Patient Information Leaflet: Package Insert

Ondansetron hydrochloride 4mg film-coated tablets

Read this leaflet carefully before you start to take 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. Do not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Ondansetrón belongs to the group of medications known as antiemetics, which prevent vomiting and nausea.

Ondansetrónintabletsis used for:

• preventing nausea and vomiting caused by:

• chemotherapy in the treatment ofcancer in adults and children over 6 months ofage.
• radiation therapy in the treatment ofcancer in adults.

• preventing postoperative nausea and vomiting in adults.

Do not take Ondansetrón ratio

• If you are allergic (hypersensitive) to ondansetrón, or to any of the other components of this medication (listed in section 6).
• If you have had an allergic reaction to another similar medication such as granisetrón, tropisetrón, or dolasetrón.
• If you are taking apomorfina (used for the treatment of Parkinson's Disease)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

• You have liver problems
• You have intestinal obstruction or suffer from severe constipation
• You have had surgery on your intestines
• You have had surgery on your tonsils
• You have had heart problems, including irregular heartbeats (arrhythmias)
• You have problems with your electrolyte levels, such as potassium, sodium, or magnesium, in your blood.

Taking Ondansetrón ratio with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any of the following medications:

• Fenitoína (used in the treatment of epilepsy).
• Carbamazepina (used in the treatment of epilepsy).
• Rifampicina (used in the treatment of tuberculosis).
• Tramadol (used to relieve mild to moderately intense pain).
• Medications that affect the heart (such as haloperidol or metadona)
• Medications used to treat irregular heart rhythm (antiarrhythmics)
• Medications that are beta-blockers (used to treat heart problems, eye problems, anxiety, or to prevent migraines)
• Medications used to treat cancer (especially antraciclinas)
• Medications used to treat infections (erythromycin, ketoconazole)

While taking ondansetrón, make sure your doctor knows that you are taking this medication, as it may affect the results of these tests.

Pregnancy and breastfeeding

Ondansetrón ratio should not be used during the first trimester of pregnancy. This is because Ondansetrón ratio may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetrón ratio. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Do not breastfeed while taking ondansetrón, as small amounts of ondansetrón pass into breast milk. Consult your doctor.

Driving and operating machinery

Ondansetrón treatment does not affect the ability to drive vehicles and operate machinery.

Ondansetrón ratio contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Ondansetrón ratio contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 radiation therapy

• Adults (including the elderly):

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

• Children (over 6 months) and adolescents

Ondansetron can be administered initially by a single injection in the vein for 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 nausea and vomiting after surgery

• Adults (including the elderly):

It can be taken at a dose of 16 mg one hour before anesthesia.

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

• Children (over 1 month) and adolescents

It is recommended to administer an intravenous injection containing ondansetron.

Patients with liver problems

The total daily dose should not exceed 8 mg.

Ondansetron should start working within 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 what your doctor has recommended. If you continue to feel unwell, you should inform your doctor.

If you take more Ondansetron ratio than you should

If youor your childtake more ondansetron than you should, talk to your doctor or go immediately to the nearest hospital. Bring the medication with you.

A overdose can cause temporary vision problems, severe constipation, dizziness, or fainting.

Bring this leaflet, any remaining tablets, and the packaging with you 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, phone 91-562 04 20 indicating the medication and the amount ingested.

If you forget to take Ondansetron ratio

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, wait until the next dose as directed. Take any pending doses at the correct time.

If you interrupt treatment withOndansetron ratio

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If the following occurs, stop taking the tablets and immediately inform your doctor or visit the nearest hospital emergency service:

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

Other adverse effects include:

Very Frequent(affects more than 1 in 10 people)

• Headache.

Frequent(affects up to 1 in 10 people)

• Sensation of heat or suffocation.
• Constipation.
• Changes in liver function test results (if taken with a medication called cisplatino, otherwise this adverse effect is rare).

Infrequent(affects up to 1 in 100 people)

• Hiccup.
• Low blood pressure, which may cause weakness or dizziness.
• Irregular heartbeat or chest pain.
• Seizures.
• Unusual body movements, agitation.

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

• Sensation of dizziness or disorientation.
• Blurred vision.
• Alterations in heart rhythm (in some cases causing loss of consciousness).

Very Rare(affects up to 1 in 10,000 people)

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

Unknown Frequency(cannot be estimated from available data)

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the blister and packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

No special storage conditions are required

Ondansetron Ratio Composition

• The active ingredient is ondansetron. Each tablet contains 4 mg of ondansetron (asondansetron hydrochloride dihydrate).
• The other components (excipients) are:

• Tablet core: lactose monohydrate, sodium carboxymethyl starch (type A), microcrystalline cellulose, pregelatinized starch, magnesium stearate
• Capsule coating: hypromellose, titanium dioxide (E171), macrogol, and iron oxide yellow (E172)

Appearance of the product and contents of the package

• Ondansetron Ratio 4 mg is presented as film-coated, oblong-shaped tablets, yellow in color, with the number “4” engraved on one side and smooth on the other.
• Ondansetron Ratio 4 mg tablets are available in package sizes of6 and15film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C /AnabelSegura,11BuildingAlbatrosB,1stfloor

Alcobendas,28108Madrid(Spain)

Responsible manufacturer

Teva Pharmaceutical Works Company Ltd

Pallagi Street 13

H-4042 Debrecen

Hungary

Ó

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Ó

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Last review date of this leaflet:February 2022

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