ZIPRASIDONE SANDOZ 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ziprasidone Sandoz 20 mg hard capsules EFG

Ziprasidone Sandoz 40 mg hard capsules EFG

Ziprasidone Sandoz 60 mg hard capsules EFG

Ziprasidone Sandoz 80 mg hard capsules EFG

Ziprasidone (monohydrochloride)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Ziprasidone Sandoz and what is it used for
2. What you need to know before taking Ziprasidone Sandoz
3. How to take Ziprasidone Sandoz
4. Possible side effects

5 Storage of Ziprasidone Sandoz

1. Package contents and additional information

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

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

Ziprasidone is indicated for the treatmentof the following mental illnesses:

• Schizophreniain adults.

Schizophrenia is characterized by 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.

• Manic or mixed episodesof moderate severity in bipolar disorderin adults and in children and adolescents from 10 to 17 years old.

It is a mental illness characterized by alternating phases of euphoric (mania) or depressed 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 repetition of risky behaviors.

2. What you need to know before taking Ziprasidone Sandoz

Do not take Ziprasidone Sandoz

• if you are allergic to ziprasidone or any of the other components of this medication (listed in section 6). The signs of an allergic reaction are 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 medications for heart rhythm disorders or medications that can affect heart rhythm.

Also, consult the section "Taking Ziprasidone Sandoz with other medications" 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 this type of medication 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 an elderly person (over 65 years old) and suffer from dementia and have a high risk of stroke,
• 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 having suffered from severe diarrhea and vomiting for a prolonged period or using diuretics (which promote the elimination of excess fluids)
• if you experience symptoms such as rapid or irregular heartbeats, fainting, syncope, or dizziness when standing up, as this 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 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 can be potentially fatal.
• Ziprasidone may cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which can cause falls. Caution should be exercised, especially if you are an elderly patient or suffer from weakness.

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

Children and adolescents

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

Taking Ziprasidone Sandoz with other medications

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

Do not takeZiprasidoneSandozif you are taking medications for heart rhythm disorders or medications that can 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 medications can alter the heart rhythm by prolonging the QT interval. If you have any further questions about this effect, consult your doctor.

Consult your doctor or pharmacist before starting to take ziprasidone.

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

• bacterial infections; these medications are known as antibiotics; e.g., macrolide antibiotics or rifampicin;
• mood changes (from depressive mood to euphoria), agitation, and irritation; these medications are known as mood stabilizers, e.g., lithium, carbamazepine, valproate;
• depression, including some serotoninergic medications, e.g., SSRIs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine, paroxetine, sertraline; or herbal remedies or natural products that contain 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 medications: verapamil, quinidine, itraconazole, or ritonavir.

See the section "Do not take Ziprasidone Sandoz" above.

Taking Ziprasidone Sandoz with food, drinks, and alcohol

Ziprasidone Sandoz MUST BE TAKEN DURING MAIN MEALS.

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

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

You should not take ziprasidone during pregnancy unless your doctor advises you to do so, as there is a risk that this medication may harm your baby.

The following symptoms may occur in newborns of mothers who have taken ziprasidone in the last trimester (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

• Breastfeeding

Do not breastfeed if you are taking ziprasidone. This is because small amounts of this medication may pass into breast milk.

• Contraception

If you can become pregnant, you should use an adequate contraceptive method while taking this medication.

Driving and using machines

Taking ziprasidone may cause drowsiness. If you experience this symptom, avoid driving and operating hazardous machinery until the drowsiness disappears.

Ziprasidone Sandoz contains lactose and sodium

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

20 mg, 40 mg, and 80 mg hard capsules:

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

3. How to take Ziprasidone Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The capsules should be swallowed whole, without chewing, and 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 should be taken twice a day, one capsule in the morning during a "breakfast" and one in the evening during "dinner". Try 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.

Use in children and adolescents with bipolar mania

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

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

Elderly patients (over 65 years old)

If you are an elderly patient, your doctor will decide the suitable dose for you. The dose for patients over 65 years old is sometimes lower than that used in younger people. Your doctor will indicate the appropriate dose for you.

Patient with liver problems

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

If you take more Ziprasidone Sandoz than you should

If you have taken more Ziprasidone than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you have taken many Ziprasidone Sandoz capsules, you may experience drowsiness, tremors, seizures, and involuntary movements of the head and neck.

If you forget to take Ziprasidone Sandoz

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

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

If you interrupt treatment with Ziprasidone Sandoz

Your doctor will indicate how long you should take ziprasidone. Do not stop taking this medication unless your doctor advises you to do so.

It is essential to continue treatment even if you feel better. If you interrupt treatment too early, the symptoms may return.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

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

• Involuntary/unusual movements, especially of your face or tongue.

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

• Rapid or irregular heartbeats, dizziness when standing up, which may indicate altered heart function. These could be symptoms of a condition known as postural hypotension.

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

• Swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing, hives. These could be symptoms of a severe allergic reaction such as angioedema,
• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased consciousness. These may be symptoms of a disease known as neuroleptic malignant syndrome,
• Skin reactions, particularly rash, fever, and swollen lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be potentially life-threatening,
• Confusion, agitation, fever, sweating, muscle coordination disorders, muscle spasms. These may be symptoms of a disease known as serotonin syndrome,
• Rapid, irregular heartbeats, fainting, which may be symptoms of a life-threatening disease known as Torsades de Pointes,
• Prolonged and painful erections.

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 can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing.

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

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

• Difficulty sleeping,
• Somnolence or excessive daytime sleepiness,
• Headache.

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

• Rhinorrhea,
• Mood elevation, unusual thought patterns, and hyperactivity, feeling agitated or anxious,
• Restlessness,
• Abnormalities of movement, including involuntary movements, muscle rigidity, 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,
• 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, and muscle cramps, decreased ability to concentrate, drooling,
• Palpitations, shortness of breath,
• Light sensitivity, dry eyes, ringing in the ears, ear pain,
• Sore throat, gas, 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 milk production,
• Breast enlargement in men,
• Absence of menstruation,
• Abnormal heart or blood test results,
• Abnormal liver function test results,
• Vertigo,
• General weakness and fatigue.

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

• Decreased calcium levels in the blood,
• Slow thinking, lack of emotions,
• Facial inclination,
• Paralysis,
• Partial or complete loss of vision in one eye, eye itching,
• Difficulty speaking, hiccups,
• Loose stools,
• Skin irritation,
• Inability to open the mouth,

Difficulty emptying the bladder,

• Drug withdrawal syndrome in newborn babies,
• Reduced orgasm,
• Feeling of heat,
• Decreased or increased white blood cell count (in blood tests),
• Red, inflamed, and elevated skin patches covered with a white scale 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 those patients treated with antipsychotics compared to those not taking antipsychotics.

Reporting of Adverse Effects

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

5. Storage of Ziprasidona Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the blister pack; bottle and packaging after "EXP". The expiration 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 or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ziprasidona Sandoz

• The active ingredient 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 ingredients are:

Ziprasidona Sandoz 20, 40, and 80 mg hard capsules:

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

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

Ziprasidona Sandoz 60 mg hard capsules:

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

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

Appearance of the Product and Package Contents

Ziprasidona Sandoz are hard gelatin capsules.

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

Package Sizes

Ziprasidona Sandoz is available in blister packs in cardboard boxes containing: 10, 14, 20, 30, 50, 56, 60, 98, 100 hard capsules.

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

Not all package 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Ziprasidon - 1 A Pharma 20 mg hard capsules

Ziprasidon - 1 A Pharma 40 mg hard capsules

Ziprasidon - 1 A Pharma 60 mg hard capsules

Ziprasidon - 1 A Pharma 80 mg hard capsules

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 hard capsules,

Ziprasidone Sandoz 40 mg hard capsules,

Date of the last revision of this prospectus: April 2020

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