GALANTAMINE NORMON 24 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information Leaflet

Galantamine Normon 24 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Galantamine Normon is an anti-dementia medicine used to treat the symptoms of mild to moderate dementia of the Alzheimer type, a disease in which the brain function is impaired.

The symptoms of Alzheimer's disease include memory loss, increased confusion, and changes in behavior. As a result, it becomes more and more difficult to perform daily routine activities.

It is thought that these symptoms are due to a lack of acetylcholine, a substance responsible for transmitting messages between brain cells. Galantamine increases the amount of acetylcholine in the brain, which may improve the symptoms of the disease.

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

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

Do not take Galantamine Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamine Normon.

Galantamine should be used in Alzheimer's disease and not in other forms of memory loss or confusion.

Medicines are not always suitable for everyone. Before starting treatment with galantamine, your doctor should know if you have or have had any of the following disorders:

• liver or kidney problems,
• a heart disorder (e.g. angina, heart attack, heart failure, slow or irregular pulse, prolonged QTc interval),
• an imbalance of electrolytes (e.g. high or low potassium levels in the blood),
• peptic ulcer (stomach),
• acute abdominal pain,
• a disorder of the nervous system (such as epilepsy or Parkinson's disease),
• a respiratory disease that interferes with breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia),
• if you have had recent surgery on the intestine or bladder,
• if you have difficulty urinating.

If you are going to have an operation with general anesthesia, inform your doctor that you are taking galantamine.

Your doctor will then decide whether treatment with galantamine is suitable for you and whether the dose needs to be changed.

Taking Galantamine Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Galantamine should not be taken 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 (for dry eyes or mouth) if taken by mouth.

Some medicines may alter the effects of galantamine or galantamine may reduce the effectiveness of other medicines when taken together, these include:

• paroxetine or fluoxetine (antidepressants),
• quinidine (for heart rhythm disorders),
• ketoconazole (antifungal),
• erythromycin (antibiotic),
• ritonavir (antiviral-protease inhibitor),
• medicines that affect the QTc interval.

Your doctor may prescribe a lower dose of Galantamine Normon if you are also taking any of the above medicines.

Some medicines may increase the number of side effects caused by galantamine, these include:

• non-steroidal anti-inflammatory painkillers (e.g. ibuprofen) that may increase the risk of ulcers,
• medicines for certain heart problems or high blood pressure (e.g. digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medicines for an irregular heartbeat, your doctor may consider it necessary to perform an electrocardiogram (ECG).

If you are going to have an operation with general anesthesia, inform your doctor that you are taking galantamine.

Consult your doctor or pharmacist if you have any doubts.

Taking Galantamine Normon with food and drinks

It is recommended to take galantamine with food.

During treatment with galantamine, you should drink enough liquids to stay hydrated (see section 3).

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 should not breastfeed while taking Galantamine Normon.

Driving and using machines

Galantamine may cause dizziness or drowsiness, especially at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machinery.

3. How to take Galantamine Normon

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, 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 Normon prolonged-release capsules, read the instructions at the end of this section carefully.

How to take your Galantamine Normon capsule

The Galantamine Normon capsules should be swallowed whole, DO NOT chew or crush. IF you have difficulty swallowing the capsules, you can empty them and swallow the contents whole- (DO NOTchew or crush the capsule contents).

Galantamine Normon should be taken in the morning, with water or other liquids, and preferably with food.

Galantamine Normon prolonged-release capsules are available in three strengths: 8 mg, 16 mg, and 24 mg.

Treatment with galantamine starts with a low dose. Your doctor may gradually increase the dose (strength) of galantamine you are taking until the most suitable dose for you is found.

1. Treatment starts with the 8 mg capsule once a day. After 4 weeks of treatment, the dose is increased.
2. You will then take the 16 mg capsule once a day. After another 4 weeks of treatment, your doctor may decide to increase the dose again.
3. You will then take the 24 mg capsule once a day.

Your doctor will explain which dose you should start with and when it should be increased. If your doctor thinks that the action of galantamine is too strong or too weak, tell your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medicine is working for you and to discuss with you how you feel. The doctor will also monitor your weight regularly during treatment with galantamine.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment starts with the 8 mg capsule once a day in the morning.
• If you have moderate liver or kidney disease, treatment starts with the 8 mg capsule every other day in the morning. After one week, start taking the 8 mg capsule once a day in the morning. Do not take more than 16 mg once a day.
• If you have severe liver or kidney disease, do not take galantamine.

Use in children and adolescents

Galantamine is not recommended for use in children and adolescents under 18 years of age.

If you take more Galantamine Normon 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 taken. Bring the package with the remaining capsules. The signs and symptoms of an overdose may include: severe nausea, vomiting, muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you forget to take Galantamine Normon

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

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

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

If you stop taking Galantamine Normon

Consult your doctor before stopping treatment with galantamine. It is important to continue taking this medicine to treat your disease.

How can I switch from galantamine tablets or oral solution to Galantamine Normon prolonged-release capsules?

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

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

DO NOT take more than one capsule a day. While taking Galantamine Normon capsules once a day, DO NOT take galantamine tablets or oral solution.

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

4. Possible side effects

Like all medicines, Galantamine Normon can cause side effects, although not everybody gets them. Some of these effects may be due to the disease itself.

Stop taking your medicine and consult your doctor immediately if youexperience:

• Heart problems including changes in heartbeat (slow or irregular).
• Palpitations (pounding heartbeat).
• Other disorders such as fainting.
• An allergic reaction. The signs can include rash, swallowing or breathing problems, or swelling of the lips, face, throat, or tongue.

Side effects include:

Very common: may affect more than 1 in 10 people

• Feeling sick with nausea and/or vomiting. If these undesirable effects occur, they are mainly experienced at the start of treatment or when the dose is increased. They usually disappear gradually as the body adapts to treatment and usually pass after a few days. If you experience these effects, your doctor may recommend drinking more liquids and if necessary, may prescribe a medicine to prevent nausea.

Common: may affect up to 1 in 10 people

• Weight loss.
• Lack of appetite.
• Decreased appetite.
• Slow heartbeat.
• Feeling weak.
• Dizziness.
• Tremors.
• Headache.
• Drowsiness.
• Unusual fatigue.
• Abdominal pain or discomfort.
• Diarrhea.
• Indigestion (with a feeling of acidity).
• Increased sweating.
• Muscle contractions.
• Falls.
• Increased blood pressure.
• Feeling weak.
• General feeling of being unwell.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Feeling sad (depression).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (the laboratory test result shows if your liver is working properly).
• Possible anomaly of the heartbeat.
• Disorder of the conduction mechanism of impulses in the heart.
• Feeling of abnormal heartbeats (palpitations).
• Numbness, tingling, or prickling sensation of the skin.
• Change in sense of taste.
• Excessive sleepiness.
• Blurred vision.
• Ringing or buzzing in the ears (tinnitus).
• Feeling of needing to vomit.
• Muscle weakness.
• Excessive loss of water in the body.
• Decreased blood pressure.
• Redness of the face.
• Allergic reaction.

Rare: may affect up to 1 in 1,000 people

• Liver inflammation (hepatitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Normon

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

No special storage conditions are required.

Do not use Galantamine Normon after the expiry date stated on the package after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicines to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of packages and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Galantamine Normon

The active substance is galantamine hydrobromide. Each prolonged-release capsule contains 24 mg of galantamine (as hydrobromide).

The other ingredients (excipients) of the tablets are: calcium hydrogen phosphate dihydrate, ethylcellulose, magnesium stearate, hypromellose, and triethyl citrate.

The other ingredients (excipients) of the capsules are: gelatin, titanium dioxide, yellow iron oxide, and red iron oxide.

Appearance of the product and pack contents

Galantamine Normon is presented in the form of hard capsules of caramel color containing three prolonged-release tablets, white and round.

Each package contains 28 prolonged-release hard capsules.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Galantamine Normon 8 mg prolonged-release hard capsules EFG.

Galantamine Normon 16 mg prolonged-release hard capsules EFG.

Galantamine Normon 4 mg/ml oral solution EFG.

Date of last revision of this leafletFebruary 2021

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