Galantamine Teva-Ratio 8 mg prolonged-release hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Galantamina Teva-ratio 8 mg prolonged-release hard capsules EFG

galantamine

Read the entire leaflet carefully before you start taking this medicine, as 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Galantamina Teva-ratio is and what it is used for

Galantamina Teva-ratio contains the active substance “galantamina”, an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that affects brain function.

Alzheimer's disease causes increasing memory loss, confusion, and behavioural changes, making it progressively more difficult to carry out routine daily activities. These effects are thought to be caused by a deficiency of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamina Teva-ratio increases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.

The capsules are in the form of “prolonged-release”. This means they release the medicine gradually.

2. What you need to know before starting to take Galantamina Teva-ratio

Do not take Galantamina Teva-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

Talk to your doctor or pharmacist before starting to take Galantamina Teva-ratio.

This medicine should only be used for Alzheimer's disease and is not recommended for other types of memory loss or confusion.

Serious adverse effects

Galantamina Teva-ratio may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking Galantamina Teva-ratio. See section 4 “Be alert to serious adverse effects”.

Before starting treatment with Galantamina Teva-ratio, your doctor must know if you have or have had any of the following conditions:

• liver or kidney problems
• a heart condition (such as chest discomfort usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in electrolyte levels (natural chemicals in the blood, such as potassium)
• a peptic ulcer (stomach)
• obstruction in the stomach or intestine (acute abdominal pain)
• a nervous system disorder (such as epilepsy or problems controlling body movements or limbs (extrapyramidal disorder))
• a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia)
• problems with urine outflow

Your doctor will decide whether Galantamina Teva-ratio is suitable for you or whether your dose needs to be adjusted.

Also tell your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will decide whether Galantamina Teva-ratio is suitable for you.

Galantamina Teva-ratio may cause weight loss. Your doctor will monitor your weight regularly while you are taking Galantamina Teva-ratio.

Children and adolescents

The use of Galantamina Teva-ratio is not recommended in children or adolescents.

Taking Galantamina Teva-ratio with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Galantamina Teva-ratio should not be taken together with other medicines that work in a similar way. These include:

• donepezil or rivastigmine (for Alzheimer's disease)
• ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness)
• pilocarpine (when taken by mouth for dry eyes or mouth)

Some medicines may increase the risk of adverse effects in people taking Galantamina Teva-ratio. These include:

• paroxetine or fluoxetine (antidepressants)
• quinidine (for irregular heartbeat)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (for human immunodeficiency virus or “HIV”)
• non-steroidal anti-inflammatory analgesics (such as ibuprofen) which 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 examine your heart using an electrocardiogram (ECG)
• medicines that affect the QTc interval.

If you are taking any of these medicines, your doctor may prescribe a lower dose of Galantamina Teva-ratio.

Galantamina Teva-ratio may affect certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well in advance that you are taking Galantamina Teva-ratio.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

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

You must not breastfeed while taking Galantamina Teva-ratio.

Driving and using machines

Galantamina Teva-ratio may make you feel dizzy or drowsy, especially during the first weeks of treatment. If Galantamina Teva-ratio affects you in this way, do not drive or operate tools or machinery.

3. How to take Galantamina Teva-ratio

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. 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 Teva-ratio prolonged-release capsules, please read carefully the instructions provided under "Switching from galantamine tablets or oral solution to Galantamina Teva-ratio prolonged-release capsules" in this section.

How much to take

You will start treatment with Galantamina Teva-ratio at a low dose. The usual starting dose is 8 mg taken once daily. Your doctor will gradually increase your dose, every 4 weeks or longer, until reaching the most appropriate dose for you. The maximum dose is 24 mg taken once daily.

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

If you are unsure what to do, or if you find that the effect of Galantamina Teva-ratio is too strong or too weak, inform your doctor or pharmacist.

Your doctor will need to see you regularly to check that this medicine is suitable for you and to discuss how you are feeling.

If you have liver or kidney problems, your doctor may prescribe a reduced dose of Galantamina Teva-ratio or may decide whether this medicine is appropriate for you.

Switching from galantamine tablets or oral solution to Galantamina Teva-ratio prolonged-release capsules

If you are currently taking immediate-release galantamine tablets or oral solution, your doctor may decide to switch you to Galantamina Teva-ratio prolonged-release capsules. If this applies to you:

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

DO NOT take more than one capsule per day. While taking Galantamina Teva-ratio once daily, DO NOT take immediate-release galantamine tablets or oral solution.

How to take it

Galantamina Teva-ratio capsules must be swallowed whole. They must NOT be chewed or crushed. Take your dose of Galantamina Teva-ratio once daily in the morning, with water or other liquids. Try to take Galantamina Teva-ratio with food.

Drink plenty of fluids while taking Galantamina Teva-ratio to stay hydrated.

If you take more Galantamina Teva-ratio than you should

If you take too much Galantamina Teva-ratio, consult your doctor or go to hospital immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. Bring the package and any remaining capsules with you. Signs of overdose may include:

• severe nausea and vomiting
• muscle weakness, slow heartbeat, seizures, and loss of consciousness.

If you forget to take Galantamina Teva-ratio

If you forget to take a dose, skip the missed dose and take the next dose at your usual time.

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

If you miss more than one dose, you must contact your doctor.

If you stop taking Galantamina Teva-ratio

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

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 Teva-ratio may cause adverse effects, although not everyone experiences them.

Be alert for serious adverse effects

Stop taking Galantamina Teva-ratio and consult a doctor or go immediately to the nearest emergency department if you experience any of the following serious adverse effects:

Skin reactions, including:

• Severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled bumps that may spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Rash that may cause blisters, with spots resembling small targets (erythema multiforme).

These skin reactions are rare in people taking Galantamina Teva-ratio (may affect up to 1 in 1,000 people).

Heart problems, including changes in heartbeat (such as slow heartbeat or extra beats) or palpitations (feeling a fast or irregular heartbeat). Heart problems may be seen as an abnormal pattern on an electrocardiogram (ECG), and may be common in people taking Galantamina Teva-ratio (may affect up to 1 in 10 people).

Seizures. This is uncommon in people taking Galantamina Teva-ratio (may affect up to 1 in 100 people).

Fainting or loss of consciousness (may affect up to 1 in 10 people).

An allergic reaction. Signs may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue (may affect up to 1 in 100 people).

You must stop taking Galantamina Teva-ratio and seek immediate medical help if you notice any of the adverse effects listed above.

Other adverse effects:

Very common (may affect more than 1 in 10 patients)

• Nausea and vomiting. These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased. They tend to gradually disappear as the body adapts to the medicine and usually last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and, if necessary, may prescribe a medicine to help relieve nausea.

Common (may affect up to 1 in 10 patients)

• Decreased appetite, weight loss
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Depression
• Dizziness or feeling faint
• Tremors or muscle spasms
• Headache
• Feeling very tired, weak, or generally unwell
• Excessive sleepiness and low energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarrhea
• Indigestion
• Falls
• Injuries

Uncommon (may affect up to 1 in 100 patients)

• Inadequate body water (dehydration)
• Tingling or numbness of the skin
• Change in taste sensation
• Daytime sleepiness
• Problems controlling body movements or limbs (extrapyramidal disorder)
• Blurred vision
• Persistent ringing in the ears (tinnitus)
• Decreased blood pressure
• Flushing
• Feeling the need to vomit (nausea)
• Excessive sweating
• Muscle weakness
• Increased levels of liver enzymes in the blood

Rare (may affect up to 1 in 1,000 patients)

• Inflamed liver (hepatitis)

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Teva-ratio

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Galantamina Teva-ratio

• The active substance is galantamine.

Each 8 mg prolonged-release hard capsule contains 8 mg of galantamine (as hydrobromide).

• The other components are:

Capsule contents:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule shell:

Gelatin, Titanium dioxide (E171).

Appearance of the product and pack contents

Galantamina Teva-ratio prolonged-release hard capsules are available in three strengths, each identified by its colour:

8 mg: white capsules containing a round, biconvex prolonged-release tablet.

The capsules are "prolonged-release", meaning they release the medicine more slowly.

The capsules are available in the following pack sizes:

7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 119, 120, 300 prolonged-release capsules.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer

Pharmathen S.A.

Dervenakion 6, Pallini, Attiki, 153 51,

Greece

or

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,

Greece

or

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren,

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Galantamin-ratiopharm 8 mg Hard capsules, prolonged-release

Austria Galantamin-ratiopharm GmbH 8 mg prolonged-release capsules

Bulgaria Tevalin 8 mg _____ _____ __________________, __________________

Spain Galantamina Teva-ratio 8 mg prolonged-release hard capsules EFG

Finland Galantamine ratiopharm 8 mg depot capsule, hard

France Galantamine Teva Santé LP 8 mg prolonged-release capsule

Northern Ireland Gazylan XL 8 mg prolonged release capsules hard

Lithuania Gazylan 8 mg prolonged-release hard capsules

Portugal Galantamina Teva 8 mg prolonged-release capsule

Slovenia Gazylan 8 mg prolonged-release hard capsules

Date of the latest revision of this leaflet: February 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77471/P_77471.html

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