Galantamine Normon 16 mg prolonged-release hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Galantamine Normon 16 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Galantamine Normon is and what it is used for.
2. What you need to know before taking Galantamine Normon.
3. How to take Galantamine Normon.
4. Possible side effects.
5. How to store Galantamine 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 medicine 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, increased 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 signals between brain cells. Galantamine increases the amount of acetylcholine in the brain, thereby potentially improving the symptoms of the disease.

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

2. What you need to know before starting Galantamina Normon

Do not take Galantamina Normon

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Galantamina 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 should know if you have or have had any of the following conditions:

• liver or kidney problems,
• a heart disorder (for example, angina, heart attack, heart failure, slow or irregular pulse, prolonged QTc interval),
• an electrolyte imbalance (for example, high or low levels of potassium 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 or infection that interferes with breathing (such as asthma, obstructive lung disease, or pneumonia),
• if you have recently had surgery on the intestine or bladder,
• if you have difficulty passing urine.

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

Your doctor will then decide whether treatment with galantamine is suitable for you and whether it is necessary to adjust the dose.

Taking Galantamina Normon with other medicines

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

Galantamine must 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 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 HIV protease inhibitor),
• 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 galantamine. These include:

• non-steroidal anti-inflammatory analgesics (for example, ibuprofen), which 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 an irregular heartbeat, your doctor may consider it necessary to perform an electrocardiogram (ECG).

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

Consult your doctor or pharmacist if you have any doubts.

Taking Galantamina Normon with food and drink

It is recommended to take galantamine with food.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking Galantamina Normon.

Driving and using machines

Galantamine may cause dizziness or drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

3. How to take Galantamina Normon

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

If you are currently taking galantamine tablets or oral solution and your doctor has informed you that you will be switching to Galantamina Normon prolonged-release capsules, please read carefully the instructions provided at the end of this section.

How to take your Galantamina Normon capsules

Galantamina Normon capsules must be swallowed whole; DO NOT chew or crush them. IF you have difficulty swallowing the capsules, you may empty the capsule and swallow its contents whole – (DO NOT chew or crush the capsule contents).

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 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 appropriate dose for you is reached.

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

Your doctor will explain which dose to start with and when to increase it. If you feel that the effect of galantamine 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 how you are feeling. Your doctor will also monitor your weight regularly during treatment with galantamine.

Liver or kidney disease

• If you have mild liver or kidney impairment, treatment should start with the 8 mg capsule once daily in the morning.
• If you have moderate liver or kidney impairment, treatment should start with the 8 mg capsule every other morning. After one week, begin taking the 8 mg capsule once daily in the morning. Do not take more than 16 mg once daily.
• If you have severe liver or kidney impairment, 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 Galantamina Normon than you should

If you have taken more galantamine than you should, contact your doctor or go immediately to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested. Bring the package and any remaining capsules 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 forget to take Galantamina Normon

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

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

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

If you stop taking Galantamina Normon

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

How can I switch 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 your last dose of galantamine tablets or oral solution in the evening.
• The next morning, take your first dose of Galantamina Normon prolonged-release capsules.

Do NOT take more than one capsule per day. While taking Galantamina Normon capsules once daily, 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 adverse effects

Like all medicines, Galantamina Normon may cause 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).
• Other disturbances such as fainting.
• An allergic reaction. Signs may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue.

Adverse effects include:

Very common: may affect more than 1 in 10 people

• Feeling unwell with nausea 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 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: may affect up to 1 in 10 people

• Weight loss.
• Loss of appetite.
• Decreased appetite.
• Slow heartbeat.
• Feeling of weakness.
• Dizziness.
• Tremors.
• Headache.
• Drowsiness.
• Abnormal tiredness.
• Abdominal pain or discomfort.
• Diarrhea.
• Bloating (with a sensation of acidity).
• Increased sweating.
• Muscle contractions.
• Falls.
• Increased blood pressure.
• Feeling of weakness.
• General feeling of malaise.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Feeling of sadness (depression).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in blood (laboratory test results show whether your liver is functioning properly).
• Possible abnormal 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 needing to vomit.
• Muscle weakness.
• Excessive loss of body water.
• Decreased blood pressure.
• Flushing of the face.
• Allergic reaction.

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

• Inflammation of the liver (hepatitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of GalantaminaNormon

The active substance is galantamine hydrobromide. Each prolonged-release capsule contains 16 mg of galantamine (as hydrobromide).

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

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

Appearance of the product and contents of the container

Galantamina Normon is presented as flesh-coloured hard capsules containing two white, round, prolonged-release tablets.

Each container 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

Galantamina Normon 8 mg prolonged-release capsules EFG.

Galantamina Normon 24 mg prolonged-release capsules EFG.

Galantamina Normon 4 mg/ml oral solution EFG.

Date of the latest review of this leaflet: February 2021

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