Galantamine Aurovitas Spain 16 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Galantamine Aurovitas Spain 16 mg prolonged-release hard capsules EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Galantamine Aurovitas Spain
6. Contents of the pack and other information

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

Galantamina Aurovitas Spain contains the active substance "galantamine", a dementia medication. It is used in adults to treat 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 behavioral changes, making it progressively more 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 and thereby treats the symptoms of the disease.

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

2. What you need to know before starting to take Galantamina Aurovitas Spain

Do not take Galantamina Aurovitas Spain

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

Warnings and precautions

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

Serious adverse effects

Galantamine may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking galantamine. See section 4, “Pay attention to serious adverse 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 disorder (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 chemicals in the blood, such as potassium).
• A peptic ulcer (in the stomach).
• Blockage in the stomach or intestines.
• A nervous system disorder [such as epilepsy or problems controlling body movements or limbs (extrapyramidal disorder)].
• A respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia).
• Problems with urine outflow.

Your doctor will decide whether galantamine is suitable for you or whether your dose needs to be adjusted.

Also inform your doctor if you have recently undergone surgery of the stomach, intestines, or bladder. Your doctor will decide whether galantamine is suitable for you.

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

Children and adolescents

The use of galantamine is not recommended in children or adolescents.

Taking Galantamina Aurovitas Spain with other medicines

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

Galantamine should not be taken together with medicines that work in a similar 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 dry eyes).

Some medicines may increase the likelihood of adverse effects 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 analgesics (such as ibuprofen), which may increase the risk of ulcers.
• Medicines for certain heart disorders 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 examine your heart with an electrocardiogram (ECG).

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

Galantamine may affect certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well in advance that you are taking galantamine.

Consult 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 become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking galantamine.

Driving and using machines

Galantamine may cause dizziness or drowsiness, especially during the first weeks of treatment. If galantamine affects you in this way, do not drive or operate tools or machinery.

Galantamina Aurovitas Spain contains sodium

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

3. How to take Galantamina Aurovitas Spain

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you are currently taking galantamine tablets or oral solution and your doctor has informed you that you will be switched to galantamine prolonged-release capsules, please read carefully the instructions under "Switching from galantamine tablets or oral solution to galantamine capsules" in this section.

How much to take

You will start treatment with galantamine at a low dose. The usual starting dose is 8 mg once daily. Your doctor will gradually increase your dose, every 4 weeks or longer, until reaching the most appropriate dose. The maximum dose is 24 mg once daily.

Your doctor will explain which dose to start with and when to increase it. If you are unsure what to do, or if you find 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 medicine is working and to discuss how you are feeling.

If you have liver or kidney problems, your doctor may prescribe you a reduced dose of galantamine or may decide whether this medicine is suitable for you.

Switching from galantamine tablets or oral solution to galantamine capsules

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

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

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

How to take

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

Drink plenty of fluids while taking galantamine to stay hydrated.

If you take more Galantamina Aurovitas Spain than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Bring the package with any 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 Galantamina Aurovitas Spain

If you forget to take a dose, skip that dose and continue 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, consult your doctor.

If you stop taking Galantamina Aurovitas Spain

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Pay attention to serious adverse effects

Stop taking Galantamina Aurovitas Spain and consult a doctor or go to the nearest emergency service immediately if you notice any of the following adverse effects.

Skin reactions, including:

• Severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled bumps that may spread over the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling 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 may appear 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 Galantamina Aurovitas Spain and seek immediate medical help if you experience any of the adverse effects listed above.

Other adverse effects:

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea and vomiting. These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the medicine and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help you feel better.

Common adverse effects (may affect up to 1 in 10 people):

• Decreased appetite, weight loss.
• Seeing, feeling, or hearing things that are not present (hallucinations).
• Depression.
• Dizziness or fainting.
• Tremors or muscle spasms.
• Headache.
• Feeling very tired, weak, or generally unwell.
• Feeling very sleepy and having low energy.
• Increased blood pressure.
• Abdominal pain or discomfort.
• Diarrhea.
• Indigestion.
• Falls.
• Injuries.

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

• Allergic reaction.
• Lack of sufficient body water (dehydration).
• Tingling or numbness of the skin.
• Change in taste sensation.
• Daytime sleepiness.
• Problems controlling body or limb movements (extrapyramidal disorder).
• Blurred vision.
• Persistent ringing in the ears (tinnitus).
• Low blood pressure.
• Feeling the need to vomit (nausea).
• Excessive sweating.
• Muscle weakness.
• Increased levels of liver enzymes in the blood.

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

• Inflamed liver (hepatitis).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the blister pack or carton following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamina Aurovitas Spain

• The active substance is galantamine.

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

• The other components are:

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

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

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

Nature of the product and contents of the pack

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

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

Pack sizes:

Blister: 28 and 30 prolonged-release hard capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product 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, harde capsules met verlengde afgifte

Portugal: Galantamina Aurovitas

Date of the most recent review of this leaflet: December 2022

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