Reminyl 16 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Reminyl 16mg prolonged-release capsules

galantamine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they 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”, a dementia-treating medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects 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 in this way helps to treat 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 taking 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

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

Serious adverse effects

Reminyl may cause serious 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 discomfort usually caused 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 movements or limbs (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 tell your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will decide whether Reminyl is suitable for you.

Reminyl may cause weight loss. Your doctor will monitor 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

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

Reminyl must 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 an 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 weeks of treatment. If Reminyl affects you in this way, 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 use of this medicine provided 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, please read carefully 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 reaching the most appropriate dose for you. 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 prescribe 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 in a 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: 91 562 04 20, indicating the medicine and the
amount ingested. Bring the pack with any remaining capsules. 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 your treatment as usual with the next scheduled dose. Do not take a double dose to make up for forgotten 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Be alert to serious adverse effects

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

Skin reactions, including:

• Severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled bumps that may spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may blister, with spots resembling small targets.

These skin reactions are rare in people taking Reminyl (they 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 tracing on an electrocardiogram (ECG), and may be common in people taking Reminyl (they may affect up to 1 in 10 people).

Seizures. This is uncommon in people taking Reminyl (they 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 mentioned.

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 adjusts 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 relieve the discomfort.

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 body movements or limbs (extrapyramidal disorder)
• Blurred vision
• Persistent ringing in the ears (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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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. Storage of Reminyl

Keep this medicine out of 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 or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 16 mg of galantamine (as hydrobromide).
• The other components are:

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

Appearance of the product and pack contents

Reminyl 16 mg capsules are pink in colour with the imprint “G16”. Each pack contains 7, 28, 56 or 84 capsules in blisters, or bottles of 300 capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Union under the following names:

Austria Reminyl 16mg Retardkapseln

Belgium Reminyl 16 mg prolonged release hard capsules

Denmark Reminyl 16 mg prolonged release hard capsules

Finland Reminyl 16 mg prolonged release hard capsules

Greece Reminyl 16 mg prolonged release hard capsules

Ireland Reminyl XL 16 mg prolonged release capsules

Italy Reminyl 16 mg prolonged release hard capsules

Luxembourg Reminyl 16 mg prolonged release hard capsules

Norway Reminyl 16 mg prolonged release hard capsules

Portugal Reminyl 16mg prolonged-release capsules

Spain Reminyl 16 mg prolonged-release hard capsules

Sweden Reminyl 16 mg depot capsules, hard

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 of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).