Package Insert: Information for the User

Galantamine Tevagen 8 mg Extended-Release Hard Capsules EFG

Galantamine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Galantamine Tevagen and for what it is used

2. What you need to know before starting to take Galantamine Tevagen

3. How to take Galantamine Tevagen

4. Possible adverse effects

5. Storage of Galantamine Tevagen

6. Contents of the package and additional information

Galantamina Tevagen contains the active ingredient “galantamine”, an anti-dementia medication. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer's disease, a type of dementia that alters brain function.

Alzheimer's disease causes an increase in memory loss, confusion, and changes in behavior, making it increasingly difficult to perform routine daily activities. It is thought that these effects are caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galantamina Tevagen increases the amount of acetylcholine in the brain and thus treats the symptoms of the disease.

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

Do not take Galantamina Tevagen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Galantamina Tevagen.

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

Severe side effects

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

Before starting treatment with Galantamina Tevagen, 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 caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• an electrolyte imbalance (natural substances in the blood, such as potassium)
• a stomach ulcer
• obstruction in the stomach or intestine (acute abdominal pain)
• a nervous system disorder (such as epilepsy or Parkinson's disease)
• a respiratory disease or infection that affects breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• problems with urination

Your doctor will decide if Galantamina Tevagen is suitable for you or if the dose needs to be changed.

Also inform your doctor if you have recently had surgeryon the stomach, intestine, or bladder. Your doctor will decide if Galantamina Tevagen is suitable for you.

Galantamina Tevagen may cause weight loss. Your doctor will check your weight regularly while you are taking Galantamina Tevagen.

Children and adolescents

Galantamina Tevagen is not recommended for use in children or adolescents.

Taking Galantamina Tevagen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Galantamina Tevagen should not be taken with other medications that work in a similar way, including:

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

Some medications may increase the risk of side effects in people taking Galantamina Tevagen. These include:

• paroxetine or fluoxetine (antidepressants)
• quinidine (for irregular heartbeat)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (for HIV)
• nonsteroidal anti-inflammatory analgesics (such as ibuprofen) that may increase the risk of ulcers
• medications for certain heart problems or high blood pressure (such as digoxin, amiodarone, atropine, beta blockers, or calcium channel blockers). If you take medications for irregular heartbeat, your doctor may examine your heart using an electrocardiogram (ECG)
• medications that affect the QTc interval.

If you are taking any of these medications, your doctor may give you a lower dose of Galantamina Tevagen.

Galantamina Tevagen may affect some anesthetics. If you are undergoing general anesthesia, inform your doctor, in advance, that you are taking Galantamina Tevagen.

Consult your doctor or pharmacist if you have any doubts.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed while taking Galantamina Tevagen.

Driving and operating machinery

Galantamina Tevagen may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If Galantamina Tevagen affects you, do not drive or operate tools or machinery.

Follow exactly the administration instructions of this medication as indicated 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 that you will be switched to Galantamina Tevagen prolonged-release capsules, read carefully the instructions that appear in “Switching from galantamine tablets or oral solution to Galantamina Tevagen prolonged-release capsules in this section.

How much to take

You will start treatment with Galantamina Tevagen at a low dose. The usual initial dose is 8 mg, taken once a day. Your doctor will gradually increase your dose, every 4 weeks or more, until you reach the most suitable dose for you. The maximum dose is 24 mg, taken once a day.

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

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

Your doctor will need to see you regularly to check that this medication is working well for you and discuss how you are feeling.

If you have liver or kidney problemsYour doctor may give you a reduced dose of Galantamina Tevagen or decide that this medication is not suitable for you.

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

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

• Take the last dose of galantamine immediate-release tablets or oral solution at night.
• The next morning, take the first dose of Galantamina Tevagen prolonged-release capsules.

Do not take more than one capsule a day. While taking Galantamina Tevagen once a day, do not take galantamine immediate-release tablets or oral solution.

How to take it

Galantamina Tevagen capsules should be swallowed whole. Do not crush or chew them. Take your dose of Galantamina Tevagen once a day in the morning, with water or other liquids. Try to take Galantamina Tevagen with meals.

Drink plenty of liquid while taking Galantamina Tevagen to stay hydrated.

If you take too much Galantamina Tevagen

If you take too much Galantamina Tevagen, consult your doctor or go to the hospital immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging with the remaining capsules. Signs of overdose may include:

• Intense nausea and vomiting
• Muscle weakness, slow heart rate, seizures, and loss of consciousness.

If you forget to take Galantamina Tevagen

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

Do not take a double dose to compensate for missed doses.

If you forget to take more than one dose, you should contact your doctor.

If you interrupt treatment with Galantamina Tevagen

Consult your doctor before interrupting treatment with Galantamina Tevagen. It is essential to continue taking this medication to treat your condition.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, Galantamina Tevagen can cause side effects, although not everyone will experience them.

Be aware of severe side effects

Stop taking Galantamina Tevagen and consult a doctor or visit the nearest emergency service immediatelyif you notice any of the following side effects:

Skin reactions, including:

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

These skin reactions are rare in people taking Galantamina Tevagen (they can affect up to 1 in 1,000 people).

Heart problemsincluding changes in heart rhythm (such as slow heartbeat or extra beats) or palpitations (feeling a rapid or irregular heartbeat). Heart problems can be seen as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking Galantamina Tevagen (they can affect up to 1 in 10 people).

Seizures. This is rare in people taking Galantamina Tevagen (they can affect up to 1 in 100 people).

Alterations such as fainting (they can affect up to 1 in 10 people).

Allergic reaction. Symptoms may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue (they can affect up to 1 in 100 people).

You should stop taking Galantamina Tevagen and seek help immediatelyif you notice any of the mentioned side effects.

Other side effects:

Very common(they can affect more than 1 in 10 patients)

• Nausea and vomiting. These side effects are more likely to occur in the first weeks of treatment or when the dose is increased. They tend to disappear gradually as the body adapts to the medication and usually only last a few days. If you experience these side effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medication to help you feel better.

Common(they can affect up to 1 in 10 patients)

• Loss of appetite, weight loss
• Seeing, feeling, or hearing things that are not there (hallucinations)
• Depression
• Feeling dizzy or faint
• Tremors or muscle spasms
• Headache
• Feeling extremely tired, weak, or generally unwell
• Feeling very sleepy and having little energy
• Increased blood pressure
• Abdominal pain or discomfort
• Diarhea
• Indigestion
• Falls
• Wounds

Rare(they can affect up to 1 in 100 patients)

• Insufficient water in the body (dehydration)
• Prickling or numbness of the skin
• Change in sense of taste
• Daytime drowsiness
• Blurred vision
• Continuous ringing in the ears (tinnitus)
• Decreased blood pressure
• Flush
• Feeling like vomiting (retching)
• Excessive sweating
• Weakness of the muscles
• Increased levels of liver enzymes in the blood.

Very rare(they can affect up to 1 in 1,000 patients)

• Inflamed liver (hepatitis)

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Galantamina Tevagen

• The active ingredient is galantamine.

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

• The other components are:

Capule content:

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.

Capule coating:

Gelatin, Titanium dioxide (E171).

Appearance of the product and contents of the package

Galantamina Tevagen prolonged-release hard capsules are available in three doses, each of which is recognized by its color:

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

The capsules are "prolonged-release". This means they release the medication more slowly.

The capsules are available in the following package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas. Madrid. Spain

Responsible 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 with the following names:

GermanyGalantamin-ratiopharm 8 mgHartkapseln, retardiert

AustriaGalantamin-ratiopharmGmbH 8mg Retardkapseln

BulgariaTevalin 8mg?????????????????????????????,??????

SpainGalantamina Tevagen 8mg prolonged-release hard capsules EFG

FinlandGalantamine ratiopharm 8 mg depotkapseli, kova

FranceGalantamine Teva Santé LP8mg gélule à libération prolongée

Republic of IrelandGazylan XL 8mg prolonged release capsules hard

LithuaniaGazylan 8mg pailginto atpalaidavimo kietosios kapsules

PortugalGalantamina Teva8mg prolonged-release capsule

SloveniaGazylan 8mg trde kapsule s podaljšanim sproščanjem

Last review date of this leaflet: February 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.