GALANTAMINE VIATRIS 8 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Galantamine Viatris 8 mg prolonged-release hard capsules EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package 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 package leaflet on their behalf.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Galantamine Viatris and what is it used for
2. What you need to know before taking Galantamine Viatris
3. How to take Galantamine Viatris
4. Possible side effects
5. Storage of Galantamine Viatris
6. Package contents and additional information

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

Galantamine Viatris contains galantamine, which is an anti-dementia medication used to treat the symptoms of mild to moderate Alzheimer's-type dementia, a disease that affects brain function.

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

It is believed that these symptoms are due to the 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 in a "prolonged-release" form, 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 any of the other components of this medication (listed in section 6).
• If you have severe liver and/or kidney disease.

Warnings and precautions

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

Before initiating treatment with this medication, your doctor should know if you have or have had any of the following disorders:

• 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, 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 (peptic ulcer).
• Obstruction in the stomach or intestine (which can cause severe abdominal pain or acute 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, inform your doctor if you have recently undergone surgeryon the stomach, intestine, or bladder. Your doctor will decide if this medication is suitable for you.

During treatment

If you need to undergo surgerythat requires general anesthesia, inform your doctor or healthcare staff that you are taking galantamine.

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

Serious side effects

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

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Other medications and Galantamine Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Galantamine should not be used with medications 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 medications may affect the functioning of galantamine, or galantamine may reduce the effectiveness of other medications taken at the same time. Your doctor may prescribe a lower dose of galantamine if you are taking any of these medications, such as:

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

Some medications may increase the risk of side effects in people taking galantamine. These include:

• Non-steroidal anti-inflammatory pain relievers (e.g., ibuprofen), which may increase the risk of ulcers.
• Medications for heart disorders or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medications for irregular heartbeat, your doctor may consider performing an electrocardiogram (ECG).
• Medications 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 medication.

You should not breastfeed while taking 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 start of treatment or when increasing the dose. 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 coloring agent) may cause allergic reactions.

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

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

3. How to take Galantamine Viatris

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult 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, NOT chewed or crushed. 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 tell you to slowly increase the dose of galantamine you are taking to find the most suitable dose for your case.

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

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

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

If you have liver or kidney problems

• If you have mild liver or kidney problems, treatment starts with the 8 mg capsule once a day in the morning.
• If you have moderate liver problems, treatment starts with the 8 mg capsule every other day in the morning. After one week, you should start taking the 8 mg capsule once a day 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 Galantamine Viatris than you should

If you take too much galantamine, consult your doctor or go to the hospital immediately. Bring the remaining capsules and 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, consult your doctor, pharmacist, or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and package leaflet of the medication 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 consult your doctor.

If you stop taking Galantamine Viatris

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

If you have any other doubts about the use of this medication, 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 per 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 medications, this medication can cause side effects, although not everyone will experience them.

Be aware of serious side effects.

Stop taking this medication and consult your 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).
• Rash covered with small bumps filled with pus, which can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• 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 adapts to the medication and generally only last a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medication to prevent nausea.

Common: may affect up to 1 in 10 people

• Weight loss.
• Decreased appetite.
• Feeling of fainting or fainting (syncope).
• Dizziness.
• Tremors.
• Headache.
• Feeling of drowsiness with low energy.
• Abnormal fatigue.
• 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 blood (test results that indicate 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 the need to vomit (retching).
• Muscle weakness.
• Excessive loss of body water.
• Low blood pressure.
• Flushing of the face.
• Excessive sweating.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Galantamine Viatris

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

Do not use this medication after the expiration date stated on the label, carton, and blister after CAD or EXP. The expiration date is the last day of the month indicated.

If your medication is packaged in aluminum/aluminum blisters:

Store in the original packaging to protect it from moisture.

If your medication is packaged in PVdC blisters:

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

If your medication 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 it from moisture. Once opened, use within the next 3 months.

If your medication is packaged in a bottle:

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. 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 8 mg of galantamine (as hydrobromide).

The other ingredients are:

Capsule Core(capsule contents): 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 of which is recognized by its inscription.

Galantamine Viatris 8 mg is a hard gelatin capsule with a white body and a pink cap, with black ink printing of “Mylan” over “GT8” on the body and cap.

The capsules are available in:

• PVdC blisters containing 7, 7 x 1 (perforated unit-dose blister), 10, 28, 28 x 1 (perforated unit-dose blister), 30, 30 x 1 (perforated unit-dose blister), 56, 84, 98, or 100 capsules. Calendar blisters of 28 or 28 x 1 (perforated unit-dose calendar blisters) capsules.
• Aluminum/aluminum blisters containing 7, 7 x 1 (perforated unit-dose blister), 10, 28, 28 x 1 (perforated unit-dose blister), 30, 30 x 1 (perforated unit-dose blister), 56, 84, 98, or 100 capsules. Calendar blisters of 28 or 28 x 1 (perforated unit-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 8 mg Retardkapseln

Slovakia Galantamine Mylan 8 mg

Spain Galantamina Viatris 8 mg hard prolonged-release capsules EFG

France Galantamine Mylan LP 8 mg prolonged-release capsules

Netherlands Galantamine Retard Mylan 8 mg capsules with prolonged release, hard

Portugal Galantamina Mylan 8 mg

United Kingdom Acumor XL 8 mg Prolonged-Release Capsules

Czech Republic Galantamin Mylan 8 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/