ONDANSETRON TEVA-RATIO 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ondansetron Teva-ratio 4mg Film-Coated Tablets EFG

ondansetron

Read all of this leaflet carefully before you start taking 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 is Ondansetron Teva-ratio and what is it used for
2. What you need to know before you take Ondansetron Teva-ratio
3. How to take Ondansetron Teva-ratio
4. Possible side effects
5. Storage of Ondansetron Teva-ratio

1. Contents of the pack and further information

1. What is Ondansetron Teva-ratio and what is it used for

Ondansetron Teva-ratio belongs to a group of medicines called antiemetics, which prevent vomiting and nausea (feeling sick or being sick).

Ondansetron Teva-ratio is used in:

• treatment of nausea (feeling sick) and vomiting (being sick) caused by chemotherapy and radiotherapy in adults, children, and adolescents from 6 months to 17 years of age.

• prevention and treatment of nausea and vomiting after an operation in adults.

2. What you need to know before you take Ondansetron Teva-ratio

Do not take Ondansetron Teva-ratio

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (a medicine used to treat Parkinson's disease).

It should not be given to children with a body surface area less than 0.6 m2 or with a body weight less than 10 kg. There are other pharmaceutical forms with a lower content of active substance for this group of patients.

Warnings and precautions

Consult your doctor or pharmacist before taking Ondansetron Teva-ratio if:

• you are allergic to medicines similar to ondansetron (5-HT3 antagonists)
• you have had heart problems, including irregular heartbeats (arrhythmias)
• you have liver problems
• you have intestinal obstruction or suffer from severe constipation
• you have had intestinal or tonsil surgery

• you have problems with your blood salt levels, such as potassium, sodium, or magnesium.

Taking Ondansetron Teva-ratio with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ondansetron Teva-ratio changes the effects and/or side effects of some medicines, including:

• Apomorphine (a medicine used in the treatment of Parkinson's disease). There have been reports of severe drop in blood pressure and loss of consciousness when ondansetron is taken at the same time as apomorphine.
• Carbamazepine, Phenytoin (used in the treatment of epilepsy).
• Rifampicin (used in the treatment of tuberculosis).
• Tramadol (used to relieve pain from mild to moderate).
• Medicines that affect the heart, such as certain cancer medicines (anthracyclines or trastuzumab) or medicines that prolong the QT interval (which can cause a change in the ECG with a risk of abnormal or irregular heartbeats that can be life-threatening)

• Fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (Selective Serotonin Reuptake Inhibitors, used to treat depression and/or anxiety)
• Venlafaxine or duloxetine (Serotonin and Noradrenaline Reuptake Inhibitors, used to treat depression and/or anxiety).

Pregnancy and breastfeedingOndansetron Teva should not be used during the first trimester of pregnancy. This is because Ondansetron Teva-ratio may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate (openings or gaps in the upper lip or in the palate). If you are already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetron Teva-ratio. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Do not breastfeed if you are taking Ondansetron Teva-ratio, as small amounts of ondansetron pass into breast milk. Consult your doctor.

Driving and using machines

The influence of ondansetron on the ability to drive and use machines is negligible.

Ondansetron Teva contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Ondansetron Teva-ratio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Ondansetron Teva-ratio

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

For the treatment of nausea and vomiting induced by chemotherapy and radiotherapy:

• Adults (including elderly people)

8 mg taken 1 to 2 hours before chemotherapy or radiotherapy, followed by 8 mg taken 12 hours later. 24 hours after chemotherapy or radiotherapy, it can be taken for up to 5 days, 8 mg twice a day.

• Children (over 6 months) and adolescents

Ondansetron Teva-ratio can be administered initially by a single intravenous injection 15 minutes before chemotherapy, followed by tablets that can be taken 2 to 3 times a day for up to 5 days after chemotherapy. The dose of the tablets will depend on the body weight of your child and will be calculated by your doctor.

For the prevention of nausea and vomiting after an operation:

• Adults (including elderly people)

A dose of 16 mg can be taken 1 hour before anesthesia.

Alternatively, a dose of 8 mg can be taken 1 hour before anesthesia, followed by two more doses of 8 mg at 8-hour intervals.

• Children (over 1 month) and adolescents

An intravenous injection containing ondansetron is recommended.

Patient with liver problems

The total daily dose should not exceed 8 mg.

Ondansetron Teva-ratio should start working 1 to 2 hours after taking the dose. If you vomit the dose in the first hour, take another dose. Otherwise, continue taking your tablets as directed, but do not take more than your doctor has recommended. If you continue to feel sick, then you should inform your doctor.

Method of administration

The tablets should be swallowed whole, preferably with the help of a glass of water.

If you take more Ondansetron Teva-ratio than you should

If you or your child take more Ondansetron Teva-ratio than you should, talk to your doctor or go immediately to the nearest hospital. Take the medicine with you.

An overdose can cause temporary vision problems, severe constipation, feeling dizzy or fainting.

Take this leaflet, any remaining tablets, and the packaging to the hospital or doctor so they know what tablets you have taken.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, telephone 91562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ondansetron Teva-ratio

Do not take a double dose to make up for forgotten doses.

If you forget to take a tablet and feel sick or vomit, take one as soon as you remember and continue as before. If you forget to take a tablet and do not feel sick, then wait until the next dose as directed. Take the missed doses at the correct time.

If you stop taking Ondansetron Teva-ratio

Do not stop taking ondansetron without consulting your doctor first, even if you feel better.

If you have any further questions on 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.

If you experience any of the following, stop taking the tablets and inform your doctor immediately or go to the casualty department of your nearest hospital:

Uncommon (may affect up to 1 in 100 people)

• seizures

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

• an allergic reaction that causes swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, skin rash.
• collapse
• changes in heart rhythm (sometimes causing loss of consciousness).

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

• widespread skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis).

Other side effects include:

Very common(may affect more than 1 in 10 people)

• headache.

Common(may affect up to 1 in 10 people)

• feeling hot or flushed
• constipation
• changes in liver function test results (if you take ondansetron with a medicine called cisplatin, otherwise this side effect is uncommon).

Uncommon(may affect up to 1 in 100 people)

• poor vision or temporary loss of vision, which usually returns within 20 minutes.
• unusual body movements, tremor
• hiccups
• low blood pressure, which can make you feel weak or dizzy
• irregular heartbeat or chest pain
• slow heart rate.

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

• feeling dizzy or faint.
• blurred vision.

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

• poor vision or temporary loss of vision after intravenous administration.

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

• Myocardial ischemia (The signs include: sudden chest pain or chest tightness).

Children and adolescents

The side effects in children and adolescents were comparable to those observed in adults.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Teva-ratio

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused tablets to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ondansetron Teva-ratio

• The active substance is ondansetron. Each film-coated tablet contains 4 mg of ondansetron (as ondansetron hydrochloride dihydrate).
• The other ingredients (excipients) are:

• Core of the tablet: lactose monohydrate, sodium carboxymethyl starch type A (derived from potato), microcrystalline cellulose, pregelatinized maize starch, magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), macrogol (400 and 6000), and yellow iron oxide (E172).

Appearance of the product and packaging

• Ondansetron Teva-ratio 4 mg is presented as film-coated tablets, oblong, yellow, with the number "4" engraved on one face and smooth on the other.
• Ondansetron Teva-ratio 4 mg film-coated tablets are available in pack sizes of 2, 4, 5, 6, 10, 15, 30, 50, 100, and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C / Anabel Segura, 11 Edificio Albatros B, 1ª Planta

Alcobendas, 28108 Madrid (Spain)

Manufacturers

Teva Pharmaceutical Works Company Ltd.

Pallagi Street 13

H-4042 Debrecen

Hungary

Or

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Or

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

CZ: Ondansetron-Teva 8mg

DE: Ondansetron ratiopharm 4 mg & 8 mg Filmtabletten

ES: Ondansetrón Teva-ratio 4 mg & 8 mg comprimidos recubiertos con película EFG

IE: Ondansetron 4 mg and 8 mg Film-Coated Tablets

IT: Ondansetron Teva 4 mg & 8 mg Compresa rivestita con film

LT: Ondansetron-Teva 8 mg plevele dengtos tabletes

NL: Ondansetron 4 & 8 PCH, filmomhulde tabletten 4mg & 8mg

SE: Ondansetron Teva 4 mg & 8 mg Filmdragerad tablett

Date of last revision of this leaflet:July 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66913/P_66913.html

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