Ziprasidone Sandoz 60 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ziprasidona Sandoz 20 mg hard capsules EFG

Ziprasidona Sandoz 40 mg hard capsules EFG

Ziprasidona Sandoz 60 mg hard capsules EFG

Ziprasidona Sandoz 80 mg hard capsules EFG

Ziprasidone (monohydrate hydrochloride)

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

Leaflet contents

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

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

Ziprasidone Sandoz contains the active substance ziprasidone and belongs to a group of medicines called antipsychotics.

Ziprasidone is indicated for the treatment of the following mental disorders:

• Schizophrenia in adults.

Schizophrenia is characterized by symptoms such as hearing, seeing, or feeling things that do not exist, believing in something that is not true, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression, or anxiety.

• Moderately severe manic or mixed episodes in bipolar disorder in adults and in children and adolescents aged 10 to 17 years.

This is a mental disorder characterized by alternating phases of euphoric (mania) or depressed mood states. During manic episodes, the most characteristic symptoms are: euphoric behavior, exaggerated self-esteem, increased energy, reduced need for sleep, lack of concentration, hyperactivity, and repetition of risky behaviors.

2. What you need to know before taking Ziprasidona Sandoz

Do not take Ziprasidona Sandoz

• 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 disease 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 "Taking Ziprasidona Sandoz 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, as this type of medicine has 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 person (over 65 years of age) with dementia and at high risk of stroke,
• if you have a significantly slow heart rate at rest, and/or if you know you may have low levels of salts in your blood due to prolonged severe diarrhoea or vomiting, or due to diuretic use (which promote elimination of excess fluid),
• if you experience symptoms such as rapid or irregular heartbeat, fainting, syncope, or dizziness when standing up, as these 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 skin lesions with a target-like appearance, 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.

Inform your doctor that you are taking ziprasidone before undergoing any diagnostic tests (including blood and urine tests, liver function tests, heart rhythm monitoring, 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 has not been established.

Taking Ziprasidona Sandoz with other medicines

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

Do not take Ziprasidona Sandoz 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, levomethadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesilate, mefloquine, sertindole, or cisapride. These medicines may alter heart rhythm by prolonging the QT interval. If you have further questions about this effect, consult your doctor.

Talk to your doctor or pharmacist before starting ziprasidone.

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

• bacterial infections; these medicines are known as antibiotics; e.g., macrolide antibiotics or rifampicin;
• mood changes (from depressive mood to euphoria), agitation, and irritability; these medicines are known as mood stabilizers, e.g., lithium, carbamazepine, valproate;
• depression, including some serotonergic medicines, e.g., SSRIs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural products containing St. John's Wort;
• epilepsy, e.g., phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, e.g., levodopa, bromocriptine, ropinirole, pramipexole;
• or if you are taking or have recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

See section "Do not take Ziprasidona Sandoz" above.

Taking Ziprasidona Sandoz with food, drinks and alcohol

Ziprasidona Sandoz MUST BE TAKEN DURING MAIN MEALS.

Do not consume alcoholic beverages during treatment with ziprasidone, as this 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 or pharmacist before using this medicine.

• Pregnancy

Do not take ziprasidone during pregnancy unless your doctor specifically instructs you to do so, because there is a risk that this medicine may harm your baby.

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 develops any of these symptoms, contact your doctor.

• Breastfeeding

Do not breastfeed while taking ziprasidone. This is because small amounts of this medicine may pass into breast milk.

• Contraception

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

Driving and using machines

Taking ziprasidone may cause drowsiness. If you experience this symptom, refrain from driving and operating dangerous machinery until the drowsiness subsides.

Ziprasidona Sandoz contains lactose and sodium

Ziprasidona Sandoz contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

20 mg, 40 mg and 80 mg hard capsules:

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

3. How to take Ziprasidona Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. 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 may affect the site in the intestine where the medicine is absorbed.

Ziprasidone should be taken twice daily, one capsule in the morning with a substantial "breakfast" and one in the evening with "dinner". Try to take this medicine at the same time each day.

Adults

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

For long-term treatment, your doctor may adjust the dose. It is recommended not to exceed the maximum daily dose of 160 mg.

Use in children and adolescents with bipolar mania

The recommended starting dose is 20 mg once daily with food. Your doctor will then indicate your optimal dose. It is recommended not to exceed the maximum dose established by weight range: 80 mg daily in children weighing less than 45 kg, and 160 mg daily in children weighing 45 kg or more.

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. The dose for patients over 65 years of age is sometimes lower than that used in younger individuals. Your doctor will inform you of the appropriate 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 tell you what the correct dose is for you.

If you take more Ziprasidona Sandoz than you should

If you have taken more ziprasidone than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you have taken too many ziprasidone capsules, symptoms such as drowsiness, tremor, seizures, and involuntary movements of the head and neck may occur.

If you forget to take Ziprasidona Sandoz

It is important to take ziprasidone at the same time each day. If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next one at the regular time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Ziprasidona Sandoz

Your doctor will advise you how long you should take ziprasidone. Do not stop taking this medicine unless instructed by your doctor.

It is important to continue treatment 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 will experience them.

However, most adverse effects are temporary. It may often be difficult to distinguish symptoms of your illness from adverse effects.

STOP taking Ziprasidone Sandoz and contact your doctor immediately if you experience any of the following serious adverse effects:

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

• involuntary/unusual movements, especially of the face or tongue.

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

• rapid or irregular heartbeat, dizziness when standing up, which may indicate impaired heart function. These could be symptoms of a condition known as orthostatic hypotension.

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

• swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing, hives. These could be symptoms of a severe allergic reaction such as angioedema,
• fever, rapid breathing, sweating, muscle rigidity, tremor, difficulty swallowing, and reduced consciousness. These may be symptoms of a disease known as neuroleptic malignant syndrome,
• skin reactions, particularly skin rash, fever, and swollen lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions may be potentially life-threatening,
• confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These may be symptoms of a disease known as serotonin syndrome,
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes,
• abnormally persistent and painful penile erection.

Adverse effects of unknown frequency (cannot be estimated from available data):

• swelling, pain, and redness in the leg. These may be symptoms of blood clots in the veins, especially in the legs, which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing.

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.

Very common adverse effects (may affect more than 1 in 10 people):

• difficulty sleeping,
• drowsiness or excessive daytime sleepiness,
• headache.

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

• runny nose,
• elevated mood, strange thought patterns, hyperactivity, feeling restless or anxious,
• restlessness,
• movement disorders including involuntary movements, muscle rigidity, slowness of movement,
• 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 weight gain,
• exhaustion,
• general feeling of illness.

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

• high levels of prolactin in the blood,
• increased appetite,
• panic attack,
• feeling nervous or depressed,
• decreased sexual desire,
• loss of consciousness,
• difficulty controlling movements / involuntary movements,
• restless legs,
• throat tightness, nightmares,
• seizures, involuntary eye movements to a fixed position, clumsiness, speech disorder, numbness, tingling sensation, muscle cramps, decreased ability to concentrate, drooling,
• palpitations, shortness of breath,
• light sensitivity, dry eyes, ringing in the ears, ear pain,
• sore throat, flatulence, stomach discomfort,
• itchy skin rash, acne,
• muscle cramps, stiff or swollen joints,
• thirst, chest discomfort, abnormal gait,
• acid reflux, stomach pain,
• hair loss,
• unusual head position,
• urinary incontinence, pain or difficulty urinating,
• abnormal production of breast milk,
• breast enlargement in males,
• absence of menstruation,
• abnormal results in heart or blood tests,
• abnormal liver function test results,
• dizziness,
• general weakness and fatigue.

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

• decreased levels of calcium in the blood,
• slowed thinking, lack of emotions,
• facial drooping,
• paralysis,
• partial or complete loss of vision in one eye, eye itching,
• difficulty speaking, hiccups,
• loose stools,
• skin irritations,
• inability to open the mouth,
• difficulty emptying the bladder,
• drug withdrawal syndrome in newborn babies,
• reduced orgasm,
• feeling of warmth,
• decrease or increase in white blood cells (in blood tests),
• red, inflamed, raised skin patches covered with white scales known as psoriasis.

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

• 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.

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 Sandoz

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 blister; bottle and packaging after “EXP”. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Bottles: after first opening: 6 months.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ziprasidone Sandoz

• The active substance is ziprasidone.

Each hard capsule contains 20 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

Each hard capsule contains 40 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

Each hard capsule contains 60 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

Each hard capsule contains 80 mg of ziprasidone (as ziprasidone hydrochloride monohydrate).

• The other components are:

Ziprasidone Sandoz 20, 40 and 80 mg hard capsules:

Capsule contents: lactose monohydrate, pregelatinized starch, magnesium stearate.

Capsule shell: indigo carmine (contains sodium) (E132), titanium dioxide (E171), gelatin and water.

Ziprasidone Sandoz 60 mg hard capsules:

Capsule contents: lactose monohydrate, pregelatinized starch, magnesium stearate.

Capsule shell: titanium dioxide (E171), gelatin and water.

Appearance of the product and contents of the pack

Ziprasidone Sandoz are hard gelatin capsules.

• Ziprasidone Sandoz 20 mg: size 4 hard capsules (height: 14.3 mm), opaque blue cap and light opaque blue body.
• Ziprasidone Sandoz 40 mg: size 3 hard capsules (height: 15.7 mm), opaque blue cap and opaque blue body.
• Ziprasidone Sandoz 60 mg: size 2 hard capsules (height: 17.6 mm), opaque white cap and opaque white body.
• Ziprasidone Sandoz 80 mg: size 1 hard capsules (height: 19.4 mm), opaque blue cap and light opaque blue body.

Pack sizes

Ziprasidone Sandoz is available in blister packs contained in cardboard packaging with: 10, 14, 20, 30, 50, 56, 60, 98, 100 hard capsules.

Ziprasidone Sandoz is also available in bottles closed with caps containing: 200 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

Lek Pharmaceuticals d.d.

Lendava Site. Trimlini 2d

SI-9220 Lendava

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

Germany Ziprasidon – 1 A Pharma 20 mg Hartkapseln

Ziprasidon – 1 A Pharma 40 mg Hartkapseln

Ziprasidon – 1 A Pharma 60 mg Hartkapseln

Ziprasidon – 1 A Pharma 80 mg Hartkapseln

Denmark Ziprasidone Sandoz

Italy ZIPRASIDONE SANDOZ

Spain Ziprasidona Sandoz 20 mg hard capsules EFG,

Ziprasidona Sandoz 40 mg hard capsules EFG,

Ziprasidona Sandoz 60 mg hard capsules EFG,

Ziprasidona Sandoz 80 mg hard capsules EFG

Sweden Ziprasidone Sandoz 20 mg capsules, hard,

Ziprasidone Sandoz 40 mg capsules, hard,

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

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