Galantamine Viatris 8 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Galantamine Viatris 8 mg prolonged-release hard capsules EFG

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you are a caregiver and administer Galantamine Viatris to the person you care for, it is also important that you read this leaflet on their behalf.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Galantamine Viatris is and what it is used for
2. What you need to know before taking Galantamine Viatris
3. How to take Galantamine Viatris
4. Possible adverse effects
5. How to store Galantamine Viatris
6. Contents of the pack and other information

1. What Galantamina Viatris is and what it is used for

Galantamina Viatris contains galantamine, a medication used to treat dementia, specifically indicated for the treatment of mild to moderate dementia of the Alzheimer's type, a disease that impairs brain function.

The symptoms of Alzheimer's disease include progressive memory loss, confusion, and behavioral disturbances. As a result, it becomes increasingly difficult to perform daily activities.

These symptoms are thought to be due to a deficiency of acetylcholine, a substance responsible for communication between brain cells. Galantamine increases the amount of acetylcholine in the brain and may therefore help alleviate the symptoms of the disease.

The capsules are manufactured as "extended-release," meaning they allow the medication to be released slowly.

2. What you need to know before starting to take Galantamine Viatris

Do not take Galantamine Viatris:

• 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 and/or kidney disease.

Warnings and precautions

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

Before starting treatment with this medicine, your doctor should know if you have or have had any of the following conditions:

• Other liver or kidney problems.
• Heart disorders (such as chest pain, usually caused by physical activity (angina), heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval).
• Reduced blood flow to the brain, stroke, or mini-stroke (also known as transient ischemic attack or 'TIA').
• Changes in electrolyte levels (if your blood potassium levels are low or high).
• Peptic ulcer (stomach).
• Blockage in the stomach or intestine (which may cause severe abdominal pain or acute constipation).
• Nervous system disorders [such as epilepsy or problems controlling body or limb movements (extrapyramidal disorder)].
• Respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia).
• Difficulty urinating.

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

Also tell your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will decide whether this medicine is suitable for you.

During treatment

If you need to undergo surgery requiring general anaesthesia, inform your doctor or healthcare professional that you are taking galantamine.

This medicine may cause weight loss. Your doctor will monitor your weight regularly while you are taking this medicine.

Serious adverse effects

This medicine may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking this medicine. See section 4 for more information.

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Other medicines and Galantamine Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Galantamine should not be used 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 (for dry mouth or dry eyes) if administered orally.

Some medicines may affect how galantamine works, or galantamine may reduce the effectiveness of other medicines taken at the same time. Your doctor may prescribe a lower dose of galantamine if you are taking any of these medicines, such as:

• Paroxetine or fluoxetine (antidepressants).
• Quinidine (used for heart rhythm problems).
• Ketoconazole (antifungal).
• Erythromycin (antibiotic).
• Ritonavir (antiviral, HIV protease inhibitor).

Some medicines may be more likely to cause adverse effects in people taking galantamine. These include:

• Non-steroidal anti-inflammatory analgesics (e.g., ibuprofen), which may increase the risk of ulcers.
• Medicines for heart disorders or high blood pressure (such as digoxin, amiodarone, atropine, β-blockers, or calcium channel blockers). If you are taking medicines for irregular heartbeat, your doctor may consider performing an electrocardiogram (ECG).
• Medicines that affect the QTc interval.

If you have any doubts, consult your doctor or pharmacist.

Pregnancy and breastfeeding

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

You must not breastfeed during treatment with galantamine.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Galantamine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Galantamine Viatris contains Allura Red (E 129) and sodium

Allura Red (E 129, a colouring agent) may cause allergic reactions.

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially "sodium-free".

3. How to take Galantamina Viatris

Always follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

If you are currently taking galantamine in tablets or oral solution and your doctor has instructed you to switch to Galantamina Viatris prolonged-release hard capsules, please read carefully the instructions provided at the end of this section.

How to take Galantamina Viatris

Galantamina Viatris must be swallowed whole, NOT chewed or crushed. Galantamina Viatris should be taken in the morning, with water or other liquid, and preferably with food.

Galantamina Viatris is available in three strengths: 8 mg, 16 mg, and 24 mg. Treatment with galantamine should be started at a low dose. Your doctor may then gradually increase the dose (strength) of galantamine you are taking, to find the most appropriate dose for you.

1. The recommended starting dose is one 8 mg capsule once daily. After four weeks of treatment, the dose may be increased.
2. Next, you will take the 16 mg capsule once daily. After at least another four weeks of treatment, your doctor may decide to increase the dose again.
3. Then, you will take the 24 mg capsule once daily.

Your doctor will advise you on which dose to start with and when the dose should be increased. If you think that the effect of galantamine is too strong or too weak, talk to your doctor or pharmacist.

You should visit your doctor regularly to check whether the medicine is working and to discuss how you are feeling. Your doctor will also monitor your weight periodically during treatment with galantamine.

If you have liver or kidney problems

• If you have mild liver or kidney problems, treatment should start with the 8 mg capsule once daily in the morning.
• If you have moderate liver problems, treatment should start with the 8 mg capsule every other morning. After one week, you should start taking the 8 mg capsule once daily in the morning. Do not take more than 16 mg per day.
• If you have severe liver or kidney problems, do not take galantamine.

If you take more Galantamina Viatris than you should

If you take too much galantamine, contact your doctor or go to hospital immediately. Take any remaining capsules and the packaging with you. Signs or symptoms of overdose may include: severe nausea, vomiting, muscle weakness, slow heartbeat, seizures, and loss of consciousness.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at Tel. 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Galantamina Viatris

If you forget to take a dose, skip the missed dose and take the next dose at your usual time.

Do not take a double dose to make up for forgotten doses.

If you miss more than one dose, you should consult your doctor.

If you stop taking Galantamina Viatris

You must consult your doctor before stopping galantamine. It is important to continue taking this medicine for the treatment of your condition.

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

How to switch from galantamine tablets or oral solution to Galantamina Viatris prolonged-release hard capsules

If you are currently taking galantamine tablets or oral solution, your doctor may decide that you should switch to Galantamina Viatris prolonged-release hard capsules.

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

Do NOT take more than one capsule per day. While taking Galantamina Viatris prolonged-release hard capsules once daily, do NOT take galantamine tablets or oral solution.

4. Possible adverse effects

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

Be alert for serious adverse effects.

Stop taking this medicine and contact your doctor immediately if you experience:

• Heart problems, including slow heartbeat (frequent: may affect up to 1 in 10 people). You may also notice changes in your heartbeat, such as extra beats or palpitations (feeling a fast or irregular heartbeat), which may appear as an abnormal pattern on an "electrocardiogram" (ECG) (uncommon: may affect up to 1 in 100 people).

• Epileptic seizures (convulsions) (uncommon: may affect up to 1 in 100 people).

• Allergic reactions. You may develop a skin rash, itching, or hives, swelling of the face, lips, tongue, and difficulty breathing (uncommon: may affect up to 1 in 100 people).

• Inflammation of the liver (hepatitis). You may notice stomach pain, yellowing of the skin or eyes (jaundice), pale stools, or dark urine (rare: may affect up to 1 in 1,000 people).

• Skin reactions (rare: may affect up to 1 in 1,000 people), 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, which may spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).

• Rash that may cause blisters, with spots resembling small targets.

Other adverse effects

Very common: 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 gradually disappear as your body adjusts 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: may affect up to 1 in 10 people

• Weight loss.
• Reduced appetite.
• Feeling faint or fainting (blackout).
• Dizziness.
• Tremor.
• Headache.
• Drowsiness with low energy.
• Unusual tiredness.
• Stomach pain or discomfort.
• Diarrhea.
• Indigestion.
• Muscle spasms.
• Falls.
• High blood pressure.
• Feeling of weakness.
• Feeling of general malaise.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Feeling of sadness (depression).
• Wounds (cuts).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (blood test results indicating how well your liver is functioning).
• Tingling, pins and needles, or numbness of the skin.
• Altered sense of taste.
• Excessive drowsiness.
• Problems controlling body movements or limbs (extrapyramidal disorder).
• Blurred vision.
• Ringing in the ears (tinnitus).
• Feeling the need to vomit (nausea).
• Muscle weakness.
• Excessive loss of body water.
• Low blood pressure.
• Flushing of the face.
• Excessive sweating.

Reporting of adverse effects:

If you experience any adverse effect, consult 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 Viatris

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

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

If your medicine is packaged in aluminium/aluminium blisters:

Store in the original packaging to protect it from moisture.

If your medicine is packaged in PVdC blisters:

Do not store above 25°C. Keep in the original packaging to protect it from moisture.

If your medicine is packaged in a tablet container:

Do not store above 25°C. Keep the container tightly closed and store in the original packaging to protect it from moisture. Once opened, use within the next 3 months.

If your medicine is packaged in a bottle:

Keep the bottle tightly closed and store in the original bottle to protect it from moisture.

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

6. Contents of the pack and other information

Composition of Galantamina Viatris:

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

The other components are:

Tablet core (contents of the capsule): polyvinyl acetate, anhydrous colloidal silica, povidone, hydrogenated vegetable oil, sodium lauryl sulfate, and magnesium stearate.

Capsule coating:

Gelatin, titanium dioxide (E-171), Allura red (E-129).

Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E-172).

Appearance of Galantamina Viatris and pack contents

Galantamina Viatris is available in three strengths, each identified by its imprint.

Galantamina Viatris 8 mg is a hard gelatin capsule with a white body and a pink cap, printed in black ink with “Mylan” over “GT8” on both the body and the cap.

The capsules are available in:

• PVdC blisters containing 7, 7 x 1 (single-dose perforated blister), 10, 28, 28 x 1 (single-dose perforated blister), 30, 30 x 1 (single-dose perforated blister), 56, 84, 98 or 100 capsules. Calendar blister packs of 28 or 28 x 1 (single-dose perforated calendar blisters) capsules.
• Aluminium/aluminium blisters containing 7, 7 x 1 (single-dose perforated blister), 10, 28, 28 x 1 (single-dose perforated blister), 30, 30 x 1 (single-dose perforated blister), 56, 84, 98 or 100 capsules. Calendar blister packs of 28 or 28 x 1 (single-dose perforated calendar blisters) capsules.
• Tablet containers containing 500 capsules.
• Bottles containing 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Slovakia Galantamine Viatris 8 mg
Spain Galantamina Viatris 8 mg prolonged-release hard capsules EFG
Netherlands Galantamine Retard Viatris 8 mg capsules met verlengde afgifte, hard
Portugal Galantamina Mylan 8 mg
United Kingdom (Northern Ireland) Acumor XL 8 mg Prolonged-Release Capsules
Czech Republic Galantamin Viatris

Date of the most recent review of this leaflet: February 2026

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