Package Insert: Information for the User

Galantamine Combix 16 mg Extended-Release Hard Capsules EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Galantamina Combix 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 thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain and thereby treats the signs of the disease.

Do not take Galantamina Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamina 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

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

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

• 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 surgeryon the stomach, intestine, or bladder. Your doctor will decide if Galantamina Combix is suitable for you

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

Children and adolescents

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

Use of Galantamina Combix with other medications

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

Galantamina Combix should not be taken with medications that act similarly. 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 produce side effects with a higher probability in people taking Galantamina Combix. These include:

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

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

Galantamina Combix may affect some anesthetics. If you are undergoing general anesthesia, inform your doctor, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed while taking Galantamina Combix.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, 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 Galantamina Combix 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 Galantamina 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 which dose you should start with and when to increase it.

If you are unsure of what to do or find that the effect of Galantamina Combix is too strong or weak, inform your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medication is working and to discuss with you how you feel.

If you have liver or kidney problems,your doctor may give you a reduced dose of Galantamina Combix or may decide that 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 Galantamina Combix 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 Galantamina Combix prolonged-release capsules.

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

How to take it

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

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

If you take more Galantamina Combix than you should

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.

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

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

If you forget to take Galantamina Combix

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

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

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

If you interrupt treatment with Galantamina Combix

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Be aware of severe side effects.

Stop taking Galantamina Combix and 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 taking Galantamina Combix (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 may be common in people taking Galantamina Combix (they can affect up to 1 in 10 people).

Seizures. This is rare in people taking Galantamina Combix (they can affect up to 1 in 100 people).

You must stop taking Galantamina Combix and seek help immediatelyif you notice any of the mentioned side effects.

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 weeks of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the medication and usually only last 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
• Feeling dizzy or faint
• Trembling or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Feeling extremely sleepy and having little energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• 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 liver enzymes in the blood

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 or pharmacist, 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 on 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 after CAD. 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 through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Galantamina Combix

• The active principle is galantamine.

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

• The other components are:

Content of the capsule

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

Capsule

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

Appearance of the product and content of the package

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

8 mg: opaque white 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 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.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Combix Laboratories, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible 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 with the following names:

Germany: Girlamen 16 mg Hartkapseln, retardiert

France: Girlamen 16 mg gélule à libération prolongée

Spain: Galantamina Combix 16 mg prolonged-release hard capsules EFG

Last review date of this leaflet: March 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es