Ondansetron Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetrone Mylan Generics 4 mg film-coated tablets, 8 mg film-coated tablets

ondansetron
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ondansetrone Mylan Generics is and what it is used for
2. What you need to know before taking Ondansetrone Mylan Generics
3. How to take Ondansetrone Mylan Generics
4. Possible side effects
5. How to store Ondansetrone Mylan Generics
6. Contents of the pack and other information

1. WHAT ONDANSETRON MYLAN GENERICS IS AND WHAT IT IS USED FOR

Ondansetrone Mylan Generics belongs to a group of medicines called antiemetics or medicines against nausea and vomiting.
Ondansetrone blocks the effects of the neurotransmitter serotonin in the brain. Serotonin causes nausea and
vomiting.
Ondansetrone Mylan Generics is used in adults for:

• controlling nausea and vomiting caused by chemotherapy or radiotherapy for cancer
• preventing nausea and vomiting following surgery

Ondansetrone Mylan Generics is used in children for:

• controlling nausea and vomiting caused by chemotherapy in children aged 6 months and older.

Ask your doctor, nurse or pharmacist if you would like further explanations about these uses.

2. WHAT YOU SHOULD KNOW BEFORE USING ONDANSETRON MYLAN GENERICS

Do not take Ondansetrone Mylan Generics:

• if you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other anti-nausea medicines belonging to the group of selective serotonin receptor antagonists (5-HT₃) (e.g. granisetron or dolasetron), as you may also be allergic to ondansetron.
• if you are taking apomorphine (used in the treatment of Parkinson's disease).

If you are unsure, speak with your doctor, nurse, or pharmacist before taking Ondansetrone Mylan Generics.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Ondansetrone Mylan Generics:

• if you have heart problems or have irregular heart rhythms (arrhythmias or disturbances in cardiac conduction).
• if you have problems with electrolyte levels in your blood, such as potassium, sodium, or magnesium.
• if you have intestinal problems such as bowel obstruction or suffer from severe constipation.
• if you are about to undergo or have recently undergone adenoid or tonsil removal, as treatment with this medicine may mask symptoms of internal bleeding.
• if you are a child with a body surface area less than 0.6 m².
• if you have liver problems.

Children and adolescents

This medicine must not be given to children for the prevention or treatment of nausea and vomiting following abdominal surgery.

If you are unsure whether any of the above points apply to you, speak with your doctor, nurse, or pharmacist before taking Ondansetrone Mylan Generics.

Other medicines and Ondansetrone Mylan Generics

Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you buy without a prescription or herbal remedies. This is because Ondansetrone Mylan Generics may affect other medicines, or other medicines may affect Ondansetrone Mylan Generics.

In particular, inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• apomorphine (a medicine used to treat Parkinson's disease), as significant drops in blood pressure and loss of consciousness have been reported when apomorphine is used together with ondansetron.
• phenytoin or carbamazepine (medicines used to treat epilepsy), which may reduce the effect of ondansetron.
• rifampicin (an antibiotic used to treat infections such as tuberculosis), which may reduce the effects of ondansetron.
• antibiotics such as erythromycin or ketoconazole.
• antiarrhythmic medicines such as amiodarone (used to treat irregular heartbeat).
• beta-blockers such as atenolol or timolol (used to treat certain heart or eye conditions, anxiety, or to prevent migraines).
• tramadol (a painkiller), whose effect may be reduced by Ondansetrone Mylan Generics.
• cancer medicines (especially anthracyclines and trastuzumab).
• certain types of antidepressants known as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors), as these may cause serotonin syndrome—a potentially life-threatening reaction—when used together with ondansetron. Symptoms of serotonin syndrome may include a combination of the following: nausea, vomiting, agitation, diarrhoea, high body temperature, increased blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination, hyperactive reflexes, and coma.

If you are unsure whether any of the above cases apply to you, talk to your doctor, nurse, or pharmacist before taking Ondansetrone Mylan Generics.

Pregnancy and breastfeeding

Ondansetrone Mylan Generics must not be used during the first trimester of pregnancy, as Ondansetrone Mylan Generics may slightly increase the risk of the baby being born with cleft lip and/or cleft palate (fissures or splits in the upper lip and/or palate).

If you are already pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking Ondansetrone Mylan Generics.

If you are a woman of childbearing age, you may be advised to use effective contraception.

Do not breastfeed while taking Ondansetrone Mylan Generics, as this medicine may pass into breast milk. Consult your doctor, pharmacist, or midwife.

Driving and using machines

Ondansetrone Mylan Generics does not impair the ability to drive or operate machinery.

Ondansetrone Mylan Generics contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. HOW TO USE ONDANSETRONE MYLAN GENERICS

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The dose prescribed for you will depend on the treatment you are receiving.
The recommended dose is:

Treatment and prevention of nausea and vomiting associated with chemotherapy or radiotherapy for cancer treatment
Adults
Take 8 mg of ondansetrone one or two hours before treatment, followed by another 8 mg of ondansetrone 12 hours later.
A dose of 8 mg of ondansetrone twice daily may be taken for up to 5 days after treatment.

Use in children (6 months of age and older) and adolescents
The dose is individual and depends on the child's weight, size/body surface area; however, the total daily dose must not exceed 32 mg. Your doctor will determine the appropriate dose for your child. See the label for further information.
The recommended dose for a child is 8 mg twice daily, depending on body weight. This may be given for up to 5 days.

Elderly
Ondansetrone is well tolerated in patients over 65 years of age undergoing chemotherapy. No dosage adjustment is required.

Prevention and treatment of post-operative nausea and vomiting
Adults
The usual dose is 16 mg of ondansetrone one hour before your surgery.

Use in children (1 month of age and older) and adolescents
It is recommended that ondansetrone be administered as an injection. Other pharmaceutical forms of this medicine are more suitable for use in children; please consult your doctor or pharmacist.

Elderly
There is limited experience with the use of ondansetrone in elderly patients; however, ondansetrone is well tolerated in patients over 65 years of age undergoing chemotherapy (see section above).

Patients with renal impairment or poor sparteine/debrisoquine metabolism
No dosage adjustment is required in patients with renal impairment or in patients unable to metabolize sparteine/debrisoquine.

Patients with hepatic impairment
The total daily dose must not exceed 8 mg per day if you have moderate to severe liver problems.
If nausea persists, contact your doctor, pharmacist, or nurse.

Method of administration:

• Swallow the tablets with a glass of water.
• Ondansetrone is also available for injection.

If you or your child take more Ondansetrone Mylan Generics than you should
Contact your doctor or nearest Emergency Department immediately. Bring the medicine pack and any remaining tablets with you. Information on overdosage with ondansetrone is limited. Reported signs of overdose include visual disturbances, severe constipation, low blood pressure which may cause dizziness or fainting, and irregular heartbeat.

If you forget to take Ondansetrone Mylan Generics
If you forget to take a dose and you begin to feel nauseous or start vomiting, take it as soon as you remember. Then take your next tablet at the usual time (as shown on the label). However, if it is already time for your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you miss a dose but do not feel nauseous, take the next dose as indicated on the label.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Ondansetrone Mylan Generics
Do not stop treatment with this medicine unless instructed by your doctor. Symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following serious adverse reactions may occur while taking this medicine. If you experience any of these
adverse reactions, stop taking the medicine immediately and consult a doctor or go to the nearest hospital.

Uncommon (may affect up to 1 in 100 people)

• involuntary eye movements (oculogyric crisis)

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

• if you have an allergic reaction, signs include:
• sudden wheezing and chest pain or tightness in the chest
• swelling of the eyelids, face, lips, mouth, or tongue
• rash
• red spots or lumps under the skin (urticaria) anywhere on the body
• collapse

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

• severe skin reaction with peeling of the top layer of the skin, severe blisters and bleeding of the skin, and also of the lips, eyes, mouth, nose and genitals

Other possible adverse reactions
Very common (may affect more than 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• constipation
• feeling of warmth or flushing

Uncommon (may affect up to 1 in 100 people):

• hiccups
• low blood pressure, which may cause fainting or dizziness
• irregular heartbeat or slow heartbeat
• chest pain with or without changes in the ECG
• seizures, unusual body movements or tremor
• muscle cramps
• changes in blood tests showing alterations in liver function (more frequently in patients undergoing chemotherapy with cisplatin)

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

• temporary blurred vision
• heart rhythm problems called QT interval prolongation (delayed conduction of electrical signals, which can be seen on an ECG, an electrical recording of the heart). In some people, this can lead to a potentially serious heart condition known as torsades de pointes. This may result in a very rapid heartbeat causing loss of consciousness.

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

• poor vision or temporary loss of vision, which usually resolves within 20 minutes
• abnormally fast heartbeat

Adverse reactions in children and adolescents
Adverse reactions reported in children and adolescents were very similar to those observed in adults and listed above.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ONDANSETRON MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the blister and on the outer carton after "EXP". The expiry
date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Ondansetrone Mylan Generics contains

• The active substance is ondansetron. Each tablet contains 4 mg or 8 mg of the active substance ondansetron (as dihydrochloride dihydrate), respectively.
• The other ingredients are: monohydrate lactose (see section 2 “Ondansetrone Mylan Generics contains monohydrate lactose”), microcrystalline cellulose, pregelatinized corn starch, and magnesium stearate. The coating contains hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, macrogol, sorbitan oleate, sorbic acid, vanillin, and quinoline yellow (E 104).

Description of the appearance of Ondansetrone Mylan Generics and pack contents

4 mg tablet: light yellow, film-coated, round, biconvex tablet, marked with “41” on one side.
8 mg tablet: light yellow, film-coated, round, biconvex tablet, marked with “42” on one side.

Blister packs:
4 mg: 3, 6, 9, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, 500 film-coated tablets.
8 mg: 3, 6, 9, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer responsible for batch release:
Mylan B.V.
Dieselweg 25, 3752 LB Bunschoten
The Netherlands
Generics [UK] Ltd.
Station Close, Darkes Lane, Potters Bar, Herts, EN6 1TL – United Kingdom
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate, Grange Road, Dublin 13 – Ireland

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: ‘Ondansetron Mylan 4 mg/8 mg Filmovertrukne Tabletter’
Belgium: ‘Ondansetron Mylan 4 mg/8 mg Filmomhulde Tabletten’
Germany: ‘Ondansetron dura 4 mg Filmtabletten’
Hungary: ‘Ondagen 4mg/ 8 mg Filmtabletta’
Iceland: ‘Ondansetron Billev 8 mg Filmuhúdud tafla’
Italy: ‘Ondansetrone Mylan Generics 4 mg/8 mg compresse rivestite con film’
Slovakia: ‘Onsetrogen 4 mg/8 mg’

May 2020