Leaflet: information for the user

Ziprasidone Stada 20 mg hard capsules EFG

Ziprasidone Stada 40 mg hard capsules EFG

Ziprasidone Stada 60 mg hard capsules EFG

Ziprasidone Stada 80 mg hard capsules EFG

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 of illness 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.

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

2. What you need to know before starting to take Ziprasidone Stada

3. How to take Ziprasidone Stada

4. Possible side effects

5. Storage of Ziprasidone Stada

6. Contents of the pack and additional information

Ziprasidona belongs to a group of medications known as antipsychotics.

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

Ziprasidona is also used for the treatment of moderate to severe manic or mixed episodes in bipolar disorderin adults, children and adolescents aged 10-17 years

- a mental disorder characterized by alternating phases of euphoria (mania) or depressive mood. 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 behavior

Do not take Ziprasidona Stada

- If you are allergic to ziprasidona or any of the other components of this medication (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 heart problems or have had a recent heart attack.

- If you take medications for heart rhythm or that may affect heart rhythm. See also the section "Interaction of Ziprasidona Stada with other medications" below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ziprasidona

- If you or a family member has a history of blood clots, as well as medications like these that have been associated with blood clot formation.

- If you have liver problems. - If you have or have had seizures or epilepsy.

- If you are an elderly patient (over 65 years old) and suffer from dementia and are at risk of having a stroke.

- If you have a significant decrease in resting heart rate and/or if you know you may have low blood sodium levels as a result of intense and prolonged diarrhea and vomiting (being ill) or the use of diuretics (urine tablets).

- If you experience rapid and irregular heartbeats, fainting, dizziness, or lightheadedness when standing, which may indicate abnormal heart rhythm.

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.

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

Interaction of Ziprasidona Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

DO NOT TAKE ZIPRASIDONA if you are taking medications for heart rhythm alterations ormedications that may affect heart rhythm, such as:

- Antiarrhythmic medications of class IA and III, arsenic trioxide, halofantrine, levometadilo acetate, mesoridazine, thioridazine, pimozide, esparfloxacine, gatifloxacine, moxifloxacine, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medications may alter heart rhythm by prolonging the QT interval. If you have any additional, consult your doctor.

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

-Bacterial infections, these medications are known as antibiotics; for example, macrolide antibiotics or rifampicin;

-Mood changes(from depressive mood to euphoria), agitation, and irritation, these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate;

-Depression, including some serotonin reuptake inhibitors, for example, SSRIs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies containing St. John's Wort;

-Epilepsyfor example, phenytoin, phenobarbital, carbamazepine, ethosuximide;

-Parkinson's diseasefor example, levodopa, bromocriptine, ropinirole, pramipexole.

- or if you are taking or have taken recently the following medications: verapamil, quinidine, itraconazole, or ritonavir.

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

Ziprasidona Stada with food, drinks, and alcohol

Ziprasidona MUST BE TAKEN DURING A MAIN MEAL (for example, breakfast and dinner).

Do not consume alcoholic beverages during treatment with ziprasidona, as this may increase the risk of adverse effects.

Pregnancy and breastfeeding

Pregnancy

Do not take ziprasidona during pregnancy unless your doctor tells you to, as there is a risk that this medication may harm your baby. Always use a suitable contraceptive method. Inform your doctor immediately if you become pregnant or are planning to become pregnant during treatment with ziprasidona.

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

Breastfeeding

Do not breastfeed while taking ziprasidona. This is because small amounts may pass into breast milk. If you plan to breastfeed your child, inform your doctor before taking this medication.

Driving and using machines

The taking of ziprasidona may cause drowsiness. If you experience this symptom, do not drive or use tools or machines until the drowsiness disappears.

Ziprasidona Stada contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

Adults

The recommended dose is 40-80 mg twice a day, taken with food.

Your doctor may adjust the dose in long-term treatments. Do not exceed the maximum dose of 160 mg per day.

Older adults (65 years and older)

If you are an older adult, your doctor will decide on the suitable dose for you. Doses in people over 65 are sometimes lower than those used in younger people. Your doctor will tell you what the correct dose is for you.

Liver problems

If you have liver problems, you may need to take a lower dose of ziprasidone. Your doctor will tell you what the correct dose is for you.

Use in children and adolescents with bipolar mania

The usual initial dose is 20 mg taken with a meal, after your doctor recommends the optimal dose 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.

Administration form

Oral.

The capsules should be swallowed whole without chewing and should be taken with meals. It is essential not to chew the capsules as it may affect the amount of the medication absorbed in the intestine.

Ziprasidone capsules should be taken twice a day, one capsule in the morning during a complete breakfast and another in the evening during dinner. You should take this medication at the same time every day.

If you take more Ziprasidone Stada than you should

Inform your doctor or go immediately to the nearest hospital emergency service. Bring your ziprasidone packaging with you.

If you have taken too much ziprasidone, you may experience drowsiness, tremors, seizures, and involuntary head and neck movements.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ziprasidone Stada

It is essential to take ziprasidone regularly at the same time every day. If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. In that case, simply take the next dose.

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

If you interrupt the treatment with Ziprasidone Stada

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

It is essential to continue with the medication, even if you feel better. If treatment is stopped too soon, symptoms may return.

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

Like all medications, ziprasidone may cause side effects, although not everyone will experience them.

However, most side effects are transient. It can often be difficult to distinguish the symptoms of your illness from side effects.

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.

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

- Restlessness

- Movement disorders, including involuntary movements, muscle stiffness, and rigidity, slowness of movement, tremors, general weakness, and fatigue,

- Dizziness

- Drowsiness

- Headache

- Constipation, nausea, vomiting, and indigestion, dry mouth, increased salivation

- Blurred vision.

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

- Increased appetite

- Difficulty controlling movements

- Feeling of agitation or anxiety, sensation of throat constriction, nightmares,

- Convulsions, involuntary eye movements in a fixed position, clumsiness, speech alteration, numbness, tingling, decreased ability to concentrate, drooling, excessive daytime sleepiness, exhaustion

- Palpitations, sensation of fainting when standing, difficulty breathing

- Sensitivity to light, buzzing in the ears

- Sore throat, difficulty swallowing, tongue inflammation, diarrhea, gas, stomach discomfort.

- Skin rash with itching, acne

- Muscle cramps, joint stiffness or swelling

- Thirst, pain, chest discomfort, altered gait

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

- Nasal discharge

- Decreased calcium levels in the blood

- Panic attack, feeling of depression, slow thinking, lack of emotions

- Unusual head position (twisted neck or torticollis), paralysis, restless legs

- Partial or complete loss of vision in one eye, eye itching, dry eyes, visual disturbances

- Ear pain

- Hiccup

- Acid reflux

- Liquid stools

- Hair loss, facial inflammation, skin irritation

- Inability to open mouth

- Urinary incontinence, pain or difficulty urinating, urinary retention (if unable to completely empty the bladder)

- Reduced or increased erection, reduced orgasm, abnormal milk production

- Breast enlargement in men and women

- Feeling of heat, fever

- Decreased or increased white blood cell count (in blood tests)

- Abnormal liver function tests

- High blood pressure

- Alterations in blood or heart rhythm tests

- Red, inflamed, scaly patches of skin, known as psoriasis.

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

- Severe allergic reaction

- 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.

- Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

- Difficulty sleeping, involuntary urination

- Extremely elevated mood, strange thought patterns, and hyperactivity.

- Loss of consciousness

- Appearance of large, itchy hives (hives).

- Facial paralysis

- Neonatal drug suppression syndrome.

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 not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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 medication.

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

Do not use this medication after the expiration date that appears on the box or blister 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 trash. Dispose of packaging and medications you no longer need at the SIGRE point of your 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 Ziprasidone Stada

-The active ingredient is ziprasidone.

Ziprasidone Stada 20 mg hard capsules: Each capsule contains 20 mg of ziprasidone as ziprasidone hydrochloride monohydrate.

Ziprasidone Stada 40 mg hard capsules: Each capsule contains 40 mg of ziprasidone as ziprasidone hydrochloride monohydrate.

Ziprasidone Stada 60 mg hard capsules: Each capsule contains 60 mg of ziprasidone as ziprasidone hydrochloride monohydrate.

Ziprasidone Stada 80 mg hard capsules: Each capsule contains 80 mg of ziprasidone as ziprasidone hydrochloride monohydrate.

-The other components (excipients) are:

Capule content:lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, magnesium stearate.

Capsule:

Ziprasidone Stada 20 mg hard capsules: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), iron oxide black (E172).

Ziprasidone Stada 40 mg hard capsules: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), iron oxide black (E172).

Ziprasidone Stada 60 mg hard capsules: gelatin, titanium dioxide (E171).

Ziprasidone Stada 80 mg hard capsules: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), iron oxide black (E172).

Appearance of the product and contents of the package

Ziprasidone Stada are hard gelatin capsules.

Ziprasidone Stada 20 mg hard capsules are blue/white hard capsules, size number 4, with an approximate length of 14.3 mm.

Ziprasidone Stada 40 mg hard capsules are blue hard capsules, size number 3, with an approximate length of 15.9 mm.

Ziprasidone Stada 60 mg hard capsules are white hard capsules, size number 1, with an approximate length of 19.4 mm.

Ziprasidone Stada 80 mg hard capsules are blue/white hard capsules, size number 0, with an approximate length of 21.7 mm.

Aluminum/aluminum blisters in boxes containing:

Ziprasidone Stada 20 mg hard capsules: 10, 14, 30, 56 or 100 capsules.

Ziprasidone Stada 40 mg hard capsules: 10, 14, 30, 56 or 100 capsules.

Ziprasidone Stada 60 mg hard capsules: 30, 56 or 100 capsules.

Ziprasidone Stada 80 mg hard capsules: 30, 56 or 100 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Stada Arzneimittel AG

Stadastrasse 2 – 18.

61118 Bad Vilbel

Germany

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

Danish:Ziprasidon STADA

German:Ziprasidon STADA 20/40/60/80 mg Hartkapseln

Portuguese:Ziprasidona Ciclum

Spanish:Ziprasidona Stada 20/40/60/80 mg hard capsules EFG

Swedish:Ziprasidon STADA kapslar, hårda

Last review date of this leaflet:July 2020.

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