GALANTAMINE CINFA 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

galantamine cinfa 16 mg prolonged-release hard capsules EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. 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 medication. 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 increased memory loss, confusion, and changes in behavior, making it increasingly difficult to perform daily routine activities.

It is believed 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 and thus treats the signs 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

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

Also, inform your doctor if you have recently had an operationon the 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 medications

Inform your doctor or pharmacist if you are using, have recently used, or are about to use other medications.

Galantamine cinfa should not be taken with medications 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 orally for dry eyes or mouth).

Some medications may produce side effects more frequently 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
• medications for certain heart disorders or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medications for an irregular heartbeat, your doctor may examine your heart using an “electrocardiogram” (ECG)
• medications 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 medications.

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

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and Breastfeeding

Before taking this medication, consult your doctor for advice if you are pregnant, may 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 operate tools or machines.

3. How to take galantamine cinfa

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If in 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 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 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 what dose you should start with and when you should increase it. If you are unsure what to do or find that the effect of galantamine cinfa 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 for you and to discuss with you how you are feeling.

If you have liver or kidney problems,your doctor may give you a reduced dose of galantamine cinfa or may 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 cinfa prolonged-release capsules. If this applies to you:

• Take the last dose of galantamine tablets or oral solution at night.
• The next morning, take the first dose of galantamine cinfa prolonged-release capsules.

DO NOT take more than one capsule per 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, consult your doctor or go to the hospital immediately. Bring the package with the remaining capsules. 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take galantamine cinfa

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, consult your doctor.

If you stop taking galantamine cinfa

Consult your doctor before stopping treatment with galantamine cinfa. It is important to continue taking this medication to treat your disease.

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

4. Possible side effects

Like all medications, galantamine cinfa can cause side effects, although not everyone gets them.

Be aware of serious side effects

Stop takinggalantamine cinfaand consult a doctor or go to the nearest emergency room 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 filled with pus 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 cinfa (they may affect up to 1 in 1,000 people).

Heart problemsincluding changes in heartbeat (such as slow or extra beats) or palpitations (feeling the heartbeat 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 (they may affect up to 1 in 10 people).

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

You must stop takinggalantamine cinfaand seek help immediatelyif 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 the body adapts to the medication and generally only last a few days. If you experience these effects, your doctor may recommend drinking more liquids and may prescribe a medication 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 disappear (tinnitus).
• low blood pressure.
• flushing.
• feeling sick (nausea).
• excessive sweating.
• muscle weakness.
• increased liver enzyme levels in blood.

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

• inflamed liver (hepatitis).

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es.

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

5. Storage of galantamine cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package and blister after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point.

Ask your pharmacist how to dispose of the packaging and any unused medication. 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 16 mg contains 16 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), red iron oxide (E172).

Appearance of the product and pack contents

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

Capsules are pale pink in color and contain two round, biconvex prolonged-release tablets.

The capsules are manufactured in a ‘prolonged-release’ form, which means they release the medication 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 medication is registered in EEA Member States with the following names:

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

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

Spain Galantamina cinfa 8mg, 16mg, 24mg prolonged-release hard capsules EFG

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

Date of last revision of this package leaflet:March 2021

Detailed and updated information on this medication 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 updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77289/P_77289.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77289/P_77289.html