GALANTAMINA 8 mg Prolonged-Release Hard Capsules

2. What you need to know before you take 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 in 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 your 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 (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 anesthetics. If you are going to have an operation under general anesthesia, inform your doctor in advance that 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

Galantamine Teva-ratio may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If Galantamine Teva-ratio affects you, do not drive or operate machinery.

3. How to take Galantamine Teva-ratio

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If you are taking galantamine tablets or oral solution and your doctor has told you to switch 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 explain which dose you should start with and when it should be increased.

If you are unsure what to do or find that the effect of Galantamine Teva-ratio is too strong or too weak, tell 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 decide if 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 once a day, 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 liquid while taking Galantamine Teva-ratio to stay hydrated.

If you take more Galantamine Teva-ratio than you should

If you take too much Galantamine Teva-ratio, consult your doctor or go to the hospital immediately, or call the Poison Information Service on 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 product, 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 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 cause 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 beats) 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 medical attentionif 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 adapts 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, feeling, or hearing 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
• diarrhea
• indigestion
• falls
• injuries

Uncommon(may affect up to 1 in 100 patients)

• insufficient water in the body (dehydration)
• tingling or numbness of the skin
• change in sense of taste
• daytime sleepiness
• blurred vision
• ringing in the ears that does not disappear (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 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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamine Teva-ratio

• The active substance is galantamine.

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

• The other ingredients are:

Contents of the capsule:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capsule shell:

Gelatin, Titanium dioxide (E171).

Appearance and packaging

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

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

The capsules are of “prolonged release”. This means 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 authorization holder and manufacturer

Marketing authorization 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 8 mg Hartkapseln, retardiert

Austria Galantamin-ratiopharm GmbH 8mg Retardkapseln

Bulgaria Tevalin 8mg ??????? ? ???????? ?????????????, ??????

Spain Galantamina Teva-ratio 8mg cápsulas duras de liberación prolongada EFG

Finland Galantamine ratiopharm 8 mg depotkapseli, kova

France Galantamine Teva Santé LP 8mg gélule à libération prolongée

Northern Ireland Gazylan XL 8mg prolonged release capsules hard

Lithuania Gazylan 8mg pailginto atpalaidavimo kietosios kapsules

Portugal Galantamina Teva 8mg cápsula de libertação prolongada

Slovenia Gazylan 8mg trde kapsule s podaljšanim sprošcanjem

Date of last revision of this 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/.