Patient Information Leaflet

Galnora 16 mg prolonged-release hard capsules EFG

galantamine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• • This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms to 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 is Galnora and what it is used for

2. What you need to know before taking Galnora

3. How to take Galnora

4. Possible side effects

5. Storage of Galnora

6. Contents of the pack and additional information

Galnora contains the active ingredient “galantamine”a dementia medication that. Is used in adults to treat the symptoms of mild to moderately severe Alzheimer's diseasea type of dementia that altersbrain function.

Alzheimer's disease causes an increase in memory loss, confusion, and changes in behavior, making it increasingly difficult to perform routine daily activities.

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

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

Do not takeGalnora

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galnora.

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

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

Before starting treatment with Galnora,your doctor must 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 caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• electrolyte level changes (natural substances in the blood, such as potassium)
• peptic ulcer (stomach)
• 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 or infection 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 surgeryin the stomach, intestine, or bladder. Your doctor will decide if Galnora is suitable for you.

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

Children and adolescents

Galnora is not recommended for use in children or adolescents.

Other medications and Galnora

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Galnorashould not be taken with medications that act in the same way, including:

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

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

• paroxetine or fluoxetine (antidepressants)
• quinidine (for irregular heartbeat)
• ketoconazole (an antifungal)
• erythromycin (an antibiotic)
• ritonavir (for HIV virus)
• nonsteroidal anti-inflammatory analgesics (such as ibuprofen) that may increase the risk of ulcers
• medications for certain heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta blockers, or calcium channel blockers). If you take medications due to irregular heartbeat, your doctor mayexamine your heart using an electrocardiogram (ECG)
• medications that affect the QTc interval.

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

Galnora may affectsome anesthetics. If you are undergoing a general anesthesia operation,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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed while taking Galnora.

Driving and operating machines

Galnora maymake you feel dizzy or drowsy, especially during the first few weeksof treatment. If Galnora affects you, do not drive or operate tools or machines.

Galnora contains sodium

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

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

If you are takinggalantaminetablets or oral solution and your doctor has told you that you will be switched togalantamineextended-release capsules, read carefully the instructions that appear in “Switching from galantamine tablets or oral solution to Galnora capsules” in this section.

How much to take

Youwill startthe treatment withGalnoraat a low dose.Theinitialusual dose is 8mg, taken once a day.Your doctorwill gradually increase your dose, every 4weeks or more,untilyou reachthe most suitable dose for you.Themaximumdose is24mg, takenonce a day.

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

Ifyou are not sure what to do or findthatthe effectofGalnorais too strong or weak, inform your doctor orpharmacist.

Your doctor needs to see you regularly to check that this medicationis workingand discuss with you how you feel.

If you haveliver or kidney problems,your doctor may give youareduced doseofGalnoraordecide if this medication is not suitable for you.

Switching from Galnora tablets or oral solution to Galnora capsules

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

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

Do not take more thanonecapsule in a 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 not be chewed or crushed. If you find the capsules difficult to swallow, you can empty the capsule and swallow the contents whole – do not chew or crush the contents.

Take your dose of Galnoraonce 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 with you the packaging with the remaining capsules. The signs of an overdose may include:

• intense nausea andvomiting
• muscle weakness, slow heart rate, convulsions, and loss ofconsciousness.

In caseofoverdose or accidental ingestion, consult immediatelyyour doctor or pharmacist or

call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the

amount ingested.

If you forget to takeGalnora

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

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

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

If you interrupt the treatment withGalnora

Consultwithyour doctor before interrupting the treatment withGalnora. It is essential to continue taking this medication to treat your condition.

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

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

Be aware of severe side effects

Stop taking your medicine and consult a doctoror go to the nearest emergency serviceimmediatelyifyou notice any of the following side effects.

Skin reactions,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 can spread throughout 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 (they can affect up to 1 in 1,000 people).

Heart problems,including changes in heart rhythm (such as slow orextra beats) or palpitations (feeling theheartbeatingrapidly orirregularly).Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking Galnora (they can affect up to 1 in 10people).

Seizures. This is rare in people taking Galnora (they can affect up to 1 in 100people).

You should stop taking this medicine and seek help immediatelyif you notice any of the side effects mentioned.

Other side effects

Frequent side effects(can affect more than 1 in 10 people):

• Nausea and/or vomiting.

These side effects are more likely to occur in the first weeksof treatment or when the dose is increased. They usually disappear gradually as the body adapts to the treatment and generallyonly lasta fewdays. If you experience these side effects, your doctor may recommend drinking more liquids and may prescribe a medication to help you feel better.

Frequent side effects (can affect up to 1 in 10 people)

• Loss of appetite, weight loss
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Sensation of dizziness or fainting
• Tremors or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Sensation of excessive sleep and low energy
• Increased blood pressure
• Abdominal pain ordiscomfort
• Diarhea
• Indigestion
• Falls
• Wounds

Infrequent side effects (can affect up to 1 in 100 people)

• Allergic reaction
• Insufficient water in the body (dehydration)
• Prickling or numbness of the skin
• Change in sense of taste
• Daytime somnolence
• Difficulty controlling body or limb movements (extrapyramidal disorder)
• Blurred vision
• Continuous ringing in the ears (tinnitus)
• Low blood pressure
• Flush
• Sensation of nausea(retching)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymesinblood.

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

• Inflamed liver (hepatitis)

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 theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister and on the box after CAD.

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

Do not store above 86°F (30°C). Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacisthow to dispose ofthecontainers and themedicines that you no longerneed.By doing so, you will help protect the environment.

Composition ofGalnora

• The active principle is galantamine.

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

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

Appearance ofGalnoraand packaging contents

Prolonged-release hard capsules of pink color, size 1 (capsule length: 19.0 - 19.8 mm) with the inscription G16.Contains two oval-shaped white and prolonged-release granules.

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

Only some packaging 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2022

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