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TAMIFLU®
(oseltamivir phosphate)

This leaflet contains important information about TAMIFLU (oseltamivir phosphate) (TAM-ih-flew). Read it well before you begin treatment. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment. This leaflet does not list all the benefits and risks of TAMIFLU (oseltamivir phosphate) . If you have any questions about TAMIFLU (oseltamivir phosphate) , ask your healthcare professional. Only your healthcare professional can determine if TAMIFLU (oseltamivir phosphate) is right for you.

What is TAMIFLU (oseltamivir phosphate) ?

TAMIFLU (oseltamivir phosphate) attacks the influenza virus and stops it from spreading inside your body. TAMIFLU (oseltamivir phosphate) treats flu at its source, by attacking the virus that causes the flu, rather than simply masking symptoms.

TAMIFLU (oseltamivir phosphate) is for treating adults and children age 1 and older with the flu whose flu symptoms started within the last day or two. TAMIFLU (oseltamivir phosphate) can also reduce the chance of getting the flu in people age 1 and older who have a higher chance of getting the flu because they spend time with someone who has the flu. TAMIFLU (oseltamivir phosphate) can also reduce the chance of getting the flu if there is a flu outbreak in the community.

What is "Flu"?

"The flu" is an infection caused by the influenza virus. Flu symptoms include fever (usually 100°F to 103°F 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 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 shot?

TAMIFLU (oseltamivir phosphate) is not a substitute for a flu vaccination. You should continue to get a flu vaccination every year, according to your healthcare professional's advice.

Who should not take TAMIFLU (oseltamivir phosphate) ?

Do not take TAMIFLU if you are allergic to the main ingredient, oseltamivir phosphate, or to any other ingredients of TAMIFLU (oseltamivir phosphate) . Before starting treatment, make sure your healthcare professional knows if you take any other medicines, or are pregnant, planning to become pregnant, or breastfeeding. TAMIFLU (oseltamivir phosphate) is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. TAMIFLU (oseltamivir phosphate) is not recommended for use in children younger than 1 year of age.

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

TAMIFLU (oseltamivir phosphate) for Oral Suspension contains sorbitol. Sorbitol may cause upset stomach and diarrhea in patients with a family history of fructose intolerance.

How should I take TAMIFLU (oseltamivir phosphate) ?

It is important that you begin your treatment with TAMIFLU (oseltamivir phosphate) as soon as possible 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 (oseltamivir phosphate) , or if your flu symptoms do not start to get better, you should contact your healthcare professional.

If you have the flu: Take TAMIFLU (oseltamivir phosphate) twice a day for 5 days, once in the morning and once in the evening. You should complete the entire treatment of 10 doses (capsules or suspension), even if you feel better.

To prevent the flu: If someone in your home has the flu, take TAMIFLU (oseltamivir phosphate) once a day for 10 days or for as long as prescribed. You can take TAMIFLU (oseltamivir phosphate) for up to 6 weeks if you are exposed to the flu because of an outbreak in your community. Follow your healthcare professional's advice on how long to take TAMIFLU (oseltamivir phosphate) .

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

If you are taking TAMIFLU (oseltamivir phosphate) for Oral Suspension, your pharmacist will give you a dosing dispenser marked with three possible doses. Follow your healthcare professional's instructions on which dose to take or how to combine them for the proper dose for you. In order to be sure you receive the proper dose, it is important that you use the dispenser provided. Review the instructions below on how to use the dispenser and ask your pharmacist if you have any questions. If you lose or damage the dispenser and cannot use it, contact your healthcare professional or pharmacist for advice on the proper dose.

If TAMIFLU (oseltamivir phosphate) for Oral Suspension is not available, your healthcare provider may instruct you to open TAMIFLU (oseltamivir phosphate) Capsules and mix the contents with sweetened liquids such as regular or sugar-free chocolate syrup. Please follow the dosing instructions below.

If you forget to take your medicine, take the missed dose as soon as you remember, except if it is 2 hours or less before your next dose. Then continue to take TAMIFLU (oseltamivir phosphate) at the usual times. Do not take 2 doses at a time to make up for a missed dose. If you miss several doses, tell your healthcare professional and follow the advice given to you.

What are the possible side effects of TAMIFLU (oseltamivir phosphate) ?

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

If you develop an allergic reaction or severe rash, stop taking TAMIFLU (oseltamivir phosphate) and contact your healthcare professional.

People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning TAMIFLU (oseltamivir phosphate) or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.

Before taking TAMIFLU (oseltamivir phosphate) , please let your healthcare provider know if you have received nasally administered influenza virus vaccine during the past two weeks.

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 healthcare professional.

How and where should I store TAMIFLU (oseltamivir phosphate) ?

TAMIFLU (oseltamivir phosphate) Capsules should be stored at room temperature, 77°F (25°C) and kept in a dry place. Keep this medication out of reach of children.

TAMIFLU (oseltamivir phosphate) for Oral Suspension should be stored under refrigeration for up to 17 days at 36° to 46°F (2° to 8°C). Do not freeze. Alternatively, store at room temperature for up to 10 days.

General advice about prescription medicines:

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TAMIFLU (oseltamivir phosphate) for a condition for which it was not prescribed. Do not give TAMIFLU (oseltamivir phosphate) 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 (oseltamivir phosphate) . If you would like more information, talk with your healthcare professional. You can ask your pharmacist or healthcare professional for information about TAMIFLU (oseltamivir phosphate) that is written for health professionals.

DOSING INSTRUCTIONS FOR PATIENTS:

How Do I Prepare TAMIFLU (oseltamivir phosphate) for Oral Suspension?

Please follow instructions carefully to ensure proper dosing of the oral suspension.

• Shake closed bottle well for about 5 seconds before each use.
• Remove child-resistant cap.
• Before inserting the tip of the oral dispenser into bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Insert tip firmly into opening of the bottle adapter.
• Turn the entire unit (bottle and oral dispenser) upside down.
• Pull the plunger out slowly until the desired amount of medication is withdrawn into the oral dispenser (see figure). The 75 mg dose is obtained by filling the dispenser twice, once to the 30 mg graduation, and a second fill to the 45 mg graduation.

• Turn the entire unit right side up and remove the oral dispenser slowly from the bottle.
• Dispense directly into mouth. Do not mix with any liquid prior to dispensing.
• Close bottle with child-resistant cap after each use.
• Disassemble oral dispenser, rinse under running tap water and air dry prior to next use.

If Directed by My Healthcare Provider, How Do I Mix the Contents of TAMIFLU (oseltamivir phosphate) Capsules with Sweetened Liquids?

Please follow instructions carefully to ensure proper dosing.

• Holding one capsule over a small bowl, carefully pull the capsule open and pour the complete contents of the capsule into the bowl.
• Add a small amount of a sweetened liquid such as chocolate syrup (regular or sugar-free) that the child will consume completely.
• Stir the mixture and give the entire dose to the child.

Last reviewed on RxList: 2/7/2011
This monograph has been modified to include the generic and brand name in many instances.