Galantamine Combix 16 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Galantamine Combix 16 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Galantamina Combix 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 impairs 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 thought to be caused by a deficiency of "acetylcholine", a substance responsible for transmitting signals between brain cells. Galantamine increases the amount of acetylcholine in the brain and thereby helps to treat the symptoms of the disease.

2. What you need to know before starting to take Galantamina Combix

Do not take Galantamina Combix

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Galantamina Combix. 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 Combix may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking Galantamina Combix. See section 4.

Before starting treatment with Galantamina 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 usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in levels of "electrolytes" (natural 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 affecting breathing (such as asthma, obstructive lung 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 Combix is suitable for you.

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

Children and adolescents

The use of Galantamina Combix is not recommended in children and adolescents.

Taking Galantamina Combix with other medicines

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

Galantamina Combix must not be taken together 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 have an increased risk of adverse effects in people taking Galantamina 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 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 Combix if you are taking any of the medicines listed above.

Galantamina Combix may affect certain anaesthetics. If you are scheduled for surgery under general anaesthesia, inform your doctor well in advance that you are taking Galantamina Combix.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

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

You must not breastfeed while taking Galantamina Combix.

Driving and using machines

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

3. How to take Galantamina Combix

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

If you are currently taking galantamine tablets or oral solution and your doctor has told you that you will be switching to Galantamina Combix 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 Galantamina Combix 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 dose most suitable 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 find that the effect of Galantamina Combix 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 and to discuss with you how you are feeling.

If you have liver or kidney problems, your doctor may prescribe a reduced dose of Galantamina Combix or may decide whether this medicine is 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 Galantamina Combix 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 Galantamina Combix prolonged-release capsules.

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

How to take it

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

Drink plenty of fluids while taking Galantamina Combix to stay hydrated.

If you take more Galantamina Combix than you should

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

Take the packaging and any remaining capsules with you. Signs of overdose may include:

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

If you forget to take Galantamina Combix

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

Do NOT take a double dose to make up for forgotten doses.

If you miss more than one dose, consult your doctor.

If you stop taking Galantamina Combix

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Be alert for serious adverse effects.

Stop taking Galantamina Combix 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 peeling skin, 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 with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling small targets.

These skin reactions are rare in people taking Galantamina Combix (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 be seen as an abnormal tracing on an "electrocardiogram" (ECG), and may be common in people taking Galantamina Combix (may affect up to 1 in 10 people).

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

You must stop taking Galantamina Combix and seek immediate medical help if you experience any of the adverse effects mentioned 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 medicine to help prevent discomfort.

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 generally unwell
• Feeling very sleepy and having low energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

Uncommon adverse effects (may affect up to 1 in 100 people)

• Allergic reaction
• Insufficient body water (dehydration)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Blurred vision
• Ringing in the ears that does not go away (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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Combix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamina Combix

• The active substance is galantamine.

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

• The other components are:

Capsule contents

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

Capsule shell

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

Description of the product and contents of the pack

Galantamina Combix prolonged-release hard capsules are available in 3 strengths, each identifiable by its colour:

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

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

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

The capsules are "prolonged-release", meaning 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.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es