ZELDOX 20 mg Hard Capsule

Зміст інструкції

1. Zeldox
   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. Package contents and other information

Zeldox

20 mg, 40 mg, 60 mg, 80 mg hard capsules
ziprasidone

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 having the sensation of things that do not exist, believing something that is not true, having unusual suspicions, being absent and having difficulty establishing social relationships, nervousness, depression or anxiety.
Zeldox capsules are also used for the treatment of moderate to severe manic or mixed episodes associated with bipolar disorder in adults and in children and adolescents aged between 10 and 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 behavior, exaggerated self-esteem, increased energy, decreased need for sleep, loss of concentration or hyperactivity and repeated high-risk 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 excipients of these capsules (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 problems or that can affect the rhythm

cardiac.

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 because this type of medicine may be associated with the formation of clots
• if you have liver problems
• if you have or have ever had seizures or epilepsy
• if you are elderly (over 65 years old) and suffer from dementia and are at risk of stroke
• if you have a slow resting heart rate and/or are aware that you may be subject to salt depletion following severe and prolonged diarrhea and vomiting (feeling unwell) or due to the use of diuretics (tablets)
• if you have ever had an irregular or fast heartbeat, fainting, collapse or dizziness when standing up which may indicate abnormal heart rhythm.

Seek immediate medical attention if you experience any of the following symptoms:

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

Tell your doctor if you are taking Zeldox capsules before undergoing laboratory tests (e.g. blood tests, urine tests, liver function tests, heartbeat, etc.) as they 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.

Other medicines and Zeldox capsules
Always tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.

Do not take Zeldox capsulesif you are taking medicines for heart rhythm problems or medicines that can affect the 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 medicines can affect the heart rhythm by prolonging the QT interval. Ask your doctor or pharmacist if you need more information.
Talk to your doctor or pharmacist before taking Zeldox capsules.
Tell 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; e.g. macrolide antibiotics or rifampicin.
• mood changes (from depression to euphoria), agitation and irritation; these medicines are known as mood stabilizers, e.g. lithium, carbamazepine, valproate;
• depression, including some serotonergic medicines such as SSRIs like fluoxetine, paroxetine, sertraline; or herbal medicines or St. John's Wort (hypericum) remedies.
• Epilepsy e.g. phenytoin, phenobarbital, carbamazepine ethosuccimide.
• Parkinson's disease e.g. 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 WITH MAIN MEALS.
Alcohol consumption should be avoided during treatment with Zeldox capsules as it may increase the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Do not take ZELDOX capsules during pregnancy unless your doctor has told you to, because there is a risk that this medicine may harm the baby.
The following symptoms have been observed in newborns of mothers who have taken Zeldox during the last trimester (the last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, you should contact your doctor.
Breastfeeding
Do not breastfeed if you are taking Zeldox capsules. This is because small amounts of the medicine can pass into breast milk.
Contraception
If you are of childbearing potential, you should use adequate contraception while taking this medicine.

Driving and using machines
Taking Zeldox capsules can cause drowsiness. If you experience this symptom, do not drive or use machines until the drowsiness has worn off.

Zeldox capsules contains lactose
Zeldox capsules contain lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

Zeldox capsules contains sodium
Zeldox capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially “sodium-free”.

3. How to take Zeldox capsules

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have 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 the medicine's absorption in the intestine.
Zeldox capsules must be taken twice a day, one capsule in the morning with a
substantial breakfast and one in the evening during the evening meal (see the blister). Take this
medicine always at the same time.

Adults
The recommended dose is 40-80 mg twice a day to be taken with meals.
In long-term treatments, your doctor may want to adjust the dose. You must not
exceed the maximum dose of 160 mg per day.

Children and adolescents with bipolar mania
The usual dose is 20 mg to be taken with meals, subsequently the doctor will advise you on the
optimal dose suitable for you. The maximum dose of 80 mg per day must not be exceeded in children of
weight equal to or less than 45 kg, 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, the doctor will want to decide the appropriate dose for you. For patients over 65 years of
age, the dose is sometimes lower than for younger patients. Your doctor will advise you what
the right dose is for you.

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 capsulesthan you should
Contact your doctor or the nearest hospital immediately. Bring the package of Zeldox
capsules with you.
If you have taken too many Zeldox capsules, the symptoms may include drowsiness, tremor,
convulsions 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 time to
take the next one. In that case, take only the next dose. Do not take a double dose
to make up for the forgotten dose.

If you stop taking ZELDOX capsules
Your doctor will tell you how long to take Zeldox capsules. Do not stop the
treatment unless your doctor has told you to.
It is important to continue treatment even if you feel better. If you stop treatment
too soon, the symptoms may reappear.
If you have any further questions about the use of this medicine, ask 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 temporary. It is often difficult to distinguish side effects from the
symptoms of the illness.

Stop treatment with Zeldox capsules and contact your doctor immediately if you notice the
appearance 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 when standing up which may indicate abnormal heart function. These can be symptoms of a condition known as postural hypotension.

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

• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, hives. These can be symptoms of a serious allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle tension, tremors, difficulty swallowing and lack of attention, these can be symptoms of a condition known as neuroleptic malignant syndrome.
• Skin reactions, in particular rash, fever and enlarged 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 be potentially fatal.
• Confusion, agitation, heat, sweating, lack of muscle coordination,

muscle contractions. These can be symptoms of a condition known as
serotonin syndrome.

• Irregular, fast heartbeat, fainting which can be symptoms of a condition known as torsades de pointes which can be life-threatening.
• Abnormal erection of the penis, persistent and painful.

You may notice 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 and hyperactivity, agitation or anxiety
• Restlessness
• Abnormal movements including involuntary movements, muscle rigidity, slowness of 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
• Fatigue
• General feeling of being unwell

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

• High levels of prolactin in the blood
• Increased appetite
• Panic attacks
• Feeling nervous or depressed
• Decreased sexual drive
• Loss of consciousness
• Difficulty controlling movements/involuntary movements
• Restless legs
• Constriction of the throat, nightmares
• Convulsions, involuntary eye movements when staring, clumsiness, speech disorders, numbness, tingling sensation, reduced ability to concentrate, increased salivation
• Palpitations, feeling short of breath
• Sensitivity to light, dry eyes, ringing in the ears, ear pain
• Sore throat, air in the stomach, stomach discomfort
• Itchy rash, acne
• Muscle cramps, swollen or stiff joints
• Thirst, chest discomfort, abnormal walking
• Acid reflux, stomach pain
• Hair loss
• Abnormal head position
• Urinary incontinence, pain or difficulty urinating
• Abnormal production of breast milk
• Enlargement of the breasts in men
• Absence of menstruation
• Abnormal heart or blood test results
• Abnormal liver function test results
• Vertigo
• Generalized weakness and fatigue

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

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

Side effects with unknown frequency (frequency cannot be estimated based on 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 the veins, especially in the legs (symptoms include sweating, pain and redness in the legs) which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

Additional side effects in children and adolescents
In clinical studies with children and adolescents, side effects have generally been
similar to those experienced by adults (see above), except for sedation and
drowsiness, which have been found more frequently in children. The most common side effects
in children and adolescents were sedation, drowsiness, headache,
fatigue, nausea, dizziness, vomiting, decreased appetite and movement abnormalities.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through 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 at a temperature below 30°C.
Do not use this medicine after the expiry date (Exp.) stated on the pack. The expiry date refers to the last day of the month.
Do not dispose of any medicine in 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 ingredient is ziprasidone. Each capsule contains 20 mg, 40 mg, 60 mg, 80 mg of ziprasidone as ziprasidone hydrochloride monohydrate.
• The other ingredients are: lactose monohydrate (see section 2 “Zeldox capsules contains lactose), Pregelatinized starch, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulfate (sodium dodecyl sulfate) (see section 2 “Zeldox capsules contains sodium”) and indigotine (E132) (only in the 20 mg, 40 mg and 80 mg capsules containing the 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 and are marked “Pfizer” on one side and “ZDX 20” on the other.
The 40 mg capsules are blue and are marked “Pfizer” on one side and “ZDX 40” on the other.
The 60 mg capsules are white and are marked “Pfizer” on one side and “ZDX 60” on the other.
The 80 mg capsules are blue and white and are marked “Pfizer” on one side and “ZDX 80” on the other.

Packs:
Blisters
ZELDOX capsules are packaged in aluminum PVC/PA blisters with an aluminum covering foil, in cartons of 14, 20, 30, 50, 56, 60 or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1
79090 Freiburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
This leaflet was last updated on: