Information för alternativet: Reminyl 8 Mg + 16 Mg Depotkapsel, Hård, visar 4 alternativ

Välj alternativ:

1. Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 24 Mg Depotkapsel, Hård
2. Reminyl 4 Mg/Ml Oral Lösning
3. Reminyl 12 Mg Filmdragerad Tablett Reminyl 4 Mg Filmdragerad Tablett Reminyl 8 Mg Filmdragerad Tablett
4. Reminyl 8 Mg + 16 Mg Depotkapsel, Hård
5. Reminyl 24 Mg Depotkapsel, Hård Reminyl 4 Mg/Ml Oral Lösning Reminyl 8 Mg Depotkapsel, Hård Reminyl 8 Mg Filmdragerad Tablett Reminyl 8 Mg Depotkapsel, Hård Reminyl 24 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg Filmdragerad Tablett Reminyl 4 Mg/Ml Oral Lösning Reminyl 8 Mg Depotkapsel, Hård Reminyl 4 Mg Filmdragerad Tablett Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg/Ml Oral Lösning Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg/Ml Oral Lösning Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Filmdragerad Tablett Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg Filmdragerad Tablett Reminyl 8 Mg Filmdragerad Tablett Reminyl 4 Mg Filmdragerad Tablett Reminyl 8 Mg Filmdragerad Tablett Reminyl 24 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg/Ml Oral Lösning Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg Filmdragerad Tablett Reminyl 4 Mg/Ml Oral Lösning Reminyl 8 Mg Depotkapsel, Hård Reminyl 4 Mg/Ml Oral Lösning Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Filmdragerad Tablett Reminyl 12 Mg Filmdragerad Tablett Reminyl 24 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 4 Mg Filmdragerad Tablett Reminyl 8 Mg Filmdragerad Tablett Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Filmdragerad Tablett Reminyl 8 Mg Depotkapsel, Hård Reminyl 16 Mg Depotkapsel, Hård Reminyl 8 Mg Filmdragerad Tablett Reminyl 4 Mg Filmdragerad Tablett Reminyl 8 Mg Depotkapsel, Hård

Document: Reminyl prolonged-release capsule, hard starter pack ENG PL change

• Reminyl 8 mg 16 mg prolonged-release capsule, hard PL
• Reminyl prolonged-release capsule, hard starter pack ENG PL

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Package leaflet: Information for the user

Reminyl 8 mg + 16 mg prolonged‑release capsules, hard (starter pack)

galantamine

Read all of this leaflet carefully before you start taking this medicine because if 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 Reminyl is and what it is used for

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.

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 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 and 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:

• 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, 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 some 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 breast‑feed 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 contains sucrose

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

3. How to take Reminyl capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you are currently taking Reminyl tablets or oral solution and have been told by your doctor to switch to Reminyl prolonged‑release capsules, carefully read the instructions under ‘Switching from taking Reminyl tablets or oral solution to Reminyl capsules’ in this section.

How much to take

You will start treatment with Reminyl at a low dose. The starter pack is only for use at the beginning of Reminyl treatment, and is not used when you reach a stable dose. The usual starting dose is 8 mg, taken once 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 24 mg, taken once 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 liver or kidney problems, your doctor may give you a reduced dose of Reminyl, or may decide this medicine is not suitable for you.

Switching from taking Reminyl tablets or oral solution to Reminyl capsules

If you are currently taking Reminyl tablets or oral solution, your doctor may decide you should switch to Reminyl prolonged‑release capsules. If this applies to you:

• Take your last dose of Reminyl tablets or oral solution in the evening

• The next morning, take your first dose of Reminyl prolonged‑release capsules.

DO NOT take more than one capsule in a day. While you are taking once-daily Reminyl capsules, DO NOT take Reminyl tablets or oral solution.

How to take

Reminyl capsules must be swallowed whole and NOT chewed or crushed. Take your dose of Reminyl once a day in the morning, with water or other liquids. Try to take Reminyl with food.

Drink plenty of liquids while you are taking Reminyl, to keep yourself hydrated.

If you take more Reminyl than you should

If you take too much Reminyl, contact a doctor or hospital straight away. Take any remaining capsules and the packaging with you. The signs of overdose may include:

• severe nausea and vomiting

• weak muscles, slow heart beat, fits (seizures) and loss of consciousness.

If you forget to take Reminyl

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, contact your doctor.

If you stop taking Reminyl

Check with your doctor before you stop taking Reminyl. 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 or pharmacist.

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 affect more than 1 in 10 people):

Common side effects (may affect up to 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.

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

• Allergic reaction

• Not enough water in the body (dehydration)

• Tingling or numb feeling of the skin (pins and needles)

• Change in sense of taste

• Daytime sleepiness

• Blurred vision

• Ringing in the ears that does not go away (tinnitus)

• Low blood pressure

• Flushing

• Feeling the need to vomit (retch)

• Excessive sweating

• Weak muscles

• Increased level of liver enzymes in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Reminyl

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 carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30C.

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 Reminyl contains

• The active substance is galantamine. Each prolonged‑release capsule contains 8 mg or 16 mg of galantamine (as hydrobromide).

• The other ingredients are:

Diethyl phthalate, ethylcellulose, hypromellose, macrogol 400, maize starch, sucrose, gelatin, titanium dioxide (E171), iron oxide black (E172), shellac and propylene glycol (E1520).

The 16 mg capsules also contain iron oxide red (E172).

What Reminyl looks like and contents of the pack

Reminyl 8 mg capsules are white and marked ‘G8’. Each pack contains blisters of 28 capsules.

Reminyl 16 mg capsules are pink and marked ‘G16’. Each pack contains blisters of 28 capsules.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy.

McGregor Cory Ltd., Exel, Site 1 Middleton Close, Banbury, Oxfordshire, OX16 4RS, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Reminyl 8 mg + 16 mg Retardkapseln (Startpackung)

Belgium Reminyl 8 mg + 16 mg harde capsules met verlengde afgifte (startverpakking)

Finland Reminyl 8 mg + 16 mg depotkapseli, kova

Greece Reminyl 8 mg + 16 mg καψάκια παρατεταμένηςαποδέσμευσης, σκληρά(συσκευασία έναρξηςθεραπείας)

Iceland Reminyl 8 mg + 16 mg hörð forðahylki (byrjunarpakkning)

Luxembourg Reminyl 8 mg + 16 mg, gélules dures à libération prolongée (emballage de départ)

Netherlands Reminyl retard capsules 1x daags 8 mg + 16 mg startverpakking, harde capsules met verlengde afgifte

Norway Reminyl startpakning 8 mg 28 stk depotkapsler, hard + 16 mg 28 stk depotkapsler, hard

Portugal Reminyl 8 mg + 16 mg cápsulas duras de libertação prolongada (embalagem inicial)

Sweden Reminyl 8 mg + 16 mg depotkapslar, hårda (upptrappningsförpackning)

This leaflet was last revised in 2015-08-21