Galantamine Sandoz 8 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Galantamine Sandoz 8 mg prolonged-release hard capsules EFG

Galantamine Sandoz 16 mg prolonged-release hard capsules EFG

Galantamine Sandoz 24 mg prolonged-release hard capsules EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Galantamine Sandoz is and what it is used for
2. What you need to know before taking Galantamine Sandoz
3. How to take Galantamine Sandoz
4. Possible side effects
5. How to store Galantamine Sandoz
6. Contents of the pack and other information

1. What Galantamina Sandoz is and what it is used for

Galantamina Sandoz contains the active substance galantamine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects brain function.

Alzheimer's disease causes increasing memory loss, confusion, and behavioral changes, making it progressively more difficult to carry out routine daily activities.

These effects are believed to be caused by a deficiency of "acetylcholine", a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain and thereby helps treat the symptoms of the disease.

The capsules are in "prolonged-release" form. This means they release the medicine gradually.

2. What you need to know before taking Galantamina Sandoz

Do not take Galantamina Sandoz

• if you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting Galantamina Sandoz.

This medicine should only be used for Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Serious adverse effects

Galantamine may cause severe skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking galantamine. See section 4, “Be alert to serious adverse effects”.

Before starting treatment with galantamine, your doctor should know if you have or have previously 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 chemicals in the blood, such as potassium),
• peptic ulcer (in the stomach),
• obstruction in the stomach or intestine,
• a nervous system disorder (such as epilepsy or Parkinson’s disease),
• a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia),
• difficulty passing urine.

Your doctor will decide whether galantamine is suitable for you or whether your dose needs to be adjusted.

Also tell your doctor if you have recently undergone surgery on the stomach, intestine, or bladder. Your doctor will decide whether galantamine is suitable for you.

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

Children and adolescents

Galantamine is not recommended for use in children or adolescents.

Other medicines and Galantamina Sandoz

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

This medicine should not be taken together with medicines that work in the same 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) if taken orally.

Some medicines may have a higher risk of adverse effects in people taking galantamine. These include:

• medicines that affect the QTc interval,
• paroxetine or fluoxetine (antidepressants),
• quinidine (for irregular heartbeat),
• ketoconazole (antifungal),
• erythromycin (antibiotic),
• ritonavir (for human immunodeficiency virus or “HIV”),
• non-steroidal anti-inflammatory analgesics (such as ibuprofen), which may increase the risk of ulcers,
• medicines for certain heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, β-blockers, or calcium channel blockers). If you are taking medicines for irregular heartbeat, your doctor may examine your heart with an “electrocardiogram” (ECG).

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

Galantamine may interact with certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking galantamine.

Driving and use of machines

Galantamine may cause dizziness or drowsiness, especially during the first weeks of treatment. If you are affected by galantamine, do not drive or operate tools or machinery.

Galantamina Sandoz contains sodium

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

3. How to take Galantamina Sandoz

Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

If you are currently taking galantamine tablets or oral solution and your doctor has informed you that you will be switched to prolonged-release galantamine capsules, please read carefully the instructions under "Switching from galantamine tablets or oral solution to prolonged-release galantamine capsules".

How much to take

You will start treatment with galantamine at a low dose. The usual starting dose is 8 mg taken once daily. Your doctor will gradually increase your dose every 4 weeks or longer until the most appropriate dose for you is reached. The maximum dose is 24 mg taken once daily.

Your doctor will advise you on which dose to start with and when to increase it.

If you are unsure 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 medicine is working and to discuss with you how you are feeling.

If you have liver or kidney problems, your doctor may prescribe a reduced dose of galantamine or may decide whether this medicine is suitable for you.

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

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

• Take your last dose of galantamine tablets or oral solution in the evening.
• The following morning, take your first dose of prolonged-release galantamine capsules.

DO NOT take more than one capsule per day. While taking a daily dose of galantamine capsules, DO NOT take galantamine tablets or oral solution.

How to take Galantamina Sandoz

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

Prolonged-release galantamine capsules should be taken once daily, preferably in the morning, with water or other liquids. Try to take galantamine with food.

Drink plenty of fluids 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. Telephone: 91 562 04 20, indicating the medicine and the amount ingested. Bring the container with any remaining capsules. Signs of overdose may include:

• severe nausea and vomiting,
• muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you forget to take Galantamina Sandoz

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

Do NOT take a double dose to make up for forgotten doses.

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

If you stop taking Galantamina Sandoz

Consult your doctor before stopping treatment with Galantamina Sandoz. It is important to continue taking this medicine to treat your condition.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Be alert for serious adverse effects

Stop taking your medicine and consult a doctor or go to the nearest emergency department immediately if you experience any of the following adverse effects:

Skin reactions, including:

• Severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled bumps that may spread over the body, sometimes accompanied by fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling small bullseyes.

These skin reactions are rare in people taking galantamine (they may affect up to 1 in 1,000 people).

Heart problems, including changes in heartbeat (such as slow heartbeat or extra beats) or palpitations (feeling a fast or irregular heartbeat). Heart problems may appear as an abnormal tracing on an "electrocardiogram" (ECG), and may be common in people taking galantamine (they may affect up to 1 in 10 people).

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

You must stop taking galantamine and seek immediate medical help if you notice any of the adverse effects listed above.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea and vomiting. These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased. They usually disappear gradually as the body adjusts to the medicine and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help prevent discomfort.

Common adverse effects (may affect up to 1 in 10 people)

• Decreased appetite, weight loss
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Feeling dizzy or faint
• Tremors or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Feeling excessively sleepy and lacking energy
• Increased blood pressure
• Slow heart rate (bradycardia)
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

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

• Allergic reaction
• Inadequate body water (dehydration)
• Seeing, hearing, or feeling things that are not real (visual and auditory hallucinations)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Blurred vision
• Persistent ringing in the ears (tinnitus)
• Heart rhythm disorder (first-degree atrioventricular block)
• Low blood pressure
• Flushing
• Feeling the need to vomit (nausea)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in blood

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

• Inflamed liver (hepatitis)
• Heart rhythm disorder (complete atrioventricular block)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton following CAD/EXP.

The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamina Sandoz

• The active substance 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, ammonium methacrylate copolymer (type B), hypromellose, carbomers, hydroxypropyl cellulose, 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, black iron oxide (E 172), potassium hydroxide).
• The other components in the 16 mg and 24 mg gelatin capsules are: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and black printing ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide).

Appearance of Galantamina Sandoz and contents of the pack

Galantamina Sandoz 8 mg: white hard capsules with the imprint "G8" on the capsule cap. The capsule contains one white, oval-shaped prolonged-release tablet. Capsule length is 17.6 - 18.4 mm.

Galantamina Sandoz 16 mg: pink hard capsules with the imprint "G16" on the capsule cap. The capsule contains two white, oval-shaped prolonged-release tablets. Capsule length is 19.0 - 19.8 mm.

Galantamina Sandoz 24 mg: orange hard capsules with the imprint "G24" on the capsule cap. The capsule contains three white, oval-shaped prolonged-release tablets. Capsule length is 23.8 - 24.6 mm.

The prolonged-release hard capsules are packed in OPA/aluminum/PVC/aluminum or PVC/PE/PVDC/aluminum blisters, contained within a cardboard carton.

Pack sizes:

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 European Economic Area member states under the following names:

Date of the most recent review of this summary: May 2022

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