ONDANSETRON RATIO 4 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ondansetron ratio 4mg film-coated tablets EFG

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 ratio and what is it used for
2. What you need to know before you take Ondansetron ratio
3. How to take Ondansetron ratio
4. Possible side effects
5. Storage of Ondansetron ratio

Contents of the pack and further information

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

Ondansetron belongs to a group of medicines called antiemetics, which prevent vomiting and nausea.

Ondansetron in tablets is used to:

• prevent nausea and vomiting caused by:

• chemotherapy in the treatment of cancer in adults and children over 6 months of age.
• radiotherapy in the treatment of cancer in adults.

• prevent post-operative nausea and vomiting in adults.

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

Do not take Ondansetron ratio

• If you are allergic (hypersensitive) to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction to another medicine similar to ondansetron, such as granisetron, tropisetron, or dolasetron.
• If you are taking apomorphine (used to treat Parkinson's disease).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• You have liver problems.
• You have intestinal obstruction or severe constipation.
• You have had intestinal or tonsil surgery.
• You have had heart problems, including irregular heartbeats (arrhythmias).
• You have problems with your blood salt levels, such as potassium, sodium, or magnesium.

Taking Ondansetron ratio with other medicines

Tell your doctor if you are taking, have recently taken, or might take any of the following medicines:

• Phenytoin (used to treat epilepsy).
• Carbamazepine (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis).
• Tramadol (used to relieve mild to moderate pain).
• Medicines that affect the heart (such as haloperidol or methadone).
• Medicines used to treat irregular heart rhythms (antiarrhythmics).
• Beta-blocker medicines (used to treat heart problems, eye problems, anxiety, or to prevent migraines).
• Cancer medicines (especially anthracyclines).
• Medicines used to treat infections (erythromycin, ketoconazole).

While taking ondansetron, if you are going to have a blood test to check your liver function, make sure your doctor knows that you are taking this medicine, as it may affect the results of these tests.

Pregnancy and breastfeeding

Ondansetron ratio should not be used during the first trimester of pregnancy. This is because Ondansetron ratio may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron ratio. If you are a woman of childbearing age, you are advised to use an effective method of birth control.

Do not breastfeed if you are taking ondansetron, as small amounts of ondansetron pass into breast milk. Ask your doctor for advice.

Driving and using machines

Treatment with ondansetron does not affect your ability to drive or use machines.

Ondansetron ratio contains lactose

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

Ondansetron 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 ratio

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

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

• Adults (including the elderly):

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 can be administered initially as 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 your body weight and will be calculated by your doctor.

For the prevention of post-operative nausea and vomiting

• Adults (including the elderly):

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.

Patients with liver problems

The total daily dose should not exceed 8 mg.

Ondansetron should start working 1 to 2 hours after taking the dose. If you vomit the dose within 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, you should inform your doctor.

If you take more Ondansetron ratio than you should

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

An overdose can 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 what tablets you have taken.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ondansetron ratio

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 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 product, 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:

• An allergic reaction that causes swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, skin rash.
• Collapse.

Other side effects include:

Very common(affect more than 1 in 10 people)

• Headache.

Common(affect up to 1 in 10 people)

• Feeling of warmth or flushing.
• Constipation.
• Changes in liver function test results (if you take ondansetron tablets with a medicine called cisplatin; otherwise, this side effect is uncommon).

Uncommon(affect up to 1 in 100 people)

• Hiccups.
• Low blood pressure, which can make you feel weak or dizzy.
• Irregular heartbeat or chest pain.
• Seizures.
• Unusual body movements, agitation.

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

• Feeling dizzy or lightheaded.
• Blurred vision.
• Changes in heart rhythm (sometimes causing loss of consciousness).

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

• Poor vision or temporary loss of vision, which usually returns within 20 minutes.

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

• Sudden chest pain or chest tightness (myocardial ischemia).

Reporting of side effects:

If you get 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 Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron ratio

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

No special storage conditions are required.

6. Contents of the pack and further information

Composition of Ondansetron ratio

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

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

Appearance of the product and pack contents

• Ondansetron 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 ratio 4 mg film-coated tablets are available in pack sizes of 6 and 15 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

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

Date of last revision of this leaflet:February 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/"