GALANTAMINE TEVA-RATIO 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Galantamine Teva-ratio 16 mg prolonged-release hard capsules EFG

Galantamine

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Galantamine Teva-ratio contains the active substance “galantamine”, an anti-dementia 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 changes in behaviour, making it increasingly difficult to carry out daily activities. It is thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamine Teva-ratio increases the amount of acetylcholine in the brain, treating the symptoms of the disease.

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

2. What you need to know before taking Galantamine Teva-ratio

Do not take Galantamine Teva-ratio

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamine Teva-ratio.

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

Severe side effects

Galantamine Teva-ratio may cause severe skin reactions, heart problems, and seizures. You should be aware of these side effects while taking Galantamine Teva-ratio. See section 4 “Be aware of severe side effects”.

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

• liver or kidney problems
• a heart condition (such as chest pain that is usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• changes in electrolyte levels (naturally occurring chemicals in the blood, such as potassium)
• a stomach ulcer (peptic ulcer)
• blockage of the stomach or intestine (abdominal pain)
• a nervous system disorder (such as epilepsy or Parkinson's disease)
• a respiratory disease that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• problems with urination

Your doctor will decide if Galantamine Teva-ratio is suitable for you or if the dose needs to be changed.

Also, inform your doctor if you have recently had an operationon the stomach, intestine, or bladder. Your doctor will decide if Galantamine Teva-ratio is suitable for you.

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

Children and adolescents

Galantamine Teva-ratio is not recommended for use in children or adolescents.

Taking Galantamine Teva-ratio with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Galantamine Teva-ratio should not be taken 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 cause side effects more easily in people taking Galantamine 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 painkillers (such as ibuprofen) that 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 check your heart using an electrocardiogram (ECG)
• medicines that affect the QTc interval.

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

Galantamine Teva-ratio may affect some anaesthetics. If you are going to have an operation under general anaesthesia, tell your doctor well in advance that you are taking Galantamine Teva-ratio.

Your doctor will also regularly check your weight while you are taking Galantamine Teva-ratio.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not breastfeed while taking Galantamine Teva-ratio.

Driving and using machines

Your illness may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Galantamine Teva-ratio affects you, do not drive or operate tools or machines.

3. How to take Galantamine Teva-ratio

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

If you are taking galantamine tablets or oral solution and your doctor has told you that you will be switched to Galantamine Teva-ratio prolonged-release capsules, read carefully the instructions in “Switching from galantamine tablets or oral solution to Galantamine Teva-ratio prolonged-release capsules” in this section.

How much to take

You will start treatment with Galantamine Teva-ratio at a low dose. The usual starting dose is 8 mg, taken once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the dose that is best for you. The maximum dose is 24 mg, taken once a day.

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

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

Your doctor will need to see you regularly to check that this medicine is working for you and to discuss with you how you feel.

If you have liver or kidney problems, your doctor may give you a lower dose of Galantamine Teva-ratio or may decide that this medicine is not suitable for you.

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

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

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

DO NOT take more than one capsule a day. While taking Galantamine Teva-ratio, DO NOT take galantamine immediate-release tablets or oral solution.

How to take it

Galantamine Teva-ratio capsules should be swallowed whole. DO NOT chew or crush them. Take your dose of Galantamine Teva-ratio once a day in the morning, with water or other liquids. Try to take Galantamine Teva-ratio with food.

Drink plenty of liquids while taking Galantamine Teva-ratio to stay hydrated.

If you take more Galantamine Teva-ratio than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. Bring the package with the remaining capsules. Signs of overdose may include:

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

If you forget to take Galantamine Teva-ratio

If you miss a dose, skip that missed dose and take the next dose at the usual time.

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

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

If you stop taking Galantamine Teva-ratio

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

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

4. Possible side effects

Like all medicines, Galantamine Teva-ratio can cause side effects, although not everybody gets them.

Be aware of severe side effects

Stop taking Galantamine Teva-ratio and consult a doctor or go to the nearest emergency department immediatelyif you notice any of the following side effects:

Skin reactions, including:

• Severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• A red rash covered with small pus-filled bumps that can spread across the body, sometimes with fever (acute generalized exanthematous pustulosis).
• A rash that can produce blisters, with spots that look like small targets.

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

Heart problemsincluding changes in heartbeat (such as slow or extra heartbeats) or palpitations (feeling your heartbeat is fast or irregular). Heart problems can be seen as an abnormal tracing on an “electrocardiogram” (ECG), and may be common in people taking Galantamine Teva-ratio (may affect up to 1 in 10 people).

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

Fainting (may affect up to 1 in 10 people).

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

You must stop taking Galantamine Teva-ratio and seek immediate helpif you notice any of the above side effects.

Other side effects:

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

• nausea and vomiting. These side effects are more likely to occur in the first few weeks of treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the medicine and usually only last a few days. If you experience these effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medicine to stop you feeling sick.

Common(may affect up to 1 in 10 patients)

• decreased appetite, weight loss
• seeing, hearing, or feeling things that are not there (hallucinations)
• depression
• feeling dizzy or faint
• tremors or muscle spasms
• headache
• feeling very tired, weak, or unwell
• feeling very sleepy and having little energy
• increased blood pressure
• abdominal pain or discomfort
• diarrhoea
• indigestion
• falls
• injuries

Uncommon(may affect up to 1 in 100 patients)

• lack of water in the body (dehydration)
• tingling or numbness of the skin
• change in taste
• daytime sleepiness
• blurred vision
• ringing in the ears that does not go away (tinnitus)
• decreased blood pressure
• flushing
• feeling sick (nausea)
• excessive sweating
• muscle weakness
• increased levels of liver enzymes in the blood.

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

• inflammation of the liver (hepatitis)

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galantamine Teva-ratio

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Galantamine Teva-ratio

• The active substance is galantamine.

Each prolonged-release hard capsule of 16 mg contains 16 mg of galantamine (as hydrobromide).

• The other ingredients are:

Contents of the capsule:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capusle shell:

Gelatine, Titanium dioxide (E171), Iron oxide red (E172).

Appearance and packaging

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

16 mg: Light pink capsules containing two round, biconvex prolonged-release tablets.

The capsules are of “prolonged release”. This means that they release the medicine more slowly.

The capsules are available in the following packs:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1ª planta

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

or

Teva Pharma B.V.,

Swensweg 5, 2031 GA Haarlem

Netherlands

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

Germany Galantamin-ratiopharm 16mg Hartkapseln, retardiert

Austria Galantamin ratiopharm GmbH 16mg Retardkapseln

Bulgaria Tevalin 16mg ??????? ? ???????? ?????????????, ??????

Spain Galantamina Teva-ratio 16mg cápsulas duras de liberación prolongada EFG

Finland Galantamine ratiopharm 16 mg depotkapseli, kova

France Galantamine Teva Santé LP 16mg gélule à libération prolongée

Northern Ireland Gazylan XL 16mg prolonged release capsules hard

Lithuania Gazylan 16mg pailginto atpalaidavimo kietosios kapsules

Portugal Galantamina Teva 16mg cápsula de libertação prolongada

Slovenia Gazylan 16mg trde kapsule s podaljšanim sprošcanjem

Date of last revision of this package leaflet: February 2021

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