Package Insert: Patient Information

galantamine cinfa 16 mg prolonged-release hard capsules EFG

Read this package insert carefully before starting to take the medicine.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this package insert, inform your doctor or pharmacist. See section 4.

Galantamine cinfa contains the active ingredient “galantamine”, an antidementia medication. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that alters brain function.

Alzheimer's disease causes an increase in memory loss, confusion, and changes in behavior, making it increasingly difficult to perform routine daily 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 thereby treats the signs of the disease.

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 a severe liver or kidney disease.

Warnings and precautions

Consult 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 (natural substances in the blood, such as potassium).
• 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 surgeryin 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 check your weight regularly while you are taking galantamine cinfa.

Children and adolescents

Galantamine cinfa is not recommended for children or adolescents.

Use of galantamine cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or are going to take 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 likely in people taking galantamine cinfa. These include:

• Paroxetine or fluoxetine (antidepressants),
• Quinidine (for irregular heartbeat),
• Ketoconazole (an antifungal),
• Erythromycin (an antibiotic),
• Ritonavir (for HIV virus)
• Nonsteroidal anti-inflammatory analgesics (such as ibuprofen), which may increase the risk of ulcers
• Medicines for certain heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you take medicines due to irregular heartbeat, your doctor may examine 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 mentioned medicines.

Galantamine cinfa may affect some anesthetics. If you are going to undergo a general anesthesia operation, 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 medicine, consult your doctor to advise you if you are pregnant, may be pregnant, or are planning to become pregnant.

Do not breastfeed while taking galantamine cinfa.

Driving and operating machines

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If you are taking galantamine tablets or oral solution and your doctor has told you that he will switch you to galantamine cinfa prolonged-release capsules, read carefully the instructions that appear in “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 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 to increase it. If you are unsure of 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 well for you and to discuss 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 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 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 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 with you the packaging with the remaining capsules. Signs of an overdose may include:

• intense nausea and vomiting
• muscle weakness, slow heart rate, seizures, and loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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, leave that dose and continue treatment as usual with the next scheduled dose.

Do not take a double dose to compensate for missed doses.

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

If you interrupt treatment with galantamine cinfa

Consult your doctor before interrupting treatment with galantamine cinfa. It is essential to continue taking this medication to treat your condition.

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

Like all medicines, it may cause side effects, although not everyone will experience them.

Be aware of severe side effects

Stop takinggalantamine cinfaand consult a doctor or go to the nearest emergency service immediatelyif you notice any of the following side 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 can spread throughout the body, sometimes with fever (acute generalized pustular psoriasis).
• Rash that can cause blisters, with spots that look like small targets.

These skin reactions are rare in people takinggalantamine cinfa(they can affect up to 1 in 1,000 people).

Heart problemsincluding changes in heart rhythm (such as slow heartbeat or extra beats) or palpitations (feeling a rapid or irregular heartbeat). Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG), and can be common in people takinggalantamine cinfa(they can affect up to 1 in 10 people).

Seizures. This is rare in people takinggalantamine cinfa(they can affect up to 1 in 100 people).

You should stop takinggalantamine cinfaand seek help immediatelyif you notice any of the side effects mentioned above.

Other side effects:

Frequent side effects(can 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 usually only last for a few days. If you experience these side effects, your doctor may recommend that you drink more liquids and may prescribe a medication to help you feel better.

Common side effects(can affect up to 1 in 10 people):

• Loss of appetite; weight loss.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Depression.
• Dizziness or fainting.
• Tremors or muscle spasms.
• Headache.
• Feeling very tired, weak, or generally unwell.
• Feeling very sleepy and having little energy.
• High blood pressure.
• Abdominal pain or discomfort.
• Diarhea.
• Indigestion.
• Falls.
• Wounds.

Rare side effects(can affect up to 1 in 100 people):

• Allergic reaction.
• Insufficient water in the body (dehydration).
• Itching or numbness of the skin.
• Change in sense of taste.
• Daytime drowsiness.
• Blurred vision.
• Tinnitus (ringing in the ears that does not go away).
• Low blood pressure.
• Flush.
• Feeling like vomiting (retching).
• Excessive sweating.
• Muscle weakness.
• Increased levels of liver enzymes in the blood.

Very rare side effects(can affect up to 1 in 1,000 people):

• Inflamed liver (hepatitis).

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.at the pharmacy.

Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of galantamine cinfa:

The active ingredient is galantamine.

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

The other components are:

Capule content

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capule coating

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

Product appearance and packaging content

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

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

The capsules are manufactured in the form of 'prolonged release', which means they release the medication more slowly.

The capsules are available in the following blister pack sizes:

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) – Spain

Responsible 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 registered in the Member States of the EEA with the following names:

GermanyMasparen 8mg, 16mg, 24mg prolonged-release hard capsules

NetherlandsMasparen Retard 1x daily 8mg, 16mg, 24mg

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

United KingdomConsion XL 8mg, 16mg, 24mg prolonged-release capsules

Last review date of this leaflet:March 2021

More detailed and updated information about this medicine 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 updated 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/77289/P_77289.html

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