GALANTAMINE STADA 24 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Galantamine Stada

Do not take Galantamine Stada

• 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 Stada. This medication is only used for Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Severe side effects

Galantamine Stada may cause severe skin reactions, heart problems, and seizures (convulsions). You should be aware of these side effects while taking Galantamine Stada. See section 4 "Be aware of severe side effects".

Before taking Galantamine Stada, your doctor needs to know if you have or have had any of the following disorders:

• 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 peptic ulcer (stomach)
• obstruction in the stomach or intestines
• 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)
• urination problems

Your doctor will decide if Galantamine Stada is suitable for you or if the dose needs to be changed.

Also, inform your doctor if you have recently had an operationon the stomach, intestines, or bladder. Your doctor will decide if Galantamine Stada is suitable for you.

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

Children and adolescents

Galantamine Stada is not recommended for use in children or adolescents.

Other medications and Galantamine Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Galantamine Stada should not be used with other 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 cause side effects more frequently in people taking Galantamine Stada. 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 examine your heart using an electrocardiogram (ECG).
• medications that affect the QTc interval

Your doctor may give you a lower dose of Galantamine Stada if you are also taking any of these medications.

Galantamine Stada 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 Stada.

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 Stada.

Driving and using machines

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

3. How to take Galantamine Stada

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 Stada tablets or oral solution and your doctor has told you that you will be switched to Galantamine Stada prolonged-release capsules, read the instructions in "Switching from galantamine tablets or oral solution to Galantamine Stada prolonged-release capsules" in this section carefully.

How much to take

You will start treatment with Galantamine Stada 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 Stada is too strong or too weak, inform your doctor or pharmacist.

Your doctor will need 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 Stada or may decide that this medication is not suitable for you.

Switching from galantamine tablets or oral solution to Galantamine Stada prolonged-release capsules

If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Galantamine Stada 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 Stada prolonged-release capsules.

Do not take more than one capsule per day.While taking Galantamine Stada once a day, do not take galantamine tablets or oral solution.

How to take it

Galantamine Stada capsules should be swallowed whole and not chewed or crushed.Take your dose of Galantamine Stada once a day in the morning, with water or other liquids. Try to take Galantamine Stada with food. Drink enough liquids during treatment with Galantamine Stada to stay hydrated.

If you take more Galantamine Stada than you should

If you take too much Galantamine Stada, consult your doctor or go to the hospital immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the package with the remaining capsules.

The signs of an overdose may include:

? severe nausea and vomiting

? muscle weakness, slow heartbeat, seizures (convulsions), and loss of consciousness.

If you forget to take Galantamine Stada

If you forget to take a dose, skip the missed dose completely 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, contact your doctor.

If you stop taking Galantamine Stada

Consult your doctor before stopping treatment with Galantamine Stada. It is important to continue taking this medication to treat your disease.

If you have any other 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 Stada and consult a doctor or go to the nearest emergency room immediatelyif you notice any of the following:

Skin reactions,including:

• severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• rash with small pus-filled bumps 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 Stada (may affect up to 1 in 1,000 people).

Heart problemsincluding changes in heartbeat (such as slow or irregular heartbeat) or palpitations (feeling the heartbeat fast or irregular). Heart problems may be seen as an abnormal tracing on an "electrocardiogram" (ECG) and may be common in people taking Galantamine Stada (may affect up to 1 in 10 people).

Seizures (convulsions). These are uncommon in people taking Galantamine Stada (may affect up to 1 in 100 people).

You must stop taking Galantamine Stada and seek help immediatelyif 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 side effects, your doctor may recommend drinking more liquids and may prescribe a medication to help you feel better.

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 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Galantamine Stada

Keep this medication out of the 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 through wastewater or household waste. Dispose of the packaging and any unused medication at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Galantamine STADA

The active substance is galantamine.

?Each 24 mg prolonged-release hard capsule contains 24 mg of galantamine (as hydrobromide).

The other ingredients are:

Capsule content:

microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule shell:

gelatin, titanium dioxide (E171), carmine indigo (132), erythrosine (E127), red iron oxide (E172), yellow iron oxide (E172).

Appearance of Galantamine Stada and package contents

Galantamine Stada prolonged-release hard capsules are available in three doses, each recognizable by its color:

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

The capsules are "prolonged-release". This means that they release the medication more slowly.

The capsules are available in the following packages:

10, 28, 30, 84, 90, 100, 300 prolonged-release capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

Pharmathen S.A.

6, Dervenakion str., Athens

Greece

or

Pharmathen International S.A.

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

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Galantamin STADA 24 mg Hartkapseln, retardiert

Denmark: Galantamin STADA 24 mg depotkapsler, hårde

Spain: Galantamina STADA 24 mg cápsulas duras de liberación prolongada EFG

Finland: Galantamin STADA 24 mg depotkapseli, kova

France: Galantamine EG 24 mg, gélule à liberation prolongée

Netherlands: Galantamine retard CF 24 mg, harde capsules met verlengde afgifte

Sweden: Galantamin STADA 24 mg depotkapslar, harda

Date of the last revision of this package leaflet:June 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/

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