Ondansetron Teva-Ratio 8 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ondansetron Teva-ratio 8 mg 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 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

3. How to take Ondansetron Teva-ratio

4. Possible side effects

5. How to store Ondansetron Teva-ratio

6. Contents of the pack and other information

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

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

Ondansetron Teva-ratio is used for:

• the treatment of nausea (feeling sick) and vomiting (being sick) caused by chemotherapy and radiotherapy in adults, children, and adolescents aged 6 months to 17 years.
• the prevention and treatment of nausea and vomiting after surgery in adults.

2. What you need to know before taking Ondansetrón Teva-ratio

Do not take Ondansetrón Teva-ratio

• if you are allergic to ondansetron or to 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 must not be administered to children with a body surface area below 0.6 m² or with a body weight below 10 kg. Other pharmaceutical forms with a lower active ingredient content are available for this patient group.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ondansetrón 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 surgery

• you have had your tonsils removed

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

Taking Ondansetrón Teva-ratio with other medicines

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

Ondansetrón Teva-ratio alters the effects and/or adverse effects of some medicines, including:

• Apomorphine (a medicine used in the treatment of Parkinson's disease). Cases of severe drop in blood pressure and loss of consciousness have been reported when ondansetron is taken together with apomorphine.

• Carbamazepine or Phenytoin (used in the treatment of epilepsy).

• Rifampicin (used in the treatment of tuberculosis).

• Tramadol (used to relieve mild to moderate pain).

Medicines affecting the heart, such as certain cancer medicines (anthracyclines or trastuzumab), or medicines that prolong the QT interval (which may cause an ECG change with risk of potentially life-threatening abnormal or irregular heartbeats)

• 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 breastfeeding

Ondansetrón Teva-ratio should not be used during the first trimester of pregnancy. This is because Ondansetrón Teva-ratio may slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits 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 Ondansetrón Teva-ratio. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Do not breast-feed while taking Ondansetrón Teva-ratio, as small amounts of ondansetron pass into breast milk. Consult your doctor.

Driving and using machines

Ondansetron has no influence on the ability to drive or operate machinery.

Ondansetrón Teva contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Ondansetrón Teva-ratio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Ondansetron Teva-ratio

Follow exactly the instructions for use of this medicine as 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, 8 mg twice daily may be taken for up to 5 days.

• Children (over 6 months of age) and adolescents

Ondansetron Teva-ratio may initially be administered as a single intravenous injection given over 15 minutes before chemotherapy, followed by tablets which may be taken two to three times daily up to 5 days after chemotherapy. The tablet dose will depend on your child's body weight and will be calculated by your doctor.

For the prevention of nausea and vomiting after surgery

• Adults (including elderly people)

A dose of 16 mg may be taken one hour before anesthesia.

Alternatively, a dose of 8 mg may be taken one hour before anesthesia, followed by two further 8 mg doses at eight-hour intervals.

• Children (over 1 month of age) and adolescents

An intravenous injection containing ondansetron is recommended.

Patients with liver problems:

The total daily dose must not exceed 8 mg.

Ondansetron Teva-ratio should start working within one or two hours after taking the dose. If you vomit the dose within the first hour, take another dose. Otherwise, continue taking your tablets as instructed, but do not take more than your doctor has recommended. If you continue to feel unwell, you must inform your doctor.

Method of administration

The tablets should be swallowed whole, preferably with a glass of water. The score line is intended only for ease of splitting and swallowing.

If you take more Ondansetron Teva-ratio than you should

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

An overdose may cause temporary vision problems, severe constipation, dizziness or fainting.

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

In case of overdose or accidental ingestion, contact the Toxicology 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 missed doses.

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

If you stop taking Ondansetron Teva-ratio

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Uncommon (may affect up to 1 in 100 people)

• seizures

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

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

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

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

Other adverse effects include:

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

• headache

Common (may affect up to 1 in 10 people)

• feeling of warmth or hot flush
• constipation
• changes in test results regarding liver function (if you take ondansetron with a medicine called cisplatin; otherwise this adverse effect is uncommon).

Uncommon (may affect up to 1 in 100 people)

• blurred vision or temporary loss of vision, usually returning within 20 minutes.
• unusual body movements, agitation.
• hiccups
• low blood pressure, which may 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 lightheaded
• blurred vision

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

• blurred vision or temporary loss of vision after intravenous administration

Frequency not known (cannot be estimated from available data)

• Myocardial ischaemia (Signs include: sudden chest pain or chest tightness)

Reporting of adverse effects:

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

5. Ondansetron Teva-ratio Storage

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

Do not use this medicine after the expiry date stated on the blister pack and container following CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ondansetron Teva-ratio

• The active substance is ondansetron. Each film-coated tablet contains 8 mg of ondansetron (as ondansetron dihydrochloride dihydrate).

• The other components (excipients) are:

• Tablet core: lactose monohydrate, sodium carboxymethyl starch type A (from potato), microcrystalline cellulose, pregelatinized corn starch, magnesium stearate

• Coating: hypromellose, titanium dioxide (E171), macrogol (400 and 6000) and yellow iron oxide (E172)

Appearance of the product and contents of the pack

• Ondansetron Teva-ratio 8 mg is presented as yellow, oblong, film-coated tablets, with the number “8” engraved on one side and a break line on the other.
• Ondansetron Teva-ratio 8 mg film-coated tablets are available in pack sizes of 2, 4, 5, 6, 9, 10, 15, 18, 30, 50, 100 and 500 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U
C/ Anabel Segura, 11 Edificio Albatros B, 1st Floor
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
The Netherlands

Or

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

This medicinal product 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 4mg and 8mg Film-Coated Tablets
IT: Ondansetron Teva 4mg & 8mg Compessa rivestita con film
LT: Ondansetron-Teva 8 mg plevele dengtos tabletes
NL: Ondansetron 4 & 8 PCH, filmomhulde tabletten 4mg & 8mg
SE: Ondansetron Teva 4mg & 8mg Filmdragerad tablet

Date of the most recent review of this leaflet: July 2022

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66914/P_66914.html

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