Informations for option: Reminyl 12mg Tablets, show other option

Select option:

1. Reminyl 12mg Tablets
2. Reminyl 12mg Tablets

Document: leaflet MAH BRAND_PL 08557-0041 change

• leaflet MAH BRAND_PL 08557-0041
• leaflet MAH BRAND_PLPI 15184-0275
• leaflet MAH BRAND_PLPI 18799-1166

---

Reminyl contains the active substance ‘galantamine’, an antidementia medicine.

It is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease, a type of dementia that alters brain function.

Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes which make it increasingly difficult to carry out normal daily activities.

These effects are thought to be caused by a lack of ‘acetylcholine’, a substance responsible for sending messages between brain cells. Reminyl increases the amount of acetylcholine in the brain and treats the signs of the disease.

2. What you need to know before you take Reminyl

Do not take Reminyl

•    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 or severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Reminyl. This medicine is only used in Alzheimer’s disease, and is not recommended for other types of memory loss or confusion.

Serious side effects Reminyl can cause serious skin reactions, heart problems, fits (seizures). You must be aware of these side effects while you are taking Reminyl. See ‘look out for serious side effects’ in section 4.

Before you take Reminyl, your doctor needs to know if you have, or have had, any of the following

•    liver or kidney problems

•    a heart condition (such as chest discomfort that is often brought on by physical activity, a heart attack, heart failure, slow or uneven heart beat)

•    changes in ‘electrolyte’ levels (naturally occurring chemicals in the blood, such as potassium)

•    a peptic (stomach) ulcer

•    blockage of the stomach or intestines

•    a disorder of the nervous system (such as epilepsy or Parkinson’s disease)

•    a respiratory disease or infection that affects breathing (such as asthma, obstructive pulmonary disease or pneumonia)

•    problems passing urine

Your doctor will decide if Reminyl is suitable for you, or if the dose needs to be changed.

Also tell your doctor if you recently had an operation on the stomach, intestines or bladder. Your doctor may decide that Reminyl is not suitable for you

Reminyl can cause weight loss. Your doctor will check your weight regularly while you are taking Reminyl.

Children and adolescents

Reminyl is not recommended for children and adolescents.

Other medicines and Reminyl

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Reminyl 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 muscle weakness)

•    pilocarpine (when taken by mouth for dry mouth or dry eyes)

Some medicines can make side effects more likely in people taking Reminyl. These include:

•    paroxetine or fluoxetine (antidepressants)

•    quinidine (for uneven heart beat)

•    ketoconazole ( an antifungal)

•    erythromycin (an antibiotic)

•    ritonavir (for human immunodeficiency virus or ‘HIV’).

•    non-steroidal anti-inflammatory painkillers (such as ibuprofen), which can increase the risk of ulcers.

•    medicines taken for heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents).

If you take medicines for an uneven heart-beat, your doctor may check your heart using an electrocardiogram (ECG).

Your doctor may give you a lower dose of Reminyl if you are taking any of these medicines.

Reminyl may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Reminyl, well in advance.

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

Pregnancy and breast-feeding

If you are pregnant, 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 breastfeed while you are taking Reminyl.

Driving and using machines

Reminyl may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Reminyl affects you, do not drive or use any tools or machinery.

Reminyl tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Reminyl 12 mg (orange -brown) tablets contain orange-yellow S aluminium lake

The colouring in these tablets may cause allergic reaction.

3. How to take Reminyl tablets

Always take this medicine exactly as your

■    doctor or pharmacist has told you. Check

■    with your doctor or pharmacist if you are not sure.

How much to take

You will start treatment with Reminyl at a low dose. The usual starting dose is 4mg, taken twice a day (a total of 8 mg a day).

Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you. The maximum dose is 12 mg, taken twice a day (a total of 24mg a day).

Your doctor will explain what dose to start with and when the dose should be increased. If you are not sure what to do, or find the effect of Reminyl 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 and to discuss how you are feeling.

If you have a liver or kidney problems,

your doctor may give you a reduced dose of Reminyl, or may decide this medicine is not suitable for you.

How to take

Take your dose of Reminyl twice a day, in the morning and evening, with water or other liquids. Try to take Reminyl with food.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Look out for serious side effects

Stop taking Reminyl and see a doctor or go to your nearest emergency department immediately if you notice any of the following.

Skin reactions, including:

•    Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).

•    Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalized exanthematous pustulosis).

•    Rash that may blister, with spots that look like small targets.

These skin reactions are rare in people taking Reminyl (may affect up to 1 in 1,000 people).

Heart problems, including changes in heart beat (such as a slow beat, extra beats) or palpitations (heart beat feels fast or uneven). Heart problems may show as an abnormal tracing on an electrocardiogram (ECG), and can be common in people taking Reminyl (may affect up to 1 in 10 people).

Fits (seizures). These are uncommon in people taking Reminyl (may affect up to 1 in 100 people).

You must stop taking Reminyl and get help immediately if you notice any of the side effects above.

Other Side effects:

Very Common side effects (may affectmore than1 in 10 people):

• Nausea and vomiting. These side effects are more likely to happen in the first few weeks of treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the medicines and generally only last for a few days. If you have these effects, your doctor may recommend that you drink more liquids and, may prescribe a medicine to stop you being sick.

Common side effects (may affect more than 1 in 10 people):

Decreased appetite; weight loss Seeing, feeling, or hearing things that are not there (hallucinations)

Depression

Feeling dizzy or fainting Muscle tremors or spasms Headache

Feeling very tired ,weak or generally unwell

Feeling very sleepy with low energy High blood pressure Stomach pain or discomfort Diarrhoea Indigestion Falls Wounds

LO