ZIPRASIDONE 20 mg Капсулы Твердые

Содержание инструкции

1. Ziprasidone Sandoz 20 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules, 80 mg hard capsules
   1. What is Ziprasidone Sandoz and what it is used for
   2. What you need to know before taking Ziprasidone Sandoz
   3. How to take Ziprasidone Sandoz
   4. Possible side effects
   5. How to store Ziprasidone Sandoz
   6. Package contents and other information

In track changes the modifications related to R001
Highlighted in yellow are the modifications related to variation 017

Ziprasidone Sandoz 20 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules, 80 mg hard capsules

Generic medicine

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 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 Ziprasidone Sandoz is and what it is used for
• 2. What you need to know before you take Ziprasidone Sandoz
• 3. How to take Ziprasidone Sandoz
• 4. Possible side effects
• 5. How to store Ziprasidone Sandoz
• 6. Contents of the pack and other information

1. What is Ziprasidone Sandoz and what it is used for

Ziprasidone Sandoz contains the active ingredient ziprasidone and belongs to a group of medicines
called antipsychotics.
Ziprasidone Sandoz is used to treatthe following mental disorders:

• schizophreniain adults. Schizophrenia is characterized by the following symptoms: hearing, seeing and feeling things that do not exist, believing in something unreal, harboring unusual suspicions, being absent and having difficulty establishing social relationships, nervousness, depression or anxiety
• manic or mixed episodesof moderate severity within bipolar disorderin adults and in children and adolescents aged 10 to 17 years. This mental illness is characterized by alternating phases of euphoric (mania) or depressive states. During manic episodes, the most characteristic symptoms are: euphoric behavior, excessive self-esteem, increased energy, decreased need for sleep, lack of concentration or hyperactivity and repeated high-risk behaviors.

2. What you need to know before taking Ziprasidone Sandoz

Do not take Ziprasidone Sandoz

• if you are allergic to ziprasidone or to any of the other ingredients of 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 problems or that can affect the heart rhythm.

See also the section below “Other medicines and Ziprasidone Sandoz”.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ziprasidone Sandoz

• 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 (being ill) 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 function.

Contact your doctor immediately if any of the following occur:

• severe skin reactions such as blistering rashes that may include ulcers in the mouth, skin peeling, fever and target-like spots on the skin, which may be symptoms of Stevens-Johnson syndrome. These skin reactions can be potentially life-threatening.
• Ziprasidone Sandoz can cause drowsiness, low blood pressure when getting up, dizziness and gait disturbances, which can cause falls. Caution should be exercised, especially if you are elderly or weak.

Tell your doctor if you are taking Ziprasidone Sandoz before undergoing laboratory tests (such as blood, urine, liver function, heart rate etc.), as this medicine 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 Ziprasidone Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Ziprasidone Sandozif 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 Ziprasidone Sandoz.
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 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 Ziprasidone Sandoz”
Ziprasidone Sandoz with food, drinks and alcohol
Ziprasidone Sandoz MUST BE TAKEN WITH MAIN MEALS.
Alcohol consumption should be avoided during treatment with Ziprasidone Sandoz, as it may increase the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

• PregnancyDo not take Ziprasidone Sandoz during pregnancy unless specifically indicated by your doctor, as there is a risk that this medicine may be harmful to the baby.

The following symptoms have been observed in newborns of mothers who have taken Ziprasidone Sandoz during the last trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.

• BreastfeedingDo not breastfeed while taking Ziprasidone Sandoz. This is because small amounts of the medicine can pass into breast milk.
• ContraceptionIf you are of childbearing potential, you should use adequate contraception while taking this medicine.

Driving and using machines
Taking Ziprasidone Sandoz can cause drowsiness. If you experience this symptom, you should not drive or operate tools or machinery until the drowsiness has worn off.

Ziprasidone Sandoz contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

20 mg, 40 mg and 80 mg hard capsules:
This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, i.e. essentially ‘sodium-free’.

3. How to take Ziprasidone Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The capsules must be swallowed whole, not chewed, and must be taken during meals.
It is important that the capsules are not chewed as this may affect the time of absorption
of the medicine in the intestine.
Ziprasidone Sandoz must be taken twice a day, one capsule in the morning with a
substantial breakfast and one in the evening during the evening meal. Take this medicine every day 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 should not exceed the
maximum dose of 160 mg per day.

Children and adolescents with bipolar mania
The usual starting dose is 20 mg to be taken with meals, subsequently your doctor will advise you on the
optimal dose suitable for you. The maximum dose of 80 mg per day should not be exceeded in children
weighing 45 kg or less, or 160 mg in children weighing more than 45 kg.
The safety and efficacy of Ziprasidone Sandoz 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 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 Ziprasidone
Sandoz capsules. Your doctor will calculate the appropriate dose for you.

If you take more Ziprasidone Sandoz than you should
In case of overdose, contact your doctor or pharmacist immediately and have the
package and any remaining capsules available.
If you have taken too many capsules, you may experience drowsiness, tremor, convulsions and involuntary
movements of the head and neck.

If you forget to take Ziprasidone Sandoz
It is important to take the capsules regularly, at the same time each day. If you forget to take
a dose, take it as soon as you remember, unless it is time to take the next dose.
In this case, take only the next dose, at the usual time. Do not take a double dose to
make up for a missed dose.

If you stop taking Ziprasidone Sandoz
Your doctor will tell you how long to take Ziprasidone Sandoz 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
early, the symptoms may return.
If you have any doubts 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 everybody gets them.
Most side effects are however transient in nature. It can often be difficult to
distinguish the symptoms of the illness from those of the side effects.

If you experience any of the following serious side effects, STOP taking
Ziprasidone Sandoz and contact your doctor immediately:
Common side effects, may affect up to 1 in 10 people:

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

Uncommon side effects, may affect up to 1 in 100 patients:

• Fast or irregular heartbeat, dizziness when getting up, 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 patients:

• 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 rigidity, tremor, difficulty swallowing and decreased level of consciousness. These may be symptoms of a condition known as neuroleptic malignant syndrome.
• Skin reactions, in particular rash, fever and swollen lymph nodes, which may be symptoms of a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be potentially life-threatening.
• Confusion, agitation, high temperature, sweating, lack of muscle coordination, muscle spasms. These may be symptoms of a condition known as serotonin syndrome.
• Fast and irregular heartbeat and fainting, which may be symptoms of a potentially fatal condition known as Torsades de Pointes.
• Abnormal, persistent and painful erection of the penis.

Not known, frequency cannot be estimated based on available data:

• Swelling, pain and redness in the legs. These may be symptoms of blood clots in the veins, particularly those in the legs, which can move through the blood vessels and reach the lungs, causing chest pain and difficulty breathing.

You may experience any of the side effects listed below. These
potential side effects are generally mild to moderate in severity and may
resolve over time. However, if the side effect is severe or persistent you should
contact your doctor.
Very common side effects, may affect more than 1 in 10 patients:

• Difficulty sleeping
• Drowsiness or excessive daytime sleepiness
• Headache

Common side effects, may affect up to 1 in 10 patients:

• 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
• Skin 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 patients:

• 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, reduced ability to concentrate, increased salivation
• Palpitations, feeling short of breath
• Intolerance to light, dry eyes, ringing in the ears, ear pain
• Sore throat, air in the stomach, stomach discomfort
• Itchy skin 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 tests
• Vertigo
• General weakness and fatigue

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

• Decreased levels of calcium in the blood
• Slowed thinking, lack of emotion
• Facial flaccidity
• Paralysis
• Partial or complete loss of vision in one eye, itchy eyes
• Difficulty speaking, hiccups
• Loose stools
• Skin irritation
• Inability to open the mouth
• Difficulty emptying the bladder
• Drug withdrawal syndrome in the newborn
• Decreased orgasm
• Feeling of warmth
• Decreased or increased white blood cells (blood tests)
• Red and raised patches of skin covered with whitish scales, known as psoriasis

Not known, frequency cannot be estimated based on available data:

• In the elderly population with dementia, a slight increase in the number of deaths has been reported in patients taking antipsychotics compared to those not taking them

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at
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 Ziprasidone Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, the bottle and the carton
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30  C.

Bottles:
Validity after first opening: 6 months.
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 Ziprasidone Sandoz contains

• The active ingredient is ziprasidone. Each hard capsule contains 20 mg of ziprasidone (as ziprasidone hydrochloride monohydrate) Each hard capsule contains 40 mg of ziprasidone (as ziprasidone hydrochloride monohydrate)

Each hard capsule contains 60 mg of ziprasidone (as ziprasidone hydrochloride monohydrate)
Each hard capsule contains 80 mg of ziprasidone (as ziprasidone hydrochloride monohydrate)

• Other ingredients are: Capsule contents: lactose monohydrate, pregelatinized starch, magnesium stearate. Capsules 20, 40 and 80 mg Capsule shell: indigo carmine (contains sodium) (E132), titanium dioxide (E171), water and gelatin. Capsules 60 mg Capsule shell: titanium dioxide (E171), water and gelatin.

Description of the appearance of Ziprasidone Sandoz and package contents
Ziprasidone Sandoz is presented in the form of gelatin hard capsules
Hard capsules 20 mg, size 4 (length: approximately 14.3 mm): capsules with opaque blue cap/opaque azure body
Hard capsules 40 mg, size 3 (length: approximately 15.7 mm): capsules with opaque blue cap/opaque blue body
Hard capsules 60 mg, size 2 (length: approximately 17.6 mm): capsules with opaque white cap/opaque white body
Hard capsules 80 mg, size 1 (length: approximately 19.4 mm): capsules with opaque blue cap/opaque azure body

Pack sizes:
Ziprasidone Sandoz is packaged in blisters in cardboard boxes containing 10, 14, 20, 30, 50, 56, 60,
98 or 100 capsules.
Ziprasidone Sandoz is packaged in closed bottles with caps, containing 200 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Germany Ziprasidon – 1 A Pharma 20 mg Hard Capsules
Ziprasidon – 1 A Pharma 40 mg Hard Capsules
Ziprasidon – 1 A Pharma 60 mg Hard Capsules
Ziprasidon – 1 A Pharma 80 mg Hard Capsules
Denmark Ziprasidone Sandoz
Italy Ziprasidone Sandoz
Spain Ziprasidona Sandoz 20 mg hard capsules EFG,
Ziprasidona Sandoz 40 mg hard capsules EFG,
Ziprasidona Sandoz 60 mg hard capsules EFG,
Ziprasidona Sandoz 80 mg hard capsules EFG
Sweden Ziprasidone Sandoz 20 mg capsules, hard,