Galantamine Ratio 24 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Galantamine Ratio 24 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.

Contents of the leaflet

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

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

Galantamina Ratio 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, increased confusion, and behavioral changes. As a result, it becomes increasingly difficult to perform routine daily activities.

These symptoms are thought to be due to a lack of acetylcholine, a substance responsible for transmitting messages between brain cells. Galantamina Ratio increases the amount of acetylcholine in the brain, thereby potentially improving the symptoms of the disease.

The capsules are in the form of "extended release." This means they release the medication slowly.

2. What you need to know before starting Galantamina Ratio

Do not take Galantamina Ratio

• 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

Galantamina Ratio 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 Ratio, 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 nervous system disorder (such as epilepsy or problems controlling body or limb movements (extrapyramidal disorder))
• a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia)
• recent surgery on the intestine or bladder
• difficulties with urine outflow.

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

Your doctor will decide whether treatment with Galantamina Ratio is suitable for you and whether the dose needs to be adjusted.

Taking other medicines

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

Galantamina Ratio 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) if taken by mouth

Some medicines may alter the effects of Galantamina Ratio, or Galantamina Ratio 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)

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

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

• non-steroidal anti-inflammatory painkillers (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)
• medicines that affect the QTc interval.

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

Consult your doctor or pharmacist if you have any doubts.

Taking Galantamina Ratio with food and drink

It is recommended to take Galantamina Ratio with food.

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking Galantamina Ratio.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not carry out these activities unless your doctor tells you it is safe to do so. Galantamine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

3. How to take Galantamina Ratio

Follow exactly the administration instructions for Galantamina Ratio given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

How to take Galantamina Ratio

Galantamina Ratio capsules must be swallowed whole; DO NOT chew or crush them.

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

Galantamina Ratio prolonged-release capsules are available in two strengths: 16 mg and 24 mg. Treatment with Galantamina Ratio starts with a low dose. Your doctor may gradually increase the dose (strength) of Galantamina Ratio 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 you should start with and when and how you should increase it.

If you feel that the effect of Galantamina Ratio 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 Galantamina Ratio.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment starts with the 8 mg capsule once daily in the morning.
• If you have moderate liver or kidney disease, treatment starts with the 8 mg capsule every other morning. After one week, you will start taking the 8 mg capsule once daily in the morning. Do not take more than 16 mg per day.
• If you have severe liver or kidney disease, do not take Galantamina Ratio.

If you take more Galantamina Ratio than you should

If you take too much Galantamina Ratio, consult your doctor or go to the hospital immediately. Take the package with any remaining capsules with you. Signs and symptoms of overdose may include: severe nausea, vomiting, muscle weakness, slow heartbeat, seizures, and loss of consciousness.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If you forget to take Galantamina Ratio

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

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

How can I switch from Galantamina tablets or oral solution to Galantamina prolonged-release capsules?

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

• Take your last dose of Galantamina tablets or oral solution in the evening.
• The following morning, take your first dose of Galantamina prolonged-release capsules.

Do NOT take more than one capsule per day. While taking Galantamina prolonged-release capsules once daily, do NOT take Galantamina tablets or oral solution.

Use in children

Galantamina Ratio is not recommended for use in children.

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 Ratio may produce adverse effects, although not everyone experiences them. Some of these adverse effects may be due to the underlying disease itself.

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

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
• Unusual tiredness
• Abdominal pain or discomfort
• Diarrhea
• Indigestion (with a feeling of acidity)
• Increased sweating
• Muscle contractions
• Falls
• Increased blood pressure
• Feeling of weakness
• General feeling of being unwell
• 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 abnormality in heartbeat
• Disturbance in the conduction mechanism of impulses in the heart
• Sensation of abnormal heartbeats (palpitations)
• Tingling, pricking, or numbness of the skin
• Change in taste sensation
• Excessive sleepiness
• Problems controlling body movements or limbs (extrapyramidal disorder)
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Feeling the need to vomit
• Muscle weakness
• Excessive loss of water from the body
• Decrease in 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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Ratio 24 mg

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Galantamine Ratio after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are 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 pack and other information

Composition of Galantamina Ratio

• The active substance is galantamine. Each capsule contains 24 mg of galantamine (equivalent to 30,756 mg of galantamine hydrobromide).

• The other components are microcrystalline cellulose, hypromellose, ethylcellulose and magnesium stearate. The components of the capsule shell are gelatin, titanium dioxide (E-171), red iron oxide (E172), yellow iron oxide (E172), erythrosine and indigo carmine.

Appearance of the product and contents of the pack

Galantamina Ratio 24 mg prolonged-release hard capsules are orange in colour.

The 24 mg capsules are available in packs containing 28 capsules.

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st Floor, Alcobendas

28108 - Madrid, Spain

Manufacturer responsible for manufacturing

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300 (Greece)

Date of the most recent revision of this leaflet: April 2024

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/