Package Leaflet: Information for the User

Galantamine Normon 4 mg/ml Oral Solution EFG

galantamine

Read this package leaflet carefully before you start taking this medicine.

• Keep this package leaflet, as 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 even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Galantamina Normon is 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, 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. Galantamina Normon increases the amount of acetylcholine in the brain, which may improve the symptoms of the disease.

• Do not take Galantamina Normon

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

• Be careful with Galantamina Normon

Galantamina Normon 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 Galantamina Normon, your doctor must know if you suffer or have suffered from any of the following conditions:

• Liver or kidney problems.
• A heart condition (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 surgery with general anesthesia, inform your doctor that you are taking Galantamina Normon.

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

• Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription.

Galantamina Normon 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 orally.

Some medicines may alter the effects of Galantamina Normon or Galantamina Normon 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 of HIV).
• Medicines that affect the QTc interval.

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

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

• Nonsteroidal anti-inflammatory analgesics (for example, ibuprofen) that may increase the risk of ulcers.
• Medicines for certain heart problems or high blood pressure (for example, digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medicines for irregular heartbeat, your doctor may consider performing an electrocardiogram (ECG).

If you are to undergo surgery with general anesthesia, inform your doctor that you are taking Galantamina Normon.

• Taking Galantamina Normon with food and drinks

It is recommended to take Galantamina Normon with food.

During treatment with Galantamina Normon, you should take 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 Galantamina 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 Galantamina Normon.

• Driving and operating machines

Galantamina 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.

• Galantamina Normon contains parahydroxybenzoic acid methyl ester (E-218), parahydroxybenzoic acid propyl ester (E-216), benzyl alcohol, and sodium.

This medicine may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E-218) and propyl ester (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 may 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 may accumulate in your 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".

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

How to take Galantamina Normon oral solution

Galantamina Normon should be taken 2 times a day, in the morning and at night, with water or other liquids and preferably with food.

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

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

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

If you estimate that the action of Galantamina Normon is too strong or too 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. Your doctor will also regularly monitor your weight during treatment with Galantamina Normon.

Liver or kidney disease

• If you have mild liver disease or mild to moderate kidney disease, follow the previous dosing instructions.
• If you have moderate liver disease, treatment begins with 4 milligrams once a day in the morning. After a week of treatment, you start taking 4 milligrams 2 times a day for at least 4 weeks. Do not take more than 8 milligrams 2 times a day.
• If you have severe liver and/or kidney disease, do not take Galantamina Normon.

The solution comes with a syringe with which the exact amount needed can be extracted 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.

Extract the solution up 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 beverage 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 Galantamina Normon than you should

If you take too much Galantamina Normon, contact your doctor or go to the hospital. Bring the bottle with the solution that is left with you. The signs and symptoms of an overdose may include, among others: intense nausea, vomiting, muscle weakness, slow heart rate, seizures, and loss of consciousness.

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

• If you forget to take Galantamina Normon

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

Do not take a double dose to compensate for the missed doses.

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

• If you interrupt treatment with Galantamina Normon

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

• Children

Galantamina Normon is not recommended for children.

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

Like all medications, Galantamina Normon may have side effects, although not everyone will experience them. Some of these side effects may be due to the underlying disease itself.

Stop taking your medication and consult your doctor immediatelyif you experience heart problems, including changes in heart rhythm (slow or irregular), palpitations (heart pounding) or other alterations such as loss of consciousness.

Side effects include:

Very common:affect more than 1 in 10 patients

Unpleasant sensation 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 to help you feel better.

Common:affect between 1 and 10 in every 100 patients

Weight loss, loss of appetite, decreased appetite, slow heart rate, feeling weak, 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 sad (depression).

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

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 impulse conduction in the heart, feeling of abnormal heartbeats (palpitations), tingling, prickling, or numbness of the skin, change in sense of taste, excessive sleep, blurred vision, ringing or buzzing in the ears (tinnitus), feeling of needing to vomit, muscle weakness, excessive water loss from the body, decreased blood pressure, facial redness.

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

Liver inflammation (hepatitis).

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

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, report it to your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not freeze.

Galantamina Normon oral solution should not be used once 3 months have passed since the bottle was first opened.

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 thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Galantamina Normon:

The active ingredient is galantamine. Each ml of oral solution contains 4 mg of galantamine (hydrobromide).

The other components are: methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), strawberry essence (contains benzyl alcohol), sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging:

Galantamina Normon is presented as a transparent, colorless oral solution with a strawberry odor. Each package contains a 100 ml bottle and a dosing syringe.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: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/.