REMINYL 4 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Reminyl 4mg/ml Oral Solution

Galantamine

Read all of this leaflet carefully before you start taking this medicine because it 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.

Contents of the Package Leaflet:

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

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 perform 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 treats the symptoms of the disease.

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 (extrapyramidal disorder))
• 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 (when taken by mouth for dry eyes or mouth).

Some medicines may increase the risk of side 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 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 using 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 a general anesthetic, tell your doctor well in advance 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.

Do not breastfeed while 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 machines.

Reminyl Oral Solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

These may rarely cause allergic reactions (which may be delayed).

Reminyl Oral Solution contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 6 ml of Reminyl 4 mg/ml oral solution (equivalent to the maximum daily dose of Reminyl); this is essentially “sodium-free”.

3. How to Take Reminyl Oral Solution

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

How much to take

You will start treatment with Reminyl at a low dose. The usual starting dose is 4 mg (1 mL of solution), taken twice a day (a total of 8 mg per 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 12 mg (3 mL of solution), taken twice a day (a total of 24 mg per day).

Your doctor will tell 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, 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 may decide that this medicine is not suitable for you.

How to take it

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

Drink plenty of liquid while taking Reminyl to stay hydrated.

The solution comes with a syringe, which can be used to draw up the exact amount needed from the bottle.

Instructions for opening the bottle and using the syringe

If you take more Reminyl than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Bring any remaining solution with you. 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 with your treatment as usual with the next scheduled dose. 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 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.

Be aware of severe side effects

Stop taking Reminyl and talk to a doctor or go to the nearest emergency room 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 help immediatelyif 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 occur in the first few weeks of treatment or when the dose is increased. They usually disappear gradually as the body gets used to the medicine and generally only last a few days. If you experience these effects, your doctor may recommend drinking more liquids and may prescribe a medicine to prevent you from feeling sick.

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
• lack of 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 experience 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 to the Spanish Medicines Agency's Pharmacovigilance 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 freeze.

Reminyl Oral Solution should not be used for more than 3 months after the bottle is first opened.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Reminyl

• The active substance is galantamine. 1 mL of Reminyl oral solution contains 4 mg of galantamine (as hydrobromide).
• The other ingredients are:

Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water, sodium saccharin, and sodium hydroxide.

Appearance and Packaging of the Product

Reminyl is a clear, colorless oral solution available in a 100 mL bottle.

The solution comes with a syringe, which can be used to draw up the exact amount needed from the bottle.

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-Pharmaceutica, N.V.

Turnhoutseweg, 30

B-2340 Beerse

Belgium

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

Austria Reminyl 4 mg/ml Oral Solution

Belgium Reminyl 4 mg/ml, oral solution

Denmark Reminyl 4 mg/ml oral solution

Finland Reminyl 4 mg/ml oral solution

France Reminyl 4 mg/ml, oral solution

Greece Reminyl 4 mg/ml ?????? ?????

Ireland Reminyl 4 mg/ml oral solution

Italy Reminyl 4 mg/ml oral solution

• Luxembourg Reminyl 4 mg/ml, oral solution

Norway Reminyl 4 mg/ml oral solution

Portugal Reminyl 4 mg/ml oral solution

Spain Reminyl 4 mg/ml oral solution

Sweden Reminyl 4 mg/ml oral solution

United Kingdom (Northern Ireland) Reminyl 4 mg/ml oral solution

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/).