Patient Information Leaflet

Galantamine Kern Pharma8 mg prolonged-release hard capsules EFG

Galantamine Kern Pharma16 mg prolonged-release hard capsules EFG

Galantamine Kern Pharma24 mg prolonged-release hard capsules EFG

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, 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, 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 Galantamine Kern Pharma and what is it used for

2.What you need to know before you start taking Galantamine Kern Pharma

3.How to take Galantamine Kern Pharma

4.Possible side effects

5.Storage of Galantamine Kern Pharma

6.Contents of the pack and additional information

This medication contains the active ingredient “galantamina”,a dementia-reversing medication that is used to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that alters brain 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 believed that these effects are caused by a lack of acetylcholine, a substance responsible for transmitting messages between brain cells.This medicationincreases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.

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

Do not takeGalantamine Kern Pharma

• 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 or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamine Kern Pharma.

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 severe side effects while taking galantamine. See section 4 “Be aware of severe side effects”.

Before starting treatment withGalantamine Kern Pharma,your doctor must know if you suffer or have suffered in the past from any of the following conditions:

• liver or kidney problems
• a heart condition (such as chest discomfort usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval).
• change in electrolyte levels (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 difficulty 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 this medication 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 this medication is suitable for you.

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

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Use of Galantamine Kern Pharma with other medications

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

Galantamine Kern Pharmashould 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 (for dry eyes or mouth) if taken orally

Some medications may cause side effects more likely in people using Galantamine Kern Pharma. 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), which 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 may examine 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 Galantamine Kern Pharma.

Galantamine may affect some anesthetics. If you are undergoing general anesthesia, inform your doctor, in advance, that you are taking this medication.

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 before using this medication.

You should not breastfeed while taking Galantamine Kern Pharma.

Driving and operating machinery

Galantamine may make you feel dizzy or drowsy, especially during the first weeks of treatment. If you experience these effects, do not drive or operate machinery

This medication contains sodium

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

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Follow exactly the administration instructions of this medication as indicated by your doctor. 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 galantamine prolonged-release capsules” in this section.

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 with which dose you should start and when you should increase it.

If you are unsure of what to do or find that the effect of galantamine is too strong or too weak, inform 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 that 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 the 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 in a day. While taking a daily capsule of galantamine prolonged-release capsules, DO NOT take galantamine tablets or oral solution.

How to take Galantamine Kern Pharma capsules

The capsules of this medication should be swallowed whole and NOT be chewed or crushed. If you have difficulty swallowing the capsules, you can empty them and swallow the entire contents – DO NOT chew or crush the contents.

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

If you take more Galantamine Kern Pharma 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring with you the packaging with the remaining capsules. The signs and symptoms of an overdose may include:

• intense nausea and vomiting
• muscle weakness, slow heart rate, seizures, and loss of consciousness

If you forget to take Galantamine Kern Pharma

If you forget to take a dose, leave that dose and continue 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, you should consult your doctor.

If you interrupt treatment with Galantamine Kern Pharma

Consult your doctor before interrupting treatment with Galantamine Kern Pharma. It is essential to continue taking this medication to treat your condition.

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

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

Be aware of severe side effects

Stop taking your medicine and consult your doctor or go to the nearest emergency service immediatelyif you 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 pustular psoriasis).
• 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 problemsincluding changes in heart rhythm (such as slow heartbeat or extra beats) or palpitations (feeling a rapid or irregular heartbeat). Heart problems can be seen as an abnormal tracing on an “electrocardiogram” (ECG), and may be common in people taking galantamine (they can affect up to 1 in 10 people).

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

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

Other side effects

Frequent side effects (can 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 treatment and generally 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.

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

• Weight loss, decreased appetite
• Seeing, feeling, or hearing things that are not there (hallucinations)
• Depression
• Sensation of dizziness or fainting
• Trembling or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Sensation of excessive sleepiness and low energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Wounds

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

• Allergic reaction
• Inadequate 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
• Tinnitus (persistent ringing in the ears)
• Low blood pressure
• Flush
• Sensation of nausea (retching)
• Excessive sweating
• Muscle weakness
• Increased liver enzymes in the blood

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

• Inflammation of the liver (hepatitis)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for 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 this medication out of the 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. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofGalantamina Kern Pharma

• The active ingredient is galantamine.

Each prolonged-release hard capsule contains 8, 16 or 24mg of galantamine (as bromide).

• The other components in prolonged-release granules are sodium lauryl sulfate, ammonio methacrylate copolymer (type B), hypromellose, carbomer, hydroxypropyl cellulose, magnesium stearate, talc. See section 2 “This medicine contains sodium”
• The other components in the 8mg capsule are gelatin, titanium dioxide (E171), printing ink (shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide).
• The other components in the 16 mg and 24 mg capsules are gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and black ink (shellac, propylenglycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide).

Appearance ofGalantamina Kern Pharmaand contents of the package

Dose 8 mg:

Prolonged-release hard capsules, No. 2 (capsule length: 17.6 – 18.4 mm) white in color with the inscription G8. Contains one prolonged-release white and oval-shaped tablet.

Dose 16 mg:

Prolonged-release hard capsules, No. 1 (capsule length: 19.0 – 19.8 mm) pink in color with the inscription G8. Contains two prolonged-release white and oval-shaped tablets.

Dose 24 mg:

Prolonged-release hard capsules, No. 0 (capsule length: 23.8 – 24.6 mm) orange in color with the inscription G24. Contains three prolonged-release white and oval-shaped tablets.

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

Only some package sizes may be marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

or

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

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: September 2022

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