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Gatalin Xl 24 Mg Prolonged Release Capsules Hard

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Package leaflet: information for the user

Gatalin XL 8mg prolonged-release capsules, hard Gatalin XL 16mg prolonged-release capsules, hard Gatalin XL 24mg prolonged-release capsules, hard

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 Gatalin XL is and what it is used for

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

3.    How to take Gatalin XL

4.    Possible side effects

5.    How to store Gatalin XL

6.    Contents of the pack and other information

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

Gatalin XL 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 acetylcholine, a substance responsible for sending messages between brain cells.

Gatalin XL increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.

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

Do not take Gatalin 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 and/or severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Gatalin XL.

Gatalin XL 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 Gatalin XL 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 Gatalin XL.

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

Other medicines and Gatalin XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Gatalin 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 (for dry mouth or dry eyes) if taken by mouth.

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

Some medicines can increase the number of side effects caused by Gatalin XL, 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 Gatalin XL.

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

Gatalin XL with food and drink

Gatalin XL capsules should be taken with food if possible.

Drink plenty of liquids during your treatment with Gatalin XL, to keep yourself hydrated.

See section 3 of this leaflet for full details about how to take this medicine.

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 breast-feed while you are taking Gatalin XL.

Driving and using machines

Gatalin XL 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.

3. How to take Gatalin 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 immediate release tablets or oral solution and have been told by your doctor to switch to Gatalin XL prolonged-release capsules, read the instructions at the end of this section carefully.

How to take Gatalin XL

Gatalin XL should be swallowed whole, NOT chewed or crushed. Gatalin XL should be taken in the morning, with water or other liquids, and preferably with food.

Gatalin XL prolonged-release capsules are available in 3 strengths: 8mg, 16mg and 24mg.

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

1.    The treatment is started with 8 mg taken once daily. After 4 weeks of treatment, the dose is increased.

2.    You would then take 16 mg once daily.

After another 4 weeks of treatment at the earliest, your doctor may decide to increase the dose again.

3.    You would then take 24 mg once daily.

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

Use in children

Gatalin XL is not recommended for children.

Liver or kidney disease

•    If you have mild liver or kidney disease, treatment is started with 8 mg once daily in the morning.

•    If you have moderate liver or kidney disease, treatment is started with 8 mg once every other day in the morning. After one week, begin taking 8 mg once daily in the morning. Do not take more than 16 mg once daily.

•    If you have severe liver and/or kidney disease, do not take Gatalin XL.

How do I switch from taking Galantamine immediate release tablets or oral solution to Gatalin XL prolonged release capsules?

If you are currently taking Galantamine immediate release tablets or oral solution, your doctor may decide to switch you to Gatalin Xl prolonged-release capsules.

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

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

DO NOT take more than one capsule in a day. While you are taking Gatalin XL prolonged-release capsules, DO NOT take Galantamine immediate release tablets or oral solution.

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

If you take more Gatalin XL than you should

If you take too much Gatalin XL, contact a doctor or hospital straight away. Take along any remaining capsules 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 Gatalin 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 Gatalin XL

You should consult your doctor before you stop taking Gatalin XL. It is important to continue taking this medicine to treat your condition.

4. Possible side effects

Like all medicines, this medicine 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, or swelling of your lips, throat or tongue.

Side effects include:

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

•    Feeling sick and/or vomiting. If these side 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: (may affect up to 1 in 10 people)

•    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).

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

•    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

•    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

•    Fits (seizures).

Rare: (may affect up to 1 in 1000 people)

•    Inflammation of the liver (hepatitis).

Reporting of side effects

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

5. How to store Gatalin XL

Keep out of the sight and reach of children.

Do not use Gatalin XL 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 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. Contents of the pack and other information

What Gatalin XL contains:

The active substance is galantamine.

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

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

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

The other ingredients are:

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

Capsule shell: Gelatin and Titanium dioxide (E 171).

The 16 mg capsule also contains red iron oxide (E 172).

The 24 mg capsule also contains Indigo carmine (E 132), Erythrosin (E 127), Red Iron Oxide (e 172) and Yellow iron oxide (E 172).

What Gatalin XL looks like and contents of the pack

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

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

16mg: Opaque, flesh size 2 hard gelatine capsules containing two round biconvex tablets 24mg: Opaque orange size 2 hard gelatine capsules containing three round biconvex tablets Pack sizes:

1,7, 14, 28, 30, 56, 60, 84, 90, 300 prolonged release capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aspire Pharma Limited

Bellamy House

Winton Road

Petersfield

Hampshire

GU32 3HA

United Kingdom

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

This leaflet was last revised in 02/2014

Aspire

1010067-P4.2