Galantamine Viatris 16 mg prolonged-release hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Galantamine Viatris 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, as you may need to read it again.
• If you are a caregiver administering 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, consult 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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 side effects
5. How to store Galantamine Viatris
6. Contents of the pack and other information

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

Galantamine Viatris contains galantamine, a medication for dementia, used to treat the symptoms of mild to moderate Alzheimer-type dementia, a disease that impairs brain function.

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

These symptoms are thought to be due to a lack of acetylcholine, a substance responsible for communication between brain cells. Galantamine increases the amount of acetylcholine in the brain, which may 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 taking 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 Galantamine Viatris. This medicine is intended only 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 discomfort, 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 determine whether this medicine is appropriate 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 severe skin reactions, heart problems, and seizures. Be aware of these adverse effects while taking this medicine. See section 4 for more information.

Children and adolescents

The use of galantamine is not recommended 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 together with medicines that have a similar mode of action. These include:

• Donepezil or rivastigmine (for Alzheimer's disease).
• Ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness).
• Pilocarpine (for dry mouth or dry eyes) when 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 the following medicines, for example:

• 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, beta-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, do 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, particularly 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

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

If you are currently taking galantamine as tablets or oral solution and your doctor has instructed you to switch to Galantamina Viatris prolonged-release hard capsules, carefully read the instructions included 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 liquids and, preferably, with food.

Galantamina Viatris is available in 3 strengths: 8 mg, 16 mg and 24 mg. Treatment with galantamine should start at a low dose. Later, your doctor may instruct you to gradually increase the dose (strength) of galantamine you are taking, to find the most suitable dose for your case.

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 4 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 explain to you which dose to start with and when the dose should be increased. If you consider that the effect of galantamine is too strong or too weak, speak with your doctor or pharmacist.

You should visit your doctor periodically 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 hepatic or renal impairment, treatment starts with the 8 mg capsule once daily in the morning.
• If you have moderate hepatic impairment, treatment starts with the 8 mg capsule on alternate mornings. 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 hepatic or renal impairment, do not take galantamine.

If you take more Galantamina Viatris than you should

If you take too much galantamine, consult your doctor or go to the hospital immediately. Take the 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, 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 that dose and take the next dose at the usual time.

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

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

If you stop taking Galantamina Viatris

You should 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 following 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 experiences 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).

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

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

• Liver inflammation (hepatitis). You may notice stomach pain, yellowing of the skin or eyes, 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 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 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: may affect up to 1 in 10 people

• Weight loss.
• Decreased 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).
• Injuries (cuts).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (laboratory test results indicating how well your liver is functioning).
• Tingling, prickling, 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 which is stated on the label, carton, and blister pack 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. Store 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 packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This 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 16 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, iron oxide black (E-172).

Appearance of Galantamina Viatris and contents of the pack

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

Galantamina Viatris 16 mg is a hard gelatin capsule with a white body and pale pink cap, printed in black ink with “Mylan” over “GT16” on both the body and the cap.

The capsules are available in:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Slovakia Galantamine Viatris 16 mg
Spain Galantamina Viatris 16 mg prolonged-release hard capsules EFG
Netherlands Galantamine Retard Viatris 16 mg capsules met verlengde afgifte, hard
Portugal Galantamina Mylan 16 mg
United Kingdom (Northern Ireland) Acumor XL 16 mg Prolonged-Release Capsules
Czech Republic Galantamin Viatris

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

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