GALNORA 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Galnora 16 mg prolonged-release hard capsules EFG

galantamine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get 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 Galnora and what is it used for
2. What you need to know before you take Galnora
3. How to take Galnora
4. Possible side effects
5. Storage of Galnora
6. Contents of the pack and other information

1. What is Galnora and what is it used for

Galnora contains the active substance “galantamine” an anti-dementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects memory and thinking.

Alzheimer's disease causes an increasing loss of memory, confusion, and changes in behavior, making it increasingly difficult to carry out daily activities.

It is thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galnora increases the amount of acetylcholine in the brain and in this way treats the signs of the disease.

The capsules are in the form of “prolonged release”. This means that they release the medicine gradually.

2. What you need to know before you take Galnora

Do not takeGalnora

• 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

Consult your doctor or pharmacist before starting to take Galnora.

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

Severe side effects

Galnora may cause severe skin reactions, heart problems, and seizures. You should be alert to these side effects while taking Galnora. See section 4 “Be aware of severe side effects”.

Before starting treatment withGalnora,your doctor should know if you have or have had in the past any of the following conditions:

• liver or kidney problems
• a heart condition (such as chest pain 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)
• a stomach ulcer
• obstruction in the stomach or intestine
• a nervous system disorder (such as epilepsy or problems controlling body or limb movements (extrapyramidal disorder))
• a respiratory disease that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• problems with urination

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

Also, inform your doctor if you have recently had an operationon the stomach, intestine, or bladder. Your doctor will decide if Galnora is suitable for you.

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

Children and adolescents

Galnora is not recommended for use in children or adolescents.

Other medicines and Galnora

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Galnora should not be taken with medicines 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 by mouth for dry eyes or mouth)

Some medicines may cause side effects more easily in people taking Galnora. These include:

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

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

Galnora may affect some anesthetics. If you are going to have an operation under general anesthesia, inform your doctor in advance that you are taking Galnora.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not breastfeed while takingGalnora.

Driving and using machines

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

Galnora contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Galnora

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, 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 carefully the instructions that appear in “Switching from galantamine tablets or oral solution to Galnora prolonged-release capsules” in this section.

How much to take

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

Your doctor will explain what dose you should start with and when it should be increased.

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

Your doctor needs to see you regularly to check that this medicine is working and to discuss with you how you are feeling.

If you haveliver orkidney problems,your doctor may give you a reduced dose of Galnora or may decide that this medicine is not suitable for you.

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

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

• Take your last dose of galantamine tablets or oral solution in the evening
• The next morning, take your first dose of Galnora prolonged-release capsules.

DO NOT take more thanone capsule per day. While takingone daily capsule of Galnora capsules, DO NOT take galantaminetablets or oral solution.

How to take it

Galnora capsules should be swallowed whole and NOTchewed or crushed. If you find the capsules difficult to swallow, you can empty the capsule and swallow the contents whole – DO NOTchew or crush the contents.

Take your dose of Galnora once a day in the morning, with water or other liquids. Try to take Galnora with food. Drink plenty of liquid while taking Galnora to stay hydrated.

If you take moreGalnorathan you should

If you take too much Galnora, consult your doctor or go to the hospital immediately. Bring the package with the remaining capsules. The signs of an overdose may include:

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or

call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeGalnora

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 takingGalnora

Consult your doctor before stopping treatment with Galnora. It is important to continue taking this medicine to treat your disease.

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

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 your medicine and consult a doctoror go to the emergency room immediatelyif 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).
• Red rash covered with small bumps filled with pus that can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that can produce 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 problems,including changes in heartbeat (such as slow or extra beats) or palpitations (feeling the heartbeat fast or irregular). Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking Galnora (may affect up to 1 in 10 people).

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

You must stop taking this medicine 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/or 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 treatment and generally only last a few days. If you experience these effects, your doctor may recommend that you drink more liquids and may prescribe a medicine 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 there (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
• 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)
• Numbness or tingling of the skin
• Change in sense of taste
• Daytime sleepiness
• Problems controlling body or limb movements (extrapyramidal disorder)
• Blurred vision
• Ringing in the ears that does not go away (tinnitus)
• Low blood pressure
• Flushing
• Feeling sick (nausea)
• Excessive sweating
• Muscle weakness
• Increased liver enzyme levels in the blood.

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

• Liver inflammation (hepatitis)

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galnora

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition ofGalnora

• The active substance is galantamine.

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

• The other ingredients in the prolonged-release granules are sodium lauryl sulfate, ammonio methacrylate copolymer (type B), hypromellose, carbomer, hydroxypropyl cellulose, magnesium stearate, talc. See section 2 “Galnora contains sodium”.
• The other ingredients in the 16 mg capsule are gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Appearance ofGalnoraand pack contents

Hard pink capsules of size 1 (capsule length: 19.0 - 19.8 mm) with the inscription G16. Contains two white and oval prolonged-release tablets.

Prolonged-release hard capsules are available in packs of 10, 14, 28, 30, 56, 60, 84, 90, and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Date of last revision of this leaflet:September 2022

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