GALANTAMINE NORMON 4 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Galantamine Normon 4 mg/ml Oral Solution EFG

galantamine

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Galantamine Normon is and what it is 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 Galantamine Normon is and what it is 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 brain function is impaired.

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

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

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

• Do not take Galantamine Normon

• If you are allergic (hypersensitive) to galantamine or any of the other ingredients of Galantamine Normon.
• If you have severe liver or kidney disease.

• Take special care with Galantamine Normon

Galantamine Normon 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 Normon, your doctor should know if you have or have had any of the following conditions:

• Liver or kidney problems.
• A heart condition (such as angina, heart attack, heart failure, slow or irregular pulse, prolonged QTc interval)
• Electrolyte imbalance (such as 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 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 surgery with general anesthesia, inform your doctor that you are taking Galantamine Normon.

Your doctor will then decide if treatment with Galantamine Normon is suitable for you and if the dose needs to be changed.

• Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Galantamine Normon 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 orally.

Some medicines may alter the effects of Galantamine Normon or Galantamine Normon 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 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 above-mentioned medicines.

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

• Non-steroidal anti-inflammatory painkillers (such as ibuprofen) that may increase the risk of ulcers.
• Medicines for certain heart problems 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 consider it necessary to perform an electrocardiogram (ECG).

If you are going to have surgery with general anesthesia, inform your doctor that you are taking Galantamine Normon.

• Taking Galantamine Normon with food and drinks

It is recommended to take Galantamine Normon with food.

During treatment with Galantamine Normon, you should drink enough liquids to stay hydrated. See section 3 of this leaflet for more information on how to take this medicine.

• Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Before taking Galantamine Normon, consult your doctor to advise you if you are pregnant, may be pregnant, or are planning to become pregnant.

You should not breastfeed while taking Galantamine Normon.

• Driving and using machines

Galantamine Normon may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or operate tools or machines.

• Galantamine Normon contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), benzyl alcohol, and sodium.

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains 0.0008 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

This medicine contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

3. How to take Galantamine Normon

Follow the instructions for administration of Galantamine Normon exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

How to take Galantamine Normon oral solution

Galantamine Normon should be taken twice a day, in the morning and at night, with water or other liquids, and preferably with food.

Galantamine Normon is started with a low dose. Your doctor may gradually increase the dose (concentration) of Galantamine Normon you are taking, until the most suitable dose for you is found.

1. Treatment starts with 4 milligrams (1 milliliter of solution) twice a day. After 4 weeks of treatment, the dose is increased.
2. You will then take 8 milligrams (2 milliliters of solution) twice a day. After another 4 weeks of treatment, your doctor may decide to increase the dose again.
3. You will then take 12 milligrams (3 milliliters of solution) twice a day.

Your doctor will explain what dose you should start with and when and how you should increase it.

If you think the effect of Galantamine Normon 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 check your weight regularly during treatment with Galantamine Normon.

Liver or kidney disease

• If you have mild liver disease or mild to moderate kidney disease, follow the above dosing instructions.
• If you have moderate liver disease, treatment starts with 4 milligrams once a day in the morning. After one week of treatment, you start taking 4 milligrams twice a day for at least 4 weeks. Do not take more than 8 milligrams twice a day.
• If you have severe liver or kidney disease, do not take Galantamine Normon.

The solution comes with a syringe that can be used to extract the exact amount needed from the bottle.

Instructions for opening the bottle and using the syringe

Remove the cap and insert the syringe into the bottle through the stopper.

Draw up the solution to the mark corresponding to the number of milliliters you want to administer. Remove the syringe from the bottle.

Empty the syringe into any non-alcoholic drink by sliding the upper ring down and drinking it immediately.

Close the bottle. Rinse the syringe with water.

The dosing syringe has a maximum volume of 5 ml.

• If you take more Galantamine Normon than you should

If you take too much Galantamine Normon, contact your doctor or go to the hospital. Take the remaining solution package with you. The signs and symptoms of an overdose may include: severe nausea, vomiting, muscle weakness, slow heart rate, seizures, and loss of consciousness.

If you have taken more Galantamine Normon than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

• 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 dose.

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

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

• If you stop taking Galantamine Normon

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

• Children

Galantamine Normon is not recommended for use in children.

If you have any other questions about the use of this product, 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 immediatelyif you experience heart problems, including changes in heart rate (slow or irregular), palpitations (pounding heartbeat), or other disorders such as loss of consciousness.

Side effects include:

Very common:affect more than 1 in 10 patients

Feeling sick and/or vomiting. If these undesirable 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 treatment and generally 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:affect between 1 and 10 in 100 patients

Weight loss, loss of appetite, decreased appetite, slow heart rate, feeling of weakness, dizziness, tremors, headache, drowsiness, abnormal fatigue, abdominal pain or discomfort, diarrhea, bloating (with a feeling of acidity), increased sweating, muscle contractions, falls, increased blood pressure, general feeling of discomfort, seeing, feeling, or hearing things that are not real (hallucinations), feeling of sadness (depression).

Uncommon:affect between 1 and 10 in 1,000 patients

Increased liver enzymes in the blood (the laboratory test result shows if your liver is working properly), possible heart rhythm anomaly, alteration of the impulse conduction mechanism in the heart, feeling of abnormal heartbeats (palpitations), tingling, pinching, or numbness of the skin, change in taste, excessive sleepiness, blurred vision, ringing or buzzing in the ears (tinnitus), feeling of nausea, muscle weakness, excessive water loss in the body, decreased blood pressure, flushing of the face.

Rare:affect between 1 and 10 in 10,000 patients

Liver inflammation (hepatitis).

Consult your doctor or pharmacist if you are concerned or think that Galantamine Normon is causing you a problem.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Galantamine Normon

Keep out of the reach and sight of children.

Do not freeze.

The oral solution of Galantamine Normon should not be used after 3 months from the first opening of the bottle.

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

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Galantamine Normon:

The active substance is galantamine. Each milliliter of oral solution contains 4 milligrams of galantamine (hydrobromide).

The other ingredients are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), strawberry flavor (contains benzyl alcohol), sodium hydroxide, and purified water.

Appearance of the product and contents of the pack:

Galantamine Normon is presented as a clear, colorless oral solution with a strawberry flavor. Each pack contains a 100 ml bottle and a dosing syringe.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet:February 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/.