Patient Information Leaflet

GalantamineNormon24 mg prolonged-release hard capsules EFG

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have similar symptoms to 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 leaflet. See section 4.

GalantaminaNormonis an antidementia medication used to treat the symptoms of mild to moderate Alzheimer's disease, a condition in which brain function is altered.

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

It is believed that these symptoms are due to a lack of acetylcholine, a substance responsible for transmitting messages between brain cells. Galantamina 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 medication gradually.

Do not take Galantamine Normon

• if you are allergic to galantamine or any of the other components of this medication (listed in section 6).
• if you have a severe liver and/or kidney disease.

Warnings and Precautions

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

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

Medicines are not always suitable for everyone. Before starting treatment with galantamine, your doctor must know if you suffer or have suffered from any of the following conditions:

• liver or kidney problems,
• a heart disorder (for example, angina, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval),
• electrolyte imbalance (for example, high or low potassium levels in the blood),
• peptic ulcer (stomach),
• acute abdominal pain,
• 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 had recent surgery in the intestine or bladder,
• if you have difficulty urinating.

If you are to undergo a general anaesthetic operation, inform your doctor that you are taking galantamine.

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

Taking Galantamine Normon with other medicines

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

Galantamine should not be taken with medicines that act in the same way, including:

• 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, including:

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

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

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

• non-steroidal anti-inflammatory analgesics (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 take medicines due to irregular heartbeat, your doctor may consider performing an electrocardiogram (ECG).

If you are to undergo a general anaesthetic operation, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You should not breastfeed while taking Galantamine Normon.

Driving and operating machinery

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

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 Galantamina Normon prolonged-release capsules, read the instructions carefully that appear at the end of this section.

How to take your Galantamina Normon capsules

Galantamina 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 NOT chew or crush the contents of the capsules).

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

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

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

1. Treatment begins 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 with which dose you should start and when to increase it. If you estimate that the action of galantamine is too strong or weak, inform your doctor or pharmacist.

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

Liver or kidney disease

• If you have mild liver or kidney disease, treatment begins with the 8 mg capsule once a day in the morning.
• If you have moderate liver or kidney disease, treatment begins with the 8 mg capsule every other day in the morning. After a 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 children and adolescents under 18 years old.

If you take more Galantamina 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Bring the packaging with the remaining capsules. The signs and symptoms of an overdose may include: intense nausea, vomiting, muscle weakness, slow heart rate, convulsions, and loss of consciousness.

If you forgot to take Galantamina

If you forgot to take a dose, leave 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 compensate for the missed doses.

If you interrupt treatment with Galantamina Normon

Consult your doctor before interrupting treatment with galantamine. It is essential to continue taking this medication to treat your disease.

How to change from galantamine tablets or oral solution to Galantamina Normon prolonged-release capsules

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

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

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines,GalantaminaNormoncan cause side effects, although not everyone will experience them. Some of these side effects may be due to the underlying disease.

Stop taking your medicine and consult your doctor immediately ifyou experience:

• Heart problems, including changes in heart rhythm (slow or irregular).
• Palpitations (heart pounding).
• Other alterations such as fainting.
• An allergic reaction. Thesignsmay includeskin rash, swallowingorbreathingproblems,orswelling of the lips,face,throat ortongue.

The side effects include:

Very common: may affectmore than 1 in 10 people

• Feeling unwell with nausea and/or vomiting. If these unwanted effects occur, they are mainly experienced at the beginning of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the treatment and usually pass within a few days. If you experience these effects, your doctor may recommend that you drink more liquids and, if necessary, prescribe a medication so that you do not feel bad.

Common: may affect up to1 in 10 people

• Weight loss.
• Loss of appetite.
• Decreased appetite.
• Slow heart rate.
• Feeling weak.
• Dizziness.
• Tremors.
• Headache.
• Drowsiness.
• Abnormal fatigue.
• Abdominal pain or discomfort.
• Diarrhea.
• Constipation (with a feeling of acidity).
• Increased sweating.
• Muscle contractions.
• Falls.
• Increased blood pressure.
• Feeling weak.
• General feeling of discomfort.
• To see, feel or hear things that are not real (hallucinations).
• Feeling of sadness (depression).

Uncommon: may affect up to1 in 100 people

• Increased liver enzymes in the blood (the laboratory test result shows if your liver is working correctly).
• Possible abnormal heart rhythm.
• Alteration of the mechanism of conduction of impulses in the heart.
• Feeling of abnormal heartbeats (palpitations).
• Prickling, pins and needles or numbness of the skin.
• Change in sense of taste.
• Excessive sleep.
• Blurred vision.
• Ringing or buzzing in the ears (tinnitus).
• Feeling of need to vomit.
• Muscle weakness.
• Excessive loss of water in the body.
• Decreased blood pressure.
• Face redness.
• Allergic reaction

Rare: may affect up to1 in 1,000 people

• Inflammation of the liver (hepatitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also communicate them directly through the Spanish System of Pharmacovigilance of Medicines for human use: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.

No special storage conditions are required.

Do not use Galantamina Normon after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Galantamine Norman

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

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

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

Appearance of the product and content of the packaging

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

Each package contains 28 hard prolonged-release capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Galantamine Norman 8 mg hard prolonged-release capsules EFG.

Galantamine Norman 16 mg hard prolonged-release capsules EFG.

Galantamine Norman 4 mg/ml oral solution EFG.

Date of the last review of this prospectus February 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/