Prospect: information for the user

Galantamine Aurovitas Spain 8 mg prolonged-release hard capsules EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must 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 prospect. See section 4.

1.What isGalantamine Aurovitas Spainand for what it is used

2.What you need to know before starting to takeGalantamine Aurovitas Spain

3.How to takeGalantamine Aurovitas Spain

4.Possible adverse effects

5.Storage ofGalantamine Aurovitas Spain

6.Contents of the package and additional information

Galantamina Aurovitas Spaincontains 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 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 thereby treats the symptoms of the disease.

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

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 a 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.

Severe side effects

Galantamine may cause severe skin reactions, heart problems, and seizures. Be aware of these side effects while taking galantamine. See section 4 “Be aware of 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 usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval).
• Changes in electrolyte levels (natural substances in the blood, such as potassium).
• A stomach ulcer.
• Obstruction in the stomach or intestine.
• A nervous system disorder[suchas epilepsy or problems controlling body or limb movements (extrapyramidal disorder)].
• A respiratory disease or infection 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 surgeryin the 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 is not recommended for use in children or adolescents.

Galantamine Aurovitas Spain with other medications

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

Galantamine should not be taken with medications that act 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 with a higher probability 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 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 due to 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 galantamine.

Galantamine may affect some anesthetics. If you are undergoing 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 operating machinery

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 machinery.

Galantamine Aurovitas Spain contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it 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.

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 carefully the instructions that appear in “Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules” in this section.

How much to take

You will start treatment with galantamine at a low dose. The usual initial 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 to increase it. If you are unsure of what to do or find that the effect of galantamine 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 galantamine or may decide that 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 the 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 in a day. While taking a daily capsule of galantamine prolonged-release capsules, 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 Galantamina Aurovitas Spain 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 packaging with the remaining capsules. Signs of overdose may include:

• Intense nausea and vomiting.
• Muscle weakness, slow heart rate, convulsions, and loss of consciousness.

If you forgot to take Galantamina Aurovitas Spain

If you forgot 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 the missed doses.

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

If you interrupt treatment with Galantamina Aurovitas Spain

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

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

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

Be aware of severe side effects

Stop takingGalantamina Aurovitas Spainand consult a doctor or visit 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 look like small targets.

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

Heart problems,including changes in heart rhythm (such as slow heartbeat, 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 galantamine (they can affect up to 1 in every 10 people).

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

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

Other side effects:

Frequent side effects(can affect more than 1 in every 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 medicine and generally only last for a few days. If you experience these side effects, your doctor may recommend drinking more liquids and may prescribe a medicine to help you feel better.

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

• Loss of appetite, weight loss.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Depression.
• Feeling dizzy or faint.
• Trembling or muscle spasms.
• Headache.
• Feeling very tired, weak, or unwell.
• Feeling very sleepy and having little energy.
• High blood pressure.
• Abdominal pain or discomfort.
• Diarhea.
• Indigestion.
• Falls.
• Wounds.

Rare side effects(can affect up to 1 in every 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 the need to vomit (retching).
• Excessive sweating.
• Muscle weakness.
• Increased levels of liver enzymes in the blood.

Very rare side effects(can affect up to 1 in every 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 the Spanish 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 blister or carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGalantamina Aurovitas Spain

• The active ingredient is galantamine.

Eachlong-acting hard capsule contains 8 mg of galantamine (as hydrobromide).

• The other components are:

Hard capsule content:cellulose microcrystals, talc, hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate.

Hard capsule coating:dioxide of titanium (E171), sodium lauryl sulfate, gelatin.

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

Appearance of the product and contents of the package

Hard gelatin capsules of white opaque color, size 1, marked with “A” on the cap and “8” on the body, containing a white to off-white round biconvex tablet.

Galantamina Aurovitas Spain long-acting hard capsules are available in blister packs.

Package sizes:

Blister pack: 28 and 30 long-acting hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain:Galantamina Aurovitas Spain 8 mg long-acting hard capsules EFG

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

Portugal:Galantamina Aurovitas

Last review date of this leaflet: December 2022

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