Galsya Xl 8 Mg Prolonged-Release Capsules Hard
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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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Galsya® XL 8 mg prolonged-release capsules, hard
Galsya® XL 16 mg prolonged-release capsules, hard
Galsya® XL 24 mg prolonged-release capsules, hard
Galantamine
What is in this leaflet
1. What Galsya XL is and what it is used for
2. What you need to know before you take Galsya XL
3. How to take Galsya XL
4. Possible side effects
5. How to store Galsya XL
6. Contents of the pack and other information
1. WHAT GALsYA XL is AND WHAT iT is
used for
Galsya XL is an anti-dementia 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. Galsya XL increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.
The capsules are made in a ‘prolonged-release' form. This means that they release the medicine more slowly.
2. what you need to know before you take galsya xl
Do not take Galsya XL
• if you are allergic to galantamine or 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 Galsya XL.
Galsya 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 Galsya 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 Galsya XL.
Your doctor will then decide whether treatment with Galsya XL is suitable for you or if the dose needs to be changed.
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 muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by mouth.
Some medicines can affect the way Galsya XL works, or Galsya XL 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 Galsya XL if you are also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by Galsya 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 Galsya XL.
If you have any questions, speak to your doctor or pharmacist for advice.
Galsya XL with food and drink
Galsya XL should be taken with food if possible.
Drink plenty of liquids during your treatment with Galsya XL, to keep yourself hydrated (see section 3).
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 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 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, read the instructions at the end of this section carefully.
How to take Galsya XL
Galsya XL capsules should 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.
Galsya XL should be taken in the morning, with water or other liquids, and preferably with food.
Galsya XL prolonged-release capsules are available in 3 strengths: 8 mg, 16 mg and 24 mg.
Galsya XL is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Galsya XL that you take to find the most suitable dose for you.
1. The treatment is started with the 8 mg capsule taken once daily. After 4 weeks of treatment, the dose is increased.
2. You would then take the 16 mg capsule 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 the 24 mg capsule 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 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 for you and to discuss how you are feeling. Your doctor will also check your weight regularly while you are taking Galsya XL.
Liver or kidney disease
If you have mild liver or kidney disease, treatment is started with the 8 mg capsule once daily in the morning.
If you have moderate liver or kidney disease, treatment is started with the 8 mg capsule once every other day in the morning.
After one week, begin taking the 8 mg capsule 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 Galsya XL.
Children
Galsya XL is not recommended for children and adolescents under 18 years of age.
if you take more Galsya XL than you should
If you take too much Galsya 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 Galsya XL
If you forget to take one dose, miss out the forgotten dose completely and take the next dose at the normal time.
If you forget to take more than one dose, you should contact your doctor.
Do not take a double dose to make up for a forgotten dose.
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.
How do i switch from taking galantamine tablets or oral solution to Galsya XL prolonged-release capsules?
If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to galantamine prolonged-release capsules.
• Take your last dose of galantamine tablets or oral solution in the evening.
• The next morning, take your first dose of galantamine prolonged-release capsules.
DO NOT take more than one capsule in a day. While you are taking once-daily galantamine capsules, DO NOT take galantamine tablets or oral solution.
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.
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
Side effects include:
Very common: may affect more than 1 in 10 people
• 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: may affect up to 1 in 10 people
• Weight loss, loss of appetite, decreased appetite, stomach pain
or discomfort, diarrhoea, indigestion
• Slow heart beat
• Feeling faint, dizziness, trembling, headache, drowsiness, abnormally tired
• 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 heartbeat, 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
• Seizures
• Allergic reaction
Rare: 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 with G8 imprinted on the capsule's cap. Content of capsule is one white oval, prolonged-release tablet core.
16 mg: Pink capsules with G16 imprinted on the capsule’s cap. Content of capsule are two white, oval, prolonged-release tablet cores.
24 mg: Orange pink capsules 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 June 2014 P026o