PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ09501LT03A

Galantamine 4 mg/ml oral solution

Active substance: Galantamine (as hydrobromide)

Read all of this leaflet carefully before you start taking this

medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

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

2.    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.    Further information

SANDOZ

What Galantamine

1    oral solution is and what it is used for

Galantamine oral solution is an antidementia medicine used to treat the symptoms of mild to moderately severe dementia of the 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 aacetylcholine, a substance responsible for sending messages between brain cells. Galantamine oral solution increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.

Before you take

2    Galantamine oral solution

Do not take Galantamine oral solution

•    If you are allergic (hypersensitive) to galantamine or to any of the other ingredients listed in section

6 of this leaflet.

•    If you have severe liver and

/ or a severe kidney disease.

Take special care with Galantamine oral solution

Galantamine oral solution 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 Galantamine oral solution if you suffer from or have suffered in the past from any of the following conditions:

•    liver or kidney problems

•    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 of the nervous system (like epilepsy or Parkinson’s disease)

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

•    if you recently had an operation on the gut or bladder

•    if you have difficulties passing urine.

If you need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Galantamine oral solution.

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

Taking other medicines

You should always tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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 muscular weakness)

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

Some medicines can affect the way Galantamine oral solution works, or Galantamine oral solution 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 Galantamine oral solution if you are also taking any of the medicines listed above.

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

If you need an operation which requires a general anaesthetic, you should inform the doctor that you are taking Galantamine oral solution.

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

Taking Galantamine oral solution with food and drink

Galantamine oral solution should be taken with food if possible.

Drink plenty of liquids during your treatment with Galantamine oral solution, to keep yourself hydrated. See section 3 of this leaflet for full details about how to take this medicine.

Pregnancy and breast-feeding

Before taking Galantamine oral solution, speak to your doctor for advice if you are pregnant, think you could be pregnant, or you are planning a pregnancy.

You should not breast-feed while you are taking Galantamine oral solution.

Driving and using machines

Galantamine oral solution 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.

Important information about some of the ingredients of Galantamine oral solution

This product 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. This product also contains Methyl-/

Propylparahydroxybenzoate which may cause allergic reactions (possibly delayed).

3

How to take Galantamine oral solution

Always take Galantamine oral solution exactly as your doctor has told you. You should check with your doctor if you are not sure.

How to take Galantamine oral solution

Galantamine oral solution should be taken twice daily, in the morning and evening, with water or other liquids, and preferably with food.

Galantamine oral solution is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Galantamine oral solution that you take, to find the most suitable dose for you.

1.    The treatment is started at 4 mg (1 millilitre of solution) taken twice daily. After 4 weeks of treatment, the dose is increased

2.    You would then take 8 mg (2 millilitres of solution) twice daily. After another 4 weeks of treatment at the earliest, your doctor may decide to increase the dose again

3.    You would then take 12 mg (3 millilitres of solution) twice daily.

Your doctor will explain what dose to start with and when the dose should be increased. If you feel that 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 for you and to discuss how you are feeling. Your doctor will also check your weight regularly while you are taking Galantamine oral solution.

Continued on the next page >>

Liver or kidney disease

•    If you have mild liver disease or mild to moderate kidney disease, the above dosing instructions are followed.

•    If you have moderate liver disease, treatment is started with 4 mg oral solution once daily in the morning. After one week, begin taking the 4 mg oral solution twice daily for at least 4 weeks. Do not take more than 8 mg twice daily.

•    If you have severe liver and/or kidney disease, do not take Galantamine oral solution.

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.

Children

Galantamine oral solution is not recommended for children.

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 along any remaining solution 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 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 forgotten individual doses. If you forget to take more than one dose, you should contact your doctor.

If you stop taking Galantamine oral solution

You should consult 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 product, ask your doctor or pharmacist.

Uncommon (affects 1 to 10 users in 1,000):

•    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, pricking, or numbness of the skin

•    Change in the sense of taste

•    Excessive sleepiness

•    Fits (seizures)

•    Blurred vision

•    Ringing or buzzing in the ears (tinnitus)

•    Feeling the need to vomit

•    Muscle weakness

•    Excessive water loss in the body

•    Low blood pressure

•    Reddening of the face

•    Allergic reaction.

Rare (affects 1 to 10 users in 10,000):

•    Inflammation of the liver (hepatitis)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5

How to store Galantamine oral solution

Keep out of the reach and sight of children.

Do not use Galantamine oral solution 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6

Further information

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

E218

Propylparahydroxybenzoate E216 Sorbitol solution (70%), non crystallising E420 Purified water

What Galantamine oral solution looks like and contents of the pack

Galantamine oral solution is a clear, 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.

4 Possible side effects

Like all medicines, Galantamine oral solution can cause side effects, although not everybody gets them. Some of these 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 of your lips, face, throat or tongue.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sandoz Ltd,

Frimley Business Park,

Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d, Verovskova 57,

1526 Ljubljana,

Slovenia.

This leaflet was last revised in 04/2013.

Side effects include:

Very common (affects more

than one user in 10):

•    Feeling sick and/or vomiting.

If these 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. If you have these effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medicine to stop you being sick.

Common (affects 1 to 10 users

in 100):

•    Weight loss

•    Loss of appetite

•    Decreased appetite

•    Slow heart beat

•    Feeling faint

•    Dizziness

•    Trembling

•    Headache

•    Drowsiness

•    Abnormally tired

•    Stomach pain or discomfort

•    Diarrhoea

•    Indigestion

•    Increased sweating

•    Muscle spasms

•    Falling

•    High blood pressure

•    Feeling weak

•    General feeling of discomfort

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

•    Feeling sad (depression).

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