Galantamine Normon 4 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Galantamina Normon 4 mg/ml oral solution EFG

galantamine

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Leaflet contents:

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

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

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

Symptoms of Alzheimer's disease include memory loss, confusion, and behavioral changes. As a result, it becomes increasingly difficult to carry out routine daily activities.

These symptoms are believed to be 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, thereby potentially improving the symptoms of the disease.

2. What you need to know before taking Galantamina Normon

• Do not take Galantamina Normon

• If you are allergic (hypersensitive) to galantamine or to any of the other ingredients of Galantamina Normon.

• If you have severe liver or kidney disease.

• Take special care 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 should know if you have or have had any of the following conditions:

• Liver or kidney problems.
• A heart disorder (e.g., angina, heart attack, heart failure, slow or irregular pulse, prolonged QTc interval).
• Electrolyte imbalance (e.g., 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 illness or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia).
• Recent surgery on the intestine or bladder.
• Difficulty passing urine.

If you are due to undergo surgery under general anaesthesia, inform your doctor that you are taking Galantamina Normon.

Your doctor will then decide whether treatment with Galantamina Normon is suitable for you and whether your dose needs to be adjusted.

• Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Galantamina Normon should not be taken together 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) when taken by mouth.

Some medicines may alter the effects of Galantamina Normon, or Galantamina 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 (HIV protease inhibitor antiviral).
• Medicines that affect the QTc interval.

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

Some medicines may increase the number of side effects caused by Galantamina Normon. These include:

• Non-steroidal anti-inflammatory painkillers (e.g., ibuprofen), which 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 performing an electrocardiogram (ECG).

If you are due to undergo surgery under general anaesthesia, 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 drink enough fluids to stay hydrated. See section 3 of this leaflet for further information on how to take this medicine.

• Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Before taking Galantamina Normon, consult your doctor for advice if you are pregnant, may be pregnant, or are planning to become pregnant.

You must not breastfeed while taking Galantamina Normon.

• Driving and using machines

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

• Galantamina 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 parahydroxybenzoates (E-218) and propyl parahydroxybenzoates (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; therefore, it is essentially “sodium-free”.

3. How to take Galantamina Normon

Follow exactly the administration instructions for Galantamina Normon provided 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 twice daily, in the morning and at night, with water or other liquids, preferably with food.

Treatment with Galantamina Normon starts with a low dose. Your doctor may gradually increase the dose (concentration) of Galantamina Normon you are taking until the most appropriate dose for you is found.

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

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

If you feel that the effect 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 medicine is suitable for you and to discuss with you how you are feeling. Your doctor will also monitor your weight regularly during treatment with Galantamina Normon.

Liver or kidney disease

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

The solution comes with a syringe that allows you to withdraw 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.

Withdraw the solution up to the mark corresponding to the number of millilitres to be administered. Remove the syringe from the bottle.

Empty the syringe into any non-alcoholic drink by sliding the upper ring down and drink 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 container with any remaining solution with you. Signs and symptoms of overdose may include, among others: severe nausea, vomiting, muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you have taken more Galantamina Normon than prescribed, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 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, skip that dose and continue your treatment as usual with the next dose.

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

If you miss more than one dose, you should consult your doctor.

• If you stop taking Galantamina Normon

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

• Children

Galantamina Normon is not recommended for use in children.

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

4. Possible adverse effects

Like all medicines, Galantamina Normon may have adverse effects, although not everyone experiences them. Some of these effects may be due to the disease itself.

Stop taking your medicine and consult your doctor immediately if you experience heart problems including changes in heartbeat (slow or irregular), palpitations (pounding heartbeat), or other disturbances such as loss of consciousness.

Adverse effects include:

Very common: affect more than 1 in 10 patients

Feeling unwell and/or vomiting. If these undesirable effects occur, they mainly happen at the beginning of treatment or when the dose is increased. They usually disappear gradually as the body adapts to the treatment and generally resolve within a few days. If you experience these effects, your doctor may recommend drinking more fluids and, if necessary, may prescribe a medicine to help you feel better.

Common: affect between 1 and 10 in every 100 patients

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

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

Increase in liver enzymes in the blood (laboratory test results show whether your liver is functioning properly), possible abnormality in heartbeat, disturbance in the conduction of electrical impulses in the heart, sensation of abnormal heartbeats (palpitations), tingling, pricking, or numbness of the skin, change in taste sensation, excessive sleepiness, blurred vision, ringing or buzzing in the ears (tinnitus), feeling of nausea, muscle weakness, excessive loss of body water, decreased blood pressure, facial flushing.

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

Inflammation of the liver (hepatitis).

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Galantamina Normon

Keep out of the reach and sight of children.

Do not freeze.

Galantamina Normon oral solution must not be used more than 3 months after the bottle was first opened.

Do not use Galantamina Normon after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Galantamine Normon:

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

The other components are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), strawberry flavour (containing benzyl alcohol), sodium hydroxide and purified water.

Appearance of the product and contents of the container:

Galantamine Normon is presented as a clear, colourless oral solution with a strawberry odour. Each package 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 most recent review of this leaflet: February 2021

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