PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ^SZ°°°°°^L™°

Galantamine 4 mg/ml oral solution

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 are a carer and will be giving Galantamine oral solution 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 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 Galantamine oral solution is and what it is used for

2.    What you need to know before you take Galantamine oral solution

3.    How to take Galantamine oral solution

4.    Possible side effects

5.    How to store Galantamine oral solution

6.    Content of the pack and other information

ASANDOZ

What Galantamine 1 oral solution is and what it is used for

Galantamine oral solution 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.

The 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 oral solution increases the amount of acetylcholine in the brain and treats the signs of the disease.

What you need to

2 know before you take Galantamine oral solution

Do not take Galantamine oral solution

• 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 Galantamine oral solution. 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 oral solution can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Galantamine oral solution.

See ‘Look out for serious side effects’ in section 4.

Before you take Galantamine oral solution, 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 heartbeat • 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 Galantamine oral solution 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 Galantamine oral solution is not suitable for you. Galantamine oral solution can cause weight loss. Your doctor will check your weight regularly while you are taking Galantamine oral solution.

Children and adolescents

Galantamine oral solution is not recommended for children and adolescents.

Other medicines and Galantamine oral solution

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

Galantamine oral solution 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 Galantamine oral solution. 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 Galantamine oral solution if you are taking some of these medicines.

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

If you have any questions, talk 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 Galantamine oral solution.

Driving and using machines

Galantamine oral solution may make you feel dizzy or sleepy, especially during the first few weeks of treatment.

If Galantamine oral solution affects you, do not drive or use any tools or machinery.

Galantamine oral solution contains sorbitol.

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

Galantamine oral solution also contains Methyl-/Propyl-para-hydroxybenzoate.

These can sometimes cause allergic reactions, which may possibly be delayed.

How to take 3 Galantamine oral solution

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

How much to take

You will start treatment with Galantamine oral solution at a low dose. The usual starting dose is 4 mg (1 ml of solution), taken twice a day (a total of 8 mg 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 12 mg (3 ml of solution), taken twice a day (a total of 24 mg 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 Galantamine oral solution 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 liver or kidney problems, your doctor may give you a reduced dose of Galantamine oral solution, or may decide this medicine is not suitable for you.

How to take

Take your dose of Galantamine oral solution twice a day, in the morning and evening, with water or other liquids. Try to take Galantamine oral solution with food. Drink plenty of liquids while you are taking Galantamine oral solution, to keep yourself hydrated.

The solution comes with a pipette which you should use to take the exact amount needed from the bottle.

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Directions for opening the bottle and using the dosing pipette

A dosing pipette is supplied with each bottle. The bottle has a child-proof stopper.

1.    Open the stopper by pressing it firmly downwards and turning it anticlockwise.

2.    Insert the pipette into the bottle. In order to measure the dose hold the pipette tightly with one hand by the lower ring and with the other hand pull the upper ring of the pipette until the correct quantity of the medicine is visible on the barrel of the pipette in ml.

3.    Draw the pipette carefully from the bottle holding it tightly by the lower ring. Transfer the quantity of medicine drawn into the pipette directly into the mouth or into a glass containing a non-alcoholic liquid by pressing the upper ring of the pipette. Drink the glass empty immediately.

4.    Close the bottle and rinse the empty pipette with water.

If you take more Galantamine oral solution than you should

If you take too much Galantamine oral solution, contact a doctor or hospital straight away. Take any remaining solution 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 Galantamine oral solution

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 doses.

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

If you stop taking Galantamine oral solution

Check with your doctor before you stop taking Galantamine oral solution. 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.

•    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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store 5 Galantamine oral solution

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 on the bottle after EXP The expiry date refers to the last day of that month. Galantamine oral solution should not be used for longer than 3 months after the bottle has first been opened.

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.

Contents of the pack and other information

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 Galantamine oral solution 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 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 oral solution (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 Galantamine oral solution (may affect up to 1 in 10 people).

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

You must stop taking Galantamine oral solution 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 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)

What Galantamine oral solution contains

The active substance is galantamine (as hydrobromide)

1 ml oral solution contains 4 mg galantamine.

The other ingredients are: Methylparahydroxybenzoate E 218

Propylparahydroxybenzoate E 216

Sorbitol solution (70%), non crystallising E 420 Purified water

What Galantamine oral solution looks like and contents of the pack

Galantamine oral solution is a clear and colourless oral solution. It is available in amber glass bottles with a white plastic child resistant closure containing 100 ml oral solution.

A dosing pipette including pipette holder is enclosed. The pipette is marked with a scale. The graduation is in steps of 0.1 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Manufacturer:

Lek Pharmaceuticals d.d Address: Verovskova 57 1526 Ljubljana Slovenia

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

This leaflet was last revised in 10/2016

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