Ziprasidone Stada 80 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ziprasidona Stada 20 mg hard capsules EFG

Ziprasidona Stada 40 mg hard capsules EFG

Ziprasidona Stada 60 mg hard capsules EFG

Ziprasidona Stada 80 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ziprasidone belongs to a group of medicines called antipsychotics.

Ziprasidone is used to treat schizophrenia in adults – a mental disorder characterized by symptoms such as hearing, seeing, or sensing things that do not exist, believing in things that are not true, unusual suspiciousness, social withdrawal and difficulty forming social relationships, restlessness, depression, or anxiety.

Ziprasidone is also used to treat moderate to severe manic or mixed episodes in bipolar disorder in adults, and in 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, inflated self-esteem, increased energy, reduced need for sleep, difficulty concentrating, hyperactivity, and repeated high-risk behavior.

2. What you need to know before taking Ziprasidona Stada

Do not take Ziprasidona Stada

• If you are allergic to ziprasidone or to 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, swelling of the face or lips, or difficulty breathing.
• If you have heart problems or have recently had a heart attack.
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm. Also refer to the section "Interaction of Ziprasidona Stada with other medicines" below.

Warnings and precautions

Talk to your doctor or pharmacist before starting ziprasidone

• If you or someone in your family has a history of blood clots, or if you have taken medicines 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 of age) with dementia and at risk of stroke.
• If you have a significantly reduced resting heart rate and/or if you know you may experience low levels of blood salts due to severe and prolonged diarrhoea and vomiting (when ill) or the use of diuretics (water tablets).
• If you experience rapid or irregular heartbeats, fainting, syncope, or dizziness upon standing, which may indicate abnormal heart rhythm.

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

• Severe skin reactions such as rash with blisters, possibly accompanied by mouth ulcers, skin peeling, fever, and target-like skin lesions, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially life-threatening.

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

Interaction of Ziprasidona Stada with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

DO NOT TAKE ZIPRASIDONE if 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, levometadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medicines may alter heart rhythm by prolonging the QT interval. If you have any questions, consult your doctor.

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

• Bacterial infections, known as antibiotics; for example, macrolide antibiotics or rifampicin;
• Mood changes (from depression to euphoria), agitation, and irritability, 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 or natural products 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 recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

Also refer to the section "Do not take Ziprasidona Stada" above.

Ziprasidona Stada with food, drinks and alcohol

Ziprasidone MUST BE TAKEN DURING A MAIN MEAL (e.g., breakfast or dinner).

You should not drink alcohol while being treated with ziprasidone, as this may increase the risk of adverse effects.

Pregnancy and breastfeeding

Pregnancy

You should not take ziprasidone during pregnancy unless your doctor specifically tells you to, because there is a risk this medicine could harm your baby. Always use an effective method of contraception. Inform your doctor immediately if you become pregnant or are planning to become pregnant while taking ziprasidone.

The following symptoms may occur in newborns whose mothers have taken ziprasidone during the last trimester (last three months of pregnancy): tremor, 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

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

Driving and using machines

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

Ziprasidona Stada contains lactose and sodium

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

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

3. How to take Ziprasidona Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults

The recommended dose is 40–80 mg twice daily, taken with food.

For long-term treatment, your doctor may adjust your dose. The maximum daily dose must not be exceeded, which is 160 mg per day.

Elderly patients (over 65 years of age)

If you are elderly, your doctor will decide the appropriate dose for you. Doses in patients over 65 may sometimes be lower than those used in younger individuals. 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 advise you on 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 your doctor has recommended the optimal dose for you. The maximum daily dose must not exceed 80 mg in children weighing 45 kg or less, or 160 mg per day 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.

Instructions for use

Oral use.

The capsules must be swallowed whole and not chewed, and should be taken with meals. It is important not to chew the capsules, as this may affect how the medicine is absorbed in the intestine.

Ziprasidona capsules should be taken twice daily—one capsule in the morning with breakfast and another in the evening with dinner. You should take this medicine at the same time each day.

If you take more Ziprasidona Stada than you should

Contact your doctor or go immediately to the nearest hospital emergency department. Take your ziprasidona packaging 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 or pharmacist, or call the Toxicology Information Service at telephone: (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ziprasidona Stada

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

Do not take a double dose to make up for a missed dose.

If you stop taking Ziprasidona Stada

Your doctor will advise you on how long you should take ziprasidona. You must not stop taking ziprasidona unless your doctor tells you to do so.

It is important to continue taking the medication, even if you feel well. If treatment is stopped 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, ziprasidone may cause adverse effects, although not everyone experiences them.

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

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

Common (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

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

• Increased appetite
• Difficulty controlling movements
• Feeling agitated or anxious, sensation of throat tightness, nightmares
• Seizures, involuntary eye movements with fixed gaze, clumsiness, speech disturbances, numbness, tingling sensations, reduced ability to concentrate, drooling, excessive daytime sleepiness, exhaustion
• Palpitations, feeling faint upon standing, difficulty breathing
• Light sensitivity, ringing in the ears (tinnitus)
• Sore throat, difficulty swallowing, tongue swelling, diarrhea, flatulence, stomach discomfort
• Itchy skin rash, acne
• Muscle cramps, joint stiffness or swelling
• Thirst, pain, chest discomfort, changes in walking pattern

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

• Runny nose
• Decreased levels of calcium in the blood
• Panic attack, feeling depressed, slowed thinking, emotional blunting
• Unusual head posture (twisted neck or torticollis), paralysis, restless legs
• Partial or complete loss of vision in one eye, eye itching, dry eyes, visual disturbances
• Ear pain
• Hiccups
• Acid reflux
• Watery stools
• Hair loss, facial swelling, skin irritations
• Inability to open the mouth
• Urinary incontinence, pain or difficulty urinating, urinary retention (if you cannot fully empty the bladder)
• Reduced or increased erection, reduced orgasm, abnormal production of breast milk
• Breast enlargement in both men and women
• Feeling of warmth, fever
• Decrease or increase in white blood cells (seen in blood tests)
• Abnormal liver function tests
• High blood pressure
• Abnormalities in blood tests or heart rhythm
• Raised, inflamed red patches on the skin covered with white scales, 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 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 may travel through 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, unusual thought patterns, and hyperactivity
• Loss of consciousness
• Appearance of large, intensely itchy hives (wheals)
• Facial paralysis
• Drug withdrawal syndrome in newborns

Reporting of adverse effects:

If you experience any adverse effect, consult 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 Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the carton or blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ziprasidona Stada

• The active substance 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 contents: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, magnesium stearate.

Capsule shell:

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

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

Appearance of the medicinal product and contents of the pack

Ziprasidona Stada are hard gelatin capsules.

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

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

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

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

Aluminium/aluminium blisters in cartons 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 certain 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 European Economic Area member states 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 capsules, hard

Date of the most recent revision of this leaflet: July 2020.

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