Reminyl 8 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Reminyl 8 mg prolonged-release capsules

galantamine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4

Package leaflet:

1. What Reminyl is and what it is used for
2. What you need to know before taking Reminyl
3. How to take Reminyl
4. Possible side effects
5. How to store Reminyl
6. Contents of the pack and other information

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 impairs brain function.

Alzheimer's disease causes increasing memory loss, confusion, and behavioral changes, making it progressively more difficult to carry out routine daily activities.

These effects are thought to be caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Reminyl increases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.

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

2. What you need to know before starting 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 kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Reminyl. This medicine is intended only for the treatment of Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Serious adverse effects

Reminyl may cause severe skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking Reminyl. See section 4, “Be alert to serious adverse 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 disorder (such as chest pain usually brought on by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in electrolyte levels (natural chemicals in the blood, such as potassium)
• peptic ulcer (stomach)
• obstruction in the stomach or intestine
• a nervous system disorder (such as epilepsy or problems controlling body or limb movements (extrapyramidal disorder))
• a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia)
• problems with urine outflow.

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

Also discuss with your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will determine whether Reminyl is appropriate for you.

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

Children and adolescents

The use of Reminyl is not recommended in children or adolescents.

Other medicines and Reminyl

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Reminyl should not be taken together 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 (when taken by mouth for dry eyes or dry mouth).

Some medicines may be more likely to cause adverse effects in people taking 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 disorders or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medicines for irregular heartbeat, your doctor may monitor your heart using an “electrocardiogram” (ECG).

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

Reminyl may affect certain anaesthetics. If you are going to have surgery under general anaesthesia, inform your doctor well in advance that you are taking Reminyl.

Consult your doctor or pharmacist if you have any questions.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking Reminyl.

Driving and operating machinery

Reminyl may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you are affected by Reminyl, do not drive or operate tools or machinery.

Reminyl contains sucrose

If your doctor has advised you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Reminyl capsules

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you are currently taking Reminyl tablets or oral solution and your doctor has told you that you will be switched to Reminyl prolonged-release capsules, carefully read the instructions under "Switching from 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 usual starting dose is 8 mg taken once daily. Your doctor will gradually increase your dose every 4 weeks or longer until the most appropriate dose for you is reached. The maximum dose is 24 mg taken once daily.

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

If you are unsure what to do or find that the effect of Reminyl is too strong or too weak, inform your doctor or pharmacist.

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

If you have liver or kidney problems, your doctor may give you a reduced dose of Reminyl or may decide whether this medicine is suitable for you.

Switching from Reminyl tablets or oral solution to Reminyl 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 in the evening.
• The following morning, take your first dose of Reminyl prolonged-release capsules.

DO NOT take more than one capsule per day. While taking one daily capsule of Reminyl capsules, DO NOT take Reminyl tablets or oral solution.

How to take it

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

Drink plenty of fluids while taking Reminyl to stay hydrated.

If you take more Reminyl than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Bring the packaging with any remaining capsules. Signs of an 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 your treatment as usual with the next scheduled dose. Do not take a double dose to make up for missed doses.

If you miss more than one dose, consult your doctor.

If you stop taking Reminyl

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Be alert for serious adverse effects

Stop taking Reminyl and consult a doctor or go to the nearest emergency department immediately if you notice any of the following adverse effects:

Skin reactions, including:

• Severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled bumps that may spread over the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling 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 heartbeat (such as slow heartbeat or extra beats) or palpitations (feeling a fast or irregular heartbeat). Heart problems may appear as an abnormal pattern 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 medical help if you experience any of the adverse effects listed above.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea and vomiting. These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased. They usually gradually disappear as the body adapts to the medicine and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help prevent nausea.

Common adverse effects (may affect up to 1 in 10 people):

• Decreased appetite, weight loss
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Feeling dizzy or faint
• Tremors or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Feeling very sleepy and having low energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

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

• Allergic reaction
• Insufficient body water (dehydration)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Problems controlling movements of the body or limbs (extrapyramidal disorder)
• Blurred vision
• Ringing in the ears that does not go away (tinnitus)
• Low blood pressure
• Flushing
• Feeling the need to vomit (nausea)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in the blood

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

• Inflamed liver (hepatitis)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Reminyl Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Reminyl

• The active substance is galantamine. Each prolonged-release capsule contains 8 mg of galantamine (as hydrobromide).
• The other components are:

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

Appearance of the product and contents of the pack

Reminyl 8 mg capsules are white with the imprint “G8”. Each pack contains blisters of 7 or 28 capsules or bottles of 300 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Essential Pharma Limited,

Vision Exchange Building,

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Manufacturer

Janssen-Cilag, SpA

Via C. Janssen

04100 Borgo San Michele

Latina (Italy)

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

Austria Reminyl 8mg Retardkapseln

Belgium Reminyl 8 mg hard capsules with prolonged release

Denmark Reminyl 8 mg depot capsules, hard

Finland Reminyl 8 mg depot capsules, hard

Greece Reminyl 8 mg prolonged release capsules, hard

Ireland Reminyl XL 8 mg prolonged release capsules

Italy Reminyl 8 mg prolonged release hard capsules

Luxembourg Reminyl 8 mg hard capsules with prolonged release

Norway Reminyl 8 mg depot capsules, hard

Portugal Reminyl 8mg prolonged-release capsules

Spain Reminyl 8 mg prolonged-release hard capsules

Sweden Reminyl 8 mg depot capsules, hard

United Kingdom (Northern Ireland) Reminyl XL 8 mg prolonged release capsules

This leaflet was approved in: October 2021.

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