Zeldox 80 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zeldox 80 mg hard capsules

ziprasidone

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Zeldox capsules are and what they are used for
2. What you need to know before taking Zeldox capsules
3. How to take Zeldox capsules
4. Possible side effects
5. How to store Zeldox capsules
6. Contents of the pack and other information

1. What Zeldox capsules are and what they are used for

Zeldox capsules is a medicine belonging to a group of medicines called antipsychotics.

Zeldox capsules are indicated for the treatment of schizophrenia in adults, a mental illness characterized by the presence of one or more of the following symptoms: 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seeing, or feeling things that do not exist, believing in something that is not true, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression, or anxiety.

In addition, Zeldox capsules are used in adults and in children and adolescents aged 10 to 17 years for the treatment of moderate severity manic symptoms in bipolar disorder, which is a mental illness 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 repetitive engagement in risky behaviors.

2. What you need to know before taking Zeldox capsules

Do not take Zeldox capsules

• If you are allergic to ziprasidone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized by the appearance of skin rash, itching, swelling of the face or lips, or difficulty breathing.
• If you have or have had heart disease or recently suffered a heart attack.
• If you are taking medicines for heart rhythm disorders (arrhythmias) or medicines that may affect heart rhythm.

See section “Use of Zeldox capsules with other medicines” below.

Warnings and precautions

Talk to 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 blood clot formation
• if you have liver problems
• if you have or have had seizures or epilepsy
• if you are over 65 years of age and have dementia, and are at high risk of stroke (cerebrovascular accident)
• if you have a significantly slow resting heart rate, and/or you know you may have low levels of blood salts (electrolytes) due to prolonged severe diarrhea or vomiting, or due to use of diuretics (which promote elimination of excess fluid)
• if you experience symptoms such as rapid or irregular heartbeat, fainting, syncope, or dizziness upon standing, 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, or skin lesions with a target-like appearance, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially life-threatening.
• Zeldox capsules may cause drowsiness, low blood pressure upon standing, dizziness, and gait disturbances, which may lead to falls. Caution should be taken, especially if you are elderly or have any physical weakness.

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

Children and adolescents

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

Use of Zeldox capsules with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Do not take Zeldox capsules 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 further questions about this effect, consult your doctor.

Talk to your doctor or pharmacist before starting Zeldox capsules.

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

• bacterial infections; these medicines are known as antibiotics; for example macrolide antibiotics or rifampicin;
• mood changes (from depression to euphoria), agitation, and irritability; these medicines are known as mood stabilizers, for example lithium, carbamazepine, valproate;
• depression, including some 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.

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 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, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Pregnancy

You should not take Zeldox capsules during pregnancy unless your doctor specifically instructs you to do so, as there is a risk that this medicine may harm your baby. Always use an appropriate method of contraception.

The following symptoms may occur in newborns whose mothers have taken Zeldox during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding

You should not breastfeed while being treated with Zeldox capsules. This is because small amounts may pass into breast milk.

Contraception

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

Driving and using machines

Taking Zeldox capsules may cause drowsiness. If you experience this symptom, refrain from driving or operating heavy machinery until the symptom resolves.

Zeldox capsules contains lactose

Zeldox capsules contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Zeldox capsules contains sodium

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

3. How to take Zeldox capsules

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The capsules should be taken with food and swallowed whole without chewing, crushing, or opening them beforehand. It is important not to chew, crush, or open the capsules, as this may affect the site in the intestine where the medicine is absorbed.

Zeldox capsules should be taken twice daily, one capsule in the morning with a substantial breakfast and one in the evening with dinner (see blister pack). 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.

Children and adolescents with bipolar mania

The recommended starting dose is 20 mg once daily with food. Your doctor will then guide you to your optimal dose. It is recommended not to exceed the maximum daily dose based on weight: 160 mg per day for children weighing 45 kg or more, and 80 mg per day for children weighing less than 45 kg.

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

Patients over 65 years

If you are over 65 years of age, your doctor will decide the appropriate dose for you. The dose for patients over 65 may sometimes be lower than that used in younger individuals. Your doctor will inform you of the appropriate dose.

Patients with liver problems

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

If you take more Zeldox capsules than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

If you forget to take Zeldox

It is important to take Zeldox capsules at the same time each day. If you forget to take a dose, take it as soon as possible. However, if it is close to the time for your next dose, skip the missed dose and take the next one at the usual time.

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

If you stop taking Zeldox capsules

Your doctor will advise you on 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 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 gets them. It may often be difficult to distinguish symptoms of your illness from adverse effects.

STOP taking Zeldox capsules 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 patients):

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

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

• Rapid or irregular heartbeat, dizziness upon standing, 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 serious allergic reaction such as angioedema.

• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and reduced consciousness—these could be symptoms of a disease known as neuroleptic malignant syndrome.

• Skin reactions, especially rash, fever, and swollen lymph nodes, which could be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). These reactions could potentially be life-threatening.

• Confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These could be symptoms of a disease known as serotonin syndrome.

• Rapid, irregular heartbeat, fainting—these may be symptoms of a potentially life-threatening condition known as Torsades de Pointes.

• Abnormally prolonged and painful penile erection.

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 patients):

• Difficulty sleeping
• Drowsiness or excessive daytime sleepiness
• Headache

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

• Runny nose
• Elevated mood, strange thought patterns and hyperactivity, feeling restless 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 weight gain
• Exhaustion
• General feeling of being unwell

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

• Elevated levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feelings of nervousness or depression
• Decreased sex drive
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Throat tightness, nightmares
• Seizures, involuntary eye movements to a fixed position, clumsiness, speech disturbance, numbness, tingling sensation, decreased ability to concentrate, drooling
• Palpitations, difficulty breathing
• Light sensitivity, dry eyes, ringing in the ears, ear pain
• Sore throat, flatulence, stomach discomfort
• Itchy skin rash, acne
• Muscle cramps, joint stiffness or swelling
• Thirst, chest discomfort, changes in gait
• Acid reflux, stomach pain
• Hair loss
• Unusual head positioning
• Urinary incontinence, pain or difficulty urinating
• Abnormal production of breast milk
• Enlargement of male breast tissue
• 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 concentration in the blood
• Slowed thinking, lack of emotional expressiveness
• Facial paralysis
• Paralysis
• Partial or complete vision loss in one eye, itchy eyes
• Difficulty speaking, hiccups
• Soft stools
• Skin irritation
• Inability to open the mouth
• Difficulty emptying the bladder
• Withdrawal syndrome in newborns
• Reduced orgasm
• Feeling of warmth
• Increase or decrease in white blood cells (in blood tests)
• Raised, red, inflamed areas of skin 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 those 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 blood vessels 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, adverse effects were generally similar to those in adults (see above), except that sedation and drowsiness were more frequent in children. The most common adverse effects in children and adolescents were sedation, drowsiness, headache, fatigue, nausea, dizziness, vomiting, decreased appetite, and movement disorders.

Reporting of 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 may 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 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Zeldox 80 mg hard capsules

• The active substance is ziprasidone. Each hard capsule contains 80 mg of ziprasidone in the form of ziprasidone hydrochloride monohydrate.
• The other components are: monohydrate lactose (see section 2), pregelatinized maize starch, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulfate (sodium dodecyl sulfate) (see section 2), indigotine (E132), shellac, propylene glycol (E1520), ammonium hydroxide (E527), potassium hydroxide (E525) and black iron oxide (E172).

Nature and contents of the container

Zeldox 80 mg hard capsules are presented as hard gelatin capsules.

The capsules are blue and white, marked with “VTRS” and “ZDX 80”.

Pack sizes:

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

Only some pack 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Date of the most recent review of this leaflet: October 2022

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