ZELDOX 20 mg HARD CAPSULES

2. What you need to know before you take Zeldox capsules

Do not takeZeldox capsules

• If you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can 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 heart rhythm disorders (arrhythmias) or medications that can affect heart rhythm.

See section "Using Zeldox capsules with other medicines" later.

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Zeldox capsules: if you or someone in your family has a history of blood clots, as this type of medicine 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 suffer from dementia and have a high risk of suffering 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 having suffered severe diarrhea and vomiting for a prolonged period or the use of 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, 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 could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially fatal.
• Zeldox capsules 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 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.

Using Zeldox capsules with other medicines

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

Do not take Zeldox capsulesif 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 Zeldox capsules.

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; for example, macrolide antibiotics or rifampicin;
• mood changes (from depressive mood to euphoria), agitation, and irritation; these medications are known as mood stabilizers, for example, lithium, carbamazepine, valproate;
• depression, including some serotoninergic medications, 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, ropinirol, pramipexole;
• or if you are taking or have recently taken the following medications: verapamil, quinidine, itraconazole, or ritonavir;

See section "Do not take Zeldox capsules" above.

Taking Zeldox with food and drinks

Zeldox capsules MUST BE TAKEN DURING MAIN MEALS.

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

Pregnancy and breastfeeding

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

Pregnancy

You should not take Zeldox capsules during pregnancy unless your doctor tells you to, as there is a risk that this medicine may harm your baby. Always use an adequate 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 child if you are taking Zeldox capsules. This is because small amounts may pass into breast milk.

Contraception

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

Driving and using machines

Taking Zeldox capsules may cause drowsiness. If you experience this symptom, avoid 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 an intolerance to certain sugars, consult them before taking this medicine.

Zeldox capsules contain sodium

Zeldox capsules contain less than 23 mg of sodium (1mmol) per capsule; this is, essentially "sodium-free".

3. How to take Zeldox capsules

Follow exactly the administration instructions of this medicine 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 important not to chew, crush, or open the capsules as this may affect the point at which the medicine 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). Try to take this medicine 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 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 established dose 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.

Over 65 years

If you are over 65 years old, your doctor will decide the suitable dose for you. The dose for people 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 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 emergency department of the nearest hospital. Consult your doctor, pharmacist, or call the toxicology information service, telephone 915620420, indicating the medicine and the amount taken, it is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

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

If you forget to take Zeldox

It is important that you take Zeldox capsules 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 stop taking Zeldox capsules

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

It is important to continue treatment even if you feel better. If you stop treatment too soon, the 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 all people suffer from them. It can often be difficult to distinguish the symptoms of your disease from the adverse effects.

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

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

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

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

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

• Rare adverse effects (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 like angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, trembling, difficulty swallowing, and decreased consciousness, these could be symptoms of a disease known as neuroleptic malignant syndrome.
• Skin reactions, especially rash, fever, and lymph node inflammation, which could be symptoms of a disease called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.
• Confusion, agitation, fever, sweating, movement disorders, muscle spasms. These could be symptoms of a disease known as serotonin syndrome.
• Fast, irregular heartbeats, fainting, which can be symptoms of a life-threatening disease known as Torsades de Pointes.
• Prolonged and painful erection of the penis.

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

• Difficulty sleeping
• Tendency to sleep or excessive daytime sleepiness
• Headache

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

• Rhinitis
• Elevated mood, unusual thought patterns, and hyperactivity, feeling agitated or anxious
• Restlessness
• Abnormal movements, 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 being unwell

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

• High levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feeling nervous or depressed
• Decreased sexual desire
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Feeling of pressure in the throat, nightmares
• Seizures, involuntary eye movements, clumsiness, speech disorders, numbness, feeling of muscle cramps, decreased concentration, drooling
• Palpitations, difficulty breathing
• Sensitivity to light, dry eyes, ear noises, ear pain
• Sore throat, gas, stomach discomfort
• Itchy skin rash, acne
• Muscle cramps, stiffness, or swelling of the joints
• Thirst, chest discomfort, gait disturbance
• Acid reflux, stomach pain
• Hair loss
• Unusual head position
• Urinary incontinence, pain or difficulty urinating
• Abnormal milk production
• Increased male breast size
• Absence of menstruation
• Abnormal blood tests and heart tests
• Abnormal liver function tests
• Dizziness
• General weakness and fatigue

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

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

Frequency not known (cannot be estimated from the 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 can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

Additional Adverse Effects in Children and Adolescents

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Zeldox Capsules

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

Do not store above 30°C.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Zeldox 20 mg Hard Capsules Composition

• The active ingredient is ziprasidone. Each hard capsule contains 20 mg of ziprasidone in the form of ziprasidone hydrochloride monohydrate.
• The other ingredients are: lactose monohydrate (see section 2), pregelatinized corn starch, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulfate (dodecyl sulfate sodium) (see section 2), indigo carmine (E132), shellac, propylene glycol (E1520), ammonium hydroxide (E527), potassium hydroxide (E525), and black iron oxide (E172).

Product Appearance and Package Contents

Zeldox 20 mg hard capsules are presented in the form of hard gelatin capsules.

The capsules are blue and white, marked with "VTRS" and "ZDX 20".

Package Sizes:

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

MEDIS INTERNATIONAL a.s., výrobní závod Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Date of the Last Revision of this Leaflet: October 2022

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