GALANTAMINE KERN PHARMA 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

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 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 and other information:

1. What is Galantamine Kern Pharma and what is it used for
2. What you need to know before you take 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 other information

1. What is Galantamine Kern Pharma and what is it used for

This medicine contains the active substance “galantamine”, an anti-dementia medicine used to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects brain function.

Alzheimer's disease causes an increasing loss of memory, confusion, and changes in behaviour, 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. This medicine 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 Galantamine Kern Pharma

Do not takeGalantamine Kern Pharma

• 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 Galantamine Kern Pharma.

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

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

Before starting treatment withGalantamine Kern Pharma,your doctor should know if you have or have had in the past 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).
• change in electrolyte levels (naturally occurring chemicals in the blood, such as potassium)
• peptic ulcer (stomach)
• obstruction in the stomach or intestine
• a disorder of the nervous system (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 this medicine 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 this medicine is suitable for you.

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

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Using Galantamine Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Galantamine Kern Pharma 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 (for dry eyes or mouth) if taken by mouth

Some medicines may produce side effects more easily in people who use Galantamine Kern Pharma. 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), which 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 check your heart using 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 Galantamine Kern Pharma.

Galantamine may affect some anaesthetics. If you are going to have an operation under general anaesthesia, inform your doctor in advance that you are taking this medicine.

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 for advice before taking this medicine.

You should not breastfeed while taking Galantamine Kern Pharma.

Driving and using machines

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

This medicine contains sodium

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

.

3. How to take Galantamine Kern Pharma

Follow exactly the administration instructions of this medicine given 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 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 tell you which dose to start with and when to 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 medicine is working and to discuss with you how you feel.

If you have liver or kidney problems, your doctor may give you a lower dose of galantamine or may decide that this medicine 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 that you should switch 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 in a day. While taking one daily capsule of galantamine prolonged-release capsules, DO NOT take galantamine tablets or oral solution.

How to takeGalantamine Kern Pharmacapsules

The capsules of this medicine should be swallowed whole and NOT chewed or crushed. If you have difficulty swallowing the capsules, you can empty them and swallow the contents whole – 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 liquids while taking this medicine to stay hydrated.

If you take moreGalantamine Kern Pharmathan 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, telephone: 91 562 04 20, indicating the medicine and the amount taken. Bring the package with the remaining capsules. The signs and symptoms of an overdose may include:

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

If you forget to takeGalantamine Kern Pharma

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, you should consult your doctor.

If you stop takingGalantamine Kern Pharma

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

If you have any further questions on 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 your doctor or go to the nearest emergency department 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).
• Rash with small pus-filled bumps 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 problemsincluding changes in heartbeat (such as slow or extra beats) or palpitations (feeling your heartbeat is fast or irregular). 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 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 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 your body adapts to the 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 you from feeling sick.

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

• Weight loss, decreased appetite
• Seeing, hearing, or feeling 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
• Lack of 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Galantamine Kern Pharma

Keep this medicine 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 shown.

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 packages and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of packages and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofGalantamine Kern Pharma

• The active substance is galantamine.

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

• 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 “This medicine contains sodium”
• The other ingredients in the 8 mg capsule are gelatin, titanium dioxide (E171), printing ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).
• The other ingredients in the 16 mg and 24 mg capsules are gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Appearance ofGalantamine Kern Pharmaand contents of the pack

Dose 8 mg:

Hard capsules, size 2 (capsule length: 17.6 – 18.4 mm) white with the inscription G8. Contains one white, oval, prolonged-release tablet.

Dose 16 mg:

Hard capsules, size 1 (capsule length: 19.0 – 19.8 mm) pink with the inscription G8. Contains two white, oval, prolonged-release tablets.

Dose 24 mg:

Hard capsules, size 0 (capsule length: 23.8 – 24.6 mm) orange with the inscription G24. Contains three white, 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 authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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 authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: September 2022

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