TAMIFLU

What is TAMIFLU?

TAMIFLU:

• is a prescription only medicine for treating or preventing influenza

• treats flu at its source, by attacking the virus that causes influenza rather than simply masking symptoms

• is for treating adults and children age 1 and older with an influenza infection whose flu symptoms started within the last day or two

• can also reduce the chance of getting an influenza infection in people age 13 and older who have a higher chance of getting the flu because they spend time with someone who has the flu

• can also reduce the chance of getting influenza if there is a flu outbreak in the community.

TAMIFLU is provided in two forms:

• capsules containing 75 mg of the antiviral oseltamivir phosphate.

• powder for oral suspension containing 12 mg/ml oseltamivir phosphate.

Oseltamivir attacks by inhibiting the neuraminidase protein on the surface of the influenza virus and thereby stops it from spreading inside your body.

What is "Flu"?

"The flu" is an infection caused by the influenza virus. Flu symptoms include fever (usually 100°F to 103°F or > 37.8° C) in adults, and sometimes higher in children and problems such as cough, sore throat, runny or stuffy nose, headaches, muscle aches, fever and extreme tiredness.

Many people use the term "flu" to mean any combination of these symptoms, such as the common cold, but true influenza infection is often worse and may last longer than a cold.

Flu outbreaks (epidemics) happen about once a year, usually in the winter, when the influenza virus spreads widely in the community. Outside of those outbreaks only a very tiny number of respiratory infections are caused by the influenza virus.

Should I get a flu vacciniation?

TAMIFLU is not a substitute for a flu vaccination. If your health care professional's recommends that you get a flu vaccination every year, TAMIFLU can be added if prescribed.

Who should not take TAMIFLU?

Do not take TAMIFLU if you are allergic to the main ingredient, oseltamivir or to any other ingredient of the capsule or suspension.

Before starting treatment, make sure your doctor knows if you take any other medicines, if you are pregnant, planning to become pregnant, or breastfeeding.

TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

TAMIFLU is not recommended for use in children younger than 1 year of age.

Tell your doctor if you have any type of kidney disease, heart disease, respiratory disease, or any other serious health condition.

How should I take TAMIFLU?

It is important that you begin your treatment with TAMIFLU as soon as possible (within 2 days) from the first appearance of your flu symptoms or soon after you are exposed to the flu.

If you feel worse or develop new symptoms during treatment with TAMIFLU, or if your flu symptoms do not start to get better, you should contact your doctor.

If you have the flu: Take TAMIFLU twice a day for 5 days, 1 capsule in the morning and 1 capsule in the evening. You should complete the entire treatment of 10 doses capsules, even if you feel better.

To prevent the flu: If someone in your home has the flu, take 1 capsule of TAMIFLU per day for at least 7 days or for as long as prescribed. You can take TAMIFLU for up to 6 weeks if you are exposed to the flu because of an outbreak in your community. Follow your doctor's advice on how long to take TAMIFLU.

You can take TAMIFLU with food or without food. There is less chance of stomach upset if you take it with a light snack, milk, or a meal.

Children aged 1 to 13 years: use TAMIFLU powder for oral suspension.
Using the plastic measuring cup, add 52 ml of pure water to the 30g powder and shake thoroughly for 15 seconds to make 75 ml of suspension. Always use 52 ml of water, filling the measuring cup to the indicated level. Remove the cap and push the bottle adapter into the neck of the bottle and place the cap tightly over the top of the bottle adapter.

Dosage for children

 The dosage for children depends on the body weight (see table below).

For treatment of influenza, the usual dosage  is:

To prevent influenza, use the same dosage once daily for at least 7 days or more as prescribed by the doctor.

How to measure the correct amount of suspension:

1. Shake the closed bottle of TAMIFLU suspension well before use.

2. Take the dispenser and push the plunger completely down toward the tip of the dispenser. With the dispenser, you can correctly measure the dose needed.

3. Remove the cap from the bottle.

4. Insert the tip of the dispenser into the bottle adapter.

5. Turn the entire unit (bottle plus dispenser) upside down.

6. Slowly pull out the plunger to the graduation which marks the dose you need.

7. Turn the entire unit upright.

8. Slowly remove the dispenser from the bottle.

9. Push the suspension directly into the mouth by pushing down the plunger of the dispenser. Swallow the medicine. You may drink and eat something after taking the medicine.

10. Immediately after administration, take the dispenser apart and rinse both parts of the dispenser under running tap water.

What should I do when I forget a dose?

Take the missed dose as soon as you remember, but do not take a double dose to make up for the dose you have forgotten.

What are the possible side effects of TAMIFLU?

 The most common side effects of TAMIFLU are nausea, vomiting. These are usually mild to moderate. They usually happen in the first 2 days of treatment. Taking TAMIFLU with food may reduce the chance of getting these side effects.

Allergic skin reactions and liver function disorders have been very rarely reported.

If you notice any side effects not mentioned in this leaflet, or if you have any concerns about the side effects you get, tell your health care professional.

How and where should I store TAMIFLU?

Keep this medication out of reach and sight of children. Store TAMIFLU capsules and TAMIFLU powder for suspension at room temperature 25°C (77°F) and keep in a dry place.

After reconstitution TAMIFLU suspension should be stored at 2°C - 8°C (36 - 46°F) in a refrigerator. The suspension should not be used for longer than 10 days after adding water.

Taking other medicines: TAMIFLU can be taken with paracetamol, ibuprofen or acetylsalicylic acid (Aspirin). It should not alter the effect of other medicines. You must tell your doctor if you take any other medicines.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use TAMIFLU for a condition for which it was not prescribed.

Do not give TAMIFLU to other people, even if they have the same symptoms you have. It may not be right for them.

This leaflet summarizes the most important information about TAMIFLU. If you would like more information, visit www.rocheusa.com/products/tamiflu/