ZIPRASIDONE VIATRIS 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ziprasidone Viatris 80 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ziprasidone Viatris and what is it used for
2. What you need to know before you take Ziprasidone Viatris
3. How to take Ziprasidone Viatris
4. Possible side effects
5. Storage of Ziprasidone Viatris
6. Contents of the pack and other information

1. What is ZIPRASIDONE VIATRIS and what is it used for

Ziprasidone Viatris belongs to a group of medicines called antipsychotics.

Ziprasidone 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.

Ziprasidone is also used for the treatment of moderate to severe manic or mixed episodes in bipolar disorder in adults and children and adolescents aged 10-17 years, which is a mental disorder characterized by alternating phases of mood, euphoric (mania) and depressed. During manic 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.

2. What you need to know before you take Ziprasidone Viatris

Do not take Ziprasidone Viatris

• If you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). The 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 medicines for heart rhythm problems or that may affect heart rhythm.

Also, read the section "Other medicines and Ziprasidone Viatris" below.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ziprasidone Viatris:

• If you or someone in your family has a history of blood clots, as medicines like this have been associated with the formation of blood clots.
• 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 you may have a deficiency of salts as a result of intense and prolonged diarrhea or vomiting or the use of diuretics.
• If you experience symptoms such as rapid or irregular heartbeat, fainting, collapse or dizziness when standing up, which could indicate abnormal heart rate function.

Tell your doctor if you are taking Ziprasidone Viatrisbefore you have any laboratory tests (blood, urine, liver function, heart rate, etc.), as it may alter the test results.

Children and adolescents

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

Contact your doctor immediately if you experience any of the following symptoms:

• Severe skin reactions such as blisters, which may include ulcers in the mouth, peeling, fever, and target-like spots on the skin, which may be symptoms of Stevens-Johnson syndrome. These skin reactions can be life-threatening.
• Ziprasidone may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. You should be careful, especially if you are an elderly patient or have some weakness.

Other medicines and Ziprasidone Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Ziprasidone Viatris

If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as:

• Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medicines alter heart rhythm by prolonging the QT interval. If you have any doubts, consult your doctor.

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

• Bacterial infections; these medicines are known as antibiotics, for example, rifampicin.
• Mood changes (swinging between depressive mood and euphoria), agitation, and irritation; these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• Depression, including certain serotoninergic medicines, for example, SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, sertraline, or herbal remedies or natural remedies that contain St. John's Wort (Hypericum perforatum).
• Epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide.
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole.

Also, read the section "Do not take Ziprasidone Viatris" above.

Ziprasidone Viatris with food, drink, and alcohol

Ziprasidone capsules MUST BE TAKEN DURING A MAIN MEAL.

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

Pregnancy and breastfeeding

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

Pregnancy

Do not take ziprasidone during pregnancy, unless your doctor advises you to do so, as there is a risk that this medicine may harm the fetus. 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.

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

Breastfeeding

You should not breastfeed while taking ziprasidone, as small amounts of the medicine may pass into breast milk. If you intend to breastfeed your child, ask your doctor for advice before taking this medicine.

Contraception

If you can become pregnant, you should use an effective method of contraception while taking this medicine.

Driving and using machines

Treatment with ziprasidone may cause drowsiness. If you experience this symptom, do not drive or use machines until the drowsiness goes away.

Ziprasidone Viatris contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking ziprasidone.

3. How to take Ziprasidone Viatris

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole, without chewing, and should be taken with food. It is important that you do not chew the capsules, as this could alter the absorption of the medicine in the intestine.

Ziprasidone should be taken twice a day, one capsule in the morning during a full breakfast and another in the evening during dinner (see the blister pack). You should take this medicine 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 recommended initial dose is 20 mg to be taken with a meal; subsequently, your doctor will indicate the optimal doses for you. Do not exceed the maximum dose of 80 mg per day in children who weigh 45 kg or less, or 160 mg per day in children who weigh more than 45 kg.

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

Elderly patients (over 65 years old)

If you are an elderly patient, your doctor will decide the suitable dose for you. The doses in elderly patients are sometimes lower than those used in younger people. Your doctor will indicate the appropriate dose for you.

Patient 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 (telephone 91 562 04 20), indicating the medicine and the amount ingested. Bring the ziprasidone package 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 forget to take Ziprasidone Viatris

It is important that you 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 make up for forgotten doses.

If you stop taking Ziprasidone Viatris

Your doctor will tell you how long you should take ziprasidone. Do not stop taking ziprasidone unless your doctor tells you to do so.

It is important that you continue taking the medication, even if you feel better. If you stop treatment too early, the symptoms may come back.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Nevertheless, most adverse effects are transient. It is often difficult to distinguish the symptoms of your disease from the adverse effects.

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

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

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

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

• Severe allergic reactions that may appear as swelling of the face, lips, tongue, or throat and cause problems with swallowing or breathing, skin itching.
• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased level of consciousness. These could be symptoms of a disorder known as malignant neuroleptic syndrome.
• Confusion, agitation, elevated temperature, sweating, loss of muscle coordination, muscle jerks. These could be symptoms of a disorder known as serotonin syndrome.
• Rapid and irregular heartbeats with fainting, these could be symptoms of a potentially fatal disorder known as "Torsades de Pointes".
• Skin reactions, especially eruptions with fever and inflamed lymph nodes, these could be symptoms of a disorder called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be fatal.
• Production of 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 the available data):

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

You may experience any of the adverse effects listed below. These possible adverse effects are generally mild or moderate and may disappear over time. However, if the adverse 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):

• Rhinitis.
• Agitated and hyperactive mood lasting a week or more (mania), agitation, anxiety.
• Restlessness, inability to sit or stay still.
• Abnormal movements, including involuntary and repetitive movements, muscle stiffness and hypertonia, slowness of movements, tremors, generalized weakness or fatigue.
• Dizziness.
• Blurred vision, other vision problems.
• Rapid heartbeat, high blood pressure.
• Constipation, diarrhea, nausea, vomiting, indigestion, dry mouth, increased salivation.
• Involuntary/unusual movements, especially of the face or tongue.
• Rash.
• Sexual problems in men.
• Fever, pain, weight gain or loss.

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

• Other allergic reactions.

• High levels of prolactin in the blood, which can be observed in a blood test.
• Increased appetite.
• Anxiety crisis, nervousness, depression.
• Decreased sexual desire (libido).
• Fainting.
• Difficulty controlling movement, restless legs.
• Feeling of pressure in the throat.
• Nightmares.
• Involuntary eye movements, which become a fixed gaze upwards, dry eyes, speech problems, numbness, muscle cramps, difficulty concentrating, drooling, excessive daytime sleepiness, exhaustion.
• Problems with balance, coordination, and speech (ataxia).
• Rapid and irregular heartbeats, which can feel like stabbing heartbeats in the chest (palpitations), feeling of dizziness when standing up, low blood pressure, difficulty breathing.
• Sensitivity to light, ringing in the ears, feeling that everything is spinning when standing up or sitting down (vertigo).
• Ear pain.
• Sore throat, difficulty swallowing, tongue problems, gas, stomach discomfort.
• Stomach inflammation, which causes 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.
• Enlargement of the breasts, both in men and women, abnormal production of breast milk, absence of menstruation in women.
• Thirst, chest discomfort, gait disturbance.
• Abnormal liver function test results, which can be observed in a blood test.
• Abnormal heart rate, which can be observed in an electrocardiogram (ECG).

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

• Decreased calcium levels in the blood.
• Agitated and hyperactive mood lasting a short period (hypomania), slowness of thought, lack of emotional expressiveness.
• Facial paralysis, muscle weakness (paresis).
• Complete or partial loss of vision in one eye, eye itching.
• Shortness of breath and difficulty breathing or speaking (laryngospasm).
• Hiccup.
• Soft stools.
• Swelling of the face, skin irritations, red skin.
• Inability to open the mouth.
• Nocturnal enuresis.
• Increased or decreased erection or erection problems, inability to reach orgasm.
• Feeling of heat.
• Increased or decreased white blood cell count, which can be observed in a blood test.
• High 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 the available data):

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

Reporting of Adverse Effects

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

5. Storage of Ziprasidona Viatris

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

Do not use this medicine after the expiration date that appears on the blister or carton. 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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at the of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment."

6. Package Contents and Additional Information

Composition of Ziprasidona Viatris

The active ingredient is ziprasidone.

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

The other ingredients are:

The capsule contents are polacrilin potassium, lactose monohydrate, povidone, magnesium stearate.

The capsule shell contains brilliant blue FCF (E-133), titanium dioxide (E-171), and gelatin.

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

Appearance of the Product and Package Contents

Hard gelatin capsule formed by a blue opaque capsule of size 1 (19.1 mm to 19.7 mm) and a white opaque body, with the printing in axial sense "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 unit-dose blisters containing 14 and 56 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 medicine 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:

Germany Ziprasidon Mylan 80 mg Hartkapseln

Slovakia Ziprasidon Mylan

Spain Ziprasidona Viatris

Portugal Ziprasidona Mylan

Czech Republic Ziprasidon Aurobindo

Date of the last revision of this leaflet:March 2020

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/