GALANTAMINE COMBIX 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Galantamine Combix 16 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 Combix and what is it used for
2. What you need to know before you take Galantamine Combix
3. How to take Galantamine Combix
4. Possible side effects
5. Storing Galantamine Combix
6. Contents of the pack and other information

1. What is Galantamine Combix and what is it used for

Galantamine Combix 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 increasing memory loss, confusion, and changes in behaviour, making it difficult to perform daily activities.

These effects are thought to be caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain, treating the signs of the disease.

2. What you need to know before you take Galantamine Combix

Do not take Galantamine Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamine Combix. This medicine should only be used in Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Severe side effects

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

Before starting treatment with Galantamine Combix,your doctor should know if you have or have had any of the following:

• liver or kidney problems
• a heart disorder (such as chest pain 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
• 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.

Also, tell your doctor if you have had a recent operationon your stomach, intestine, or bladder. Your doctor will decide if Galantamine Combix is suitable for you.

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

Children and adolescents

Galantamine Combix is not recommended for use in children and adolescents.

Using Galantamine Combix with other medicines

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

Galantamine Combix should not be taken with medicines that work in a similar 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 Combix. 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 Combix if you are taking any of the above medicines.

Galantamine Combix may affect some anaesthetics. If you are going to have an operation under general anaesthetic, tell your doctor that you are taking Galantamine Combix well in advance.

Consult your doctor or pharmacist if you have any questions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Do not breastfeed while taking Galantamine Combix.

Driving and using machines

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

3. How to take Galantamine Combix

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

If you are taking galantamine tablets or oral solution and your doctor has told you to switch to Galantamine Combix 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 Combix 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 Combix 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 Combix or may 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 Combix 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 Combix prolonged-release capsules.

DO NOT take more than one capsule in a day. While taking one Galantamine Combix capsule daily, DO NOT take galantamine tablets or oral solution.

How to take it

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

Drink plenty of liquid while taking Galantamine Combix to stay hydrated.

If you take more Galantamine Combix than you should

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

Bring the package and any remaining capsules with you. Signs of an overdose may include:

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

If you forget to take Galantamine Combix

If you forget to take a dose, skip the missed dose and take the next dose at the usual time.

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 Combix

Consult your doctor before stopping treatment with Galantamine Combix. It is important to continue taking this medicine to treat your condition.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Be aware of serious side effects.

Stop taking Galantamine Combix and consult a doctor or go to the nearest emergency 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 filled with pus 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 Combix (may affect up to 1 in 1,000 people).

Heart problemsincluding 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 Combix (may affect up to 1 in 10 people).

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

You must stop taking Galantamine Combix and seek immediate helpif you notice any of the side effects mentioned.

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 drinking more liquids and may prescribe a medicine to prevent you from feeling sick.

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
• increased 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 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)

• inflammation of the liver (hepatitis).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Galantamine Combix

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 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 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

Composition of Galantamine Combix

• The active substance is galantamine.

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

• The other ingredients are:

Contents of the capsule

Microcrystalline cellulose (E461i), hypromellose (E464), ethylcellulose (E462), and magnesium stearate (E470b).

Capsule

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

Appearance and packaging of the product

Galantamine Combix prolonged-release hard capsules are available in 3 strengths, each of which can be recognized by its color:

8 mg: white opaque capsules containing 1 round, biconvex prolonged-release tablet.

16 mg: pale pink capsules containing 2 round, biconvex prolonged-release tablets.

24 mg: orange capsules containing 3 round, biconvex prolonged-release tablets.

The capsules are “prolonged-release”. This means that they release the medicine more slowly.

The capsules are available in the following pack sizes:

8 mg: 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 119, 120, 300 prolonged-release hard capsules.

16 mg: 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 119, 120, 300 prolonged-release hard capsules.

24 mg: 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 119, 120, 300 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmathen International S.A.

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

or

Pharmathen S.A.

6, Dervenakion str., Pallini Attiki (Greece)

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

Germany: Girlamen 16 mg Hartkapseln, retardiert

France: Girlamen 16 mg gélule à libération prolongée

Spain: Galantamina Combix 16 mg cápsulas duras de liberación prolongada EFG

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