Package Insert: Information for the Patient

Galantamine Sandoz 8 mg Extended-Release Hard Capsules EFG

Galantamine Sandoz 16 mg Extended-Release Hard Capsules EFG

Galantamine Sandoz 24 mg Extended-Release Hard Capsules EFG

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Galantamina Sandoz contains the active ingredient galantamine. 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 that make it increasingly difficult to perform routine daily activities.

It is believed 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 thus treats the symptoms of the disease.

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

Do not take Galantamina Sandoz

• 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 Sandoz.

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

Galantamine may cause severe skin reactions, heart problems, and seizures. Be aware of these side effects while taking galantamine. See section 4 “Be aware of severe side effects”.

Before starting treatment with galantamineyour doctor must know if you have or have had in the past 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),
• electrolyte level changes (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 interferes with breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia),
• if you have difficulty urinating.

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

Also, inform your doctorif you have recentlyhad surgery in the stomach, intestine, or bladder. Your doctor will decide if galantamine is suitable for you.

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

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Other medications and Galantamina Sandoz

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

This medication should not be taken with medications that act in the same 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) if taken orally.

Some medications may cause side effects more likely in people taking galantamine. These include:

• medications that affect the QTc interval,
• paroxetine or fluoxetine (antidepressants),
• quinidine (for irregular heartbeat),
• ketoconazole (antifungal),
• erythromycin (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).
  

If you are taking any of these medications, your doctor may give you a lower dose of galantamine.

Galantamine may affect some anesthetics. If you are undergoing general anesthesia, inform your doctor, in advance, that you are taking galantamine.

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 galantamine.

Driving and operating machines

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

Galantamina Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 galantamine prolonged-release capsules, read carefully the instructions that appear in “Switching from galantamine tablets or oral solution to galantamine prolonged-release capsules”.

How much to take

You will start treatment with galantamine 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 galantamine is too strong or too 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 galantamine or 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 galantamine prolonged-release capsules. If this applies to you:

• Take the last dose of galantamine tablets or oral solution at night.
• The next morning, take your first dose of galantamine prolonged-release capsules.

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

How to take Galantamina Sandoz

Galantamine capsules should be swallowed whole and NOT chewed or crushed. Take your dose of galantamine once a day in the morning, with water or other liquids – DO NOT chew or crush the contents.

Galantamine prolonged-release capsules should be taken once a day, preferably in the morning, with water or other liquids. Try to take galantamine with food.

Drink plenty of liquid while taking galantamine to stay hydrated.

If you take more Galantamina Sandoz than you should

If you have taken more galantamine than you should, consult your doctor or go to the nearest 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. 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 Sandoz

If you forget to take a dose, leave that dose and continue treatment as usual with the next scheduled dose.

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

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

If you interrupt treatment with Galantamina Sandoz

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

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

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

Be aware of severe side effects

Stop taking your medicine and consult a doctor or go to the nearest emergency service immediately if 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 exanthematous pustulosis).

-Rash that can cause blisters, with spots that appear like small targets.

These skin reactions are rare in people taking galantamine (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 galantamine (they can affect up to 1 in 10 people).

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

You should stop taking galantamine and seek help immediatelyif you notice any of the mentioned side effects.

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 recommend drinking 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
• Dizziness or fainting
• Trembling or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Feeling extremely sleepy and having little energy
• Increased blood pressure
• Slow heart rate (bradycardia)
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Wounds

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

• Allergic reaction
• Insufficient water in the body (dehydration)
• Seeing, hearing, or feeling things that do not exist (visual and auditory hallucinations)
• 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)
• Heart rhythm disorder (first-degree atrioventricular block)
• Low blood pressure
• Rubor
• Sensation of nausea (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)
• Heart rhythm disorder (complete atrioventricular block)

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 national notification system: 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 blister pack and on the box after CAD/EXP.

The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Galantamina Sandoz

• The active ingredient is galantamine.

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

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

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

• The other components in the prolonged-release tablets are: sodium lauryl sulfate, copolymer of amine methacrylate (type B), hypromellose, carbomers, hydroxypropylcellulose, magnesium stearate, and talc.
• The other components in the 8 mg gelatin capsule are: gelatin, titanium dioxide (E 171), black printing ink (shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E 172), potassium hydroxide).
• The other components in the 16 mg and 24 mg gelatin capsules are: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), and black printing ink (shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E 172), potassium hydroxide).

Appearance of Galantamina Sandoz and packaging contents

Galantamina Sandoz 8 mg:White hard capsules with the inscription G8 on the capsule cap. The capsule contains a white and oval-shaped prolonged-release tablet. The length of the capsule is 17.6 - 18.4 mm.

Galantamina Sandoz 16 mg:Pink hard capsules with the inscription G16 on the capsule cap. The capsule contains two white and oval-shaped prolonged-release tablets. The length of the capsule is 19.0 - 19.8 mm.

Galantamina Sandoz 24 mg:Orange hard capsules with the inscription G24 on the capsule cap. The capsule contains three white and oval-shaped prolonged-release tablets. The length of the capsule is 23.8 - 24.6 mm.

The prolonged-release hard capsules are packaged in OPA/aluminum/PVC/aluminum blisters or PVC/PE/PVDC/aluminum blisters, inside a cardboard box.

Package sizes:

10, 14, 28, 30, 56, 60, 84, 90, and 100 prolonged-release hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

KRKA, d.d.

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last revision date of thisleaflet:May 2022

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/