GALANTAMINE STADA 16 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Galantamine Stada

Do not take Galantamine Stada

• if you are allergic to galantamine or any of the other ingredients of this medicine (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 medicine is only used in 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 Stadayour 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 pain 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 (peptic ulcer)
• obstruction in the stomach or intestines
• 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

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 your 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 medicines and Galantamine Stada

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

Galantamine Stada should not be taken with other 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 increase the risk of side effects when taken with 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
• 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 check your heart using an electrocardiogram (ECG).
• medicines that affect the QTc interval

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

Galantamine Stada may affect some anaesthetics. If you are going to have an operation under general anaesthetic, inform your doctor in advance that you are taking Galantamine Stada.

Consult your doctor or pharmacist if you have any questions.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not breast-feed 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 use machines.

3. How to take Galantamine Stada

Follow exactly the instructions given to you 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 carefully the instructions in “Switching from galantamine tablets or oral solution to Galantamine Stada prolonged-release capsules” in this section.

How much to take

You will start treatment with Galantamine Stada at a low dose. The usual starting dose is 8 mg, taken once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the dose that is best for you. The maximum dose is 24 mg, taken once a day.

Your doctor will tell you which dose to start with and when to increase it. If you are unsure what to do or find that the effect of Galantamine Stada is too strong or too weak, consult your doctor or pharmacist.

Your doctor will need 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 give you a lower dose of Galantamine Stada or may decide that this medicine 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 your last dose of galantamine tablets or oral solution in the evening.
• The next morning, take your first dose of Galantamine Stada prolonged-release capsules.

Do not take more than one capsule a 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 plenty of liquids during treatment with Galantamine Stada to keep yourself hydrated.

If you take more Galantamine Stada than you should

If you take too much Galantamine Stada, contact your doctor or go to the hospital immediately, or call the Poison Information Service on 91 562 04 20, quoting the name of the medicine and the amount taken. Take the pack with the remaining capsules with you.

Signs of 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 that dose completely and take the next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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 medicine to treat your condition.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Be aware of severe side effects

Stop taking Galantamine Stada and contact a doctor or go to the casualty department immediatelyif you notice any of the following:

Severe 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 Stada (they may affect up to 1 in 1,000 people).

Heart problems, including changes in heartbeat (such as slow or extra beats) or palpitations (feeling your heartbeat is 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 (they may affect up to 1 in 10 people).

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

You must stop taking Galantamine Stada 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 your body adapts to the medicine and usually only last a few days. If you experience these effects, your doctor may recommend that you drink more liquids and may prescribe a medicine to stop you feeling sick.

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
• high blood pressure
• abdominal pain or discomfort
• diarrhoea
• indigestion
• falls
• injuries

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

• allergic reaction
• lack of 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 stop (tinnitus)
• low blood pressure
• flushing
• feeling sick (nausea)
• excessive sweating
• muscle weakness
• increase in liver enzyme levels in the blood

Rare side effects(may affect up to 1 in 1,000 people)

• inflammation of the liver (hepatitis)

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Stada

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Galantamine Stada contains

The active substance is galantamine.

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

The other ingredients are:

Contents of the capsule:

microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule shell:

gelatin, titanium dioxide (E171), red iron oxide (E172).

Appearance of Galantamine Stada and contents of the pack

Galantamine Stada prolonged-release hard capsules are available in three strengths, each of which can be recognized by its colour:

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

The capsules are “prolonged-release”. This means that they release the medicine more slowly.

The capsules are available in the following packs:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Galantamin STADA 16 mg Hartkapseln, retardiert

Denmark: Galantamin STADA 16 mg depotkapsler, hårde

Spain: Galantamina STADA 16 mg cápsulas duras de liberación prolongada EFG

Finland: Galantamin STADA 16 mg depotkapseli, kova

France: Galantamine EG 16 mg, gélule à liberation prolongée

Netherlands: Galantamine retard CF 16 mg, harde capsules met verlengde afgifte

Sweden: Galantamin STADA 16 mg depotkapslar, harda

Date of last revision of this leaflet:June 2021

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