REMINYL 16 mg PROLONGED-RELEASE HARD CAPSULES

1. What is Reminyl and what is it used for

Reminyl contains the active substance “galantamine”, an anti-dementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects memory and thinking.

Alzheimer's disease causes increasing memory loss, confusion, and changes in behavior, making it difficult to carry out daily activities.

It is thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Reminyl increases the amount of acetylcholine in the brain, treating the symptoms of the disease.

The capsules are in the form of “prolonged release”. This means that they release the medicine gradually.

2. What you need to know before you take Reminyl

Do not take Reminyl

• if you are allergic to galantamine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver or kidney disease.

Warnings and precautions

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

Severe side effects

Reminyl may cause severe skin reactions, heart problems, and seizures. You should be aware of these side effects while taking Reminyl. See section 4 “Be aware of severe side effects”.

Before starting treatment with Reminyl, your doctor should know if you have or have had any of the following conditions:

• liver or kidney problems
• a heart condition (such as chest pain that is usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in electrolyte levels (naturally occurring chemicals in the blood, such as potassium)
• a stomach ulcer
• blockage in the stomach or intestine
• a nervous system disorder (such as epilepsy or problems controlling body or limb movements)
• a respiratory disease that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• problems with urination.

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

Tell your doctor if you have recently had an operationon your stomach, intestine, or bladder. Your doctor will decide if Reminyl is suitable for you.

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

Children and adolescents

Reminyl is not recommended for use in children or 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 taken with medicines that work in the same way. These include:

• donepezil or rivastigmine (for Alzheimer's disease)
• ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness)
• pilocarpine (taken by mouth for dry eyes or mouth).

Some medicines may increase the risk of side effects when taken with Reminyl. These include:

• medicines that affect the QTc interval
• paroxetine or fluoxetine (antidepressants)
• quinidine (for irregular heartbeat)
• ketoconazole (an antifungal)
• erythromycin (an antibiotic)
• ritonavir (for human immunodeficiency virus or HIV)

• non-steroidal anti-inflammatory painkillers (such as ibuprofen), which may increase the risk of ulcers
• medicines for certain heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medicines for an irregular heartbeat, your doctor may check your heart with an “electrocardiogram” (ECG).

If you are taking any of these medicines, your doctor may give you a lower dose of Reminyl.

Reminyl may affect some anesthetics. If you are going to have an operation under general anesthesia, tell your doctor that you are taking Reminyl.

Talk to your doctor or pharmacist if you have any questions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 taking Reminyl.

Driving and using machines

Reminyl may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If Reminyl affects you, do not drive or use machines.

Reminyl contains sucrose

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Reminyl capsules

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

If you are taking Reminyl tablets or oral solution and your doctor has told you to switch to Reminyl prolonged-release capsules, read the instructions carefully in “Switching from Reminyl tablets or oral solution to Reminyl prolonged-release capsules” in this section.

How much to take

You will start treatment with Reminyl at a low dose. The usual starting dose is 8 mg, taken once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the dose that is best for you. The maximum dose is 24 mg, taken once a day.

Your doctor will tell you which dose to start with and when to increase it.

If you are not sure what to do or find that the effect of Reminyl is too strong or too weak, talk to your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medicine is working and to talk to you about how you are feeling.

If you have liver or kidney problems,your doctor may give you a lower dose of Reminyl or decide that this medicine is not suitable for you.

Switching from Reminyl tablets or oral solution to Reminyl prolonged-release capsules

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

• Take your last dose of Reminyl tablets or oral solution at night
• The next morning, take your first dose of Reminyl prolonged-release capsules.

DO NOT take more than one capsule a day. While taking one Reminyl capsule a day, DO NOT take Reminyl tablets or oral solution.

How to take it

Reminyl capsules should 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 liquid while taking Reminyl to stay hydrated.

If you take more Reminyl than you should

If you have taken too much Reminyl, talk to your doctor or pharmacist immediately or call the Poison Information Service on 91 562 04 20, quoting the name of the medicine and the amount taken. Take the pack with the remaining capsules with you. Signs of overdose may include:

• severe nausea and vomiting
• muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you forget to take Reminyl

If you forget to take a dose, skip that dose and continue with your usual schedule. DO NOT take a double dose to make up for forgotten doses.

If you forget to take more than one dose, talk to your doctor.

If you stop taking Reminyl

Talk to your doctor before stopping treatment with Reminyl. It is important to continue taking this medicine to treat your condition.

If you have any other questions about taking 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.

Be aware of severe side effects

Stop taking Reminyl and see a doctor or go to the casualty department immediatelyif you notice any of the following side effects:

Skin reactions,including:

• severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• rash with small pus-filled bumps that can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• rash that can cause blisters, 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 problemsincluding changes in heartbeat (such as slow or extra beats) or palpitations (feeling your heartbeat is fast or irregular). Heart problems can be seen as an abnormal tracing on an “electrocardiogram” (ECG), and may be common in people taking Reminyl (may affect up to 1 in 10 people).

Seizures. This is uncommon in people taking Reminyl (may affect up to 1 in 100 people).

You must stop taking Reminyl and seek immediate helpif you notice any of the side effects mentioned.

Other side effects

Very common side effects(may affect more than 1 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 usually go away gradually as your body gets used to the medicine and generally only last a few days. If you experience these side effects, your doctor may recommend drinking more liquids and may prescribe a medicine to prevent nausea.

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 faint
• tremors or muscle spasms
• headache
• feeling very tired, weak, or unwell
• feeling very sleepy and having little energy
• increased blood pressure
• abdominal pain or discomfort
• diarrhea
• indigestion
• falls
• injuries

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

• allergic reaction
• not having enough water in the body (dehydration)
• tingling or numbness of the skin
• change in sense of taste
• daytime sleepiness
• problems controlling body or limb movements (extrapyramidal disorder)
• blurred vision
• ringing in the ears that does not go away (tinnitus)
• low blood pressure
• flushing
• feeling sick (nausea)
• excessive sweating
• muscle weakness
• increased levels of liver enzymes in the blood.

Rare side effects(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 the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 label after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

What Reminyl contains

• The active substance is galantamine. Each prolonged-release capsule contains 16 mg of galantamine (as hydrobromide).
• The other ingredients are:

diethyl phthalate, ethylcellulose, hypromellose, macrogol 400, corn starch, sucrose, gelatin, titanium dioxide (E171), iron oxide black (E172), shellac, and propylene glycol (E1520), iron oxide red (E172)

Appearance and packaging

Reminyl 16 mg prolonged-release capsules are pink and marked with “G16”. Each pack contains 7, 28, 56, or 84 capsules or 300 capsules in a bottle.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Essential Pharma Limited,

Vision Exchange Building,

Territorials Street, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Manufacturer

Janssen-Cilag, SpA

Via C. Janssen

04100 Borgo San Michele

Latina (Italy)

This medicine is authorized in the Member States of the European Union under the following names:

Austria

Belgium Reminyl 16 mg hard capsules with prolonged release

Denmark Reminyl 16 mg depot capsules, hard

Finland Reminyl 16 mg depot capsule, hard

Greece Reminyl 16 mg καψ?κια παρατεταμ?νης αποδ?σμευσης, σκληρ?

Ireland Reminyl XL 16 mg prolonged release capsules

Italy Reminyl 16 mg capsule rigide a rilascio prolungato

Luxembourg Reminyl 16 mg gélules dures à libération prolongée

Norway Reminyl 16 mg depotkapsler, hard

Portugal

Spain Reminyl 16 mg hard capsules with prolonged release

Sweden Reminyl 16 mg depotkapslar, hårda

United Kingdom (Northern Ireland) Reminyl XL 16 mg prolonged release capsules

This leaflet was approved in: October 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).