Zeldox

Package leaflet: Information for the user

Zeldox

20 mg, 40 mg, 60 mg, 80 mg hard capsules
ziprasidone
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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 belong to a class of medicines called antipsychotics.
Zeldox capsules are indicated for the treatment of schizophrenia in adults –
schizophrenia is a mental disorder characterized by the following symptoms: hearing, seeing, or sensing things that do not exist, believing something that is not true, having unusual suspicions, being withdrawn, having difficulty establishing social relationships, nervousness, depression, or anxiety.
Zeldox capsules are also used for the treatment of moderate manic or mixed episodes associated with bipolar disorder in adults and in children and adolescents aged 10 to 17 years – Bipolar disorder is a mental disorder characterized by alternating periods of euphoria (mania) or depressed mood. During manic episodes, the most common symptoms are: euphoric behaviour, exaggerated self-esteem, increased energy, reduced need for sleep, loss of concentration, hyperactivity, and repeated high-risk behaviours.

2. What you need to know before taking Zeldox capsules

Do not take ZELDOX capsules

• if you are allergic to ziprasidone or to any of the excipients in this medicine (listed in section 6). Signs of allergic reactions include rash, itching, swelling of the face or lips, difficulty breathing.
• if you have or have ever had heart problems or have recently had a heart attack
• if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm.

See also the section below “Other medicines and Zeldox capsules”.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Zeldox capsules

• if you or a family member has a history of blood clots, as this type of medicine may be associated with blood clot formation
• if you have liver problems
• if you have or have ever had seizures or epilepsy
• if you are elderly (over 65 years) and have dementia and are at risk of stroke
• if you have a slow resting heart rate and/or are aware that you may be prone to salt depletion following severe and prolonged diarrhoea and vomiting (illness) or due to use of diuretics (tablets)
• if you have ever had irregular or rapid heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm function.

Contact your doctor immediately if you experience any of the following symptoms:

• severe skin reactions, such as rash with blisters, which may include mouth ulcers, skin peeling, fever, and target-shaped spots, which could be symptoms of Stevens-Johnson syndrome. These skin reactions can potentially be fatal.
• Zeldox capsules may cause drowsiness, low blood pressure when standing up, dizziness, and impaired gait, conditions which may lead to falls. You should be cautious, especially if you are an elderly or frail patient.

Inform your doctor that you are taking Zeldox capsules before undergoing laboratory tests
(e.g. blood tests, urine tests, liver function, heart rhythm, etc.), as they may alter test results.
Children and adolescents
The safety and efficacy of ziprasidone in the treatment of schizophrenia in children and adolescents have not been established.
Other medicines and Zeldox capsules
Always inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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, mesylate dolasetron, mefloquine, sertindole, or cisapride. These medicines may affect heart rhythm by prolonging the QT interval. Ask your doctor or pharmacist if you need further information.
Talk to your doctor or pharmacist before taking Zeldox capsules.
Inform your doctor or pharmacist if you are taking or have recently taken medicines for the treatment of:

• bacterial infections; these medicines are known as antibiotics; for example, macrolide antibiotics or rifampicin.
• mood disorders (from depression to euphoria), agitation, and irritability; these medicines are known as mood stabilizers, e.g. lithium, carbamazepine, valproate;
• depression, including certain serotonergic medicines such as SSRIs like fluoxetine, paroxetine, sertraline; or herbal or natural remedies containing St. John’s wort (Hypericum perforatum).
• epilepsy, for example phenytoin, phenobarbital, carbamazepine, ethosuximide.
• Parkinson’s disease, for example levodopa, bromocriptine, ropinirole, pramipexole.
• If you are taking or have recently taken the following medicines: verapamil, quinidine, itraconazole, or ritonavir.

See also the section above “Do not take ZELDOX capsules”
ZELDOX capsules with food and drink:
Zeldox capsules MUST BE TAKEN DURING MAIN MEALS.
Alcohol consumption should be avoided during treatment with Zeldox capsules, as it may increase the risk of adverse effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Do not take ZELDOX capsules during pregnancy unless your doctor has instructed you to do so, as there is a risk that this medicine may harm the unborn baby.
The following symptoms have been observed in newborns of mothers who took Zeldox during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Breastfeeding
Do not breastfeed while taking Zeldox capsules. This is because small amounts of the medicine may pass into breast milk.
Contraception
If you are of childbearing age, you must use an adequate method of contraception while taking this medicine.
Driving and using machines
Taking Zeldox capsules may cause drowsiness. If this occurs, do not drive or operate machinery until the drowsiness has resolved.
Zeldox capsules contain lactose
Zeldox capsules contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Zeldox capsules contain sodium
Zeldox capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Zeldox capsules

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The capsules must be taken with food and swallowed whole without chewing, crushing, or opening them in advance. It is important that the capsules are not chewed, crushed, or opened, as this may affect the extent of drug absorption in the intestine.
Zeldox capsules must be taken twice daily—one capsule in the morning with a substantial breakfast and one in the evening during the evening meal (see the blister pack). Always take this medicine at the same time each day.

Adults
The recommended dose is 40–80 mg twice daily, taken with meals.
During long-term treatment, your doctor may adjust the dose. Do not exceed the maximum daily dose of 160 mg.

Children and adolescents with bipolar mania
The usual dose is 20 mg taken with meals. Your doctor will then advise you on the optimal dose suitable for you. The maximum daily dose must not exceed 80 mg in children weighing 45 kg or less, or 160 mg in children weighing more than 45 kg.
The safety and efficacy of Zeldox for the treatment of schizophrenia in children and adolescents have not been established.

Elderly (over 65 years of age)
If you are elderly, your doctor will determine the appropriate dose for you. For patients over 65 years of age, the dose is sometimes lower than in younger patients. Your doctor will advise you on the correct dose.

Patients with hepatic impairment
If you have liver problems, you may need to take a lower dose of Zeldox capsules. Your doctor will calculate the appropriate dose for you.

If you take more Zeldox capsules than you should
Contact your doctor or the nearest hospital immediately. Take the Zeldox capsule packaging with you.
If you have taken too many Zeldox capsules, symptoms may include drowsiness, tremor, seizures, and involuntary movements of the head and neck.

If you forget to take ZELDOX capsules
It is important to take Zeldox capsules regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, take only the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking ZELDOX capsules
Your doctor will tell you how long to take Zeldox capsules. Do not stop treatment unless your doctor advises you to do so.
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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. However, some side effects may be transient. It is often difficult to distinguish side effects from symptoms of the disease.
Stop treatment with Zeldox capsules and contact your doctor immediately if
you notice any of the following serious side effects:
Common side effects (may affect up to 1 in 10 people):

• Involuntary/unusual movements, especially of the face and tongue

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

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

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

• Swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, hives. These may be symptoms of a severe allergic reaction such as angioedema.

• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and lack of alertness, which may be symptoms of a condition 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 Drug Rash with Eosinophilia and Systemic Symptoms). These reactions can potentially be fatal.

• Confusion, agitation, warmth, sweating, lack of muscle coordination,
  muscle contractions. These may be symptoms of a condition known as
  serotonin syndrome.

• Irregular, rapid heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as torsades de pointes.

• Abnormal, persistent, and painful erection of the penis.

You may experience one of the following side effects listed below. These potential
side effects are generally mild to moderate and may resolve over time. However, if they
become severe or persistent, contact your doctor.
Very common side effects (may affect more than 1 in 10 people)

• Difficulty sleeping
• Drowsiness or excessive daytime sleepiness
• Headache

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

• Runny nose
• Extremely elevated mood, bizarre thinking patterns, hyperactivity, agitation, or anxiety
• Restlessness
• Abnormal movements including involuntary movements, muscle stiffness, 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
• Weakness
• General feeling of being unwell

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

• Elevated levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feelings of nervousness or depression
• Decreased sexual desire
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Throat tightness, nightmares
• Seizures, involuntary eye movements when staring, clumsiness, speech disorders, numbness, tingling sensations, reduced ability to concentrate, increased salivation
• Palpitations, shortness of breath
• Light sensitivity, dry eyes, ringing in the ears, ear pain
• Sore throat, stomach bloating, stomach discomfort
• Itchy rash, acne
• Muscle cramps, swollen or stiff joints
• Thirst, chest discomfort, abnormal gait
• Acid reflux, stomach pain
• Hair loss
• Abnormal head positioning
• Urinary incontinence, pain or difficulty urinating
• Abnormal production of breast milk
• Breast enlargement in men
• Absence of menstruation
• Abnormal results in heart or blood tests
• Abnormal liver function test results
• Vertigo
• Generalized weakness and fatigue

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

• Decreased levels of calcium in the blood
• Slowed thinking, lack of emotions
• Facial flaccidity
• 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
• Drug withdrawal syndrome in the newborn
• Reduced orgasm
• Feeling of warmth
• Decreased or increased white blood cells (blood tests)
• Red, raised patches of skin covered with whitish scales, known as psoriasis

Side effects not known (frequency cannot be estimated from available data)

• In elderly patients with dementia, a small increase in deaths has been reported in those taking antipsychotics compared to those not treated with antipsychotics.
• Blood clots in veins, especially in the legs (symptoms include sweating, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek medical advice immediately.

Additional side effects in children and adolescents
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above), except for sedation and drowsiness, which occurred more frequently in children. The most frequent side effects in children and adolescents were sedation, drowsiness, headache, fatigue, nausea, dizziness, vomiting, reduced appetite, and movement abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zeldox capsules

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date (Exp.) stated on the carton. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZELDOX capsules contain

• The active substance is ziprasidone. Each capsule contains 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone as ziprasidone hydrochloride monohydrate.
• The other excipients are: lactose monohydrate (see section 2 “Zeldox capsules contain lactose”), pregelatinized maize starch, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulphate (sodium dodecyl sulphate) (see section 2 “Zeldox capsules contain sodium”), indigotine (E132) (only in the 20 mg, 40 mg, and 80 mg capsules containing blue dye), shellac, propylene glycol (E1520), ammonium hydroxide (E527), potassium hydroxide (E525), and black iron oxide (E172).

Description of the appearance of ZELDOX capsules and package contents
ZELDOX capsules are hard gelatin capsules.
The 20 mg capsules are blue and white, marked “Pfizer” on one side and “ZDX 20” on the other.
The 40 mg capsules are blue, marked “Pfizer” on one side and “ZDX 40” on the other.
The 60 mg capsules are white, marked “Pfizer” on one side and “ZDX 60” on the other.
The 80 mg capsules are blue and white, marked “Pfizer” on one side and “ZDX 80” on the other.
Packaging:
Blister packs
ZELDOX capsules are packaged in PVC/PA-aluminium-aluminium blisters, in cartons containing 14, 20, 30, 50, 56, 60, or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1
79090 Freiburg, Germany

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

This leaflet was last updated on: