GALANTAMINE AUROVITAS SPAIN 8 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Galantamine Aurovitas Spain 8 mg prolonged-release hard capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Galantamine Aurovitas Spain is and what it is used for
2. What you need to know before taking Galantamine Aurovitas Spain
3. How to take Galantamine Aurovitas Spain
4. Possible side effects
5. Storage of Galantamine Aurovitas Spain
6. Package Contents and Additional Information

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

Galantamine Aurovitas Spain contains the active substance "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 affects brain function.

Alzheimer's disease causes increased memory loss, confusion, and behavioral changes, making it increasingly difficult to perform daily activities. It is thought that these effects are caused by a lack of "acetylcholine", a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain and thus treats the signs of the disease.

The capsules are in the form of "prolonged release". This means that they release the medication gradually.

2. What you need to know before taking Galantamine Aurovitas Spain

Do not takeGalantamine Aurovitas Spain

• If you are allergic to galantamine or any of the other components of this medication (listed in section 6).
• If you have severe liver or kidney disease.

Warnings and Precautions

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

Serious 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 "Pay attention to serious side effects".

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

• Liver or kidney problems.
• A heart disorder (such as chest discomfort that is usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval).
• Change in electrolyte levels (naturally occurring chemicals in the blood, such as potassium)
• A 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 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 inform your doctor if you have recently had surgeryon the stomach, intestine, or bladder. Your doctor will decide if galantamine is suitable for you.

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

Children and Adolescents

Galantamine is not recommended for use in children or adolescents.

Taking Galantamine Aurovitas Spain with other medications

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

Galantamine 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 mouth or eyes).

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

• Medications 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 pain relievers (such as ibuprofen), which may increase the risk of ulcers.
• Medications for certain heart disorders or high blood pressure (such as digoxin, amiodarone, atropine, beta blockers, or calcium channel blockers). If you are taking medications for an irregular heartbeat, your doctor may examine your heart with an electrocardiogram (ECG).

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

Galantamine may affect some anesthetics. If you are going to have surgery under general anesthesia, inform your doctor in advance that you are taking galantamine.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy, Breastfeeding, and Fertility

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

Do not breastfeed while taking galantamine.

Driving and Using Machines

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

Galantamine Aurovitas Spain contains sodium

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

3. How to take Galantamine Aurovitas Spain

Follow your doctor's or pharmacist's instructions for taking this medication exactly. 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 that you will be switched to galantamine prolonged-release capsules, read the instructions in "Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules" in this section carefully.

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 explain what dose you should start with and when you should increase it. If you are unsure what to do or find that the effect of galantamine is too strong or too 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 galantamine or may decide if this medication 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 at night.
• The next morning, take your first dose of galantamine prolonged-release capsules.

DO NOT take more than one capsule per day. While taking one daily galantamine capsule, 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 liquid while taking galantamine to stay hydrated.

If you take more Galantamine Aurovitas Spain than you should

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

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

amount ingested. 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 treatment as usual with the next scheduled dose. DO NOT take a double dose to make up for missed doses.

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

If you stop taking Galantamine Aurovitas Spain

Consult your doctor before stopping treatment with galantamine. It is important to continue taking this medication to treat your disease.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Pay attention to serious side effects

Stop takingGalantamine Aurovitas Spainand consult 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 covered 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 a fast or irregular heartbeat). 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 adapts to the medication and generally only last a few days. If you experience these effects, your doctor may recommend drinking more liquids and may prescribe a medication to prevent nausea.

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.
• Diarrhea.
• Indigestion.
• Falls.
• Injuries.

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

• Allergic reaction.
• Insufficient water in the body (dehydration).
• Numbness or tingling 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 the need to vomit (retching).
• Excessive sweating.
• Muscle weakness.
• Increased liver enzyme levels in blood.

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

• Liver inflammation (hepatitis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Galantamine Aurovitas Spain

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack or carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofGalantamine Aurovitas Spain

• The active substance is galantamine.

Each prolonged-release hard capsule contains 8 mg of galantamine (as hydrobromide).

• Other components are:

Capsule content:microcrystalline cellulose, talc, hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate.

Capsule shell:titanium dioxide (E171), sodium lauryl sulfate, gelatin.

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

Appearance of the product and package contents

White opaque hard gelatin capsules, size 1, marked with "A" on the cap and "8" on the body, containing a white to off-white round biconvex tablet.

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

Package sizes:

Blister pack: 28 and 30 prolonged-release hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. 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 medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Galantamine Aurovitas Spain 8 mg prolonged-release hard capsules EFG

Netherlands: Galantamine Aurobindo Retard 8 mg, hard capsules with prolonged release

Portugal: Galantamine Aurovitas

Date of the last revision of this package leaflet: December 2022

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