Leaflet: information for the user

Ziprasidone hydrochloride 20 mg hard capsules EFG

ziprasidone hydrochloride

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

• Keep this leaflet, as 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Ziprasidone cinfa capsules is a medication belonging to the group of medications known as antipsychotics.

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

Furthermore, ziprasidone is used in adults and in children and adolescents from 10 to 17 years old for the treatment of symptoms of moderate severity mania in bipolar disorder, a mental illness characterized by alternating phases of euphoric mood states (mania) or depressed states. 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 repetition of risky behaviors.

Do not take ziprasidona cinfa

• If you are allergic to ziprasidona or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognized by the appearance of a skin rash, itching, swollen face or lips, difficulty breathing.
• If you have or have had any heart disease or have recently had a heart attack.
• If you are taking medicines for heart rhythm disturbances (arrhythmias) or medicines that can affect heart rhythm.

See the section “Taking ziprasidona cinfa with other medicines” later.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ziprasidona cinfa:

• If you or a family member has a history of blood clots, as this type of medicine has 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 and have dementia and are at high risk of having a stroke (cerebrovascular accident)
• If you have a significant decrease in resting heart rate and/or know that you may have low levels of salts in the blood as a result of prolonged diarrhea and vomiting or the use of diuretics (which promote the elimination of excess fluids)
• If you experience symptoms such as rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, as this may indicate abnormal heart rhythm function.

Immediately contact your doctor if you experience any of the following symptoms:

• Severe skin reactions such as, for example, a rash with blisters that could be accompanied by mouth ulcers, skin peeling, fever, and skin spots in the shape of a target that could be symptoms of Stevens-Johnson syndrome.These skin reactions could be potentially fatal.
• Ziprasidona can cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. You should be cautious, especially if you are an elderly patient or have weakness.

Inform your doctor that you are taking ziprasidona cinfa capsules before undergoing any diagnostic tests (including blood tests, urine tests, liver function tests, heart rhythm tests, etc.) as it may alter the results.

Children and adolescents

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

Taking ziprasidona cinfa with other medicines

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

Do not take Ziprasidona cinfaif you are taking medicines for heart rhythm disturbances or medicines that can affect heart rhythm, such as:

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

Consult your doctor or pharmacist before starting to take Ziprasidona cinfa.

Inform your doctor or pharmacist if you are using or have used recently medicines for the treatment of:

• Bacterial infections; these medicines are known as antibiotics; for example, macrolide antibiotics or rifampicin;
• Mood changes (from depressive mood to euphoria), agitation, and irritability; these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate;
• Depression, including some selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies containing St. John's Wort;
• Epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole;
• Or if you are taking or have taken recently the following medicines: see the section “Do not take ziprasidona cinfa” earlier.

See the section “Do not take ziprasidona cinfa” earlier.

Taking ziprasidona cinfa with food, drinks, and alcohol

Ziprasidona cinfa capsules MUST BE TAKEN DURING MAIN MEALS.

Do not consume alcoholic beverages during treatment with ziprasidona cinfa capsules, as this 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 medicine.

Pregnancy:

Do not take ziprasidona cinfa capsules during pregnancy unless your doctor tells you to, as this medicine may harm your baby. Always use a suitable contraceptive method.

The following symptoms may occur in newborn babies of mothers who have taken ziprasidona in the last trimester (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, tendency to sleep, agitation, respiratory problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding:

Do not breastfeed your baby while taking ziprasidona cinfa capsules. This is because small amounts may pass into breast milk.

Contraception:

If you can become pregnant, you should use a suitable contraceptive method while taking this medicine.

Driving and operating machinery

Ziprasidona may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Ziprasidona cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

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

The capsules should be swallowed whole, without chewing, and should be taken with food. It is essential not to chew the capsules, as this may affect the point at which the medication is absorbed in the intestine.

Ziprasidone hydrochloride capsules should be taken twice a day, one capsule in the morning during a consistent breakfast and one in the evening during dinner (see blister). Make sure to take this medication at the same time every day.

Adults

The recommended dose is 40 to 80 mg of ziprasidone twice a day with food.

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

Children and adolescents with bipolar mania

The recommended starting dose for treatment is 20 mg per day in a single dose with food, after which your doctor will indicate your optimal dose. It is recommended not to exceed the maximum dose established by weight range of 160 mg per day in the case of children weighing 45 kg or more and 80 mg per day in children weighing less than 45 kg.

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

Individuals 65 years of age or older

If you are 65 years of age or older, your doctor will decide on the suitable dose for you. The dose for individuals 65 years of age or older is sometimes lower than that used in younger individuals. Your doctor will indicate the appropriate dose for you.

Patients with liver problems

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

If you take more ziprasidone hydrochloride than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken too much ziprasidone hydrochloride, you may experience drowsiness, tremors, convulsions, and involuntary movements of the head and neck.

If you forget to take ziprasidone hydrochloride

It is essential to take ziprasidone hydrochloride at the same time every day. If you forget to take a dose, take it as soon as you remember. However, if it is close to the next dose, skip the missed dose and take the next one at its scheduled time.

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

If you interrupt treatment with ziprasidone hydrochloride

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

It is essential to continue treatment, even if you feel better. If you stop treatment too soon, symptoms may return.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It can often be difficult to distinguish the symptoms of your illness from side effects.

STOP taking ziprasidone cinfa and contact your doctor immediately if you experience any of the following serious side effects:

Frequent side effects (may affect up to 1 in 10 patients):

• Unusual or involuntary movements, especially in your face or tongue.

Rare side effects (may affect up to 1 in 100 patients):

• Fast or irregular heartbeat, feeling of dizziness when standing, which may indicate an abnormal heart function. These could be symptoms of a condition known as postural hypotension.

Very rare side effects (may affect up to 1 in 1,000 patients):

• Swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing, urticaria. These could be symptoms of a severe allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle rigidity, tremor, difficulty swallowing, and decreased consciousness, these could be symptoms of a condition known as malignant neuroleptic syndrome.
• Skin reactions, especially hives, fever, and inflammation of the lymph nodes, which could be symptoms of a condition known as drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially fatal.
• Confusion, agitation, fever, sweating, muscle movement disorder, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Fast, irregular heartbeat, dizziness, which could be symptoms of a life-threatening condition known as Torsades de Pointes.
• Persistent and painful erection of the penis.

You may experience some of the side effects mentioned below. These potential side effects are generally mild to moderate in nature and may disappear over time. However, if the side effect is severe or persistent, contact your doctor.

Very frequent side effects (may affect more than 1 in 10 patients):

• Difficulty sleeping.
• Excessive daytime sleepiness or drowsiness.
• Headache.

Frequent side effects (may affect up to 1 in 10 patients):

• Coughing.
• Exalted mood, strange thought patterns, and hyperactivity, feeling of agitation or anxiety.
• Restlessness.
• Abnormal movements, including involuntary movements, muscle stiffness, slow movements.
• Dizziness.
• Sedation.
• Blurred or impaired vision.
• High blood pressure.
• Constipation, diarrhea, nausea, vomiting, and indigestion, dry mouth, increased salivation.
• Rash.
• Male sexual problems.
• Fever.
• Pain.
• Weight loss or gain.
• Fatigue.
• General feeling of being unwell.

Rare side effects (may affect up to 1 in 100 patients):

• Elevated levels of prolactin in the blood.
• Increased appetite.
• Panic attack.
• Feeling of nervousness or depression.
• Decreased libido.
• Loss of consciousness.
• Difficulty controlling movements/involuntary movements.
• Restless legs.
• Sensation of throat constriction, nightmares.
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech alteration, numbness, feeling of pins and needles, decreased concentration ability, drooling.
• Palpitations, difficulty breathing.
• Sensitivity to light, dry eyes, ear noises, ear pain.
• Throat pain, gas, stomach discomfort.
• Rash on the skin that often itches, acne.
• Muscle cramps, stiffness, or swelling of the joints.
• Thirst, chest discomfort, gait alteration.
• Acid reflux, stomach pain.
• Hair loss.
• Abnormal head position.
• Incontinence, pain or difficulty urinating.
• Abnormal milk production.
• Male breast enlargement.
• Amenorrhea.
• Abnormal blood and heart function tests.
• Abnormal liver function tests.
• Dizziness.
• General weakness and fatigue.

Very rare side effects (may affect up to 1 in 1,000 patients):

• Decreased calcium levels in the blood.
• Slowness of thought, lack of emotional expressiveness.
• Facial paralysis.
• Paralysis.
• Partial or complete loss of vision in one eye, eye itching.
• Difficulty speaking, hiccups.
• Soft stools.
• Skin irritation.
• Inability to open the mouth.
• Difficulty emptying the bladder.
• Withdrawal syndrome in newborns.
• Reduced orgasm.
• Sensation of heat.
• Increased or decreased white blood cell count (in blood tests).
• Areas of red, inflamed skin covered with white scales, known as psoriasis.

Unknown frequency (cannot be estimated from available data):

• In elderly patients with dementia, a small increase in the number of deaths has been observed in those patients treated with antipsychotics compared to those not taking antipsychotics.
• Clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

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 Vigilance of Medicinal Products 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.

Blister packs:

Do not store at a temperature above 30°C.

Bottles:

Do not store at a temperature above 30°C.

Shelf life once the packaging is opened: 6 months

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of ziprasidone cinfa

• The active ingredient is ziprasidone. Each hard capsule contains 20 mg of ziprasidone in the form of ziprasidone hydrochloride.
• The other components are:
  Hard capsule content:anhydrous colloidal silica, sodium croscarmellose, pregelatinized maize starch, magnesium stearate.
  Body and cap of the hard capsule:gelatin, titanium dioxide (E-171), indigotin blue (E-132).

Appearance of the product and contents of the packaging

Ziprasidone cinfa 20 mg hard capsules are presented in the form of hard gelatin capsules. The capsules are blue and white.

Packaging sizes:

Aluminum/aluminum blisters containing 14, 20, 30, 50, 56, 60, or 100 capsules.

HDPE plastic bottles containing 100 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra)-Spain

Responsible manufacturer

PharmaPath S.A

28is October 1,

Agia Varvara, 123 51

Greece

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:May 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80958/P_80958.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80958/P_80958.html