Galantamine Kern Pharma 8 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Galantamine Kern Pharma 8 mg prolonged-release hard capsules EFG

Galantamine Kern Pharma 16 mg prolonged-release hard capsules EFG

Galantamine Kern Pharma 24 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Galantamine Kern Pharma is and what it is used for
2. What you need to know before taking Galantamine Kern Pharma
3. How to take Galantamine Kern Pharma
4. Possible side effects
5. How to store Galantamine Kern Pharma
6. Contents of the pack and other information

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

This medicine contains the active substance "galantamine", an antidementia 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 increasing memory loss, confusion, and behavioural changes, making it progressively more difficult to carry out routine daily activities.

These effects are believed to be 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 thereby treats the symptoms of the disease.

The capsules are in "prolonged-release" form. This means they release the medicine gradually.

2. What you need to know before taking Galantamina Kern Pharma

Do not take Galantamina Kern Pharma

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Galantamina Kern Pharma.

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

Serious adverse effects

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

Before starting treatment with Galantamina Kern Pharma, your doctor should know if you currently have or have previously had any of the following conditions:

• liver or kidney problems
• a heart disorder (such as chest pain usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in electrolyte levels (natural chemicals in the blood, such as potassium)
• peptic ulcer (in the stomach)
• obstruction in the stomach or intestines
• a nervous system disorder (such as epilepsy or problems controlling body movements or limbs (extrapyramidal disorder))
• a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia)
• problems with urine outflow.

Your doctor will decide whether this medicine is suitable for you or whether your dose needs to be adjusted.

Also discuss with your doctor if you have recently had surgery on the stomach, intestines, or bladder. Your doctor will decide whether this medicine is appropriate for you.

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

Children and adolescents

The use of galantamine is not recommended in children or adolescents.

Use of Galantamina Kern Pharma with other medicines

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

Galantamina Kern Pharma should not be taken together 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 have a higher risk of adverse effects in people taking Galantamina 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 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 using an “electrocardiogram” (ECG)
• medicines that affect the QTc interval.

If you are taking any of these medicines, your doctor may prescribe a lower dose of Galantamina Kern Pharma.

Galantamine may interact with certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well 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 become pregnant, consult your doctor before using this medicine.

You must not breastfeed while taking Galantamina Kern Pharma.

Driving and using machines

Galantamine may cause dizziness or drowsiness, especially during the first weeks of treatment. If you experience these effects, you should not drive or operate 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 Galantamina Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

How much to take

Your treatment with galantamine will start at a low dose. The usual starting dose is 8 mg taken once daily. Your doctor will gradually increase your dose every 4 weeks or longer until reaching the most appropriate dose for you. The maximum dose is 24 mg taken once daily.

Your doctor will explain which dose you should 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, inform 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 have liver or kidney problems, your doctor may prescribe a reduced dose of galantamine or may decide whether this medicine is suitable for you.

Switching from galantamine tablets or oral solution to galantamine 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 in the evening.
• The following morning, take your first dose of galantamine prolonged-release capsules.

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

How to take Galantamina Kern Pharma capsules

The capsules of this medicine must be swallowed whole and must NOT be chewed or crushed. If you have difficulty swallowing the capsules, you may open them and swallow the entire contents – DO NOT chew or crush the contents.

Take your dose of galantamine once daily in the morning, with water or other liquid. Try to take galantamine with food. Drink plenty of fluids while taking this medicine to stay hydrated.

If you take more Galantamina Kern Pharma than you should

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

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

If you forget to take Galantamina Kern Pharma

If you forget to take a dose, skip that dose and continue your treatment as usual with the next scheduled dose. Do NOT take a double dose to make up for a missed dose.

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

If you stop taking Galantamina Kern Pharma

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

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

4. Possible adverse effects

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

Be alert for serious adverse effects

Stop taking your medicine and consult your doctor or go immediately to the nearest emergency department if you notice any of the following adverse 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 pus-filled bumps that may spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling 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 heartbeat or extra beats) or palpitations (feeling a fast or irregular heartbeat). Heart problems may 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 help if you notice any of the adverse effects listed above.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea and vomiting. These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased.

They usually gradually disappear as the body adapts to the treatment and generally last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help you feel better.

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

• Weight loss, decreased appetite
• 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 general discomfort
• Feeling very sleepy and having low energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

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

• Allergic reaction
• Lack of sufficient body water (dehydration)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Problems controlling body movements or limbs (extrapyramidal disorder)
• Blurred vision
• Ringing in the ears that does not go away (tinnitus)
• Low blood pressure
• Flushing
• Feeling the need to vomit (nausea)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in blood

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

• Inflammation of the liver (hepatitis)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamina Kern Pharma

• The active substance is galantamine.

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

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

Appearance of Galantamina Kern Pharma and contents of the pack

Dose 8 mg:

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

Dose 16 mg:

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

Dose 24 mg:

Orange hard capsules size 0 (capsule length: 23.8 – 24.6 mm) with the imprint 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.

Only some pack sizes may be marketed.

Marketing Authorization 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 medicinal product is authorized in the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: September 2022

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