GALANTAMINE SANDOZ 8 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Galantamine Sandoz 8 mg prolonged-release hard capsules EFG

Galantamine Sandoz 16 mg prolonged-release hard capsules EFG

Galantamine Sandoz 24 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 have any questions, 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 Galantamine Sandoz is and what it is used for
2. What you need to know before taking Galantamine Sandoz
3. How to take Galantamine Sandoz
4. Possible side effects
5. Storage of Galantamine Sandoz
6. Package contents and additional information

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

Galantamine Sandoz contains the active substance galantamine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects brain function.

Alzheimer's disease causes increased memory loss, confusion, and behavioral changes that make it increasingly difficult to perform daily routine activities.

It is believed that these effects are caused by a lack of "acetylcholine," a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain and thus treats the signs of the disease.

The capsules are in the form of "prolonged release." This means that they release the medication gradually.

2. What you need to know before taking Galantamine Sandoz

Do not take Galantamine Sandoz

• if you are allergic to galantamine or any of the other components of this medication (listed in section 6),
• if you have severe liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamine Sandoz.

This medication should only be used for Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Severe side effects

Galantamine may cause severe skin reactions, heart problems, and seizures. You should be aware of these side effects while taking galantamine. See section 4 "Be aware of severe side effects."

Before starting treatment with galantamine, your doctor should know if you have or have had any of the following disorders:

• liver or kidney problems,
• a heart disorder (such as chest discomfort that is usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval),
• changes in electrolyte levels (naturally occurring chemicals in the blood, such as potassium)
• peptic ulcer (stomach),
• obstruction in the stomach or intestine,
• a nervous system disorder (such as epilepsy or Parkinson's disease),
• a respiratory disease or infection that interferes with breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia),
• if you have difficulty urinating.

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

Also, discuss with your doctorif you have recentlyhad surgery on the stomach, intestine, or bladder. Your doctor will decide if galantamine is suitable for you.

Galantamine may cause weight loss. Your doctor will regularly check your weight while you are taking galantamine.

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Other medications and Galantamine Sandoz

Tell your doctor or pharmacist if you are using, have used, or may need to use any other medication.

This medication should not be taken with medications that work in the same way. These include:

• donepezil or rivastigmine (for Alzheimer's disease),
• ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness),
• pilocarpine (when taken orally for dry eyes or mouth) if taken orally.

Some medications may cause side effects more frequently in people taking galantamine. These include:

• medications that affect the QTc interval,
• paroxetine or fluoxetine (antidepressants),
• quinidine (for irregular heartbeat),
• ketoconazole (antifungal),
• erythromycin (antibiotic),
• ritonavir (for human immunodeficiency virus or "HIV"),
• non-steroidal anti-inflammatory analgesics (such as ibuprofen), which may increase the risk of ulcers,
• medications for certain heart disorders or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medications for an irregular heartbeat, your doctor may examine your heart with an "electrocardiogram" (ECG).

If you are taking any of these medications, your doctor may give you a lower dose of galantamine.

Galantamine may affect some anesthetics. If you are going to undergo surgery under general anesthesia, inform your doctor in advance that you are taking galantamine.

Consult your doctor or pharmacist if you have any questions.

Pregnancy and breastfeeding

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

Do not breastfeed while taking galantamine.

Driving and using machines

Galantamine may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If galantamine affects you, do not drive or operate tools or machines.

Galantamine Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule; this is essentially "sodium-free."

3. How to take Galantamine Sandoz

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

If you are taking galantamine tablets or oral solution and your doctor has told you that you will be switched to galantamine prolonged-release capsules, read the instructions in "Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules" carefully.

How much to take

You will start treatment with galantamine at a low dose. The usual initial dose is 8 mg, taken once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the most suitable dose for you. The maximum dose is 24 mg, taken once a day.

Your doctor will explain which dose you should start with and when you should increase it.

If you are unsure what to do or find that the effect of galantamine is too strong or too weak, tell your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medication is working and to discuss with you how you feel.

If you have liver or kidney problems, your doctor may give you a reduced dose of galantamine or decide if this medication is not suitable for you.

Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules

If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to galantamine prolonged-release capsules. If this applies to you:

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

DO NOT take more than one capsule per day. While taking one daily galantamine capsule, DO NOT take galantamine tablets or oral solution.

How to take Galantamine Sandoz

Galantamine capsules should be swallowed whole and NOT chewed or crushed. Take your dose of galantamine once a day in the morning, with water or other liquids – DO NOT chew or crush the contents.

Galantamine prolonged-release capsules should be taken once a day, preferably in the morning, with water or other liquids. Try to take galantamine with food.

Drink plenty of liquid while taking galantamine to stay hydrated.

If you take more Galantamine Sandoz than you should

If you have taken more galantamine than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the package with the remaining capsules. Signs of an overdose may include:

• severe nausea and vomiting,
• muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you forget to take Galantamine Sandoz

If you forget to take a dose, skip that dose and continue treatment as usual with the next scheduled dose.

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

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

If you stop taking Galantamine Sandoz

Consult your doctor before stopping treatment with Galantamine Sandoz. It is important to continue taking this medication to treat your disease.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Be aware of severe side effects

Stop taking your medication and consult a doctor or go to the nearest emergency room immediately if you notice any of the following side effects:

Skin reactions, 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 pus-filled bumps that can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• rash that can cause blisters, with spots that look like small targets.

These skin reactions are rare in people taking galantamine (may affect up to 1 in 1,000 people).

Heart problemsincluding changes in heartbeat (such as slow or irregular heartbeat) or palpitations (feeling a fast or irregular heartbeat). Heart problems can be seen as an abnormal tracing on an "electrocardiogram" (ECG), and may be common in people taking galantamine (may affect up to 1 in 10 people).

Seizures. This is uncommon in people taking galantamine (may affect up to 1 in 100 people).

You must stop taking galantamine and seek immediate helpif you notice any of the side effects mentioned.

Other side effects

Very common side effects (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 liquids and may prescribe a medication to prevent nausea.

Common side effects (may affect up to 1 in 10 people)

• decreased appetite, weight loss
• seeing, feeling, or hearing things that are not present (hallucinations)
• depression
• feeling dizzy or faint
• tremors or muscle spasms
• headache
• feeling very tired, weak, or unwell
• feeling very sleepy and having little energy
• increased blood pressure
• slow heartbeat (bradycardia)
• abdominal pain or discomfort
• diarrhea
• indigestion
• falls
• injuries

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reaction
• insufficient water in the body (dehydration)
• seeing, hearing, or feeling things that do not exist (visual and auditory hallucinations)
• tingling or numbness of the skin
• change in sense of taste
• daytime sleepiness
• blurred vision
• ringing in the ears that does not go away (tinnitus)
• heart rhythm disorder (first-degree atrioventricular block)
• low blood pressure
• flushing
• feeling sick (nausea)
• excessive sweating
• muscle weakness
• increased liver enzyme levels in blood.

Rare side effects (may affect up to 1 in 1,000 people):

• inflamed liver (hepatitis)
• heart rhythm disorder (complete atrioventricular block)

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 national reporting system: Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Galantamine Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after CAD/EXP.

The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Galantamine Sandoz

• The active ingredient is galantamine.

Galantamine Sandoz 8 mg: each prolonged-release hard capsule contains 8 mg of galantamine (as hydrobromide).

Galantamine Sandoz 16 mg: each prolonged-release hard capsule contains 16 mg of galantamine (as hydrobromide).

Galantamine Sandoz 24 mg: each prolonged-release hard capsule contains 24 mg of galantamine (as hydrobromide).

• The other ingredients in the prolonged-release tablets are: sodium lauryl sulfate, ammonio methacrylate copolymer (type B), hypromellose, carbomers, hydroxypropylcellulose, magnesium stearate, and talc.
• The other ingredients in the 8 mg gelatin capsule are: gelatin, titanium dioxide (E 171), black printing ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide).
• The other ingredients in the 16 mg and 24 mg gelatin capsules are: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and black printing ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide).

Appearance of Galantamine Sandoz and Container Content

Galantamine Sandoz 8 mg:white hard capsules with the inscription G8 on the capsule cap. The capsule contains a white, oval, prolonged-release tablet. The length of the capsule is 17.6 - 18.4 mm.

Galantamine Sandoz 16 mg:pink hard capsules with the inscription G16 on the capsule cap. The capsule contains two white, oval, prolonged-release tablets. The length of the capsule is 19.0 - 19.8 mm.

Galantamine Sandoz 24 mg:orange hard capsules with the inscription G24 on the capsule cap. The capsule contains three white, oval, prolonged-release tablets. The length of the capsule is 23.8 - 24.6 mm.

The prolonged-release hard capsules are packaged in OPA/aluminum/PVC/aluminum or PVC/PE/PVDC/aluminum blisters, inside a cardboard box.

Package sizes:

10, 14, 28, 30, 56, 60, 84, 90, and 100 prolonged-release hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

KRKA, d.d.

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of thisleaflet:May 2022

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