Package Insert: Information for the User

Zeldox 20 mg/ml Powder for Injection

Ziprasidone

Read this package insert carefully before starting to use this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

6. Contents of the pack and additional information

Zeldox belongs to a group of medicines called antipsychotics.

Zeldox injectable solution is used forthe rapid control of agitation (anxiety) in thetreatment of schizophrenia in adults, a mental illness characterized by the following symptoms: hearing, seeing, or feeling things that do not exist, believing in something that is not true, having unusual suspicions, being absent, and having difficulty establishing social relationships, nervousness, depression, or anxiety.

Zeldox injectable solution may be usedfor a maximum of three consecutive days.

You may have been given Zeldox in an emergency, and you are reading this leaflet after it has been given to you. Your doctor will have taken the following points into account, but please check them yourself if you are to be given Zeldox again.

Do not useZeldox

• if you are allergic to ziprasidone or any of the other ingredients in this medicine(listed in section 6). An allergic reaction can be recognised 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 had a recent heart attack.
• if you are using medicines for heart rhythm disturbances or medicines that can affect heart rhythm.

See also the section “Use of Zeldox injectable solution with other medicines” later.

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to use Zeldox injectable solution:

• if you or a family member 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 convulsions or epilepsy.
• if you are over 65 years old and have dementia and are at high risk of having a stroke (cerebrovascular accident).
• if you have a significant decrease in resting heart rate and/or know that you can have low levels of salts in the blood as a result of having severe diarrhoea and vomiting for a long time or the use of diuretics (which promote the elimination of excess fluids).
• if you experience symptoms such as rapid or irregular heartbeats, dizziness, fainting or dizziness when standing up, as this may indicate abnormal heart rhythm.

Immediately contact your doctor if you experience any of the following symptoms:

• Severe skin reactions such as, for example, a rash with blisters that could be accompanied by mouth ulcers, skin peeling, fever and skin spots in the shape of a target that could be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially fatal.
• Zeldox injectable solution can cause drowsiness, low blood pressure when standing up, dizziness and gait disturbances, which can cause falls. You should be careful, especially if you are an elderly patient or have weakness.

Inform your doctor that you are using Zeldox before undergoing any diagnostic tests (including blood, urine, liver function, heart rhythm tests, etc.) as it may alter the results.

Children and adolescents

Zeldox injectable solution should not be administered to children and adolescents under 18years old.

Use of Zeldox injectable solution with other medicines

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

Do not use Zeldox injectable solution if you are using medicines for heart rhythm disturbances or medicines that can affect heart rhythm, such as:

• Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levometadilo acetate, mesoridazine, thioridazine, pimozide, esparfloxacine, gatifloxacine, moxifloxacine, dolasetron mesylate, mefloquine, sertindole or cisapride. These medicines can alter 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 use Zeldox injectable solution.

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

• skin and fungal infections such as ketoconazole;
• mood changes (from depressive mood to euphoria), agitation and irritability; these medicines are known as mood stabilisers, for example lithium, carbamazepine, valproate;
• depression, including some serotonin reuptake inhibitors, for example ISRSs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine, paroxetine, sertraline;
• epilepsy, for example phenytoin, phenobarbital, carbamazepine, ethosuximide;
• Parkinson's disease, for example levodopa, bromocriptine, ropinirole, pramipexole

See also the section “Do not use Zeldox” above.

Administration of Zeldox with food and drinks

You should not consume alcoholic beveragesduring treatment with Zeldox injectable solution, as this may increase the risk of adverse effects.

Pregnancy and breastfeeding

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

Pregnancy

You should not use Zeldox during pregnancy unless your doctor tells you to, as there is a risk that this medicine may harm your baby.

The following symptoms may appear in newborn babies, from mothers who have used antipsychotics during the last trimester (last three months of pregnancy): agitation, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. Contact your doctor if your baby develops any of these symptoms.

Breastfeeding

You should not breastfeed your baby while you are being treated with Zeldox. This is because small amounts may pass into the breast milk.

Contraception

If you can become pregnant, you should use an appropriate contraceptive method while using this medicine.

Driving and operating machinery

The use of Zeldox may cause drowsiness. If you experience this symptom, refrain from driving and operating hazardous machinery until it disappears.

Zeldox injectable solution contains sodium

This medicine contains less than 23 mg of sodium (1mmol)per ml of reconstituted injectable solution; this is, essentially “sodium-free”.

Adults

Zeldox injectable solution is administered via intramuscular injection. Your doctor or pharmacist will decide how many injections you should receive.The recommended dose is 10 mg, but some people may need 20 mg as the first dose. If the dose you receive in your first injection is 10 mg, you may receive another injection 2 hours later. If your first dose is 20 mg, you may receive another injection 4 hours later.

Your doctor will adjust the amount of medication you receive to control your symptoms adequately.

Zeldox injectable solution will be administered for a maximum of 3 consecutive days.

If you need further treatment, your doctor may decide to continue your treatment using Zeldox hard capsules.

Zeldox should not be injected into blood vessels.

Children and adolescents

Zeldox injectable solution is not recommended for use in children and adolescents under 18 years of age.

People over 65 years

Zeldox injectable solution is not recommended for use in people over 65 years of age.

Patients with liver problems

If you have liver problems, you will generally receive a lower dose of this medication. Your doctor will decide on the correct dose for you.

Patients with kidney problems

Inform your doctor if you have kidney problems, as this may affect the dose your doctor prescribes for you.

If you think you have been given too much Zeldox

If you think you have been given too much Zeldox, inform your doctor or nurse immediately.

If you have been given too much of this medication, you may experience drowsiness, tremor, convulsions, anxiety, and involuntary head and neck movements.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. However, most side effects are temporary. It can often be difficult to distinguish the symptoms of your illness from side effects.

STOP using Zeldox and contact your doctor immediately if you experience any of the following serious side effects:

Less common side effects (may affect up to 1 in 100 patients):

• Fast or irregular heartbeats, a feeling of dizziness when standing, which may indicate an abnormal heart function. These could be symptoms of a condition known as postural hypotension.
• Uncontrollable or involuntary movements, especially in your face or tongue.
• Persistent and painful erection of the penis.

Frequency not known (cannot be estimated from available data):

• Swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing, hives. These could be symptoms of a severe allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, tremors, difficulty swallowing, and decreased consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome.
• Skin reactions, especially rash, fever, and lymph node inflammation, which could be symptoms of a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially fatal.
• Confusion, agitation, fever, sweating, muscle movement disorder, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Fast, irregular heartbeats, dizziness, which could be symptoms of a life-threatening condition known as Torsades de Pointes.

You may experience some of the side effects listed below. These potential side effects are generally mild to moderate in nature and may disappear over time. However, if the side effect is severe or persistent, contact your doctor.

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

• Difficulty sleeping
• Sensation of agitation or anxiety
• Restlessness
• Abnormal movements, including muscle stiffness, slowness of movement, and tremors
• Sensation of drowsiness
• Headache
• Dizziness
• High blood pressure
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth
• Sensation of weakness or loss of strength
• Burning sensation and/or pain at the injection site
• Increased fatigue

Less common side effects (may affect up to 1 in 100 patients):

• Decreased appetite
• Increased difficulty with social interactions, seeing or hearing things that are not there
• Mania (extremely elevated mood, strange thought patterns, and hyperactivity)
• Difficulty controlling movements or making involuntary sounds such as throat clearing, inhaling, or grunting, difficulty or inability to move parts of the body, clumsiness
• Loss of consciousness
• Speech disorders
• Slow heart rate
• Loss of balance, dizziness
• Sensation of suffocation
• Stomach problems such as diarrhea
• Increased sweating and/or excessive sweating
• Rash
• Symptoms similar to the flu
• Discomfort, redness at the injection site
• Withdrawal syndrome
• Increased liver enzymes

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

• Urinary incontinence, pain or difficulty urinating.

Frequency not known (cannot be estimated from available data):

• Facial paralysis
• Blood clots in the veins, especially in the legs (symptoms may include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• Urinary incontinence.
• Withdrawal syndrome in newborns
• Abnormal milk production

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above30°C. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging and vial after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.Please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Zeldox injectable solution

-The active ingredient is ziprasidone. Each vial contains 20 mg of ziprasidone (as mesilate).

-The other component (excipient) is sodium sulfobutyl ether-beta-cyclodextrin (see section 2).

Appearance of the product and contents of the pack

Zeldox injectable solution is presented as a white to off-white powder for injection solution. Each pack contains 1 vial (powder).

The vials are made of glass, closed with rubber stoppers and provided with aluminium flip-off caps.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible

Fareva Amboise,

Zone Industrielle

29 route des industries

37530 Pocé-sur-Cisse (France).

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the member states of the European Economic Area with the following names:

Date of thelast revision of this leaflet:September 2022

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.

Healthcare professional: please read and remove before giving the leaflet to the patient

PREPARATION AND ADMINISTRATION OF ZELDOX 20 mg/ml POWDER FOR INJECTION SOLUTION

Preparation

• Aseptic technique must be used for the preparation of the final intramuscular solution since the product does not include any preservative or bacteriostatic agent.
• The contents of the vial (ziprasidone mesilate powder) must be reconstituted by adding 1.2 ml of water for injection (solvent), obtaining a concentration of 20 mg of ziprasidone per ml. Agitate for approximately half or 1 minute until the solution is complete.
• Zeldox 20 mg/ml injectable solution must be reconstituted with water for injection.
• The vials are for single use, so any unused portion must be discarded.
• Before administration, the vial must be carefully inspected for any particles or discoloration. Discard those vials that contain a discolored solution or visible particles.

Administration

• Once the vial is reconstituted, withdraw the appropriate volume (0.5 ml or 1 ml) of solution and administer it by intramuscular route.

Compatibility and stability

• No additives or other medications should be incorporated into Zeldox 20 mg/ml injectable solution. If Zeldox 20 mg/ml injectable solution has to be administered at the same time as another medication, each medication must be administered separately according to the recommended dosage and administration route of the manufacturer.
• After reconstitution, Zeldox 20 mg/ml injectable solution has been shown to be stable for a maximum of 24 hours at 25°C or a maximum of 7 days if refrigerated at 2°C-8°C.
• Once reconstituted, the solution must be protected from light and from a microbiological point of view, it must be used immediately.
• When reconstituted as instructed, a volume of 1.5 ml (excess of 50%) is created that contains 30 mg of ziprasidone. This excess facilitates the extraction of 1 ml to provide 20 mg of ziprasidone.
• Once the dose is withdrawn, discard the unused solution.
• Do not store above 30°C.
• Store in the original container.