Prospect: information for the user

Ziprasidone Viatris 80 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other peopleeven if they present the same symptoms of illness as you, as it may harm them.

-If you experience any adverse effect, consult your doctor or pharmacist,even if it is an adverse effect that does not appear in this prospect. See section 4.

1.What is Ziprasidone Viatris and for what it is used

2.What you need to know before starting to takeZiprasidone Viatris

3.How to take Ziprasidone Viatris

4.Possible adverse effects

5.Storage of Ziprasidone Viatris

6.Contents of the package and additional information

Ziprasidona Viatris belongs to a group of medicines called antipsychotics.

Ziprasidona is indicated for the treatment of schizophrenia in adults, a mental disorder characterized by the following symptoms:hearing, seeing or feeling things that do not exist, believing in something that is not real, having unusual suspicions, being absent and having difficulty establishing social relationships, nervousness, depression or anxiety.

Ziprasidona is also used for the treatment of episodes of moderate intensity mania or mixed episodes in adult bipolar disorder and in children and adolescents aged 10-17 years, which is a mental disorder characterized by alternating phases of euphoric mood (mania) and depressed mood.During mania episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, decreased need for sleep, lack of concentration or hyperactivity and repeated high-risk behaviors.

Do not take Ziprasidona Viatris

• If you are allergic to ziprasidona or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include skin rash, itching, swelling of the face or lips, difficulty breathing.
• If you have or have had heart problems or have recently had a heart attack.
• If you are taking medications to treat heart rhythm problems or that may affect heart rhythm.

Also see the section “Other medications and Ziprasidona Viatris” below.

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Ziprasidona Viatris:

• If you or a family member has a history of blood clots, as medications like this have been linked to blood clot formation.
• If you have liver problems
• If you have or have had seizures or epilepsy.
• If you are over 65 years old, have dementia, and are at risk of having a stroke.
• If you have a low resting heart rate and/or know that you may have a deficiency of salts due to intense and prolonged diarrhea or vomiting or the use of diuretics.
• If you experience symptoms such as rapid or irregular pulse, fainting, collapse, or dizziness when standing up, which could indicate abnormal heart rhythm.

Inform your doctor if you are taking Ziprasidona Viatrisbefore they perform a blood test (blood, urine, liver function, heart rate, etc.), as it may alter the test results.

Children and adolescents

The safety and efficacy of ziprasidona in the treatment of schizophrenia in children and adolescents have not been established.

Seek medical attention immediately if you experience any of the following symptoms:

• Severe skin reactions such as blistering, which may include mouth ulcers, peeling, fever, and skin lesions similar to a bullseye, which may be symptoms of Stevens-Johnson syndrome. These skin reactions may be potentially fatal.
• Ziprasidonamay cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which may cause falls. You should be cautious, especially if you are an elderly patient or have any weakness.

Other medications and Ziprasidona Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Ziprasidona Viatris

If you are taking medications for heart rhythm or medications that may alter heart rhythm, such as:

• Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levacetilmetadol, mesoridazine, thioridazine, pimozide, sparflloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medications alter heart rhythm by prolonging the QT interval. If you are unsure, consult your doctor.

Inform your doctor or pharmacist if you are taking or have taken recently medications for the treatment of:

• Bacterial infections; these medications are known as antibiotics, for example, rifampicin.
• Mood changes (oscillating between depressive and euphoric states), agitation, and irritability; these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• Depression, including certain serotonin reuptake inhibitors, for example, SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, sertralineor herbal remedies or natural remedies containing St. John's Wort (Hypericum perforatum).
• Epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide.
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole.

Also see the section "Do not take Ziprasidona Viatris" above.

Ziprasidona Viatris with food, drink, and alcohol

Ziprasidona capsules MUST BE TAKEN WITH A MAIN MEAL.

You should not drink alcohol during treatment with ziprasidona, as it may increase the risk of adverse effects.

Pregnancy and breastfeeding

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

Pregnancy

Do not take ziprasidona during pregnancy, unless your doctor tells you to, as there is a risk that this medication may harm the fetus. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The following symptoms may occur in newborns of mothers who have used ziprasidona in the last trimester (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby experiences any of these symptoms, you may need to contact your doctor.

Breastfeeding

You should not breastfeed while taking ziprasidona, as small amounts of the medication may pass into breast milk. If you plan to breastfeed your baby, consult your doctor before taking this medication.

Contraception

If you can become pregnant, you should use an appropriate contraceptive method while taking this medication.

Driving and operating machinery

Treatment with ziprasidona may cause drowsiness. If you experience this symptom, you should not drive or operate machinery until the drowsiness has disappeared.

Ziprasidona Viatris contains lactose.

If your doctor has told you that you have a certain sugar intolerance, contact him before taking ziprasidona.

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

The capsules must be swallowed whole, without chewing, and must be taken with food. It is essential not to chew the capsules, as this could alter the absorption of the medication in the intestine.

Ziprasidone must be taken twice a day, one capsule in the morning during a complete breakfast and another at night during dinner (see blister pack). This medication should be taken at the same time every day.

Adults

The recommended dose is 40-80 mg twice a day during meals.

In long-term treatments, your doctor may adjust the dose. Do not exceed the maximum dose of 160 mg per day.

Use in children and adolescents with bipolar mania

The initial recommended dose is 20 mg to be taken with a meal; subsequently, your doctor will indicate which are the optimal doses for you. Do not exceed the maximum dose of 80 mg per day in children weighing 45 kg or less, or 160 mg per day in children weighing more than 45 kg.

The safety and efficacy of ziprasidone in the treatment of schizophrenia in children and adolescents have not been established.

Older adults (65 years or older)

If you are an older adult, your doctor will decide on the suitable dose for you. Doses in patients over 65 years old are sometimes lower than those used in younger people. Your doctor will indicate which dose is appropriate for you.

Patients with liver problems

If you have liver problems, you may need to take a lower dose of ziprasidone capsules. Your doctor will determine the suitable dose for you.

If you take more Ziprasidone Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested. Bring the ziprasidone box with you.

If you have taken too many ziprasidone capsules, you may experience drowsiness, tremors, seizures, and involuntary movements of the head and neck.

If you forgot to take Ziprasidone Viatris

It is essential to take ziprasidone regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is already time for the next dose. In that case, take the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ziprasidone Viatris

Your doctor will indicate for how long you should take ziprasidone. Do not stop taking ziprasidone unless your doctor tells you to.

It is essential to continue taking the medication, even if you feel better. If you interrupt treatment too soon, symptoms may reappear.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. However, most side effects are temporary. It can often be difficult to distinguish the symptoms of your illness from side effects.

Get in touch with your doctor immediately if you experience any of the following serious side effects:

Rare(may affect up to 1 in 100 people):

• Intense chest pain, headache with confusion and blurred vision, feeling unwell (nausea), feeling queasy (vomiting), severe anxiety or difficulty breathing. These are indicative signs of very high blood pressure, which can affect organs (hypertensive crisis).
• Seizures (convulsions).

Very rare(may affect up to 1 in 1,000 people):

• Severe allergic reactions that may present as swelling of the face, lips, tongue, or throat and cause difficulty swallowing or breathing, itching on the skin.
• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased level of consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome.
• Confusion, agitation, high temperature, sweating, loss of muscle coordination, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Irregular and rapid heartbeats with fainting, these could be symptoms of a potentially fatal condition known as "Torsades de Pointes".
• Skin reactions, especially rashes with fever and inflamed lymph nodes, these could be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be fatal.
• Producing little or no urine, pain or discomfort while urinating, cloudy or dark urine with lower back pain. These signs could be indicative of severe kidney problems.
• Persistent, abnormal, and painful erection of the penis.

Frequency not known(cannot be estimated from available data):

• Clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which could pass from blood vessels to the lungs, causing chest pain and difficulty breathing.

You may experience any of the side effects listed below. These possible side effects are generally of mild or moderate intensity and may disappear over time. However, if the side effect is severe or persistent, consult your doctor.

Very common(may affect more than 1 in 10 people):

• Difficulty sleeping (insomnia), drowsiness.
• Headache.

Common(may affect up to 1 in 10 people):

• Coughing.
• Agitated and hyperactive mood that lasts for a week or more (mania), agitation, anxiety.
• Restlessness, inability to sit or stay still.
• Movement abnormalities, including involuntary and repetitive movements, muscle stiffness and hypertonia, slowness of movement, tremors, generalized weakness or fatigue.
• Dizziness.
• Blurred vision, other vision problems.
• Fast heart rate, high blood pressure.
• Constipation, diarrhea, nausea, vomiting, indigestion, dry mouth, increased salivation.
• Involuntary and abnormal movements, especially of the face or tongue.
• Rash.
• Sexual problems in men.
• Fever, pain, weight gain or loss.

Rare(may affect up to 1 in 100 people):

• Other allergic reactions.

• Elevated levels of prolactin in the blood, which can be observed in a blood test.
• Increased appetite.
• Panic attacks, nervousness, depression.
• Decreased libido.
• Fainting.
• Difficulty controlling movement, restless legs.
• Sensation of throat constriction.
• Nightmares.
• Involuntary eye movements, which transform into a fixed gaze upwards, dry eyes, speech problems, numbness, stiffness, difficulty concentrating, drooling, excessive daytime sleepiness, exhaustion.
• Balance, coordination, and speech problems (ataxia).
• Irregular and rapid heartbeats, which may feel like stabbing heartbeats in the chest (palpitations), sensation of dizziness when standing up, low blood pressure, difficulty breathing.
• Sensitivity to light, ringing in the ears, sensation of everything spinning when standing up or sitting down (vertigo).
• Ear pain.
• Throat pain, difficulty swallowing, tongue problems, gas, stomach discomfort.
• Stomach inflammation, causing abdominal swelling, pain, vomiting blood or black stools.
• Acid reflux.
• Hives, acne, flat red skin patches covered with small bumps, hair loss.
• Unusual head position (torticollis).
• Pain in the arms, legs, hands, or feet, muscle or bone discomfort.
• Muscle cramps, stiff joints.
• Inability to control urination, pain or difficulty urinating.
• Enlarged breasts, both in men and women, abnormal milk production, absence of menstruation in women.
• Thirst, chest discomfort, gait alteration.
• Anomalous results in liver function tests that can be observed in a blood test.
• Abnormal heart rate that can be observed in an electrocardiogram (ECG).

Rare(may affect up to 1 in 1,000 people):

• Decreased levels of calcium in the blood.
• Agitated and hyperactive mood that lasts for a short period (hypomania), slowness of thought, lack of emotional expression.
• Facial paralysis, muscle weakness (paresis).
• Complete or partial loss of vision in one eye, itching in the eyes.
• Asphyxia and difficulty breathing or speaking (laryngospasm).
• Hiccup.
• Soft stools.
• Swelling of the face, skin irritation, red skin.
• Inability to open the mouth.
• Nocturnal incontinence.
• Increased or decreased erections, inability to achieve orgasm.
• Sensation of heat.
• Increased or decreased white blood cell count, which can be observed in a blood test.
• Blood pressure that changes from normal to high and then back to normal.
• Alteration of blood tests.
• Red, inflamed, and elevated skin patches covered with white scales, known as psoriasis.
• Neonatal withdrawal syndrome in newborn babies (see section 2: Pregnancy).

Frequency not known(cannot be estimated from available data):

• In elderly people with dementia, a small increase in the number of deaths in patients taking antipsychotics compared to those not taking them has been reported.
• Strange patterns of thought and hyperactivity.

Reporting of 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 the 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 blister pack or the box.The expiration date is the last day of the month indicated.

Store below 30°C. Store in the original packaging to protect it from moisture.

“Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at > of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.”

Composition of Ziprasidona Viatris

The active ingredient is ziprasidone.

Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 80 mg of ziprasidone.

The other components are:

The capsule content is potassium polacrilex, lactose monohydrate, povidone, magnesium stearate.

The capsule coating contains Brilliant Blue FCF (E-133), titanium dioxide (E-171), and gelatin.

The printing components are shellac, propylene glycol, iron oxide black (E-172), and potassium hydroxide.

Appearance of the product and contents of the package

Hard gelatin capsule formed by an opaque blue-colored size 1 capsule (19.1 mm to 19.7 mm) and an opaque white body, with the imprint in the axial direction “MYLAN” above “ZE80”, in black ink on the capsule and body.

Ziprasidona Viatris is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, and 180 hard capsules and in perforated single-dose blisters containing 14 and 56 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer

Mylan Germany GmbH

Benzstrasse 1

61352 Bad Homburg

Germany

or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyZiprasidon Mylan 80 mg Hartkapseln

SlovakiaZiprasidon Mylan

SpainZiprasidona Viatris

PortugalZiprasidona Mylan

Czech RepublicZiprasidon Aurobindo

Last review date of this leaflet:March 2020

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