Ondansetron Mylan Generics Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Mylan Generics Italia 2 mg/ml, solution for injection

Generic Medicine
Please read this leaflet carefully before using 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ondansetron Mylan Generics Italia is and what it is used for
What you need to know before using Ondansetron Mylan Generics Italia
How to use Ondansetron Mylan Generics Italia
Possible side effects
How to store Ondansetron Mylan Generics Italia
Contents of the pack and other information

1. What Ondansetrone Mylan Generics Italia is and what it is used for

Ondansetrone Mylan Generics Italia belongs to a group of medicines called antiemetics, which are drugs used to prevent or treat nausea and vomiting. Ondansetrone Mylan Generics Italia can be used to prevent or treat nausea or vomiting following surgery, cancer chemotherapy, or radiotherapy.
Ask your doctor, nurse, or pharmacist if you need further explanations regarding the use of this product.

2. What you should know before using Ondansetrone Mylan Generics Italia

Do not take Ondansetrone Mylan Generics Italia if:

you are allergic to ondansetron, to any of the other ingredients of this medicine (listed in section 6) or to medicines of the same class (e.g. granisetron or dolasetron).
you are taking apomorphine (used to treat Parkinson’s disease).

If you are unsure, speak with your doctor, nurse, or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ondansetrone Mylan Generics Italia if:

you have a blockage in your intestine or suffer from constipation,
your doctor has told you that your liver is not functioning properly,
you have recently undergone or are about to undergo removal of adenoids or tonsils,
you suffer from heart problems or are about to undergo surgery under anaesthesia,
you have an irregular heartbeat (arrhythmia),
you have problems with blood electrolyte levels, such as potassium, sodium, or magnesium.

Special precautions should be taken if Ondansetrone Mylan Generics Italia is to be administered
to children receiving anticancer medicines that may affect liver function.
Other medicines and Ondansetrone Mylan Generics Italia
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Make sure your doctor knows if you are taking any of the following medicines:

a painkiller called Tramadol: the pain-relieving effect may be reduced.
certain antiepileptic medicines, such as phenytoin or carbamazepine: the effects of ondansetron may be reduced.
antibiotics such as rifampicin (used to treat tuberculosis, leprosy, and other infections: the action of ondansetron may be reduced) or erythromycin.
ketoconazole, a medicine used to treat fungal infections.
medicines used to treat irregular heartbeat (arrhythmias): their effects may be increased by ondansetron.
anticancer medicines (e.g. anthracyclines or trastuzumab), antibiotics (e.g. erythromycin), antifungals (e.g. ketoconazole), or other medicines that may affect your heart rhythm.
beta-blockers used to treat certain heart or eye conditions, anxiety, or to prevent migraine.
medicines used to treat depression, such as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors), as they may cause serotonin syndrome, a potentially life-threatening reaction. Symptoms of serotonin syndrome may include a combination of the following: nausea (feeling unwell), vomiting, agitation, confusion, diarrhoea, high temperature, increased blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination, hyperactive reflexes, and coma.

Pregnancy and breastfeeding
It is not known whether the use of ondansetron is safe during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before being given this medicine.
Do not breastfeed while being treated with Ondansetrone Mylan Generics Italia. This is because a small amount of ondansetron passes into breast milk. Ask your doctor or midwife for advice.
Driving and using machines
Ondansetrone Mylan Generics Italia does not affect or has a negligible effect on the ability to drive or use machines.
Ondansetrone Mylan Generics Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 2 ml or 4 ml dose, i.e. it is practically “sodium-free”.

3. How to use Ondansetrone Mylan Generics Italia

Method of administration
Ondansetrone Mylan Generics Italia is administered intravenously or, when diluted, by intravenous infusion (over a longer period). It is usually administered by a doctor or nurse.

Dosage
Your doctor will determine the appropriate dose of ondansetrone for your treatment.
The dose varies depending on the specific medical treatment (chemotherapy/radiotherapy or surgery), liver function, and the route of administration (injection or infusion).

To prevent nausea and vomiting caused by chemotherapy or radiotherapy in adults
On the day of chemotherapy or radiotherapy:

The usual dose in adults is 8 mg given as a slow intravenous injection (over no less than 30 seconds), shortly before your treatment, followed by another 8 mg dose 12 hours later. After chemotherapy, the medicine is usually continued orally as 8 mg tablets or 8 mg of syrup. In the following days:
The usual dose for adults is one 8 mg tablet or 8 mg of syrup taken twice daily.
This may be given for up to five days.

If your chemotherapy or radiotherapy is likely to cause you severe nausea and vomiting, you may be given a higher than usual dose. Your doctor will decide this.
A single dose higher than 16 mg must not be administered, or higher than 8 mg if the patient is aged 75 years or older, due to the increased risk of QT interval prolongation (delayed electrical conduction seen on ECG, an electrical recording of the heart) with single doses exceeding 16 mg or 8 mg in patients aged 75 years or older.

To prevent nausea and vomiting caused by chemotherapy or radiotherapy in children (from 6 months of age) and adolescents
The doctor will determine the dose based on the child's size (body surface area) or weight.
On the day of chemotherapy:

The first dose is given as an intravenous injection, just before your child's treatment. After chemotherapy, the medicine is usually given orally to the child 12 hours later, in the form of syrup or tablets. In the following days:
2 mg syrup twice daily for younger children and those weighing 10 kg or less
One 4 mg tablet or 4 mg of syrup twice daily for older children and those weighing more than 10 kg
Two 4 mg tablets and 8 mg of syrup twice daily for adolescents (or those with a larger body surface area)
These doses may be administered for up to five days.

There are no recommendations for the use of ondansetrone for the prevention of delayed or prolonged chemotherapy-induced nausea and vomiting, or for nausea and vomiting caused by radiotherapy.

For the prevention and treatment of postoperative nausea and vomiting

Adults

The usual dose for adults is 4 mg administered by slow intravenous injection (over no less than 30 seconds). For prevention, the medicine will be given just before surgery.

Children

For children over 1 month of age and adolescents, the doctor will determine the dose. The maximum dose is 4 mg given by slow intravenous injection (over no less than 30 seconds). For prevention, the medicine will be administered just before surgery. There are no recommendations for the use of ondansetrone in the treatment of postoperative nausea and vomiting in children under 2 years of age.

Patients with moderate or severe liver problems
The total daily dose must not exceed 8 mg.
Ondansetrone injection should start working immediately after administration. If you continue to experience nausea or vomiting, inform your doctor or nurse.

If you take more Ondansetrone Mylan Generics Italia than you should
Experience with ondansetrone overdose is limited. In a few patients, the following effects have been observed: visual disturbances, severe constipation, low blood pressure, and unconsciousness. In all cases, symptoms completely resolved. There is no specific antidote for ondansetrone; therefore, in case of suspected overdose, only symptomatic treatment should be given. The electrical activity of the heart should be monitored. The use of medicines that induce vomiting (e.g., ipecacuanha) is not recommended.
Inform your doctor if any of these symptoms occur.
Since your doctor or nurse will administer Ondansetrone Mylan Generics Italia to you or your child, it is unlikely that you or your child will receive too much. However, if you think that you or your child has received too much or has missed a dose, inform your doctor or nurse.

If you forget to use Ondansetrone Mylan Generics Italia, inform your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or a member of medical staff immediately if you experience:
Uncommon side effects (may affect up to 1 in 100 people)

seizures

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

sudden allergic reaction, sometimes life-threatening (a reaction in which the body responds with an exaggerated immune response to a foreign agent). Signs may include: swelling of the hands, feet, ankles, eyelids, face, lips, mouth or tongue or throat which may cause difficulty in swallowing and breathing, in addition to skin rash, itching and hives. Altered allergic reactions have also been observed in patients allergic to medicines of the same class.
a heart rhythm disorder called QT prolongation (delayed conduction of electrical signals, which may be visible on an ECG, the electrical recording of the heart). In some people, this may lead to a potentially serious heart condition known as Torsades de Pointes. This causes a very rapid heartbeat leading to sudden loss of consciousness.

Other side effects include:
Very common side effects (may affect more than 1 in 10 people)

headache.

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

constipation
sensations of warmth or hot flushes.
redness and irritation around the injection site (e.g. skin rash, hives, itching), sometimes extending along the vein into which the medicine was administered.
changes in liver function test results (if you receive an injection of ondansetron with a medicine called cisplatin; otherwise this side effect is rare).

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

movement disorders, e.g. convulsive eye movements, abnormal muscle contractions which may cause body distortions or spasms.
chest pain, cardiac arrhythmias (changes in heartbeat), hypotension (low blood pressure) and bradycardia (slow heart rate).
hiccups.

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

dizziness during rapid intravenous administration of ondansetron.
transient visual disturbances (e.g. blurred vision), mainly during intravenous administration.

Very rare side effects (may affect up to 1 in 10,000 people)

temporary or transient loss of vision, mainly during intravenous administration. Most reported cases of blindness resolved within 20 minutes. Many patients had received chemotherapeutic agents, including cisplatin. Some cases of transient blindness have been reported as being of cortical origin.

Side effects in children and adolescents are comparable to those observed in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ONDANSETRON MYLAN GENERICS ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging following "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once diluted, the infusion solution must be used immediately and must not be stored.
Perform a visual inspection of the solution before administration (even after dilution). Use only clear solutions without particles.
For single use only. Any unused solutions must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ondansetrone Mylan Generics Italia contains

The active substance is: ondansetron (as ondansetron hydrochloride dihydrate). 1 ml of injection solution contains 2 mg of ondansetron. One 2 ml vial contains 4 mg of ondansetron. One 4 ml vial contains 8 mg of ondansetron.
The other components are: sodium chloride, monohydrate citric acid (E330), sodium citrate (E331), water for injections.

Appearance of Ondansetrone Mylan Generics Italia and package contents
Ondansetrone Mylan Generics Italia is a clear solution in amber type I glass vials, containing 2 ml or 4 ml of solution.
Pack sizes: packs of 1, 2, 5 and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milano
Batch release responsible manufacturer:
Pharmathen Pharmaceutical Industry
6 Dervenakion Str., 15351 Pallini Attikis, Athens – Greece
Mylan Dura GmbH
Wittichstraße 6
64295 Darmstadt
Germany
Mylan S.A.S
117, Allée des Parcs
F 69792 Saint-Priest cedex
France
DEMO SA
21st Km National Road Athens-Lamia
145 68 Athens
Greece
Mylan S.p.A
Viale Dell’Innovazione 3
20126 Milano

This medicinal product is authorized in European Union Member States under the following names:
Belgium: Ondansetron Mylan 2 mg/ml solution for injection
Denmark: Setrogen, solution for injection 2 mg/ml
Germany: Ondansetron dura 2 mg/ml Injektionslösung
Iceland: Ondansetron Mylan 2 mg/ml Stungulyf, lausn
Italy: Ondansetrone Mylan Generics Italia
Slovakia: Onsetrogen 2 mg/ml
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The following information is intended for healthcare professionals only:
Instructions for use/handling
Ondansetrone Mylan Generics Italia may be diluted with one of the following infusion solutions:

sodium chloride 0.9%,
glucose 5%,
mannitol 10%,
potassium chloride 0.3% + sodium chloride 0.9%,
potassium chloride 0.3% + glucose 5%,
Ringer's infusion solution.

Incompatibilities
This medicinal product must not be mixed with other medicinal products except the infusion solutions listed above.