Patient Information Leaflet

Galantamine Viatris 16 mg Extended-Release Hard Capsules EFG

Read 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 carer 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Galantamine Viatris

3.How to take Galantamine Viatris

4.Possible side effects

5.Storage of Galantamine Viatris

6.Contents of the pack and additional information

Galantamina Viatris contains galantamine, which is a dementia medication, used to treat the symptoms of mild to moderate Alzheimer's disease, a condition that alters brain function.

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

It is believed 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 alleviate the symptoms of the disease.

The capsules are manufactured in a "prolonged release" form, meaning they allow the medication to be released slowly.

Do not take GalantamineViatris:

• If you are allergic to galantamine or any of the other components of this medication (listed in section 6).
• If you have a 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 starting treatment with this medication, your doctor must know if you have or have had any of the following conditions:

• Other liver or kidney problems.
• Heart problems (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 blood potassium levels are reduced or elevated).
• Peptic ulcer (stomach).
• Obstruction in the stomach or intestine (which may cause acute abdominal pain or acute constipation).
• Nervous system disorders (such as epilepsy or Parkinson's disease).
• Respiratory disease or infection affecting 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, consult your doctor if you have recently had surgeryin the stomach, intestine, or bladder. Your doctor will decide ifthis medicationis 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 check your weight regularly while you are taking this medication.

Severe side effects

This medication may cause severe skin reactions, heart problems, and seizures. 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 taken recently, or may need to take any other medication, including those purchased without a prescription.

Galantamine should not be used with medications that act 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 administered 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 lower doses of galantamine if you are taking any of these medications, for example:

Some medications may cause side effects with a higher probability in people taking galantamine. These include:

• Nonsteroidal anti-inflammatory analgesics (such as ibuprofen), which may increase the risk of ulcers.
• Medications for heart problems or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you take 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 during treatment with galantamine.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and should not do so unless your doctor tells you it is safe to do so. Galantamine may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

GalantamineViatriscontains Red 40 (E 129) and sodium

Red 40 (E-129, a coloring agent) may cause allergic reactions.

It may 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".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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 doses: 8 mg, 16 mg, and 24 mg. Galantamine treatment should start with a low dose. Your doctor may then instruct you to gradually increase the galantamine dosage (dose) you are taking, to find the most suitable dose for your case.

1. The initial recommended dose is one 8 mg capsule taken once a day. After four weeks of treatment, you may increase the dose.
2. Next, 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. Then, you will take one 24 mg capsule once a day.

Your doctor will explain which dose to start with and when to increase the dose. If you consider that 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 for you and to discuss how you are feeling. Your doctor will also monitor your weight periodically during galantamine treatment.

If you have liver or kidney problems

• If you have mild liver or kidney problems, treatment starts with one 8 mg capsule taken 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 a week, you should start taking one 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 Galantamina Viatris than you should

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

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

If you forgot to take Galantamina Viatris

If you forgot to take a dose, do not take that dose and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you forgot to take more than one dose, you should consult your doctor.

If you interrupt treatment with Galantamina Viatris

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

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

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

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

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

Do not takemore than one capsule per day. While taking Galantamina Viatrisprolonged-release hard capsules once a day,do not takegalantamine capsules or oral solution.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Be aware of serious side effects.

Stop taking this medicine and see your doctor immediatelyif you experience:

• Cardiac problems, including slow heart rate (frequent: may affect up to 1 in 10 people). You may also notice changes in heart rhythm, such as extra beats or palpitations (feeling a rapid or irregular heartbeat), which may be seen as an abnormal tracing on an electrocardiogram (ECG) (infrequent: may affect up to 1 in 100 people).
• Seizures (epileptic crises)(convulsions) (infrequent: may affect up to 1 in 100 people).

• Allergic reactions. You may notice a skin rash, itching or hives, facial inflammation, lip, tongue, and difficulty breathing (infrequent: 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small, pus-filled bumps that may spread throughout the body, sometimes with fever (acute generalized pustular psoriasis).
• Rash that may cause blisters, with spots that appear 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 weeks of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the medicine, and usually only last for a few days. If you experience these side effects, your doctor may recommend that you drink more liquids and may prescribe a medication to help you feel better.

Frequent: may affect up to 1 in 10 people

• Weight loss.
• Reduced appetite.
• Sensation of fainting or fainting (syncope).
• Dizziness.
• Tremor.
• Headache.
• Sensation of drowsiness with low energy.
• Unusual fatigue.
• Abdominal pain or discomfort.
• Diarhea.
• Indigestion.
• Muscle spasms.
• Falls.
• High blood pressure.
• Sensation of weakness.
• General feeling of discomfort.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Sensation of sadness (depression).
• Wounds (cuts).

Infrequent: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (test results indicating how well your liver is functioning).
• Prickling, pins and needles, or numbness of the skin.
• Alteration of taste.
• Excessive drowsiness.
• Blurred vision.
• Ringing in the ears (tinnitus).
• Feeling the need to vomit (retching).
• Weakness of the muscles.
• Excessive loss of body water.
• Low blood pressure.
• Face redness.
• Excessive sweating.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label, the container, and the blister pack 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 at a temperature above 25°C. Store in the original packaging to protect it from moisture.

If your medication is packaged in a bottle of tablets:

Do not store at a temperature above 25°C. Keep the bottle perfectly 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 perfectly closed and store in the original bottle to protect it from moisture.

Medications should not be disposed of through the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Galantamina Viatris:

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

The other components are:

Capsule 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 package

Galantamina Viatris is available in three doses, each of which is recognized by its inscription:

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

The capsules are available in:

• PVC blisters containing 7,7x 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 blisters of 28 or 28 x 1 (single-dose perforated calendar blisters) capsules.
• Aluminum/aluminum blisters containing 7,7x 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 blisters of 28 or 28 x 1 (single-dose perforated calendar blisters) capsules.
• Bottles containing 500 capsules.
• Flasks containing 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 medicine by contacting 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 EEA member states with the following names:

GermanyGalantamin Mylan 16 mg Retardkapseln

SlovakiaGalantamine Mylan 16 mg

SpainGalantamina Viatris 16 mg hard capsules with prolonged release EFG

FranceGalantamine Mylan LP 16 mg prolonged-release capsule

NetherlandsGalantamine Retard Mylan 16 mg capsules with prolonged release, hard

PortugalGalantamina Mylan 16 mg

United KingdomAcumor XL 16 mg Prolonged-Release Capsules

Czech RepublicGalantamin Mylan 16 mg prolonged-release capsules

Last review date of this leaflet:March 2021

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/