Ziprasidone Viatris 40 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ziprasidone Viatris 40 mg hard capsules EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ziprasidone VIATRIS is and what it is 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seeing, or feeling things that do not exist, believing in something that is not real, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression, or anxiety.

Ziprasidone is also used for the treatment of moderate 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 euphoric (manic) and depressed mood. During manic episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, reduced need for sleep, lack of concentration, hyperactivity, and repeated high-risk behaviors.

2. What you need to know before starting to take Ziprasidona Viatris

Do not take Ziprasidona Viatris

• If you are allergic to ziprasidone or to any of the other ingredients of this medicine (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 medicines to treat heart rhythm problems or medicines that may affect heart rhythm.

See also the section “Other medicines and Ziprasidona Viatris” below.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ziprasidona Viatris:

• If you or a family member has a history of blood clots, as medicines like this have been associated with 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 stroke.
• If you have a low resting heart rate and/or know you may have a deficiency of salts due to severe and prolonged diarrhoea or vomiting, or due to diuretic use.
• If you experience symptoms such as rapid or irregular pulse, fainting, collapse, or dizziness upon standing, which could indicate abnormal heart rhythm function.

Inform your doctor that you are taking Ziprasidona Viatris before undergoing any laboratory test (blood, urine, liver function, heart rate, etc.), as it may alter 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 blistering rashes, which may include mouth ulcers, skin peeling, fever, and target-like spots on the skin, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could potentially be life-threatening.
• Ziprasidone may cause drowsiness, low blood pressure upon standing, dizziness, and gait disturbances, which may lead to falls. Caution is advised, especially if you are an elderly patient or have any physical weakness.

Other medicines and Ziprasidona Viatris

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

Do not take Ziprasidona Viatris

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

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

Inform 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 (oscillating between depressive mood and euphoria), agitation, and irritability; these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate.
• Depression, including certain serotonergic medicines, for example, SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, sertraline, or herbal remedies containing St. John's wort (Hypericum perforatum).
• Epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide.
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole.

See also the section "Do not take Ziprasidona Viatris" above.

Ziprasidona 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 adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not take ziprasidone during pregnancy unless specifically instructed by your doctor, as there is a risk that this medicine may harm the unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborns whose mothers have taken ziprasidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows 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 plan to breastfeed, consult your doctor before taking this medicine.

Contraception

If you are able to become pregnant, you should use an appropriate method of contraception while taking this medicine.

Driving and using machines

Treatment with ziprasidone may cause drowsiness. If you experience this symptom, you should not drive or operate machinery until drowsiness subsides.

Ziprasidona Viatris contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking ziprasidone.

3. How to take Ziprasidone Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Ziprasidone should be taken twice daily, one capsule in the morning with a full breakfast and another in the evening with dinner (see the blister pack). You must take this medicine at the same time each day.

Adults

The recommended dose is 40–80 mg twice daily with meals.

For long-term treatment, your doctor may adjust the dose. The maximum daily dose must not exceed 160 mg.

Use in children and adolescents with bipolar mania

The recommended initial dose is 20 mg to be taken with a meal; thereafter, your doctor will indicate the optimal doses for you. The maximum daily dose must not exceed 80 mg in children weighing 45 kg or less, or 160 mg daily in children weighing more than 45 kg.

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

Elderly patients (over 65 years of age)

If you are an elderly patient, your doctor will decide the appropriate dose for you. Doses in patients over 65 years of age are sometimes lower than those used in younger individuals. Your doctor will indicate the suitable dose 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 appropriate dose for you.

If you take more Ziprasidone Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested. Take the ziprasidone package with you.

If you have taken too many ziprasidone capsules, you may experience drowsiness, tremor, 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 a missed dose.

If you stop taking Ziprasidone Viatris

Your doctor will indicate 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, symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most adverse effects, however, are temporary. It is often difficult to distinguish the symptoms of your illness from adverse effects.

Contact 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 unwell (nausea), discomfort (vomiting), severe anxiety, or difficulty breathing. These are signs of very high blood pressure, which may affect organs (hypertensive crisis).
• Seizures (fits).

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, causing difficulty swallowing or breathing, or skin itching.
• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and decreased level of consciousness. These could be symptoms of a disorder known as neuroleptic malignant syndrome.
• Confusion, agitation, high 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 life-threatening disorder known as "Torsades de Pointes".
• Skin reactions, especially rashes with fever and swollen lymph nodes; these could be symptoms of a disorder called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be fatal.
• Little or no urine production, pain or discomfort when urinating, cloudy or dark urine with lower back pain. These signs could indicate serious kidney problems.
• Persistent, abnormal, and painful penile erection.

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

• Blood clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which could travel from 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 in intensity 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):

• Runny nose.
• Agitated and hyperactive mood lasting one week or more (mania), restlessness, anxiety.
• Inability to sit still or remain at rest (akathisia).
• Movement disorders, including involuntary and repetitive movements, muscle rigidity and hypertonia, slowness of movement, tremors, generalized weakness or fatigue.
• Dizziness.
• Blurred vision, other vision problems.
• Fast 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 weight loss.

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

• Other allergic reactions.
• Elevated levels of prolactin in the blood, which may be observed in a blood test.
• Increased appetite.
• Panic attacks, nervousness, depression.
• Decreased sexual desire (libido).
• Fainting.
• Difficulty controlling movement, restless legs.
• Sensation of tightness in the throat.
• Nightmares.
• Involuntary eye movements resulting in fixed upward gaze, dry eyes, speech difficulties, numbness, muscle cramps, difficulty concentrating, drooling, excessive daytime sleepiness, exhaustion.
• Problems with balance, coordination, and speech (ataxia).
• Rapid and irregular heartbeats, which may be felt as pounding in the chest (palpitations), dizziness upon standing, low blood pressure, difficulty breathing.
• Light sensitivity, ringing in the ears (tinnitus), sensation of spinning when standing up or sitting (vertigo).
• Ear pain.
• Sore throat, difficulty swallowing, tongue problems, flatulence, stomach discomfort.
• Stomach inflammation causing abdominal bloating, pain, vomiting blood, or black stools.
• Acid reflux.
• Hives, acne, flat red areas on the skin covered with small bumps, hair loss.
• Unusual head position (torticollis).
• Pain in arms, legs, hands, or feet, muscle or bone discomfort.
• Muscle cramps, stiff joints.
• Inability to control urination, pain or difficulty urinating.
• Breast enlargement in both men and women, abnormal production of breast milk, absence of menstruation in women.
• Thirst, chest discomfort, gait disturbance.
• Abnormal liver function test results, which may be seen in a blood test.
• Abnormal heart rate as seen on an electrocardiogram (ECG).

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

• Decreased levels of calcium in the blood.
• Brief periods of agitated and hyperactive mood (hypomania), slowed thinking, reduced emotional expressiveness.
• Facial paralysis, muscle weakness (paresis).
• Complete or partial loss of vision in one eye, itchy eyes.
• Suffocation and difficulty breathing or speaking (laryngospasm).
• Hiccups.
• Soft stools.
• Swelling of the face, skin irritations, red skin.
• Inability to open the mouth.
• Involuntary nighttime urination (nocturnal enuresis).
• Increased erection or erection problems, inability to achieve orgasm.
• Feeling of warmth.
• Increase or decrease in white blood cell count, which may be observed in a blood test.
• High blood pressure that fluctuates from normal to high and then returns to normal.
• Abnormal blood test results.
• Red, inflamed, and raised skin areas 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 patients with dementia, a small increase in the number of deaths has been reported in patients taking antipsychotics compared to those who did not.
• Unusual patterns of thinking and hyperactivity.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ziprasidone Viatris

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

Do not use this medicine after the expiry date stated on the blister pack or the carton. The expiry date is the last day of the month indicated.

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

“Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.”

6. Contents of the pack and other information

Composition of Ziprasidone Viatris

The active substance is ziprasidone.

Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 40 mg of ziprasidone.

The other components are:

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

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

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

Appearance of the product and contents of the pack

Hard gelatin capsule consisting of an opaque blue size 3 cap (from 15.6 mm to 16.2 mm) and an opaque blue body, printed axially with "MYLAN" above "ZE40" in black ink on both the cap and body.

Ziprasidone 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 certain 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Ziprasidon Mylan 40 mg Hartkapseln
Slovakia: Ziprasidon Mylan
Spain: Ziprasidona Viatris
Portugal: Ziprasidona Mylan
Czech Republic: Ziprasidon Aurobindo

Date of the most recent revision of this leaflet: March 2020

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