To be sold on retail on prescription of a Registered Medical Practitioner only.
Patient Information Leaflet
Oseltamivir Capsules IP 75 mg
Read all of this carefully before you start taking this medicine.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse.
What is in this leaflet
What Tamibid 75 is and what it is used for
What you need to know before you take Tamibid 75
How to take Tamibid 75
Possible side effects
How to store Tamibid 75
Contents of the pack and other information
1. What Tamibid 75 is and what it is used for
Tamibid 75 contains oseltamivir, an antiviral medicine belonging to a group of medicines called neuraminidase inhibitors.
Tamibid 75 works by preventing influenza (flu) viruses from spreading in your body. It helps to reduce or prevent symptoms caused by influenza virus infection.
Your doctor may prescribe Tamibid 75 for:
Treatment of influenza (flu) in adults, adolescents and children who have symptoms of influenza when the influenza virus is circulating in the community.
Prevention of influenza after close contact with a person infected with influenza.
Prevention of influenza during a community influenza outbreak, if considered appropriate by your doctor.
Tamibid 75 is effective only against influenza viruses. It is not effective against infections caused by bacteria or other viruses. Tamibid 75 is not a substitute for annual influenza vaccination. You should continue to receive influenza vaccination according to national recommendations.
2. What you need to know before you take Tamibid 75
Do NOT take Tamibid 75
if you are allergic to oseltamivir or any of the other ingredients of this medicine.
if you have previously experienced a serious allergic reaction such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme after taking oseltamivir.
Warnings and precautions
Talk to your doctor before taking Tamibid 75 if you:
have kidney disease.
have severe liver disease.
have a weakened immune system.
have chronic heart disease.
have chronic respiratory disease.
are taking medicines for influenza or recently received a live influenza vaccine.
have any severe medical condition requiring hospitalisation.
Tell your doctor immediately if you or your child develops:
confusion,
hallucinations,
unusual behaviour,
agitation,
self-injury thoughts,
seizures.
These reactions have been reported rarely, particularly in children and adolescents.
Children Tamibid 75 capsules may not be suitable for children who cannot swallow capsules. Other strengths or oral suspension may be available.
Other medicines and Tamibid 75
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Particular care is needed with:
Live attenuated influenza vaccine (nasal influenza vaccine)
Probenecid
Methotrexate
Chlorpropamide
Phenylbutazone
Inactivated influenza vaccines may be given while taking Tamibid 75.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will decide whether the benefits of treatment outweigh any possible risks.
Small amounts of oseltamivir pass into breast milk. Your doctor will decide whether Tamibid 75 is appropriate during breastfeeding.
Driving and using machines Tamibid 75 has no influence on the ability to drive and use machines.
3. How to take Tamibid 75
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
For treatment of influenza
Adults and adolescents (13 years and older)
The usual dose is:
75 mg twice daily for 5 days.
Treatment should be started as soon as possible, preferably within 48 hours after the first symptoms appear.
Immunocompromised patients may require treatment for 10 days.
For prevention of influenza
After close contact with an infected person:
75 mg once daily for 10 days.
During a community influenza outbreak:
75 mg once daily for up to 6 weeks, or up to 12 weeks in immunocompromised patients.
Children
Children receive doses according to body weight. Your doctor will prescribe the appropriate strength or oral suspension if required.
Patients with kidney disease
Your doctor may reduce your dose if you have impaired kidney function.
Method of administration
Swallow the capsule whole with water.
Capsules may be taken with or without food.
Taking the medicine with food may reduce nausea or stomach upset.
If you take more Tamibid 75 than you should
Contact your doctor, pharmacist or nearest hospital immediately.
Symptoms of overdose may include nausea and vomiting.
If you forget to take Tamibid 75
Take the missed dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tamibid 75
Do not stop treatment without talking to your doctor, even if you feel better.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Tamibid 75 and seek medical help immediately if you notice:
swelling of the face, lips or throat
difficulty breathing
severe skin rash or blistering
peeling skin
widespread rash with fever
These may be signs of a serious allergic reaction.
Very common side effects (may affect more than 1 in 10 people)
Nausea
Headache
In children:
Vomiting
Cough
Nasal congestion
Common side effects (may affect up to 1 in 10 people)
Vomiting
Abdominal pain
Indigestion
Dizziness
Fever
Tiredness
Pain in limbs
Cough
Runny nose
Sore throat
Difficulty sleeping
Uncommon side effects
Skin rash
Hives
Dermatitis
Increased liver enzymes
Irregular heartbeat
Convulsions
Altered consciousness
Allergic reactions
Rare side effects
Severe allergic reactions
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Hepatitis
Liver failure
Gastrointestinal bleeding
Hallucinations
Delirium
Confusion
Abnormal behaviour
Self-injury
Visual disturbances
Children and adolescents may experience neuropsychiatric symptoms more frequently than adults. Parents and caregivers should monitor behavioural changes carefully.
Reporting of side effects 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.
5. How to store Tamibid 75
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
6. Contents of the pack and other information
What Tamibid 75 contains
Active substance
Each hard gelatin capsule contains:
Oseltamivir Phosphate IP equivalent to Oseltamivir 75 mg
Other ingredients: Excipients and approved colours used in the capsule shell.
What Tamibid 75 looks like and contents of the pack Tamibid 75 is supplied as hard gelatin capsules.
Pack size: Blister pack containing 10 capsules.
Marketing Authorisation Holder
Zorvia Healthcare Limited Suite 4, 10th Floor, "Centaurus" Central Avenue, Hiranandani Estate Ghodbunder Road, Thane West Maharashtra 400607, India.
