ZELDOX 20 mg/ml POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Zeldox 20 mg/ml Powder for Injection

Ziprasidone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Zeldox injection is and what it is used for
2. What you need to know before you use Zeldox injection
3. How to use Zeldox injection
4. Possible side effects
5. Storage of Zeldox injection

1. Contents of the pack and other information

1. What Zeldox injection is and what it is used for

Zeldox belongs to a group of medicines called antipsychotics.

Zeldox injection is used to rapidly control agitation (anxiety) in the treatment 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 injection may be used for a maximum of three consecutive days.

2. What you need to know before you use Zeldox injection

You may have been given Zeldox in an emergency, so you will be reading this leaflet after it has been given to you. Your doctor will have taken into account the following points, however, check them yourself in case you need to be given Zeldox again.

Do not useZeldox

• 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 a skin rash, itching, swollen face or lips, difficulty breathing.
• if you have or have had any heart disease or have recently had a heart attack.
• if you are using medicines for heart rhythm disturbances or medicines that may affect heart rhythm.

See also the section “Using Zeldox injection with other medicines” below.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start using Zeldox injection:

• if you or someone in your family 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 seizures or epilepsy.
• if you are over 65 years old and suffer from dementia and are at high risk of having a stroke.
• if you have a significant decrease in resting heart rate and/or know that you may have low levels of salts in the blood as a result of having suffered from severe and prolonged diarrhea and vomiting or the use of diuretics (which promote the elimination of excess fluids).
• if you experience symptoms such as rapid or irregular heartbeats, fainting, syncope or dizziness when standing up, as this 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 that may be accompanied by ulcers in the mouth, skin peeling, fever and skin spots with a target shape that may be symptoms of Stevens-Johnson syndrome. These skin reactions could be potentially life-threatening.
• Zeldox injection may 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 suffer from weakness.

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

Children and adolescents

Zeldox injection should not be given to children and adolescents under 18 years of age.

Using Zeldox injection with other medicines

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

Do not use Zeldox injection if you are using medicines for heart rhythm disturbances 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 the heart rhythm by prolonging the QT interval. If you have any further questions about this effect, consult your doctor.

Talk to your doctor or pharmacist before you start using Zeldox injection.

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

• skin and fungal infections such as ketoconazole;
• mood changes (from depressive mood to euphoria), agitation and irritation; these medicines are known as mood stabilizers, for example lithium, carbamazepine, valproate;
• depression, including some serotoninergic medicines, for example SSRIs (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.

Taking Zeldox with food and drinks

You should not drink alcoholic beverages during treatment with Zeldox injection, as this may increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

The following symptoms may appear in newborn babies of mothers who have used antipsychotics during the last trimester (last three months of pregnancy): agitation, muscle stiffness and/or weakness, drowsiness, agitation, breathing 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 breast milk.

Contraception

If you can become pregnant, you should use a suitable method of contraception while you are being treated with this medicine.

Driving and using machines

Zeldox may cause drowsiness. If you experience this symptom, do not drive or operate machinery until it has passed.

Zeldox injection contains sodium

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

3. How to use Zeldox injection

Adults

Zeldox injection is given by intramuscular injection. Your doctor or pharmacist will decide how many injections you should be given. The recommended dose is 10 mg, but some people may need 20 mg as their first dose. If the dose you are given in your first injection is 10 mg, you may be given another injection 2 hours later. If your first dose is 20 mg, you may be given another injection 4 hours later.

Your doctor will adjust the amount of medicine you are given so that your symptoms are adequately controlled.

Zeldox injection will be given to you 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 injection is not recommended for use in children and adolescents under 18 years of age.

Elderly (over 65 years old)

Zeldox injection is not recommended for use in elderly patients over 65 years old.

Patients with liver problems

If you have liver problems, you will usually be given a lower dose of this medicine. Your doctor will decide the correct dose for you.

Patients with kidney problems

Tell your doctor if you have kidney problems, as this may affect the dose that 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, tell your doctor or nurse immediately.

If you have been given too much of this medicine, you may experience drowsiness, tremors, seizures, anxiety and involuntary movements of the head and neck.

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 everybody gets them. However, most side effects are temporary and may disappear over time. It can be difficult to distinguish the symptoms of your illness from the side effects.

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

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

• Rapid or irregular heartbeats, feeling dizzy when standing up, which may indicate abnormal heart function. These could be symptoms of a condition known as postural hypotension.
• Involuntary movements, especially of your face or tongue.
• Prolonged and painful erections of the penis.

Frequency not known (cannot be estimated from the 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 inflammation of the lymph nodes, which could be symptoms of a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.
• Confusion, agitation, fever, sweating, uncoordinated muscle movements, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Rapid, irregular heartbeats, fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes.

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

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

• Difficulty sleeping
• Feeling agitated or anxious
• Restlessness
• Abnormal movements, including muscle stiffness, slow movements, and tremors
• Drowsiness
• Headache
• Dizziness
• High blood pressure
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth
• Feeling weak or loss of strength
• Burning or pain at the injection site
• Increased fatigue

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

• Decreased appetite
• Increased difficulty with social relationships, seeing or hearing things that are not there
• Mania (very excited mood, unusual thought patterns, and hyperactivity)
• Difficulty controlling movements or making involuntary sounds such as clearing your throat, inhaling, or grunting, difficulty or inability to move parts of your body, clumsiness
• Loss of consciousness
• Speech disorders
• Slow heart rate
• Loss of balance, dizziness
• Feeling of suffocation
• Stomach problems such as diarrhea
• Increased sweating
• Rash
• Flu-like symptoms
• 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 the 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 bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• Urinary incontinence.
• Withdrawal syndrome in newborns
• Abnormal production of breast milk

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zeldox injection

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

Do not store above 30°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the package and vial after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Zeldox Injectable Solution

• The active ingredient is ziprasidone. Each vial contains 20 mg of ziprasidone (as mesylate).
• The other component (excipient) is sulfobutylether-beta-cyclodextrin sodium (see section 2).

Appearance and Container Contents of the Product

Zeldox injectable solution is presented as a powder for injectable solution, white to off-white in color. Each container contains 1 vial (powder).

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Fareva Amboise,

Zone Industrielle

29 route des industries

37530 Pocé-sur-Cisse (France).

Further information on this medicinal product can be obtained 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 last revision of this leaflet:September 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (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 INJECTABLE SOLUTION

Preparation

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

Administration

• Once the vial is reconstituted, extract the appropriate volume (0.5 ml or 1 ml) of solution and administer it intramuscularly.

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 is to be administered at the same time as another medication, each medication should be administered separately according to the manufacturer's dosage and administration recommendations.
• After reconstitution, Zeldox 20 mg/ml injectable solution has been shown to be stable for up to 24 hours at 25°C or up to 7 days if refrigerated at 2°C-8°C.
• Once reconstituted, the solution should be protected from light and, from a microbiological point of view, should be used immediately.
• When reconstituted following the given instructions, a fill volume of 1.5 ml (50% excess) is created, which contains 30 mg of ziprasidone. This excess facilitates the extraction of 1 ml to provide 20 mg of ziprasidone.
• Once the dose is extracted, discard the unused solution.
• Do not store above 30°C.
• Store in the original container.