Label: information for the user

Reminyl 4mg/ml oral solution

galantamine

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section4

Label content:

1. What Reminyl is and for what it is used
2. What you need to know before starting to take Reminyl
3. How to take Reminyl
4. Possible adverse effects
5. Storage of Reminyl
6. Contents of the package and additional information

Reminyl contains the active ingredient “galantamine”, an anti-dementia medication. 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 an increase in memory loss, confusion, and changes in behavior, making it increasingly difficult to perform routine 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 and thereby treats the signs of the disease.

Do not take Reminyl

• if you are allergic to galantamine or any of the other ingredients in this medication (listed in section6).
• if you have a severe liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Reminyl. This medication should only be used for 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 section4 “Be aware of severe side effects”.

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

• liver or kidney problems
• a heart condition (such as chest discomfort usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• electrolyte level changes (natural substances in the blood, such as potassium)
• peptic ulcer (stomach)
• obstruction in the stomach or intestine
• a nervous system disorder (such as epilepsy or difficulty controlling body or limb movements (extrapyramidal disorder))
• respiratory disease or infection 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.

Also, inform your doctor if you have recently had surgeryin the 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 children or adolescents.

Other medications and Reminyl

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

Reminyl should not be taken with medications 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 orally for dry eyes or mouth)

Some medications may cause side effects more likely in people taking Reminyl. These include:

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

• nonsteroidal anti-inflammatory analgesics (such as ibuprofen), which may increase the risk of ulcers
• medications for certain heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta blockers, or calcium channel blockers). If you take medications for irregular heartbeat, your doctor may examine your heart using an electrocardiogram (ECG).

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

Reminyl may affect some anesthetics. If you are undergoing general anesthesia, inform your doctor, in advance, that you are taking Reminyl.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed while taking Reminyl.

Driving and operating machinery

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

Reminyl oral solution contains methylo- and propylparahydroxybenzoates.

These may sometimes cause allergic reactions (possibly delayed).

Reminyl oral solution contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

You will start treatment with Reminyl at a low dose. The usual initial dose is 4mg (1mL of solution), taken twice a day (a total of 8mg per day). Your doctor will gradually increase your dose, every 4weeks or more, until you reach the most suitable dose for you. The maximum dose is 12mg (3ml of solution), taken twice a day (a total of 24mg per day).

Your doctor will explain with which dose you should start and when to increase it.If you are unsure of what to do or find that the effect of Reminyl is too strong or weak, inform your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medication is working and to discuss with you how you feel.

If you have liver or kidney problems,your doctor may give you a reduced dose of Reminyl or decide if this medication is not suitable for you.

How to take it

Take your Reminyl dose twice a day, in the morning and at night, 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, with which you can extract 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, consult your doctor or pharmacist immediately or

call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the

amount ingested. Bring the remaining solution bottle with you. The signs of an overdose may include:

• intense nausea and vomiting
• muscle weakness, slow heart rate, convulsions, and loss of consciousness.

If you forget to take Reminyl

If you forget to take a dose, leave that dose and continue treatment as usual with the next scheduled dose.Do not take a double dose to compensate for missed doses.

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

If you interrupt treatment with Reminyl

Consult with your doctor before interrupting treatment with Reminyl. It is essential to continue taking this medication to treat your disease.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Be aware of severe side effects

Stop taking Reminyl and consult a doctor or go to the nearest emergency service immediatelyif you notice any of the following side effects

Skin reactions,including:

• Severe rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

• Red rash covered with small, pus-filled bumps that can spread throughout the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that can cause blisters, with spots that appear like small targets.

These skin reactions are rare in people taking Reminyl (they can affect up to 1 in 1,000 people).

Heart problemsincluding changes in heart rhythm (such as slow heartbeat or extra beats) or palpitations (feeling a rapid or irregular heartbeat). Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking Reminyl (they can affect up to 1 in 10 people).

Seizures. This is rare in people taking Reminyl (they can affect up to 1 in 100 people).

You should stop taking Reminyl and seek help immediatelyif you notice any of the mentioned side effects.

Other side effects

Frequent side effects(they can affect more than 1 in 10 people):

• Nausea and vomiting. These side effects are more likely to occur in the first weeks of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the medication and usually only last for a few days. If you experience these side effects, your doctor may recommend that you drink more liquids and may prescribe a medication to help you feel better.

Common side effects(they can affect up to 1 in 10 people):

• Loss of 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 generally unwell
• Feeling very sleepy and having little energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Wounds

Rare side effects(they can affect up to 1 in 100 people):

• Allergic reaction
• Insufficient water in the body (dehydration)
• Itching or numbness of the skin
• Change in sense of taste
• Daytime drowsiness
• Difficulty controlling body or limb movements (extrapyramidal disorder)
• Blurred vision
• Continuous ringing in the ears that does not go away (tinnitus)
• Low blood pressure
• Rubor
• Feeling like vomiting (retching)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in the blood.

Very rare side effects(they can affect up to 1 in 1,000 people):

• Inflamed liver (hepatitis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Reminyl oral solution should not be used once 3 months have passed since the bottle was first opened.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at theSIGREpharmacy drop-off point.Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Reminyl

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

Parahydroxybenzoate of methyl (E218), parahydroxybenzoate of propyl (E216), purified water, sodium saccharin, and sodium hydroxide.

Appearance of the product and contents of the packaging

Reminyl is a transparent and colorless oral solution that comes in a 100 ml container.

The solution comes with a syringe with which the exact amount needed can be drawn from the bottle.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Essential Pharma Limited,

Vision Exchange Building,

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Responsible for manufacturing

Janssen-Pharmaceutica, N.V.

Turnhoutseweg, 30

B-2340 Beerse

Belgium

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

AustriaReminyl4mg/ml- oral solution

BelgiumReminyl 4mg/ml, oral solution

DenmarkReminyl4mg/ml oral solution

FinlandReminyl 4mg/ml oral solution

FranceReminyl 4mg/ml, oral solution

GreeceReminyl 4mg/mlsolubleformulation

IrelandReminyl4mg/ml oral solution

ItalyReminyl4mg/mloral solution

• LuxembourgReminyl 4mg/ml, oral solution

NorwayReminyl4mg/ml mixture, solution

PortugalReminyl 4mg/mloral solution

SpainReminyl4mg/ml oral solution

SwedenReminyl4mg/ml oral solution

United Kingdom (Northern Ireland)Reminyl4mg/ml oral solution

This leaflet has been approved in:October 2021.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).