GALANTAMINE COMBIX 8 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Galantamine Combix

Do not take Galantamine Combix

• If you are allergic to galantamine or any of the other components of this medication (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 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 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 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
• obstruction 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, inform your doctor if you have recently had an operationon the 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 medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

Some medications may increase the risk of side effects 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
• 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 check your heart using an electrocardiogram (ECG)
• medications that affect the QTc interval.

Your doctor may give you a lower dose of Galantamine Combix if you are taking any of the above medications.

Galantamine Combix 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 Combix.

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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed while taking Galantamine Combix.

Driving and using machines

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

3. How to take Galantamine Combix

Follow the instructions for taking this medication exactly as indicated 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 that you will be switched to Galantamine Combix prolonged-release capsules, read the instructions carefully in "Switching from galantamine tablets or oral solution to galantamine capsules" in this section.

How much to take

You will start treatment with Galantamine Combix 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 Combix 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 and to discuss how you are feeling.

If you have liver or kidney problems,your doctor may give you a lower dose of Galantamine Combix or decide if 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 Combix prolonged-release capsules. If this applies to you:

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

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

How to take it

The 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 missed 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 medication to treat your disease.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Be aware of severe side effects.

Stop taking Galantamine Combix and 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 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 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 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 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
• increased 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 liver enzyme levels in the 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 or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Galantamine Combix

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package 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. Return the package and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Package contents and further information

Composition of Galantamine Combix

• The active substance is galantamine.

Each 8 mg prolonged-release capsule contains 8 mg of galantamine (as hydrobromide).

• The other ingredients are:

Capsule contents

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

Capsule

Gelatin and titanium dioxide (E171).

Appearance of the product and package contents

Galantamine Combix prolonged-release hard capsules are available in 3 doses, 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 they release the medication more slowly.

The capsules are available in the following package 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 package 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 medication is authorized in the Member States of the European Union under the following names:

Germany: Girlamen 8 mg Hartkapseln, retardiert

France: Girlamen 8 mg gélule à libération prolongée

Spain: Galantamina Combix 8 mg cápsulas duras de liberación prolongada EFG

Date of last revision of this package leaflet: March 2021

Detailed and up-to-date information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es