprinted on the capsule's cap. Content of capsule are two white, oval, prolonged-release tablet cores.

24 mg: Orange pink capsules size 0 el (capsule length: 23.8 -24.6 mm) with G24 imprinted on the capsule's cap. Content of capsule are three white, oval, prolonged-release tablet cores.

Capsules are available in cartons of 10, 14, 28, 30, 56, 60, 84, 90 and 100 prolonged-release capsules, hard in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany

Distributed by

Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in 03/2016

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