Zontron Injection Solution

Description

Zontron 8 mg/4ml I.V. bulb containing injectable solution is applied into the case or vein.

Active item: In each bulb (4ml); It contains 8 mg of ondansetron (hydrochloride dihydrate).

Auxiliary substances: Sodium chloride, citric acid, sodium citrate, injection water

Before you start using this drug, read this INSTRUCTION CAREFULLY, as it contains important information for you.

• Keep this instructions for use. You may need to read again later.
• If you have any additional questions, please consult your doctor or pharmacist.
• This drug has been personally prescribed to you, do not give it to others.
• During the use of this drug, when you go to the doctor or hospital, you must tell me you’re using it.
• Follow the instructions in this instruction. Except for the dose recommended to you about the drug

Caution before using Zontron DO NOT use Zontron® in the following situations

If you’re going to

• If you are hypersensitive (allergic) to any substance contained in ondansetron or Zontron

USE Zontron WITH CAUTION if

If you’re going to

• If you are hypersensitive (allergic) to other selective 5-HT3 receptor antagonists such as Granisetron (a group of drugs that prevent nausea and vomiting)
• If you have complaints of obstruction or severe constipation in your intestines
• If you are pregnant or thinking of getting pregnant soon
• If you are breastfeeding
• If you have a liver condition
• If you have heart problems that include irregularity in heart rate (arrhythmia)
• If you have respiratory conditions.

If these warnings apply to you, even in any period in the past, please consult your doctor.

Use of Zontron with food and beverages

There is no data.

Pregnancy

Consult your doctor or pharmacist before using the drug.

If you find that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Lactation

Consult your doctor or pharmacist before using the drug.

If you are using Zontron, you should not breastfeed your baby.

Driving

It is unlikely to have any effect.

Important information about some of the auxiliary substances contained in Zontron

Each dose contains less than 1 mmol (23 mg) of sodium; no side effects due to sodium are expected at this dose.

Use in combination with other drugs

If you are using any drug containing the active ingredient phenytoin, carbamazepine and rifampisin, the effect of Zontron may decrease.
If you are using any drug containing the active substance tramadol, Zontron can reduce the pain relief effect of this drug.
If you are on medication with side effects on the heart, the risk of developing heart meat irregularity (arrhythmia) may increase.

If you are currently using any prescription or over-the-counter medication or have recently used it, please inform your doctor or pharmacist about them.

How to use Zontron

Instructions for appropriate use and dose/frequency of application:
Your doctor will determine the dose of your drug and apply it to you, depending on your illness.

Application path and method

It is applied into the muscle or into the vein.

Different age groups

children

Vomiting after chemotherapy and radiotherapy

(From 6 months to 17 years of age):
The doctor will determine the dose of the drug and apply it to your child, depending on the disease.

Postoperative nausea and vomiting

The doctor will determine the dose of the drug depending on the disease and apply it to your child.

Use in the elderly

In patients over the age of 65, Zontron does not need to be changed in its dose, frequency and method of application.

Exceptions

Renal failure

There is no need to change the dose, frequency and way of application of Zontron in renal failure.

Liver failure

The total daily dose of Zontron should not exceed 8 mg in patients with moderately severe or severe liver dysfunction.

If you have the impression that the effect of Zontron is too strong or weak, talk to your doctor or pharmacist.

If you’ve used more Zontron than you should have

talk to a doctor or pharmacist if you have used more than you should.

If you forget to use Zontron

Do not take double doses to balance forgotten doses.

Effects that may occur when treatment with Zontron is terminated

Your doctor will give you Zontron as soon as you need to.

What are the possible side effects

Like all drugs, people who are sensitive to the substances contained in Zontron may have side effects.
This drug did not cause any problems in the vast majority of patients who used it.

If any of the following occurs, stop using Zontron and immediately notify your doctor or contact the emergency department of the hospital closest to you

• Hypersensitivity reactions. Symptoms;
• Sudden wheezing and jaw pain or jaw tension.
• Swelling of eyelids, face, lips, mouth or tongue.
• Lumpy skin rash or urticaria anywhere in the body.
• These are all very serious side effects.
• If you have one of these, you are severely allergic to ZONTRON®. You may need urgent medical attention or hospitalized.
• Other side effects are classified as shown in the following categories:
• Very common: it can be seen in at least one in 10 patients.
• Common: Less than one in 10 patients, but more than one in 100 patients.
• Not common: Less than one in 100 patients, but more than one in 1,000 patients.
• Sparse: Less than one in 1,000 patients.
• Very rare: less than one in 10,000 patients.
• Unknown: Unpredictable based on available data.

Very common side effects:

• Headache

Common side effects:

• Feeling of heat or hot flash
• Constipation
• If you take it with a drug called Sisplatin, there may be a change in your tests showing liver function, otherwise it is an unsus common side effect.

Unsym pervasive side effects:

• Hiccups
• Low blood pressure, weakness
• Slow or irregular heartbeats
• Chest pain
• Seizures
• Movements or wobbles
  that are not normally present in the body • Changes in tests showing liver function

Rare side effects:

• Dizziness or dizziness
• Blurred vision
• Impaired heart rhythm (Sometimes it can cause sudden loss of consciousness.)

Very rare side effects:

• Decreased vision or temporary vision loss, which usually disappears within 20 minutes

If you experience any side effects not mentioned in this instructions for use, inform your doctor or pharmacist.

Store Condition Zontron

Keep in places and packaging that children cannot see or access.

1. Store at room temperature below 30°C. Protect it from the light.
2. There is no need to protect against light during infusion.
3. The prescribed drug should not be stored at 2-8°C for more than 24 hours.

Use in accordance with the expiration date.

Do not use Zontron after the expiration date on the packaging.

Licensee

I.E.Ulagay Pharmaceutical Industry TÜRK A.S.
Davutpasa cad. No.12 ( 34010)
Topkapi-Istanbul

Producer

I.E.Ulagay Pharmaceutical Industry TÜRK A.S.