Galantamine Stada 16 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Galantamine STADA 16 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further 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. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

What is in this leaflet

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

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

Galantamina Stada contains the active substance “galantamina”, an antidementia medicine. 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 memory loss, confusion, and changes in behaviour, making it increasingly difficult to carry out normal daily activities.

These effects are believed to be caused by a lack of “acetylcholine”, a substance responsible for transmitting signals between brain cells. Galantamina Stada increases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.

The capsules are formulated as “prolonged-release”. This means they release the medicine gradually.

2. What you need to know before taking Galantamina Stada

DO NOT take Galantamina Stada

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

Serious adverse reactions

Galantamina Stada may cause serious skin reactions, heart problems, and seizures (fits). You should be aware of these adverse reactions while taking Galantamina Stada. See section 4, “Be alert to serious adverse reactions”.

Before taking Galantamina Stada, your 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 pain 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 (stomach ulcer)
• obstruction in the stomach or intestines
• 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)
• problems with passing urine

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

Also tell your doctor if you have recently had surgery on your stomach, intestines, or bladder. Your doctor will decide whether Galantamina Stada is suitable for you.

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

Children and adolescents

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

Other medicines and Galantamina Stada

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

Galantamina Stada should not be used 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 likelihood of adverse effects in people taking Galantamina 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 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, beta-blockers, or calcium channel blockers). If you are taking medicines for an irregular heartbeat, your doctor may check your heart with an electrocardiogram (ECG)
• medicines that affect the QTc interval

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

Galantamina Stada may affect certain anaesthetics. If you are scheduled for surgery under general anaesthesia, inform your doctor well in advance that you are taking Galantamina 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking Galantamina Stada.

Driving and using machines

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

3. How to take Galantamina Stada

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

If you are currently taking Galantamina Stada tablets or oral solution and your doctor has informed you that you will be switched to Galantamina Stada prolonged-release capsules, read carefully the instructions under "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 starting dose is 8 mg taken once daily. Your doctor will gradually increase your dose every 4 weeks or more until reaching the most appropriate dose for you. The maximum dose is 24 mg taken once daily.

Your doctor will explain to you at which dose to start and when to increase it. If you are unsure 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 medicine is working and to discuss with you how you are feeling.

If you have liver or kidney problems, your doctor may prescribe you a reduced dose of Galantamina Stada or may decide that this medicine 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 your last dose of galantamine tablets or oral solution in the evening.
• The following morning, take your first dose of Galantamina prolonged-release capsules.

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

How to take it

Galantamina Stada capsules must be swallowed whole and must NOT be chewed or crushed. Take your dose of Galantamina Stada once daily in the morning, with water or other liquids. Try to take Galantamina Stada with food. Drink an adequate amount of fluids during treatment with Galantamina Stada to maintain hydration.

If you take more Galantamina Stada than you should

If you take too much Galantamina Stada, contact your doctor or go to the hospital immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Bring the container with any remaining capsules.

Signs of an overdose may include:

? severe nausea and vomiting
? muscle weakness, slow heartbeat, seizures (fits), and loss of consciousness.

If you forget to take Galantamina Stada

If you forget to take a dose, skip the missed dose completely and take the next dose at your usual time.

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

If you miss more than one dose, contact your doctor.

If you stop taking Galantamina Stada

Consult your doctor before stopping treatment with Galantamina Stada. 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 to serious adverse effects

Stop taking Galantamina Stada and consult a doctor or go immediately to the nearest emergency service if 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).
• Red rash covered with small pus-filled bumps that may spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling small targets.

These skin reactions are rare in people taking Galantamina Stada (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 be seen as an abnormal tracing on an "electrocardiogram" (ECG), and may be common in people taking Galantamina Stada (may affect up to 1 in 10 people).

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

You must stop taking Galantamina Stada and seek immediate help if you experience 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 gradually disappear as the body adapts to the medicine and generally last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help relieve nausea.

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 very sleepy and lacking energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

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

• Allergic reaction
• Lack of sufficient water in the body (dehydration)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Blurred vision
• Persistent ringing in the ears (tinnitus)
• Low blood pressure
• Flushing
• Feeling the need to vomit (nausea)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in the blood

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

• Inflamed liver (hepatitis)

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the 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 Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. Doing so will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamina Stada

The active substance is galantamine.

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

The other components are:

Capsule contents:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule shell:

Gelatin, Titanium dioxide (E171), Iron oxide red (E172).

Appearance of Galantamina Stada and contents of the pack

Galantamina Stada prolonged-release hard capsules are available in three strengths, each identified by its colour:

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

The capsules are "prolonged-release", meaning they release the medicine more slowly.

The capsules are available in the following pack sizes:

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

Only certain pack sizes may be commercially available.

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 authorised in the European Economic Area member states under the following names:

Germany: Galantamin STADA 16 mg Hartkapseln, retardiert

Denmark: Galantamin STADA 16 mg depotkapslar, 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 the most recent review of this leaflet: June 2021

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