GALANTAMINE AUROVITAS SPAIN 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Galantamine Aurovitas Spain 16 mg prolonged-release hard capsules EFG

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 experience 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 pack

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

1. What Galantamine Aurovitas Spain is and what it is used for

Galantamine Aurovitas Spain 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 brain function.

Alzheimer's disease causes increasing memory loss, confusion, and changes in behaviour, making it difficult to carry out daily activities. These effects are thought to be caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain, treating the signs 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 you take Galantamine Aurovitas Spain

Do not takeGalantamine Aurovitas Spain

• 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 starting to take galantamine. 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

Galantamine may cause severe skin reactions, heart problems, and seizures. You should be aware of these side effects while taking galantamine. See section 4 “Look out for severe side effects”.

Before starting treatment with galantamine, your doctor needs to know if you have or have had any of the following conditions:

• Liver or kidney problems.
• A heart condition (such as chest discomfort 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 disorder of the nervous system [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 galantamine is suitable for you or if the dose needs to be changed.

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

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

Children and adolescents

Galantamine should not be used in children or adolescents.

Taking Galantamine Aurovitas Spain with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Galantamine 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 orally for dry mouth or eyes).

Some medicines may cause side effects more easily in people taking galantamine. 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 galantamine.

Galantamine may affect some anaesthetics. If you are going to have an operation under general anaesthetic, tell your doctor that you are taking galantamine.

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

Pregnancy, breastfeeding, and fertility

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 galantamine.

Driving and using machines

Galantamine may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If galantamine affects you, do not drive or use tools or machines.

Galantamine Aurovitas Spain contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Galantamine Aurovitas Spain

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

How much to take

You will start treatment with galantamine at a low dose. The usual starting dose is 8 mg, once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the most suitable dose. The maximum dose is 24 mg, once a 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 galantamine 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 discuss with you how you feel.

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

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

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

• Take your last dose of galantamine tablets or oral solution in the evening.
• The next morning, take your first dose of galantamine prolonged-release capsules.

DO NOT take more than one capsule in a day. While taking one galantamine prolonged-release capsule per day, DO NOT take galantamine tablets or oral solution.

How to take

Galantamine capsules should be swallowed whole and NOT chewed or crushed. Take your dose of galantamine once a day in the morning, with water or other liquids. Try to take galantamine with food.

Drink plenty of liquids while taking galantamine to stay hydrated.

If you take more Galantamine Aurovitas Spain than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or

call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the

amount taken. Bring the package with the 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 Galantamine Aurovitas Spain

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 Galantamine Aurovitas Spain

Talk to your doctor before stopping treatment with galantamine. 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.

Look out for severe side effects

Stop takingGalantamine Aurovitas Spainand contact a doctor or go to the emergency 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 galantamine (may affect up to 1 in 1,000 people).

Heart problems,including changes in heartbeat (such as slow heartbeat, extra beats) or palpitations (feeling the heartbeat fast or irregular). Heart problems can be seen as an abnormal tracing on an “electrocardiogram” (ECG), and may be common in people taking galantamine (may affect up to 1 in 10 people).

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

You must stop taking Galantamine Aurovitas Spain 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 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 side 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 lacking energy.
• Increased blood pressure.
• Abdominal pain or discomfort.
• Diarrhoea.
• Indigestion.
• Falls.
• Injuries.

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

• Allergic reaction.
• Lack of water in the body (dehydration).
• Numbness or tingling of the skin.
• Changes in 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 liver enzyme levels in the blood.

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

• Liver inflammation (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 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 Galantamine Aurovitas Spain

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 blister or carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for 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

What Galantamine Aurovitas Spain contains

• The active substance is galantamine.

Each prolonged-release hard capsule contains 16 mg of galantamine (as hydrobromide).

• The other ingredients are:

Contents of the capsule:microcrystalline cellulose, talc, hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate.

Capsule shell:titanium dioxide (E171), red iron oxide (E172), sodium lauryl sulfate, gelatin.

Printing ink:shellac, black iron oxide (E172).

Appearance and packaging

Hard gelatin capsules, opaque pink, size 1, marked with “A” on the cap and “16” on the body, containing two white to off-white round biconvex tablets.

Galantamine Aurovitas Spain prolonged-release hard capsules are available in blister packs.

Pack sizes:

Blister: 28 and 30 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Galantamina Aurovitas Spain 16 mg prolonged-release hard capsules EFG

Netherlands: Galantamine Aurobindo Retard 16 mg, hard capsules with prolonged release

Portugal: Galantamina Aurovitas

Date of last revision of this leaflet: December 2022

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