Acumor Xl 16 Mg Prolonged Release Capsules
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PACKAGE LEAFLET: INFORMATION FORTHE USER
Acumor XL 8 mg prolonged release capsules
Acumor XL 16 mg prolonged release capsules
Acumor XL 24 mg prolonged release capsules
(galantamine)
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 Acumor XL 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 Acumor XL is and what it is used for
2. What you need to know before you take Acumor XL
3. How to take Acumor XL
4. Possible side effects
5. How to store Acumor XL
6. Contents of the pack and other information
1. What Acumor XL is and what it is used for
Acumor 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. Acumor 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 slowly.
2. What you need to know before you take Acumor XL
Do not take Acumor XL
• If you are allergic (hypersensitive) to galantamine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver and/or kidney disease
Warnings and precautions
Talk to your doctor before taking Acumor XL.
Acumor 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 Acumor XL if you suffer from or have suffered in the past from any of the following conditions:
• liver or kidney problems
• heart disorders (e.g. angina, heart attack, heart failure, slow or irregular pulse)
• electrolyte disturbances (if your blood potassium levels are decreased or increased)
• peptic (stomach) ulcer disease
• acute abdominal pain
• a disorder of the nervous system (like epilepsy or Parkinson's disease)
• respiratory diseases 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 in passing urine
If you need an operation, which requires a general anaesthetic, you should inform the doctor that you are taking Acumor XL.
Your doctor will then decide whether treatment with Acumor XL is suitable for you or if the dose needs to be changed.
Other medicines and Acumor XL
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Acumor 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 Acumor XL works, or Acumor XL itself can reduce the effectiveness of other medicines taken at the same time. Your doctor may prescribe a smaller dose of Acumor XL if you are taking any of those medicines. These include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral - HIV protease inhibitor)
Some medicines can increase the number of side effects caused by Acumor 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 heartbeat, your doctor may consider an electrocardiogram (ECG).
If you need an operation, which requires general anaesthetic, please inform your doctor that you are taking Acumor XL.
If you have any questions, speak to your doctor or pharmacist for advice.
Acumor XL with food and drink
Acumor XL should be taken with food, if possible.
Drink plenty of liquids during your treatment with Acumor 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 for advice before taking this medicine.
You should not breast-feed while you are taking Acumor XL. Driving and using machines
Acumor 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.
Acumor XL contains Allura Red AC (E 129)
This product contains Allura Red AC (E 129, an azo colouring agent) which may cause allergic reactions.
3. How to take Acumor XL
Always take Acumor XL exactly as your doctor has told you. Check with your doctor 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 Acumor XL read the instructions at the end of this section carefully.
How to take Acumor XL
Acumor XL should be swallowed whole, NOT chewed or crushed. Acumor XL should be taken in the morning, with water or other liquids, and preferably with food.
Acumor XL is available in 3 strengths: 8 mg, 16 mg and 24 mg. Acumor XL is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Acumor XL that you take to find the most suitable dose for you.
1. The recommended starting dose is 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 Acumor 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 Acumor 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 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 Acumor XL
If you take more Acumor XL than you should
If you take too much Acumor 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: severe nausea, vomiting, muscle weakness, slow heartbeat, seizures and loss of consciousness.
If you forget to take Acumor 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 Acumor XL
You should consult your doctor before you stop taking Acumor 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.
How do I switch from taking Galantamine tablets or oral solution to Acumor XL?
If you are currently taking Galantamine tablets or oral solution, your doctor may decide to switch you to Acumor XL.
• Take your last dose of Galantamine tablets or oral solution in the evening
• The next morning, take your first dose of Acumor XL.
Do not take more than one capsule in a day. While you are taking once-daily Acumor XL, do not take Galantamine tablets or oral solution.
Children
Acumor XL is not recommended for children.
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)(uncommon)
• palpitations (pounding heart beat) (uncommon)
• Disturbance in the mechanism of conducting impulses in the heart (uncommon)
• conditions like blackout (uncommon)
• Fits (uncommon)
• Allergic reaction. Signs include rash, itching or hives, swelling of the face, lips, tongue, shortness of breath (uncommon)
• Inflammation of the liver (hepatitis) (rare)
Common: may affect up to 1 in 10 people
• weight loss
• loss of appetite
• decreased appetite
• 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)
• 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
Other side effects:
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.
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.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Acumor 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 label, carton and blister after the letters EXP. The expiry date refers to the last day of that month.
If your medicine is packaged in Aluminium/Aluminium blisters: Store in the original carton to protect from moisture.
If your medicine is packaged in PVDC blisters:
Do not store above 25 °C. Store in the original carton to protect from moisture
If your medicine is packaged in a tablet container:
Do not store above 25 °C. Keep the container tightly closed and store the medicine in the original container to protect from moisture.
If your medicine is packaged in a bottle:
Keep the container tightly closed and store the medicine in the original container to protect from moisture.
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 Acumor XL contains:
The active substance is galantamine
• Acumor XL 8 mg prolonged release capsules contains 8 mg galantamine (as hydrobromide).
• Acumor XL 16 mg prolonged release capsules contains 16 mg galantamine (as hydrobromide).
• Acumor XL 24 mg prolonged release capsules contains 24 mg galantamine (as hydrobromide).
The other ingredients are:
Tablet core (Contents of the capsule): Polyvinyl acetate, silica colloidal anhydrous, povidone, hydrogenated vegetable oil, sodium lauryl sulphate and magnesium stearate.
Capsule Shell:
Gelatin, titanium dioxide (E171), Allura Red AC (E129)
Printing Ink: Shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
What Acumor XL looks like and contents of the pack
Acumor XL is available in three strengths, each of which can be recognised by its lettering:
Acumor XL 8 mg prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink 'MYLAN' over 'GT8' on the body and the cap.
Acumor XL 16 mg prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink 'MYLAN' over 'GT16' on the body and the cap.
Acumor XL 24 mg prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink 'MYLAN' over 'GT24' on the body and the cap.
The 8 mg, 16 mg and 24 mg are available in:
• PVDC blisters containing 7, 10, 28, 28 x 1 (unit dose), 30,
30 x 1 (unit dose), 56, 84, 98, or 100 capsules.
• PVDC calendar blisters containing 28 and 28 x 1 (unit dose) capsules.
• Aluminium/Aluminium blisters containing 7, 10, 28, 28 x 1 (unit dose), 30, 30 x 1 (unit dose), 56, 84, 98, or 100 capsules.
• Aluminium/Aluminium calendar blisters containing 28 and 28 x 1 (unit dose) capsules.
• Tablet containers containing 500 capsules
• Bottles containing 90 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
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