Package Insert: Information for the User

Zeldox 40mg Hard Capsules

ziprasidone

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms 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 package insert. See section 4.

Zeldox capsules is a medication belonging to the group of medications known as antipsychotics.

Zeldox capsules is indicated for the treatment of schizophrenia in adults, a mental illness characterized by the appearance of any of 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.

In addition, Zeldox capsules is used in adults and in children and adolescents from 10 to 17 years old for the treatment of symptoms of moderate severity mania in bipolar disorder, a mental illness characterized by alternating phases of euphoric mood states (mania) or depressed states. During the episodes of mania, 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.

Do not takeZeldox capsules

• If you are allergic to ziprasidone or any of the other ingredients in this medication (listed in section6). 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 any heart disease or have recently had a heart attack.
• If you are taking medications for irregular heart rhythms (arrhythmias) or medications that may affect heart rhythm.

See the section “Taking Zeldox capsules with other medications” later.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Zeldox capsules

• If you or a family member 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 over 65 years old and have dementia and are at high risk of having a stroke (cerebrovascular accident)
• 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 prolonged diarrhea and vomiting or the use of diuretics (which promote the elimination of excess fluids)
• If you experience symptoms such as rapid or irregular heartbeat, dizziness, fainting, or dizziness when standing up, 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 may be accompanied by mouth ulcers, skin peeling, fever, and skin spots in the shape of a target that may be symptoms of Stevens-Johnson syndrome. These skin reactions may be potentially fatal.
• Zeldoxcapsulesmay cause drowsiness, low blood pressure when standing up, dizziness, and gait disturbances, which may cause falls. You should be cautious, especially if you are an elderly patient or have weakness.

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

Children and adolescents

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

Taking Zeldox capsules with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Do not take Zeldox capsulesif you are taking medications for irregular heart rhythms or medications 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 medications may prolong the QT interval and alter heart rhythm. If you have any additional questions about this effect, consult your doctor.

Consult your doctor or pharmacist beforestarting to take Zeldox capsules.

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 irritability; these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate;
• depression, including some serotonin reuptake inhibitors, such as ISRSs (Selective Serotonin Reuptake Inhibitors) like fluoxetine, paroxetine, sertraline; or herbal remedies or natural remedies 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 taken recently the following medications: see the section “Do not take Zeldox capsules” earlier.

See the section “Do not take Zeldox capsules” earlier.

Taking Zeldox with food and drinks

Zeldox capsules SHOULD BE TAKEN DURING MAIN MEALS.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before taking this medication.

Pregnancy

You should not take Zeldox capsules during pregnancy unless your doctor tells you to, as this medication may harm your baby. Always use a suitable contraceptive method.

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

Breastfeeding

You should not breastfeed your baby while taking Zeldox capsules. This is because small amounts may pass into breast milk.

Contraception

If you can become pregnant, you should use a suitable contraceptive method while taking this medication.

Driving and operating machinery

The taking of Zeldox capsules may cause drowsiness. If you experience this symptom, refrain from driving and operating hazardous machinery until it disappears.

Zeldox capsules contain lactose

Zeldox capsules contain lactose. If your doctor has told you that you have

a intolerance to certain sugars, consult him before taking this medication.

Zeldox capsules contain sodium

Zeldox capsules contain less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

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

The capsules should be taken with food and swallowed whole without chewing, crushing, or opening beforehand.It is essential not to chew, crush, or open the capsules, as this may affect the point at which the medication is absorbed in the intestine.

Zeldox capsules should be taken twice a day, one capsule in the morning during a consistent breakfast and one in the evening during dinner (see blister). Make sure 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.

Children and adolescents with bipolar mania

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

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

Individuals 65 years of age or older

If you are 65 years of age or older, your doctor will decide on the suitable dose for you. The dose for individuals 65 years of age or older is sometimes lower than that used in younger individuals. Your doctor will indicate the appropriate dose for you.

Patients with liver problems

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

If you take more Zeldox capsules than you should

Consult your doctor immediately or go to the nearest hospital emergency room. Consult your doctor, pharmacist, or call the toxicology information service, phone 915620420, indicating the medication and the amount taken, and it is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

If you forget to take Zeldox:

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

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

If you interrupt the treatment with Zeldox capsules

Your doctor will indicate for how long you should take Zeldox capsules. Do not stop taking this medication unless your doctor tells you to.

It is essential to continue treatment even if you feel better. If you stop treatment too soon, symptoms may return.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It can often be difficult to distinguish the symptoms of your illness from side effects.

STOP taking Zeldox capsules and contact your doctor immediately if you experience any of the following serious side effects:

Frequent side effects (may affect up to 1 in 10 patients):

• Uncontrollable, involuntary movements, especially in your face or tongue.

Rare side effects (may affect up to 1 in 100 patients):

• Fast or irregular heartbeat, feeling of dizziness when standing, which may indicate an abnormal heart function. These could be symptoms of a condition known as postural hypotension.

• Side effects rare (may affect up to 1 in 1,000 patients):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 could be symptoms of a condition known as malignant neuroleptic syndrome.
• Skin reactions, especially hives, fever, and inflammation of the lymph nodes, which may be symptoms of a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions may be potentially fatal.
• Confusion, agitation, fever, sweating, muscle movement disorder, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Fast, irregular heartbeat, dizziness, which may be symptoms of a life-threatening condition known as Torsades de Pointes.
• Persistent and painful erection of the penis.

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.

Very frequent side effects (may affect more than 1 in 10 patients):

• Difficulty sleeping
• Excessive daytime drowsiness
• Headache

Frequent side effects (may affect up to 1 in 10 patients):

• Coughing
• Elated mood, strange thought patterns, and hyperactivity, feeling of agitation or anxiety
• Restlessness
• Abnormal movements, including involuntary movements, muscle rigidity, slow movements
• Dizziness
• Sedation
• Blurred or impaired vision
• High blood pressure
• Constipation, diarrhea, nausea, vomiting, indigestion, dry mouth, increased salivation
• Rash
• Male sexual problems
• Fever
• Pain
• Weight loss or gain
• Fatigue
• General feeling of being unwell

Rare side effects (may affect up to 1 in 100 patients):

• Elevated levels of prolactin in the blood
• Increased appetite
• Panic attack
• Feeling of nervousness or depression
• Decreased libido
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Sensation of throat constriction, nightmares
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech alteration, numbness, feeling of pins and needles, decreased concentration ability, drooling
• Palpitations, difficulty breathing
• Sensitivity to light, dry eyes, ear noises, ear pain
• Throat pain, gas, stomach discomfort
• Rash on the skin that often itches, acne
• Muscle cramps, stiffness, or swelling of the joints
• Thirst, chest discomfort, gait alteration
• Acid reflux, stomach pain
• Hair loss
• Abnormal head position
• Urinary incontinence, pain or difficulty urinating
• Abnormal milk production
• Male breast enlargement
• Amenorrhea
• Abnormal liver function tests
• Abnormal heart function tests
• Dizziness
• General weakness and fatigue

Rare side effects (may affect up to 1 in 1,000 patients):

• Decreased calcium levels in the blood
• Slowness of thought, lack of emotional expression
• Facial paralysis
• Paralysis
• Partial or complete loss of vision in one eye, eye itching
• Difficulty speaking, hiccups
• Soft stools
• Skin irritation
• Inability to open the mouth
• Difficulty emptying the bladder
• Neonatal withdrawal syndrome
• Reduced orgasm
• Sensation of heat
• Increased or decreased white blood cell count (in blood tests)
• Red, inflamed skin patches covered with white scales, known as psoriasis

Unknown frequency (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.
• Blood clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

Additional side effects in children and adolescents

In clinical trials with children and adolescents, side effects were generally similar to those of adults (see above), except for sedation and somnolence, which were more frequent in children. The most common side effects in children and adolescents were sedation, somnolence, headache, fatigue, nausea, dizziness, vomiting, decreased appetite, and movement disorders.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Zeldox 40mg hard capsules

• The active ingredient is ziprasidone. Each hard capsule contains 40mg of ziprasidone in the form of ziprasidone hydrochloride monohydrate.
• The other components are: lactose monohydrate (see section 2), maize pregelatinised starch, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulfate (dodecyl sulfate of sodium) (see section 2), indigotin (E132), shellac, propylene glycol (E1520), ammonium hydroxide (E527), potassium hydroxide (E525) and iron oxide black (E172).

Appearance of the product and contents of the pack

Zeldox 40mg hard capsules are presented in the form of hard gelatin capsules. The capsules are blue marked with “Pfizer” and “ZDX 40”.

Pack sizes:

Aluminium PVC/PVA blisters containing 14, 20, 30, 50, 56, 60 or 100 capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible

MEDIS INTERNATIONAL a.s., production plant Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

or

Pfizer ManufacturingDeutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Last update of this leaflet: October 2022

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