GALANTAMINE CINFA 8 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

galantamine cinfa 8 mg prolonged-release hard capsules EFG

Read the package leaflet carefully before you start taking the medicine.

• Keep this package 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is galantamine cinfa and what is it used for.
2. Before taking galantamine cinfa.
3. How to take galantamine cinfa.
4. Possible side effects.
5. Storage of galantamine cinfa.
6. Contents of the pack and further 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 brain function.

Alzheimer's disease causes an increasing loss of memory, confusion, and changes in behavior, 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. Galantamine cinfa increases the amount of acetylcholine in the brain, thereby treating the symptoms of the disease.

2. What you need to know before taking 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 package 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 disorder (such as chest discomfort that is usually 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 (peptic 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).
• Difficulty urinating.

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 (when taken by mouth for dry eyes or mouth).

Some medicines may cause side effects more easily 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 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 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 well in advance that you are taking galantamine cinfa.

Ask your doctor or pharmacist if you have any questions.

Pregnancy and Breast-feeding

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

Do not breast-feed while taking galantamine cinfa.

Driving and using machines

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

3. How to take galantamine cinfa

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask 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 the instructions in “Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules” in this section carefully.

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 are feeling.

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.
• The next morning, take your first dose of galantamine cinfa prolonged-release capsules.

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

The 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 liquid 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 with the remaining capsules with you. Signs of an 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, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take galantamine cinfa

If you forget to take a dose, skip that dose and continue with your 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, 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 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 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 problemsincluding changes in heartbeat (such as slow or extra heartbeats) or palpitations (feeling your heartbeat is fast or irregular). Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG) and are 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 adapts to the medicine and generally only last a few days. If you experience these effects, your doctor may recommend drinking 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 very 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.
• insufficient water in the body (dehydration).
• tingling or numbness of the skin.
• change in sense of taste.
• daytime sleepiness.
• blurred vision.
• ringing in the ears that does not go away (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):

• inflamed liver (hepatitis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storage of 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 pack and blister after “EXP”. The expiry date refers to the last day of the month shown.

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 a pharmacy for disposal.

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

6. Contents of the pack and further information

Composition of galantamine cinfa:

The active substance is galantamine.

• Each prolonged-release hard capsule of galantamine 8 mg contains 8 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).

Appearance and packaging of the product

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

white capsules containing a round, biconvex prolonged-release tablet.

The capsules are manufactured in a ‘prolonged-release’ form, which means 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 package 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 package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77288/P_77288.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77288/P_77288.html