Ondansetron Doc Generici

PT/H/2703/001-002/DC
ONDANSETRON DOC 4 mg orodispersible tablets

Package leaflet: Information for the user

ONDANSETRON DOC 4 mg orodispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
What ONDANSETRON DOC is and what it is used for
What you need to know before taking ONDANSETRON DOC
How to take ONDANSETRON DOC
Possible side effects
How to store ONDANSETRON DOC
Contents of the pack and other information
What ONDANSETRON DOC is and what it is used for
ONDANSETRON DOC belongs to a group of medicines called antiemetics. Ondansetron blocks the action of serotonin, a neurotransmitter in the brain. Serotonin causes nausea and vomiting.
ONDANSETRON DOC is used to:

• prevent and control nausea (feeling unwell) and vomiting caused by chemotherapy or radiotherapy
• prevent and treat nausea and vomiting after surgery.
  An orodispersible tablet is a special type of tablet that dissolves very quickly when placed on the tongue. Contact your doctor, nurse or pharmacist for further information on how to use this medicine.
  ONDANSETRON DOC orodispersible should start working within one to two hours after taking a dose. You should speak to a doctor if you do not feel better or if you feel worse.
  What you need to know before taking ONDANSETRON DOC
  Do not take ONDANSETRON DOC if:

• you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• you are taking apomorphine (used to treat Parkinson’s disease). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking ONDANSETRON DOC if:
• you have intestinal stenosis or constipation, as you may require special monitoring by your doctor.
• you are hypersensitive to other medicines belonging to the group of selective serotonin receptor antagonists (5-HT3) (e.g. granisetron, dolasetron). In this case, you may also be allergic to ondansetron.
• you are about to have or have recently had your tonsils removed, because treatment with ONDANSETRON DOC may mask symptoms of internal bleeding.
• you have heart problems (with arrhythmias or conduction disorders) and are being treated simultaneously with other medicines such as anaesthetics, antiarrhythmics or beta-blockers, due to limited experience with this combination.
• you have liver problems. Always inform the laboratory during blood and urine tests that you are being treated with ONDANSETRON DOC.

Other medicines and ONDANSETRON DOC
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Do not use apomorphine (a medicine used to treat Parkinson’s disease). Cases of severe drop in blood pressure and loss of consciousness have been reported when ondansetron was taken together with apomorphine.
ONDANSETRON DOC may alter the effects and/or side effects of certain medicines, including:

• medicines used to treat epilepsy (carbamazepine or phenytoin)
• antibiotics (rifampicin, erythromycin, ketoconazole)
• pain medicine (tramadol)
• medicines used to treat heart conditions such as irregular heartbeats (amiodarone) and high blood pressure (atenolol, timolol)
• other medicines that, like Ondansetron Orifarm, affect the brain neurotransmitter serotonin, for example medicines used to treat depression
• cancer medicines (doxorubicin, daunorubicin, trastuzumab)
  ONDANSETRON DOC with food and drinks
  ONDANSETRON DOC can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

• You should not use ONDANSETRON DOC during the first trimester of pregnancy. This is because ONDANSETRON DOC may slightly increase the risk of a child being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or roof of the mouth). If you are already pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking ONDANSETRON DOC.
• If you are a woman of childbearing age, you may be advised to use an effective contraceptive method.
• Do not breastfeed while taking ONDANSETRON DOC. This is because small amounts pass into breast milk. Ask your doctor for advice.

2/11
Driving and using machines
ONDANSETRON DOC has not shown effects on the ability to drive or use machinery.
ONDANSETRON DOC contains aspartame and lactose
ONDANSETRON DOC 4 mg contains 0.99 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
If your doctor has told you that you have lactose intolerance, contact them before taking this medicine.
How to take ONDANSETRON DOC
Always take this medicine exactly as your doctor or pharmacist has instructed. If you are unsure, consult your doctor, pharmacist or nurse. The dose is always determined by your doctor, who will adjust it to achieve the best possible effect.
If you think the effect of ONDANSETRON DOC is too strong or too weak, inform your doctor or pharmacist.
Ondansetron is for oral use only.
The orodispersible tablet should be placed on the tongue, where it will rapidly disperse in saliva and can then be easily swallowed.
The recommended dose is:
To treat nausea and vomiting caused by chemotherapy or radiotherapy:

• Adults (including elderly): 8 mg taken 1 to 2 hours before chemotherapy or radiotherapy, followed by another 8 mg 12 hours later. Starting 24 hours after chemotherapy or radiotherapy, 8 mg twice daily may be taken for up to 5 days.
• Use in children (over 6 months of age) and adolescents ONDANSETRON DOC may initially be administered as a single intravenous injection over 15 minutes before chemotherapy, followed by tablets that may be given two or three times daily for up to 5 days after chemotherapy. The tablet dose will depend on body size and will be calculated by the doctor.

To prevent nausea and vomiting after surgery:

• Adults (including elderly): A single dose of 16 mg may be taken one hour before anaesthesia. Alternatively, a dose of 8 mg may be taken one hour before anaesthesia, followed by two additional 8 mg doses given at eight-hour intervals.
• Use in children (over 1 month of age) and adolescents Intravenous ondansetron injection is recommended.
• Children and adolescents ONDANSETRON DOC should only be administered to children aged ≥ 6 months, and for prevention and treatment of PONV (postoperative nausea and vomiting) in children aged ≥ 1 month.

Patients with liver problems
The total daily dose must not exceed 8 mg.
ONDANSETRON DOC should start working within one to two hours after taking the dose. If you vomit the dose within one hour, take another dose. Otherwise, continue taking the tablets as directed, but do not take more than your doctor has recommended. If you continue to feel unwell, you must inform your doctor.
If you take more ONDANSETRON DOC than you should
If you or your child take more ONDANSETRON DOC than you should, contact a doctor or go to hospital immediately. Bring the medicine pack with you.
Overdose may cause temporary vision problems, severe constipation, dizziness or fainting.
If you forget to take ONDANSETRON DOC
If you forget to take a tablet and feel unwell or vomit, take one as soon as you remember, then continue as before. If you forget to take a tablet and do not feel unwell, wait until your next scheduled dose. Take the remaining doses at the correct times.
Do not take a double dose to make up for a forgotten dose.
If you stop taking ONDANSETRON DOC
Do not stop taking this medicine without first talking to your doctor, even if you feel better.
If you have any doubts about how to use this medicine, contact your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. If any of the following occur, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:
If you experience any of the following allergic reactions, stop taking ONDANSETRON DOC and contact your doctor immediately or go to the nearest hospital emergency department:

• Severe skin itching, rash.
• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing.
• Collapse.

Other side 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 flushes
• constipation
• changes in liver function test results (if taking ONDANSETRON DOC with a medicine called cisplatin; otherwise this side effect is rare).
  Uncommon (may affect up to 1 in 100 people):
• hiccups
• low blood pressure, which may cause fainting or dizziness
• irregular heartbeat or chest pain
• unusual body movements or tremors.

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

• dizziness or lightheadedness

4/11

• blurred vision.
  Very rare (may affect up to 1 in 10,000 people):
• poor vision or temporary loss of vision, which usually returns within 20 minutes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.
How to store ONDANSETRON DOC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Exp" or "Scad".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What ONDANSETRON DOC contains

• The active substance is ondansetron. Each orodispersible tablet contains 4 mg ondansetron (as ondansetron).
• The other ingredients are: lactose monohydrate, low-substituted hydroxypropylcellulose, crospovidone, calcium silicate, aspartame, peppermint flavour, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ONDANSETRON DOC and contents of the pack

• ONDANSETRON DOC 4 mg orodispersible tablets are round, flat-faced, white tablets with bevelled edges.
• ONDANSETRON DOC 4 mg orodispersible tablets are available in packs containing 6 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, SPAIN
This medicine is authorised in European Economic Area Member States under the following names:
Member State Name
Portugal Ondansetrom Doc
Italy ONDANSETRON DOC
Package leaflet: information for the user

ONDANSETRON DOC 8 mg orodispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet
What ONDANSETRON DOC is and what it is used for
What you need to know before taking ONDANSETRON DOC
How to take ONDANSETRON DOC
Possible side effects
How to store ONDANSETRON DOC
Contents of the pack and other information

What ONDANSETRON DOC is and what it is used for

ONDANSETRON DOC belongs to a group of medicines called antiemetics. Ondansetron blocks the action of serotonin, a neurotransmitter in the brain. Serotonin causes nausea and vomiting.
ONDANSETRON DOC is used to:

• Prevent and control nausea (feeling unwell) and vomiting caused by chemotherapy or radiotherapy
• Prevent and treat nausea and vomiting after surgery

An orodispersible tablet is a special type of tablet that dissolves very quickly when placed on the tongue. Consult your doctor, nurse, or pharmacist for further information on how to use this medicine.
ONDANSETRON DOC orodispersible should start working within one or two hours after taking a dose. You should speak to a doctor if you do not feel better or if you feel worse.

What you need to know before taking ONDANSETRON DOC

Do not take ONDANSETRON DOC if:

• You are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• You are taking apomorphine (used to treat Parkinson's disease).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking ONDANSETRON DOC if:

• You have intestinal stenosis or constipation – you may require special monitoring by your doctor.
• You are hypersensitive to other medicines in the group of selective serotonin receptor antagonists (5-HT3) (e.g., granisetron, dolasetron). In such cases, you may also be allergic to ondansetron.
• You have recently had or are about to have your tonsils removed – treatment with ONDANSETRON DOC may mask symptoms of internal bleeding.
• You have heart problems (such as arrhythmias or conduction disorders) and are being treated simultaneously with other medicines such as anesthetics, antiarrhythmics, or beta-blockers, due to limited clinical experience.
• You have liver problems. Always inform the laboratory when undergoing blood or urine tests that you are being treated with ONDANSETRON DOC.

Other medicines and ONDANSETRON DOC
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not use apomorphine (a medicine used to treat Parkinson's disease). There have been reports of severe drop in blood pressure and loss of consciousness when ondansetron is taken together with apomorphine.
ONDANSETRON DOC may alter the effects and/or side effects of certain medicines, including:

• Medicines used to treat epilepsy (carbamazepine or phenytoin)
• Antibiotics (rifampicin, erythromycin, ketoconazole)
• Painkillers (tramadol)
• Medicines used to treat heart conditions such as irregular heartbeat (amiodarone) and high blood pressure (atenolol, timolol)
• Other medicines that, like Ondansetron Orifarm, affect the brain neurotransmitter serotonin, for example, medicines used to treat depression
• Cancer medicines (doxorubicin, daunorubicin, trastuzumab)

ONDANSETRON DOC with food and drink
ONDANSETRON DOC can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

• You should not use ONDANSETRON DOC during the first trimester of pregnancy. This is because ONDANSETRON DOC may slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or roof of the mouth). If you are already pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking ONDANSETRON DOC.
• If you are a woman of childbearing age, you may be advised to use an effective contraceptive method.
• Do not breastfeed while taking ONDANSETRON DOC. Small amounts pass into breast milk. Consult your doctor.

Driving and using machines
ONDANSETRON DOC has not shown effects on the ability to drive or operate machinery.

ONDANSETRON DOC contains aspartame and lactose
ONDANSETRON DOC 8 mg contains 0.99 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
If your doctor has told you that you are intolerant to lactose, contact them before taking this medicine.

How to take ONDANSETRON DOC

Take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse. The dose is always determined by your doctor, who will adjust it to achieve the best effect.
If you think the effect of ONDANSETRON DOC is too strong or too weak, inform your doctor or pharmacist.
Ondansetron is for oral use only.
The orodispersible tablet should be placed on the tongue, where it will rapidly disperse in saliva and can then be easily swallowed.

Recommended dose:

To treat nausea and vomiting caused by chemotherapy or radiotherapy:

• Adults (including elderly): 8 mg taken 1 to 2 hours before chemotherapy or radiotherapy, followed by another 8 mg 12 hours later. Starting 24 hours after chemotherapy or radiotherapy, 8 mg twice daily may be taken for up to 5 days.
• Use in children (over 6 months of age) and adolescents: ONDANSETRON DOC may initially be administered as a single intravenous injection over 15 minutes before chemotherapy, followed by oral tablets administered two or three times daily for up to 5 days after chemotherapy. The tablet dose will depend on body size and will be calculated by the doctor.

To prevent nausea and vomiting after surgery:

• Adults (including elderly): A single 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 additional 8 mg doses at eight-hour intervals.
• Use in children (over 1 month of age) and adolescents: Intravenous ondansetron injection is recommended.
• Children and adolescents: ONDANSETRON DOC should only be administered to children aged ≥ 6 months for the treatment of chemotherapy-induced nausea and vomiting, and to children aged ≥ 1 month for the prevention and treatment of postoperative nausea and vomiting (PONV).

Patients with liver problems
The total daily dose should not exceed 8 mg.
ONDANSETRON DOC should start working within one or two hours after taking the dose. If you vomit within one hour of taking the dose, take another dose. Otherwise, continue taking the tablets as directed on the label, but do not exceed the dose recommended by your doctor. If you continue to feel unwell, inform your doctor.

If you take more ONDANSETRON DOC than you should
If you or your child take more ONDANSETRON DOC than prescribed, contact a doctor immediately or go to the nearest hospital. Bring the medicine packaging with you.
Overdose may cause temporary vision problems, severe constipation, dizziness, or fainting.

If you forget to take ONDANSETRON DOC
If you forget to take a tablet and feel unwell or vomit, take one as soon as you remember, then continue as before. If you forget to take a tablet and do not feel unwell, wait until your next scheduled dose. Take the remaining doses at the correct times.
Do not take a double dose to make up for a missed dose.

If you stop taking ONDANSETRON DOC
Do not stop taking this medicine without first talking to your doctor, even if you feel better.

If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If any of the following occur, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:

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

• Severe skin itching, rash
• Swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing
• Collapse

Other side 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 flushes
• Constipation
• Changes in liver function test results (if taking ONDANSETRON DOC with a medicine called cisplatin; otherwise this side effect is rare)

Uncommon (may affect up to 1 in 100 people):

• Hiccups
• Low blood pressure, which may cause dizziness or fainting
• Irregular heartbeat or chest pain
• Unusual body movements or tremors

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

• Dizziness or lightheadedness
• Blurred vision

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

• Poor vision or temporary loss of vision, usually returning within 20 minutes

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects helps provide more information on the safety of this medicine.

How to store ONDANSETRON DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Exp" or "Scad." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.

Contents of the pack and other information

What ONDANSETRON DOC contains

• The active substance is ondansetron. Each orodispersible tablet contains 8 mg of ondansetron (as ondansetron).
• Other components: monohydrate lactose, low-substituted hydroxypropyl cellulose, crospovidone, calcium silicate, aspartame, peppermint flavor, anhydrous colloidal silica, magnesium stearate

Description of the appearance of ONDANSETRON DOC and contents of the pack

• ONDANSETRON DOC 8 mg orodispersible tablets are round, flat-faced, white tablets with beveled edges.
• ONDANSETRON DOC 8 mg orodispersible tablets are available in packs of 6 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, SPAIN

This medicine is authorized in the European Economic Area countries under the following names:

| Member State | Name | |------------------|----------| | Portugal | Ondansetrom Doc | | Italy | ONDANSETRON DOC |