ZIPRASIDONE STADA 80 mg HARD CAPSULES

Introduction

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

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

Ziprasidone belongs to a group of medicines called antipsychotics.

Ziprasidone 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, feeling 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 disorderin adults, children, and adolescents aged 10-17 years

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

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

Do not take Ziprasidone Stada

• If you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may 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 recently had a heart attack.
• If you are taking medicines for heart rhythm disorders or that may affect heart rhythm. See also the section "Interaction of Ziprasidone Stada with other medicines" below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ziprasidone

• If you or someone in your family has a history of blood clots, as well as medications such as these that 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 an elderly patient (over 65 years old) and suffer from dementia and are at risk of suffering a stroke.
• If you have a significant decrease in resting heart rate and/or if you know that you may have low levels of salts in the blood as a result of intense and prolonged diarrhea and vomiting (being sick) or the use of diuretics (pills to urinate).
• If you experience rapid and irregular heartbeats, fainting, syncope, or dizziness when standing up, which may indicate abnormal heart rhythm function.

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

• Severe skin reactions such as, for example, rash with blisters that may be accompanied by ulcers in the mouth, skin peeling, fever, and skin spots with a target shape that may be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially fatal.

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

Interaction of Ziprasidone Stada with other medicines

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

DO NOT TAKE ZIPRASIDONEif you are taking medicines for heart rhythm disorders or medicines that may 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 may alter the heart rhythm by prolonging the QT interval. If you have any additional questions, consult your doctor.

Tell your doctor or pharmacist if you are using or have recently used 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 irritation, these medicines are known as mood stabilizers, for example, lithium, carbamazepine, valproate;
• Depression, including some 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;
• Epilepsy, for example, phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, for example, levodopa, bromocriptine, ropinirole, pramipexole.
• or if you are taking or have recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

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

Ziprasidone Stada with food, drinks, and alcohol

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

You should not drink alcoholic beverages during treatment with ziprasidone, as this may increase the risk of side effects.

Pregnancy and breastfeeding

Pregnancy

You should not take ziprasidone during pregnancy unless your doctor tells you to, because there is a risk that this medicine may harm your baby. Always use an adequate contraceptive method. Tell your doctor immediately if you become pregnant or plan to become pregnant during treatment with ziprasidone.

The following symptoms may occur in newborns of mothers who have used ziprasidone 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 has any of these symptoms, it is possible that you need to contact your doctor.

Breastfeeding

Do not breastfeed if you are taking ziprasidone. This is because small amounts may pass into breast milk. If you plan to breastfeed your child, tell your doctor before taking this medicine.

Driving and using machines

Taking ziprasidone may make you feel drowsy. If you experience this symptom, do not drive or use tools or machines until the drowsiness disappears.

Ziprasidone 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 medicine.

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

3. How to take Ziprasidone Stada

Follow the instructions for administration of this medicine exactly as 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.

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

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 tell you what the correct dose is for you.

Liver problems

If you have liver problems, it may be necessary to take a lower dose of ziprasidone. Your doctor will tell you the correct dose for you.

Use in children and adolescents with bipolar mania

The usual initial dose is 20 mg taken with a meal, after the 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.

Method of administration

Oral use.

The capsules should be swallowed whole without chewing and should be taken with meals. It is important not to chew the capsules as this may affect the way the medicine is 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 medicine at the same time every day.

If you take more Ziprasidone Stada than you should

Tell your doctor or go immediately to the emergency department of the nearest hospital. Take your ziprasidone package with you.

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

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

If you forget to take Ziprasidone Stada

It is important that you 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 make up for forgotten doses.

If you stop taking Ziprasidone Stada

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

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

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

4. Possible side effects

Like all medicines, ziprasidone can cause side effects, although not everybody gets them.

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

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

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

• Restlessness
• Abnormalities of movement, including involuntary movements, muscle stiffness, and rigidity, slowness of movement, tremors, weakness, and fatigue
• Dizziness
• Drowsiness
• Headache
• Constipation, nausea, vomiting, and indigestion, dry mouth, increased salivation
• Blurred vision

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

• Increased appetite
• Difficulty controlling movements
• Feeling of agitation or anxiety, feeling of oppression in the throat, nightmares
• Seizures, involuntary movements in the eyes from a fixed position, clumsiness, speech disturbance, numbness, tingling sensation, decreased ability to concentrate, drooling, excessive daytime sleepiness, exhaustion
• Palpitations, feeling of fainting when standing up, difficulty breathing
• Sensitivity to light, ringing in the ears
• Sore throat, difficulty swallowing, tongue inflammation, diarrhea, gas, stomach discomfort
• Itchy skin rash, acne
• Muscle cramps, stiffness, or swelling of the joints
• Thirst, pain, discomfort in the chest, alteration in gait

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

• Rhinorrhea
• Decreased calcium levels in the blood
• Panic attack, feeling of depression, slow thinking, lack of emotions
• Unusual position of the head (twisted neck or torticollis), paralysis, restless legs
• Partial or total loss of vision in one eye, itchy eyes, dry eyes, vision disturbances
• Ear pain
• Hiccup
• Acid reflux
• Diarrhea
• Hair loss, facial inflammation, skin irritation
• Inability to open the mouth
• Urinary incontinence, pain or difficulty urinating, urinary retention (if you cannot empty the bladder completely)
• Reduced or increased erection, reduced orgasm, abnormal production of breast milk
• Increased breast size 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
• Abnormalities in blood tests or heart rhythm
• Red, raised, and inflamed areas of skin covered with white scales, known as psoriasis.

Frequency not known (cannot be estimated from the 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 who were 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, go to the doctor immediately.
• Difficulty sleeping, involuntary urination
• Extremely elevated mood, strange thought patterns, and hyperactivity.
• Loss of consciousness
• Appearance of large hives with intense itching.
• Facial paralysis
• Drug withdrawal syndrome in newborns.

Reporting of side effects:

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

5. Storage of Ziprasidone Stada

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

Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Ziprasidona Stada

• The active ingredient is ziprasidone.

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

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

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

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

• The other components (excipients) are:

Capsule content:lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.

Capsule:

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

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

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

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

Appearance of the Product and Container Content

Ziprasidona Stada are hard gelatin capsules.

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

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

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

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

Aluminum/aluminum blisters in boxes containing:

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

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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 under the following names:

Denmark: Ziprasidon STADA

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

Portugal: Ziprasidona Ciclum

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

Sweden: Ziprasidon STADA kapslar, hårda

Date of the Last Revision of this Leaflet:July 2020.

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