GALANTAMINE VIATRIS 24 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Galantamine Viatris 24 mg prolonged-release hard capsules EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Galantamine Viatris contains galantamine, which is a medicine used to treat the symptoms of mild to moderate Alzheimer's disease, a condition that affects brain function.

The symptoms of Alzheimer's disease include progressive memory loss, confusion, and changes in behavior. As a result, it becomes increasingly difficult to carry out daily activities.

It is thought that these symptoms are 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 to alleviate the symptoms of the disease.

The capsules are manufactured in a "prolonged-release" form, which means they allow the medicine to be released slowly.

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

Do not take Galantamine Viatris:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Galantamine Viatris. This medicine should only be used in 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 problems (such as chest pain, which is usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval).
• Reduced blood flow to the brain, a stroke, or a mini-stroke (also known as a transient ischemic attack or 'TIA').
• Changes in electrolyte levels (if your potassium blood levels are low or high).
• A stomach ulcer.
• Blockage in the stomach or intestine (which can cause severe abdominal pain or constipation).
• Nervous system disorders (such as epilepsy or Parkinson's disease).
• Respiratory disease or infection that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia).
• Difficulty urinating.

Your doctor will decide if galantamine is suitable for you or if the dose needs to be changed.

Also, tell your doctor if you have recently had an operationon your stomach, intestine, or bladder. Your doctor will decide if this medicine is suitable for you.

During treatment

If you need to have an operationthat requires general anesthesia, tell your doctor or healthcare staff that you are taking galantamine.

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

Severe side effects

This medicine may cause severe skin reactions, heart problems, and seizures. You should be aware of these side effects while taking this medicine. See section 4 for more information.

Children and adolescents

Galantamine should not be used in children or adolescents.

Other medicines and Galantamine Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 eyes) if taken 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 increase the risk of side effects when taken with galantamine. These include:

• Non-steroidal anti-inflammatory painkillers (e.g., ibuprofen), which may increase the risk of ulcers.
• Medicines for heart problems 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 doing an electrocardiogram (ECG).
• Medicines that affect the QTc interval.

If you are unsure, talk to your doctor or pharmacist.

Pregnancy and breastfeeding

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

You should not breastfeed while taking galantamine.

Driving and using machines

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

Galantamine Viatris contains Allura Red (E 129) and sodium

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

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

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

3. How to take Galantamine Viatris

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

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

How to take Galantamine Viatris

Galantamine Viatris should be swallowed whole, without chewing or crushing. Galantamine Viatris should be taken in the morning, with water or other liquids, and preferably with food.

Galantamine Viatris is available in 3 doses: 8 mg, 16 mg, and 24 mg. Treatment with galantamine should be started with a low dose. Your doctor may then increase the dose of galantamine you are taking, to find the dose that is best for you.

1. The recommended starting dose is one 8 mg capsule taken once a day. After 4 weeks of treatment, the dose may be increased.
2. Then, you will take one 16 mg capsule once a day. After at least another 4 weeks of treatment, your doctor may decide to increase the dose again.
3. Finally, you will take one 24 mg capsule once a day.

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

You should see your doctor regularly to check if the medicine is working and to discuss how you are feeling. Your doctor will also check your weight regularly while you are taking galantamine.

If you have liver or kidney problems

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

If you take more Galantamine Viatris than you should

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

In case of overdose or accidental ingestion, talk to 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 take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Galantamine 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 should talk to your doctor.

If you stop taking Galantamine Viatris

You should talk to your doctor before you stop taking galantamine. It is important to keep taking this medicine to treat your condition.

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

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

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

• Take the last dose of galantamine tablets or oral solution at night.
• The next morning, take the first dose of Galantamine Viatris prolonged-release hard capsules.

DO NOT takemore than one capsule a day. While taking Galantamine Viatris prolonged-release hard capsules once a day, DO NOT takegalantamine tablets or oral solution.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Be aware of severe side effects.

Stop taking this medicine and see a doctor immediatelyif 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 your heartbeat is fast or irregular), which can be seen as an abnormal tracing 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 of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A red rash covered with small bumps filled with pus, which can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• A rash that can cause blisters, with spots that look like small targets.

Other side effects

Very common: 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 gets used to the medicine and generally only last a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to prevent nausea.

Common: may affect up to 1 in 10 people

• Weight loss.
• Loss of appetite.
• Feeling faint or fainting (syncope).
• Dizziness.
• Tremors.
• Headache.
• Feeling drowsy with low energy.
• Abnormal tiredness.
• Stomach pain or discomfort.
• Diarrhea.
• Indigestion.
• Muscle spasms.
• Falls.
• High blood pressure.
• Feeling weak.
• Feeling unwell.
• Seeing, hearing, or feeling things that are not real (hallucinations).
• Feeling sad (depression).
• Cuts (injuries).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (test results that show how well your liver is working).
• Numbness, tingling, or prickling sensation of the skin.
• Altered sense of taste.
• Excessive drowsiness.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Feeling sick (retching).
• Muscle weakness.
• Excessive loss of body water.
• Low blood pressure.
• Flushing.
• Excessive sweating.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side 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 after EXP. The expiry date is the last day of the month shown.

If your medicine is packaged in aluminum/aluminum blisters:

Store in the original packaging to protect from moisture.

If your medicine is packaged in PVdC blisters:

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

If your medicine is packaged in a capsule container:

Do not store above 25°C. Keep the container tightly closed and store in the original packaging to protect 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 from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Galantamine Viatris:

The active ingredient is galantamine. Each prolonged-release hard capsule contains 24 mg of galantamine (as hydrobromide).

The other ingredients are:

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

Capsule shell:

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

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

Appearance of Galantamine Viatris and Container Contents

Galantamine Viatris is available in three doses, each recognized by its inscription.

Galantamine Viatris 24 mg is a hard gelatin capsule with a white body and a pink cap, with black ink printing of “Mylan” over “GT24” on the body and cap.

The capsules are available in:

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

Only some 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the EEA member states under the following names:

Germany Galantamin Mylan 24 mg Retardkapseln

Slovakia Galantamine Mylan 24 mg

Spain Galantamina Viatris 24 mg hard prolonged-release capsules EFG

France Galantamine Mylan LP 24 mg prolonged-release capsule

Netherlands Galantamine Retard Mylan 24 mg capsules with prolonged release, hard

Portugal Galantamina Mylan 24 mg

United Kingdom Acumor XL 24 mg Prolonged-Release Capsules

Czech Republic Galantamin Mylan 24 mg prolonged-release capsules

Date of the Last Revision of this Leaflet:March 2021

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