Leaflet: information for the user

Galantamine STADA 8 mg prolonged-release hard capsules EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Galantamine Stada

3. How to take Galantamine Stada

4. Possible side effects

5. Storage of Galantamine Stada

6. Contents of the pack and additional information

Galantamina Stada contains the active ingredient “galantamine”, an anti-dementia 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 loss of memory, confusion, and changes in behavior that make it increasingly difficult to perform normal daily activities. It is believed that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamina Stada increases the amount of acetylcholine in the brain and treats the signs of the disease.

The capsules are made in the form of “prolonged release”. This means that they release the medication gradually.

Do not take Galantamina Stada

• if you are allergic to galantamine or any of the other ingredients 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 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

Galantamina Stada may cause severe skin reactions, heart problems, and seizures. You must be aware of these severe side effects while taking Galantamina Stada. See section 4 “Be aware of severe side effects”.

Before taking Galantamina Stadayour doctor needs to know if you have or have had any of the following conditions:

• liver or kidney problems
• a heart condition (such as chest discomfort usually 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 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)
• problems with urination

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

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

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

Children and adolescents

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

Other medications and Galantamina Stada

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

Galantamina 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 increase the risk of side effects in people taking Galantamina Stada. These include:

• paroxetine or fluoxetine (antidepressants)
• quinidine (for irregular heartbeat)
• ketoconazole (an antifungal)
• erythromycin (an antibiotic)
• ritonavir (for HIV virus)
• 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 Stada if you are also taking any of these medications.

Galantamina Stada may affect some anesthetics. If you are undergoing a general anesthetic operation, inform your doctor, in advance, that you are taking Galantamina Stada.

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 Stada.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If you are taking Galantamina Stada tablets or oral solution and your doctor has told you that you will be switched to Galantamina Stada prolonged-release capsules, read carefully the instructions that appear in “Switching from galantamine tablets or oral solution to Galantamina Stada capsules” in this section.

How much to take

You will start treatment with Galantamina 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 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 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 with you how you are feeling.

If you have liver or kidney problems, your doctor may give you a reduced dose of Galantamina Stada or may decide that this medication is not suitable for you.

Switching from galantamine tablets or oral solution to Galantamina Stada capsules

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

DO NOT take more than one capsule a day. While taking Galantamina Stada once a day, DO NOT take galantamine tablets or oral solution.

How to take it

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

If you take more Galantamina Stada than you should

If you take too much Galantamina 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 packaging with the remaining capsules with you.

The signs of an overdose may include:

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

If you forget to take Galantamina Stada

If you forget to take a dose, completely skip that missed dose and take the next dose at the usual time.Do not take a double dose to make up for the missed doses.

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

If you interrupt treatment with Galantamina Stada

Consult your doctor before interrupting treatment with Galantamina Stada. 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 medicinecan cause side effects, although not everyone will experience them.

Be aware of severe side effects

Stop taking Galantamina Stadaand consult a doctor or go to the nearest emergency service immediatelyif you notice any of the following:

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 exanthematous pustulosis).
• Rash that can cause blisters, with spots that look like small targets.

These skin reactions are rare in people taking Galantamina Stada(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 may be seenas an abnormal tracing on an “electrocardiogram” (ECG), and maybe more common in people taking Galantamina Stada(they can affect up to 1 in 10 people).

Seizures (convulsions).They are relativelyuncommonin people taking Galantamina Stada(they can affect up to 1 in 100people).

You must stop taking Galantamina Stadaand seek help immediatelyif you notice any of the side effects mentionedabove.

Other side effects

Very common 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 medicine and generally only last for a few days. If you experience these side effects, your doctor may recommendyoutake more liquids and may prescribe a medicine to make you feel better.

Common side effects(can affect up to 1 in 10 people)

• Decreased appetite, weight loss
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Sensation of dizziness or fainting
• Trembling or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Sensation of excessive sleep and lack of energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarhea
• Indigestion
• Falls
• Wounds

Uncommon side effects(can affect up to 1 in 100 people)

• Allergic reaction
• Inadequate water in the body (dehydration)
• Prickling 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
• Rubor
• Sensation of needing to vomit (retching)
• Excessive sweating
• Weakness of muscles
• Increased level of liver enzymes in 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 or nurse, 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 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Galantamina Stada

The active principle is galantamine.

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

The other components are:

Content of the capsule:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule coating:

Gelatin, titanium dioxide (E171).

Appearance of Galantamina Stada and contents of the package

Galantamine prolonged-release hard capsules are available in three doses, each of which is recognized by its color:

8 mg: White capsules containing a rounded biconvex prolonged-release tablet.

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

The capsules are available in the following package sizes:

10, 28, 30, 56, 90, 100, 300 prolonged-release capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible 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 with the following names:

Germany: Galantamin STADA 8 mg Hartkapseln, retardiert

Denmark: Galantamin STADA 8 mg depotkapslar, hårde

Spain: Galantamina STADA 8 mg prolonged-release hard capsules EFG

Finland: Galantamin STADA 8 mg depotkapseli, kova

France: Galantamine EG 8 mg, gélule à liberation prolongée

Netherlands: Galantamine retard CF 8 mg, harde capsules met verlengde afgitte

Sweden: Galantamin STADA 8 mg depotkapslar, harda

Last review date of this leaflet:June 2021

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

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