Read all of this carefully before you or your child start taking this medicine.
Tamibid Suspension contains the active substance oseltamivir. It belongs to a group of medicines called neuraminidase inhibitors, which are antiviral medicines.
Tamibid Suspension is used:
Oseltamivir works by reducing the ability of influenza viruses to spread in the body.
Treatment should be started as soon as possible after flu symptoms appear, preferably within 48 hours.
Tamibid Suspension may also be prescribed to prevent influenza after exposure to an infected person, when considered appropriate by your doctor.
Tamibid Suspension is not a substitute for influenza vaccination.
Do not take Tamibid Suspension
If you are not sure whether this applies to you or your child, talk to your doctor or pharmacist before taking Tamibid Suspension.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamibid Suspension if:
Important information about influenza
Tamibid Suspension works only against influenza viruses. It does not treat illnesses caused by other viruses or bacteria.
Tamibid Suspension is not a substitute for influenza vaccination. Continue to follow your doctor's advice regarding annual influenza vaccination.
Behavioural and nervous system effects
Influenza itself can sometimes cause behavioural or neurological symptoms. Neuropsychiatric events have also been reported in patients receiving oseltamivir, particularly children and adolescents.
Watch carefully for unusual behaviour or changes in behaviour. If you notice abnormal behaviour, confusion, hallucinations, convulsions or other unusual neurological symptoms, contact your doctor immediately.
Serious allergic or skin reactions
Serious allergic reactions and severe skin reactions have been reported with oseltamivir.
Stop taking Tamibid Suspension and seek immediate medical attention if you notice:
Children
There are limited data regarding the use of oseltamivir in premature infants and in children with severe kidney impairment.
Tamibid Suspension should be used in children according to the dose prescribed by the doctor.
The dosing recommendations for premature infants with a post-conceptual age of less than 36 weeks are not established.
Other medicines and Tamibid Suspension
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you or your child are taking:
No clinically important interactions have been observed with medicines such as paracetamol, acetylsalicylic acid, cimetidine, antacids containing magnesium or aluminium, calcium carbonate, rimantadine or warfarin in the circumstances described in the prescribing information.
Influenza vaccines
Tamibid Suspension is not a substitute for influenza vaccination.
Oseltamivir may reduce the effectiveness of a live attenuated influenza vaccine (LAIV). Your doctor will advise you about the appropriate timing of vaccination.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor may consider treatment with oseltamivir during pregnancy when necessary, taking into account the available safety information and the potential benefits of treatment.
If you are breast-feeding, talk to your doctor before taking Tamibid Suspension. Oseltamivir and its active metabolite can pass into breast milk, although the amount is expected to be low. Your doctor will decide whether treatment is appropriate.
There is no evidence that oseltamivir affects male or female fertility.
Driving and using machines
Tamibid Suspension is not expected to affect your ability to drive or use machines. However, if you experience dizziness or other symptoms that affect your ability to concentrate, do not drive or use machines until you feel better.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The dose depends on the age and body weight of the patient and whether Tamibid Suspension is being used to treat influenza or to prevent influenza.
Tamibid Suspension contains 12 mg of oseltamivir per mL after reconstitution.
Treatment of influenza
Children 1 year of age or older
The usual treatment dose is taken twice a day for 5 days, according to body weight.
| Body weight | Dose | Volume of Tamibid Suspension 12 mg/mL |
|---|---|---|
| 10 kg to 15 kg | 30 mg twice daily | 2.5 mL twice daily |
| More than 15 kg to 23 kg | 45 mg twice daily | 3.8 mL twice daily |
| More than 23 kg to 40 kg | 60 mg twice daily | 5.0 mL twice daily |
| More than 40 kg | 75 mg twice daily | 6.2 mL twice daily |
For immunocompromised patients aged 1 year or older, the recommended treatment duration is 10 days.
Children weighing more than 40 kg who can swallow capsules may receive oseltamivir 75 mg capsules instead of the suspension, if prescribed by their doctor.
Infants below 1 year of age
The recommended treatment dose is 3 mg/kg twice daily.
The exact volume will depend on your baby's body weight. Your doctor or pharmacist will tell you the exact amount to give.
For immunocompromised infants, the recommended treatment duration is 10 days.
Do not use the dosing recommendations in this leaflet for premature infants with a post-conceptual age of less than 36 weeks unless specifically instructed by a specialist.
Prevention of influenza after exposure
If Tamibid Suspension has been prescribed to prevent influenza after exposure to an infected person, it is usually taken once daily for 10 days, according to body weight.
Children 1 year of age or older
| Body weight | Dose | Volume of Tamibid Suspension 12 mg/mL |
|---|---|---|
| 10 kg to 15 kg | 30 mg once daily | 2.5 mL once daily |
| More than 15 kg to 23 kg | 45 mg once daily | 3.75 mL once daily |
| More than 23 kg to 40 kg | 60 mg once daily | 5 mL once daily |
| More than 40 kg | 75 mg once daily | 6.25 mL once daily |
Children weighing more than 40 kg who can swallow capsules may receive a 75 mg capsule as an alternative, if prescribed by their doctor.
Infants below 1 year of age
During a pandemic influenza outbreak, the recommended prevention dose for infants below 1 year of age is 3 mg/kg once daily for 10 days.
Your doctor will calculate the exact dose according to your baby's body weight.
Patients with liver or kidney problems
If you or your child have liver or kidney problems, tell your doctor before treatment.
No dose adjustment is recommended for patients with mild or moderate liver impairment. There is insufficient information to recommend a dose for children with kidney impairment.
How to prepare Tamibid Suspension
If your pharmacist has already prepared the suspension, you do not need to reconstitute it.
If preparation is required:
Always use the measuring device supplied or recommended by your pharmacist to measure the dose accurately.
How to take the medicine
If you take more Tamibid Suspension than you should
If you or your child accidentally take more than the prescribed dose, contact your doctor, pharmacist or nearest hospital for advice.
Most reported cases of overdose did not result in adverse reactions. When reactions occurred, they were generally similar to those seen with normal doses.
If you forget to take Tamibid Suspension
Take the missed dose as soon as you remember.
However, if it is nearly time for the next dose (within 2 hours), skip the missed dose and continue with the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tamibid Suspension
Do not stop treatment early unless your doctor tells you to do so.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Tamibid Suspension and seek immediate medical attention if you notice:
These may be signs of a serious allergic or skin reaction.
Other possible side effects
Common side effects
The most frequently reported gastrointestinal effects include nausea, vomiting and abdominal pain.
Uncommon or rare side effects
These may include:
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Tamibid Suspension contains
The active substance is oseltamivir.
After reconstitution:
Each mL of suspension contains oseltamivir phosphate equivalent to 12 mg of oseltamivir.
The other ingredients are excipients.
Colour: Titanium Dioxide IP.
What Tamibid Suspension looks like and contents of the pack
Tamibid Suspension is supplied as a powder for oral suspension, which after reconstitution contains 12 mg/mL of oseltamivir.