ONDANSETRON 4 mg Orodispersible Tablet

Зміст інструкції

1. ONDANSETRON DOC 4 mg orodispersible tablets
2. ONDANSETRON DOC 8 mg orodispersible tablets

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

ONDANSETRON DOC 4 mg orodispersible tablets

Equivalent medicinal product
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 pass it on to others, even if their symptoms are the
same as yours, as it may be harmful.
If any side effect occurs, including those not listed in this leaflet, tell 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 you take 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 anti-emetics. Ondansetron inhibits
the effect of serotonin neurotransmitter in the brain. Serotonin causes nausea and vomiting.
ONDANSETRON DOC is used for:
controlling nausea (feeling sick) and vomiting caused by chemotherapy or
radiotherapy
preventing and treating nausea and vomiting after a surgical operation.
An orodispersible tablet is a special type of tablet that dissolves very quickly if placed
on the tongue. Ask your doctor, nurse or pharmacist for further information on how to use this
medicine.
ONDANSETRON DOC orodispersible should start to work within one or two hours of taking a
dose. You should talk to a doctor if you do not feel better or if you feel worse.

What you need to know before you take ONDANSETRON DOC
Do not take ONDANSETRON DOC if:

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (used to treat Parkinson's disease). Warnings and precautionsAsk your doctor, pharmacist or nurse before taking ONDANSETRON DOC if:
• if you have intestinal stenosis or constipation you will need special monitoring by your doctor.
• if 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.
• if you are about to have or have recently had your tonsils removed, because treatment with ONDANSETRON DOC may mask symptoms of internal bleeding.
• if you are a patient with heart problems (with arrhythmias or conduction disorders) and are being treated at the same time with other drugs such as anesthetics, antiarrhythmics or beta-blockers, due to limited experience with this.
• 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). There have been reports of a
severe drop in blood pressure and loss of consciousness when ondansetron has been taken
at the same time as apomorphine.
ONDANSETRON DOC changes the effects and/or side effects of some medicines, including:

• medicines used to treat epilepsy (carbamazepine or phenytoin)
• antibiotics (rifampicin, erythromycin, ketoconazole)
• pain relieving medicine (tramadol)
• medicines used to treat heart problems such as irregular heartbeats (amiodarone) and high blood pressure (atenolol, timolol)
• other medicines that, like Ondansetron Orifarm, affect the neurotransmitter serotonin in the brain, such as medicines used to treat depression
• cancer medicine (doxorubicin, daunorubicin, trastuzumab)
• ONDANSETRON DOC with food and drinkONDANSETRON DOC can be taken independently 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 that a baby is born with a cleft lip and/or palate (openings or splits in the upper lip and/or roof of the mouth). If you are already pregnant, suspect you are or are planning a pregnancy, ask your doctor or pharmacist for advice before taking ONDANSETRON DOC.
• If you are a woman of childbearing potential, you may be advised to use effective contraception.
• Do not breastfeed while taking ONDANSETRON DOC. This is because small amounts pass into breast milk. Ask your doctor.

2/11

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

ONDANSETRON DOC contains aspartame and lactose
ONDANSETRON DOC 4 mg contains 0.99 mg of aspartame in each tablet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which the
phenylalanine accumulates because the body cannot remove it properly.
If your doctor has told you that you have lactose intolerance, contact him before taking this medicine.

How to take ONDANSETRON DOC
Take this medicine exactly as your doctor or pharmacist has told you. If you have doubts
ask your doctor, pharmacist or nurse. The dose is always determined by the doctor who is adjusting
the dose for you so that you get an optimal effect.
If you think that the effect of ONDANSETRON DOC is too strong or too weak, tell your doctor or pharmacist.
Ondansetron is for oral use only.
The orodispersible tablet should be placed on the tongue, where it will disperse rapidly in saliva and then
easily swallowed.
The recommended dose is:

To treat nausea and vomiting induced by chemotherapy or radiotherapy:

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

To prevent nausea and vomiting after an operation:

• Adults (including the elderly):A dose of 16 mg can be taken one hour before anesthesia. Alternatively, a dose of 8 mg can be taken one hour before anesthesia, followed by two further doses of 8 mg at eight-hour intervals.
• Use in children (over 1 month of age) and adolescentsIt is recommended to administer an intravenous injection containing ondansetron.
• Children and adolescentsONDANSETRON DOC should only be administered to children aged ≥ 6 months and for the prevention and treatment of PONV in children aged ≥ 1 month.

Patients with liver problems
The total daily dose should not exceed 8 mg.
ONDANSETRON DOC should start to work within one or two hours of taking the dose. If you vomit the
dose within an hour, take another dose. Otherwise, continue to take the tablets as on the label, but
3/11
do not take more than your doctor has recommended. If you continue to feel unwell, you should tell your doctor.

If you take more ONDANSETRON DOC than you should
If you or your childtake more ONDANSETRON DOC than you should, talk to a doctor or go to the nearest hospital immediately.
Bring the medicine pack with you.
An overdose can cause temporary vision problems, severe constipation, feeling dizzy or
fainting.

If you forget to take ONDANSETRON DOC
If you forget to take a tablet and feel sick or vomit, take it as soon as you remember and then
continue as before. If you forget to take a tablet and do not feel sick, wait until the next dose
as on the label. Take the remaining doses at the right time.
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 talking to your doctor first, even if you feel better.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
gets them. If you experience the following, stop taking the tablets and tell your doctor immediately or go to the nearest hospital emergency room:
If you experience any of the following allergic reactions, stop taking ONDANSETRON DOC and
tell your doctor immediately or go to the nearest hospital emergency room:

• Severe skin itching, rash.
• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which can 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:

• a feeling of warmth or hot flushes
• constipation
• changes in liver function tests (if you take ONDANSETRON DOC with a medicine called cisplatin, otherwise this side effect is rare). Uncommon (may affect up to 1 in 100):
• hiccups
• low blood pressure, which can make you feel faint or dizzy
• irregular heartbeat or chest pain
• unusual body movements or tremors.

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

• feeling dizzy or lightheaded

4/11

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help 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 which is stated on the box and the blister after Scad. or EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any 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 ingredient 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 with beveled edges, round with flat face, white in colour.
• ONDANSETRON DOC 4 mg orodispersible tablets are available in packs of 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.
5/11
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, SPAIN

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Member StateName
Portugal Ondansetrom Doc
Italy ONDANSETRON DOC

ONDANSETRON DOC 8 mg orodispersible tablets

Equivalent medicinal product
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 only for you. Do not pass it on to others, even if their symptoms are the
same as yours, as it may be harmful.
If any side effect occurs, including those not listed in this leaflet, tell 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 you take 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 anti-emetics. Ondansetron inhibits
the effect of serotonin neurotransmitter in the brain. Serotonin causes nausea and vomiting.
ONDANSETRON DOC is used for:
controlling nausea (feeling sick) and vomiting caused by chemotherapy or
radiotherapy
preventing and treating nausea and vomiting after a surgical operation.
An orodispersible tablet is a special type of tablet that dissolves very quickly if placed
6/11
on the tongue. Ask your doctor, nurse or pharmacist for more information about using this
medicine.
ONDANSETRON DOC orodispersible should start to work within one or two hours of taking a
dose. You should talk to your doctor if you do not feel better or if you feel worse.

What you need to know before you take ONDANSETRON DOC
Do not take ONDANSETRON DOC if:

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (used to treat Parkinson's disease). Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking ONDANSETRON DOC if:
• if you have intestinal stenosis or constipation you will need special monitoring by your doctor.
• if 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.
• if you are about to have or have recently had your tonsils removed, because treatment with ONDANSETRON DOC may mask symptoms of internal bleeding.
• if you are a patient with heart problems (with arrhythmias or conduction disturbances) and are being treated at the same time with other drugs such as anesthetics, antiarrhythmics or beta-blockers, due to limited experience with this.
• 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). There have been reports of a
severe drop in blood pressure and loss of consciousness when ondansetron has been taken
at the same time as apomorphine.
ONDANSETRON DOC changes the effects and/or side effects of some medicines, including:

• medicines used to treat epilepsy (carbamazepine or phenytoin)
• antibiotics (rifampicin, erythromycin, ketoconazole)
• pain relief medicine (tramadol)
• medicines used to treat heart problems such as irregular heartbeats (amiodarone) and high blood pressure (atenolol, timolol)

7/11

• other medicines that, like Ondansetron Orifarm, affect the neurotransmitter serotonin in the brain, such as medicines used to treat depression
• cancer medicine (doxorubicin, daunorubicin, trastuzumab)

ONDANSETRON DOC with food and drink
ONDANSETRON DOC can be taken independently 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 that a baby is born with a cleft lip and/or 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, ask your doctor or pharmacist for advice before taking ONDANSETRON DOC.
• If you are a woman of childbearing potential, you may be advised to use effective contraception.
• Do not breastfeed while taking ONDANSETRON DOC. This is because small amounts pass into breast milk. Ask your doctor.

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

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

How to take ONDANSETRON DOC
Take this medicine exactly as your doctor or pharmacist has told you. If you have doubts
ask your doctor, pharmacist or nurse. The dose is always determined by the doctor who is adjusting the
dose for you in order to obtain an optimal effect.
If you think that the effect of ONDANSETRON DOC is too strong or too weak, tell your doctor or pharmacist.
Ondansetron is for oral use only.
The orodispersible tablet should be placed on the tongue, where it will disperse rapidly in saliva and then
easily swallowed
The recommended dose is:

To treat nausea and vomiting induced by chemotherapy or radiotherapy:

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

8/11

To prevent nausea and vomiting after an operation:

• Adults (including the elderly):A dose of 16 mg can be taken one hour before anesthesia. Alternatively, a dose of 8 mg can be taken one hour before anesthesia, followed by two further doses of 8 mg at eight-hour intervals.
• Use in children (over 1 month of age) and adolescentsIt is recommended to administer an intravenous injection containing ondansetron.
• Children and adolescentsONDANSETRON DOC should only be given to children aged ≥ 6 months and for the prevention and treatment of PONV in children aged ≥ 1 month.

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

If you take more ONDANSETRON DOC than you should
If you or your childtake more ONDANSETRON DOC than you should, talk to a doctor or go to the nearest
hospital immediately. Bring the medicine pack with you.
An overdose can cause temporary vision problems, severe constipation, feeling dizzy or
fainting.

If you forget to take ONDANSETRON DOC
If you forget to take a tablet and feel sick or vomit, take one as soon as you remember and then
continue as before. If you forget to take a tablet and do not feel sick, wait until the next dose
as on the label. Take the remaining doses at the right time.
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 talking to your doctor first, even if you feel better.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
gets them. If you experience any of the following, stop taking the tablets and tell your doctor immediately or go to the nearest hospital emergency room:
If you experience any of the following allergic reactions, stop taking ONDANSETRON DOC and
tell your doctor immediately or go to the nearest hospital emergency room:

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

Other side effects include:
Very common (may affect more than 1 in 10 people):

• headache.

9/11
Common (may affect up to 1 in 10 people:

• a feeling of warmth or flushing
• constipation
• changes in liver function test results (if you take 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 can make you feel faint or dizzy
• irregular heartbeat or chest pain
• unusual body movements or tremors.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help 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 which is stated on the carton and blister after Scad. or EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via water 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 ingredient is ondansetron. Each orodispersible tablet contains 8 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
10/11

• ONDANSETRON DOC 8 mg orodispersible tablets with chamfered edges, round with flat face, white in colour.
• ONDANSETRON DOC 8 mg orodispersible tablets are available in packs of 6 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy.

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

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Member StateName
Portugal Ondansetrom Doc
Italy ONDANSETRON DOC
11/11