Patient Information Leaflet

Ondansetrón Teva-ratio 4mg Film-Coated Tablets

ondansetrón

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 as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

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

Ondansetrón Teva-ratio is usedin:

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

• the prevention and treatment of nausea and vomiting after surgery in adults.

Do not take Ondansetrón Teva-ratio

• if you are allergic to ondansetrón, or to any of the other components of this medication (listed in section 6).
• if you take apomorfina (medication used for the treatment of Parkinson's Disease).

This medication should not be administered in children with a body surface area less than 0.6 m2or a body weight less than 10 kg. There are other pharmaceutical forms with a lower active ingredient content for this group of patients.

Warnings and precautions

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

• you are allergic to similar medications to ondansetrón (5-HT3antagonists)
• 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 tonsil surgery

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

Taking Ondansetrón Teva-ratio with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Ondansetrón Teva-ratio changes the effects and/or side effects of some medications, including:

• Apomorfina (medication used in the treatment of Parkinson's Disease). Cases of severe blood pressure drop and loss of consciousness have been reported when ondansetrón is taken at the same time as apomorfina.
• Carbamazepina, Fenitoína (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 certain cancer medications (antraciclinas or trastuzumab) or medications that prolong the QT interval (which may cause a change in the ECG with a risk of abnormal or irregular heartbeats that can be potentially fatal)

• Fluoxetina, paroxetina, sertralina, fluvoxamina, citalopram, escitalopram (Selective serotonin reuptake inhibitors, used to treat depression and/or anxiety)
• Venlafaxina or duloxetina (Inhibitors of serotonin and noradrenaline reuptake, used to treat depression and/or anxiety).

Pregnancy and breastfeedingOndansetrónTeva 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 palate (openings or clefts in the upper lip or palate). If you are already pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using Ondansetrón Teva-ratio. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

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

Driving and operating machinery

The influence of ondansetrón on the ability to drive and operate machinery is negligible.

Ondansetrón Teva contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Ondansetrón Teva-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 indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

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 Teva-ratio can be administered initially by a single intravenous injection over 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 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 other doses of 8 mg at 8-hour intervals.

• Children (over 1 month) and adolescents

A recommended intravenous injection containing ondansetron should be administered.

Patients with liver problems

The total daily dose should 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 what your doctor has recommended. If you continue to feel unwell, you should inform your doctor.

Administration form

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 youor your childtake more Ondansetron Teva-ratio 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 to the hospital or doctor so they know what tablets you have consumed.

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

If you forgot to take Ondansetron Teva-ratio

Do not take a double dose to compensate for the 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 the pending doses at the correct time.

If you interrupt the treatment withOndansetron Teva-ratio

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Rarely (may affect up to 1 in 100 people)

• seizures

Uncommon (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
• alterations in heart rhythm (sometimes causing loss of consciousness).

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

• widespread skin eruption with blisters and peeling, affecting a large part of the body surface (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)

• sensation of heat or suffocation
• constipation
• changes in liver function test results (if taken with a medication called cisplatino, otherwise this side effect is rare).

Rarely(may affect up to 1 in 100 people)

• poor vision or temporary loss of vision, which usually returns in 20 minutes.
• unusual body movements, tremors
• hypotension
• low blood pressure, which may make you feel weak or dizzy
• irregular heartbeat or chest pain
• slow heart rhythm.

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

• sensation of dizziness or disorientation
• blurred vision.

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

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

Unknown frequency (cannot be estimated from available data)

• myocardial ischemia (Symptoms 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side 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.

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

This medication does not require special storage conditions.

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.

Ondansetron Teva-ratio Composition

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

• Tablet core: lactose monohydrate, carboxymethylcellulose sodium type A (from potato), microcrystalline cellulose, pregelatinized maize starch, magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), macrogol (400 and 6000), and iron oxide yellow (E172).

Appearance of the product and contents of the package

• Ondansetron Teva-ratio 4 mg is presented as oblong, yellow film-coated tablets, with the number “4” engraved on one side and smooth on the other.
• Ondansetron Teva-ratio 4 mg film-coated tablets are available in package sizes of2, 4, 5, 6, 10, 15, 30, 50, 100, and 500film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U

C /AnabelSegura,11EdificioAlbatrosB,1stfloor

Alcobendas,28108Madrid(Spain)

Manufacturers

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

This medicine is authorized in the member states of theEuropean Economic Area with the following names:

CZ: Ondansetron-Teva 8mg

DE: Ondansetron ratiopharm 4 mg & 8 mg Filmtabletten

ES: Ondansetron Teva-ratio 4 mg & 8 mg film-coated tablets

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

IT: Ondansetron Teva 4 mg & 8 mg Compessa 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

Last review date of this leaflet:July 2022

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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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