GALANTAMINE CINFA 24 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

galantamine cinfa 24 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 galantamine cinfa and what is it used for.
2. Before you take galantamine cinfa.
3. How to take galantamine cinfa.
4. Possible side effects.
5. Storing galantamine cinfa.
6. Contents of the pack and other information.

1. What is galantamine cinfa and what is it used for

galantamine cinfa 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 increasing memory loss, confusion, and changes in behavior, making it difficult to perform daily activities.

It is thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamine cinfa increases the amount of acetylcholine in the brain, treating the symptoms of the disease.

2. What you need to know before you take galantamine cinfa

Do not take galantamine cinfa

• If you are allergic to galantamine or any of the other ingredients listed in section 6 of this leaflet.
• If you have severe liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking galantamine cinfa. This medicine should only be used for Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Severe side effects

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

Before starting treatment with galantamine cinfa, your doctor should know if you have or have had 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).
• Changes in electrolyte levels (naturally occurring chemicals in the blood, such as potassium).
• A stomach ulcer.
• Blockage in the stomach or intestine.
• A nervous system disorder (such as epilepsy or Parkinson's disease).
• A respiratory disease that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia).
• Problems with urination.

Tell your doctor if you have recently had an operationon your stomach, intestine, or bladder. Your doctor will decide if galantamine cinfa is suitable for you.

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

Children and adolescents

Galantamine cinfa is not recommended for use in children or adolescents.

Using galantamine cinfa with other medicines

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

Galantamine cinfa 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 (taken by mouth for dry eyes or mouth).

Some medicines may increase the risk of side effects in people taking galantamine cinfa. 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 stomach ulcers,
• medicines for certain heart conditions 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 check your heart using an electrocardiogram (ECG),
• medicines that affect the QTc interval.

Your doctor may give you a lower dose of galantamine cinfa if you are also taking any of the above medicines.

Galantamine cinfa may affect some anesthetics. If you are going to have an operation under general anesthesia, tell your doctor before the operation that you are taking galantamine cinfa.

Talk to your doctor or pharmacist if you have any questions.

Pregnancy and Breastfeeding

Before taking this medicine, talk to your doctor to get advice if you are pregnant, might be pregnant, or are planning to become pregnant.

Do not breastfeed while taking galantamine cinfa.

Driving and using machines

Galantamine cinfa may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If galantamine cinfa affects you, do not drive or use machines.

3. How to take galantamine cinfa

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, talk to 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 cinfa prolonged-release capsules, read carefully the instructions in the section “Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules”.

How much to take

You will start treatment with galantamine cinfa 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 cinfa is too strong or too weak, talk to 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 cinfa or 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 to switch you to galantamine cinfa prolonged-release capsules. If this applies to you:

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

DO NOT take more than one capsule a day. While taking galantamine capsules once a day, DO NOT take galantamine tablets or oral solution.

How to take it

Galantamine cinfa capsules should be swallowed whole and NOT chewed or crushed. Take your dose of galantamine cinfa once a day in the morning, with water or other liquids. Try to take galantamine cinfa with food.

Drink plenty of liquids while taking galantamine cinfa to stay hydrated.

If you take more galantamine cinfa than you should

If you take too much galantamine cinfa, talk to your doctor or go to the hospital immediately. Take the pack and any remaining capsules with you. Signs of overdose may include:

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

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take galantamine cinfa

If you miss a dose, skip that dose and continue with your next scheduled dose as usual.

DO NOT take a double dose to make up for a forgotten dose.

If you miss more than one dose, talk to your doctor.

If you stop taking galantamine cinfa

Talk to your doctor before stopping treatment with galantamine cinfa. It is important to continue taking this medicine to treat your condition.

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

4. Possible side effects

Like all medicines, galantamine cinfa can cause side effects, although not everybody gets them.

Be aware of serious side effects

Stop taking galantamine cinfa and see a doctor or go to the casualty department immediatelyif you notice any of the following serious 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 pus-filled bumps that can spread across 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 cinfa (may affect up to 1 in 1,000 people).

Heart problems, including 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 cinfa (may affect up to 1 in 10 people).

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

You must stop taking galantamine cinfa and seek immediate helpif you notice any of the above side effects.

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 gets used to the medicine 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 sleepy and having little energy,
• high 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 body water (dehydration),
• tingling or numbness of the skin,
• change in sense of taste,
• daytime sleepiness,
• blurred vision,
• ringing in the ears that does not stop (tinnitus),
• low blood pressure,
• flushing,
• feeling sick (nausea),
• excessive sweating,
• muscle weakness,
• increased levels of liver enzymes in the blood.

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

• inflammation of the liver (hepatitis).

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing galantamine cinfa

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist.

Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in galantamine cinfa:

The active substance is galantamine.

• Each prolonged-release hard capsule of galantamine 24 mg contains 24 mg of galantamine (as galantamine hydrobromide).

The other ingredients are:

Contents of the capsule

microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Coating of the capsule

gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), red iron oxide (E172), yellow iron oxide (E172).

Appearance and packaging

Galantamine cinfa prolonged-release hard capsules are available in three strengths, each of which can be recognized by its color:

orange-colored capsules containing three prolonged-release tablets that are round and biconvex.

The capsules are manufactured in a ‘prolonged-release’ form, which means that they release the medicine more slowly.

The capsules are available in the following blister packs:

7, 28, 30, 56, 84, 98, 100 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Pharmaten, S.A.

6, Dervenakion Str., Pallini Attiki

Greece

or

Pharmaten International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No. 5, Rodopi 69300

Greece

This medicine is authorized in the Member States of the EEA under the following names:

Germany Masparen 8mg, 16mg, 24mg Hartkapseln, retardiert

Netherlands Masparen Retard 1x daags 8mg, 16mg, 24mg

Spain Galantamina cinfa 8mg, 16mg, 24mg cápsulas duras de liberación prolongada EFG

United Kingdom Consion XL 8mg, 16mg, 24mg prolonged release capsules

Date of last revision of this leaflet:March 2021

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77290/P_77290.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77290/P_77290.html