Zeldox 20 mg/ml powder for injection solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zeldox 20 mg/ml powder for injectable solution

Ziprasidone

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Zeldox injectable solution is and what it is used for

2. What you need to know before using Zeldox injectable solution

3. How to use Zeldox injectable solution

4. Possible adverse effects

5. How to store Zeldox injectable solution

6. Contents of the pack and other information

1. What Zeldox Injectable Solution is and what it is used for

Zeldox belongs to a group of medicines called antipsychotics.

Zeldox Injectable Solution is used for the rapid control of 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seeing, or feeling things that do not exist, believing in something that is not true, having unusual suspicions, being withdrawn, having difficulty forming social relationships, nervousness, depression, or anxiety.

Zeldox Injectable Solution can be used for up to three consecutive days.

2. What you need to know before using Zeldox injectable solution

You may have been given Zeldox in an emergency situation, so you are reading this leaflet after the medicine has already been administered. Your doctor will have considered the points below; however, please check them yourself in case Zeldox needs to be administered again.

Do not use Zeldox

• if you are allergic to ziprasidone or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized by the appearance of skin rash, itching, swelling of the face or lips, or difficulty breathing.
• if you have or have had a heart condition 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 “Use of Zeldox injectable solution with other medicines” below.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Zeldox injectable solution:

• if you or someone in your family has a history of blood clots, as this type of medicine has been associated with blood clot formation.
• if you have liver problems.
• if you have or have had seizures or epilepsy.
• if you are over 65 years of age and have dementia, as you may have an increased risk of stroke (cerebrovascular accident).
• if you have a significantly slow resting heart rate and/or if you know you may have low levels of blood salts due to prolonged severe diarrhea and vomiting or due to the use of diuretics (which promote elimination of excess fluids).
• if you experience symptoms such as rapid or irregular heartbeat, fainting, syncope, or dizziness upon standing, as these may indicate abnormal heart rhythm.

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

• Severe skin reactions such as blistering rash, possibly accompanied by mouth ulcers, skin peeling, fever, or target-like skin lesions, which could be symptoms of Stevens-Johnson syndrome. These skin reactions could potentially be life-threatening.
• Zeldox injectable solution may cause drowsiness, low blood pressure upon standing, dizziness, and gait disturbances, which may lead to falls. Caution should be exercised, especially if you are elderly or have any physical weakness.

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

Children and adolescents

Zeldox injectable solution must not be given to children and adolescents under 18 years of age.

Use of Zeldox injectable solution with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Do not use Zeldox injectable solution 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, dolasetron mesylate, mefloquine, sertindole, or cisapride. These medicines may alter heart rhythm by prolonging the QT interval. If you have further questions about this effect, consult your doctor.

Talk to your doctor or pharmacist before starting Zeldox injectable solution.

Tell your doctor or pharmacist if you are taking or have recently taken medicines for:

• skin infections and fungal infections such as ketoconazole;
• mood changes (from depression to euphoria), agitation, and irritability; these medicines are known as mood stabilizers, for example lithium, carbamazepine, valproate;
• depression, including certain serotonergic 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 drink

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

Pregnancy and breastfeeding

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

Pregnancy

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

The following symptoms may occur in newborns whose mothers have taken antipsychotics during the third trimester (last three months of pregnancy): agitation, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. Contact your doctor if your baby develops any of these symptoms.

Breastfeeding

You should not breastfeed while being treated with Zeldox, as small amounts of the medicine may pass into breast milk.

Contraception

If you are able to become pregnant, you should use an appropriate contraceptive method while taking this medicine.

Driving and using machines

Zeldox may cause drowsiness. If you experience this symptom, refrain from driving or operating heavy machinery until the symptom resolves.

Zeldox injectable solution contains sodium

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

3. How to use Zeldox injectable solution

Adults

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

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

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

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

Zeldox must not be injected into blood vessels.

Children and adolescents

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

Patients over 65 years

The use of Zeldox injectable solution is not recommended in patients over 65 years of age.

Patients with liver problems

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

Patients with kidney problems

Inform your doctor if you have kidney problems, as this may influence the dose prescribed by your doctor.

If you think you have been given more Zeldox than you should

If you think you have been given more Zeldox than you should, inform your doctor or nurse immediately.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. However, most adverse effects are temporary. It may often be difficult to distinguish symptoms of your illness from adverse effects.

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

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

• Rapid or irregular heartbeat, dizziness upon standing, which may indicate abnormal heart function. These could be symptoms of a condition known as postural hypotension.
• Involuntary or unusual movements, especially of the face or tongue.
• Abnormally persistent and painful penile erection.

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 serious allergic reaction such as angioedema.
• Fever, rapid breathing, sweating, muscle stiffness, tremor, difficulty swallowing, and reduced consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome.
• Skin reactions, especially rash, fever, and swollen lymph nodes, which could be symptoms of a disease called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions could be potentially life-threatening.
• Confusion, agitation, fever, sweating, lack of muscle coordination, muscle spasms. These could be symptoms of a condition known as serotonin syndrome.
• Rapid or irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as Torsades de Pointes.

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

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

• Difficulty sleeping
• Feelings of restlessness or anxiety
• Agitation
• Abnormal movements including muscle stiffness, slowness of movement, and tremor
• Drowsiness
• Headache
• Dizziness
• High blood pressure
• Low blood pressure
• Nausea, vomiting
• Constipation
• Dry mouth
• Feeling of weakness or loss of strength
• Burning and/or pain at the injection site
• Increased tiredness

Uncommon adverse 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, unusual thought patterns, and hyperactivity)
• Difficulty controlling movements or making involuntary sounds such as throat clearing, sniffing, or grunting; difficulty or inability to move parts of the body; clumsiness
• Loss of consciousness
• Speech disorders
• Slow heart rate
• Loss of balance, dizziness
• Feeling of hot flushes
• Stomach problems such as diarrhea
• Increased and/or excessive sweating
• Rash
• Flu-like symptoms
• Discomfort, redness at the injection site
• Withdrawal syndrome
• Increased liver enzymes

Rare adverse 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 may travel through 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 production of breast milk

Reporting of adverse effects

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

5. Storage of Zeldox Injectable Solution

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

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

Do not use this medicine after the expiry date stated on the packaging and vial after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zeldox injectable solution

• The active substance is ziprasidone. Each vial contains 20 mg of ziprasidone (as mesilate).
• The other component (excipient) is sodium sulfobutylether-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 injectable solution. Each pack contains 1 vial (powder).

The vials are made of glass, closed with rubber stoppers and sealed with aluminium 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).

For further information about this medicinal product, please contact 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 most recent review of this leaflet: September 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.

Healthcare Professional: please read this and remove it before giving the leaflet to the patient

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

Preparation

• An aseptic technique must be used in the preparation of the final intramuscular solution, as the product does not contain any preservative or bacteriostatic agent.
• The contents of the vial (ziprasidone mesylate powder) must be reconstituted by adding 1.2 ml of water for injection (diluent), resulting in a concentration of 20 mg of ziprasidone per ml. Shake for approximately 30 seconds to 1 minute until complete dissolution is achieved.
• Zeldox 20 mg/ml injectable solution must be reconstituted with water for injection.
• The vials are for single use only; therefore, any unused portion must be discarded.
• Before administration, the vial should be carefully inspected for particles or discoloration. Discard any vials containing discolored solution or visible particles.

Administration

• After reconstitution, withdraw the appropriate volume (0.5 ml or 1 ml) of solution and administer by intramuscular route.

Compatibility and stability

• No additives or other medications should be added to Zeldox 20 mg/ml injectable solution. If Zeldox 20 mg/ml injectable solution must be administered at the same time as another medication, each medication should be administered separately according to the manufacturer's recommended dosage and route of administration.
• 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.
• After reconstitution, the solution must be protected from light and, from a microbiological standpoint, should be used immediately.
• When reconstituted according to the instructions provided, a fill volume of 1.5 ml (50% excess) containing 30 mg of ziprasidone is created. This excess facilitates withdrawal of 1 ml to deliver 20 mg of ziprasidone.
• After withdrawal of the dose, discard any unused solution.
• Do not store above 30°C.
• Store in the original container.