Galantamine CINFA 16 mg prolonged-release hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

galantamine cinfa 16 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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; do not pass it on to others, even if they have similar symptoms, as it may harm them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

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

galantamina cinfa contains the active substance "galantamine", an antidementia 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 increasing memory loss, confusion, and behavioral 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. galantamina cinfa increases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.

2. What you need to know before starting to take galantamina cinfa

Do not take galantamina cinfa

• If you are allergic to galantamine or to 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 galantamina cinfa. 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

Galantamina cinfa may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking galantamina cinfa. See section 4.

Before starting treatment with galantamina 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 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).
• A peptic ulcer (stomach ulcer).
• Blockage in the stomach or intestine.
• A nervous system disorder (such as epilepsy or Parkinson's disease).
• A respiratory disease or infection affecting breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia).
• Problems with urine outflow.

Also tell your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will decide whether galantamina cinfa is suitable for you.

Galantamina cinfa may cause weight loss. Your doctor will regularly monitor your weight while you are taking galantamina cinfa.

Children and adolescents

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

Taking galantamina cinfa with other medicines

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

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

Some medicines may be more likely to cause adverse effects in people taking galantamina 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 analgesics (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.

Your doctor may prescribe a lower dose of galantamina cinfa if you are also taking any of the medicines listed above.

Galantamina cinfa may affect certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well in advance that you are taking galantamina cinfa.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

Before taking this medicine, consult your doctor for advice if you are pregnant, think you may be pregnant, or are planning to become pregnant.

You must not breastfeed while taking galantamina cinfa.

Driving and using machines

Galantamina cinfa may make you feel dizzy or drowsy, especially during the first weeks of treatment. If galantamina cinfa affects you in this way, do not drive or operate tools or machinery.

3. How to take galantamine cinfa

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

How much to take

You will start treatment with galantamine cinfa 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 to start with and when to increase it. If you are unsure what to do, or if you 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 medicine is working well for you and to discuss how you are feeling.

If you have liver or kidney problems, your doctor may prescribe a reduced dose of galantamine cinfa 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 cinfa 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 cinfa prolonged-release capsules.

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

How to take it

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

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

If you take more galantamine cinfa than you should

If you take too much galantamine cinfa, contact your doctor or go to the hospital immediately. Bring the package 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take galantamine cinfa

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 miss 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 medicine to treat your condition.

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

4. Possible adverse effects

Like all medicines, this one may cause adverse effects, although not everyone experiences them.

Be alert for serious adverse effects

Stop taking galantamine cinfa and consult a doctor or go immediately to the nearest emergency service if you notice any of the following adverse effects.

Skin reactions, including:

• Severe rash with blisters and skin peeling, 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 accompanied by fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling small targets.

These skin reactions are rare in people taking galantamine cinfa (they 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 appear as an abnormal pattern 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 (they may affect up to 1 in 100 people).

You must stop taking galantamine cinfa and seek immediate medical help if you experience 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 medicine and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medication to help prevent nausea.

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

• Decreased appetite; weight loss.
• 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 malaise.
• Feeling very sleepy and having low energy.
• High 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.
• Blurred vision.
• Persistent ringing in the ears (tinnitus).
• Low blood pressure.
• Flushing.
• Feeling the need to vomit (nausea).
• Excessive sweating.
• Muscle weakness.
• Increased levels of liver enzymes in the blood.

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

• Inflamed liver (hepatitis).

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse 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 stated on the packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy.

Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of galantamina cinfa:

The active substance is galantamine.

• Each prolonged-release hard capsule containing galantamine 16 mg contains 16 mg of galantamine (as galantamine hydrobromide).

The other components are:

Capsule contents

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule coating

Gelatin, titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the pack

Prolonged-release hard capsules of galantamine are available in three strengths, each identifiable by its colour:

Pale pink capsules containing two round, biconvex prolonged-release tablets.

The capsules are formulated as 'prolonged-release', meaning they release the medicine more slowly.

The capsules are available in the following blister pack sizes:

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is registered in the EEA Member States under the following names:

Germany Masparen 8mg, 16mg, 24mg Hard capsules, prolonged-release

Netherlands Masparen Retard 1x daily 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 the most recent review of this leaflet: March 2021

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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77289/P_77289.html

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