Lotprosin XL 8mg, 16mg and 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.

•    The full name of this medicine is Lotprosin XL 8mg, 16mg and 24mg Prolonged-release Capsules, hard but within the leaflet it will be referred to as Lotprosin XL capsules.

What is in this leaflet:

T| What Lotprosin XL capsules are and what they are used for

^1 What you need to know before you take How to take _4| Possible side effects How to store

^1 Contents of the pack and other information

T| What Lotprosin XL capsules are and what they are used for

Lotprosin XL capsules are 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 behavioral 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. Lotprosin XL capsules increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.

^1 What you need to know before you take

Do not take Lotprosin XL capsules

•    If you are allergic (hypersensitive) 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 Lotprosin XL capsules. Lotprosin XL capsules 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 Lotprosin XL capsules 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 Lotprosin XL capsules.

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

Other medicines and Lotprosin XL capsules

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

Lotprosin XL capsules 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 Lotprosin XL capsules work, or Lotprosin XL capsules 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 Lotprosin XL capsules if you are also taking any of the medicines listed above.

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

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

Lotprosin XL capsules with food and drink

Lotprosin XL capsules should be taken with food if possible.

Drink plenty of liquids during your treatment with Lotprosin XL capsules, 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 Lotprosin XL capsules, speak to your doctor for advice if you are pregnant, think you could be pregnant, or you are planning a pregnancy.

You should not breastfeed while you are taking Lotprosin XL capsules.

Driving and using machines

Lotprosin XL capsules 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.

How to take

Always take Lotprosin XL capsules exactly as your doctor has told you. You should 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 Lotprosin XL capsules, read the instructions at the end of this section carefully.

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

Lotprosin XL capsules are available in 3 strengths: 8mg, 16mg and 24mg. Lotprosin XL capsules are started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Lotprosin XL capsules that you take to find the most suitable dose for you.

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

2.    You would then take 16mg 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 24mg 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 Lotprosin 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 Lotprosin XL capsules.

Use in children

Lotprosin XL capsules are not recommended for children.

Liver or kidney disease

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

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

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

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

If you are currently taking Galantamine immediate release tablets or oral solution, your doctor may decide to switch you to Lotprosin XL capsules.

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

•    The next morning, take your first dose of Lotprosin XL capsules.

DO NOT take more than one capsule in a day. While you are taking Lotprosin XL 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 Lotprosin XL capsules than you should

If you take too much Lotprosin XL capsules, 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 Lotprosin XL capsules

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 Lotprosin XL capsules

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

Q 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.

Side effects include:

Very common side effects: affects more than one user in 10

•    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 side effects: 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).

Continued top of next column AAAF6544

Uncommon side effects: affects 1 to 10 users in 1000

•    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

•    Hypersensitivity

•    Seizures

Rare side effects: affects 1 to 10 users in 10000

•    Inflammation of the liver (hepatitis).

Reporting of side effects

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

This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine

B How to store

Keep out of the sight and reach of children.

Do not use Lotprosin XL capsules 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.

B Contents of the pack and other information

What Lotprosin XL capsules contain:

The active substance is galantamine.

•    Lotprosin XL 8mg Prolonged-release Capsules contain 8mg galantamine (as hydrobromide).

•    Lotprosin XL 16mg Prolonged-release Capsules contain 16mg galantamine (as hydrobromide).

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

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

What Lotprosin XL capsules look like and contents of the pack

Lotprosin 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 size: 28

Marketing Authorisation Holder

Actavis Group PTC ehf., Reykjavikurvegur 76-78,

220 Hafnarfjordur, Iceland

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 July 2013

If you would like a leaflet with larger text, please contact

01271 311257.    .

y actavis

Actavis, Barnstaple, EX32 8NS, UK