Tamiflu 45 mg hard capsule

• Tamiflu is prescribed to you for treating or preventing influenza.
• Tamiflu belongs to a group of medicines named ?neuraminidase inhibitors?. These medicines prevent the influenza virus from spreading inside the body and so help to ease or prevent the symptoms arising from the influenza virus infection.
• Influenza is an infection caused by the influenza virus. The signs (symptoms) of influenza include the sudden onset of fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and often extreme fatigue. These symptoms may also be caused by infections other than influenza. True influenza infection only occurs during annual outbreaks (epidemics) at times when influenza viruses are spreading in the local community. Outside of the epidemic period, these symptoms will mainly be caused by a different type of infection or illness.

Do not take Tamiflu

• if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu.

Take special care with Tamiflu

Before you take Tamiflu, make sure your prescribing doctor knows if you

• are allergic to other medicines
• have problems with your kidneys.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tamiflu can be taken with appropriate medicines to treat fever (high temperature). Tamiflu is not expected to alter the effect of any other medicines.

Are there any interactions with an influenza vaccination?
Tamiflu is not a substitute for influenza vaccination. Tamiflu will not change the effectiveness of the influenza vaccine. Even if a vaccination against influenza has been given to you Tamiflu may be prescribed by your doctor.

Taking Tamiflu with food and drink
Swallow Tamiflu with water. Tamiflu can be taken with or without food, although it is recommended to take Tamiflu with food to reduce the chance of feeling or being sick (nausea or vomiting).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu is right for you.

The effects on nursing infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.

Driving and using machines
Tamiflu has no effect on your ability to drive or use machines.

Always take Tamiflu exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take Tamiflu as soon as you get the prescription as this will help to slow the spread of the influenza virus in the body.

Swallow Tamiflu capsules whole with water. Do not break or chew Tamiflu capsules.

The usual dose is as follows:

Treatment

Adolescents (13 to 17 years of age) and adults:
30 mg and 45 mg capsules can be used by adults and adolescents as an alternative to 75 mg capsules. For treatment of influenza take one 30 mg and one 45 mg capsule as soon as you get the prescription and then take one 30 mg and one 45 mg capsule twice a day (usually it is convenient to take one 30 mg and one 45 mg in the morning and one 30 mg and one 45 mg in the evening for five days). It is important to complete the whole 5 day course, even if you start to feel better quickly.

Infants 1 year of age and older, and children 2 to 12 years of age: Tamiflu oral suspension can be used instead of capsules.

Children weighing more than 40 kg and who can swallow capsules may take a 75 mg dose of Tamiflu capsules twice daily for 5 days.

You must give the amount of capsules to your child as prescribed by your doctor.

The usual dose for treatment of influenza in children depends on the body weight of the child (see table below).

Children 1 year of age and older Body Weight Recommended dose for 5 days Treatment Less than or equal to 15 kg 30 mg twice daily More than 15 kg and up to 23 kg 45 mg twice daily More than 23 kg and up to 40 kg 60 mg twice daily More than 40 kg 75 mg twice daily 75 mg is made up of a 30 mg dose plus a 45 mg dose

Infants below 12 months of age: Limited pharmacokinetic and safety data are available for infants less than 2 years of age. Pharmacokinetic modeling was undertaken using these data in addition to data from studies in adults and children older than 1 year of age. The results demonstrate that doses of 3 mg/kg twice daily for infants aged 3 to 12 months and 2.5 mg/kg twice daily for infants aged between 1 and 3 months provide exposures similar to those shown to be clinically efficacious in adults and children older than 1 year of age (see table below for weight-based dosing recommendations). There are currently no data available in infants less than 1 month of age using Tamiflu.

Age Recommended dose for 5 days Treatment 3 months to 12 months 3 mgkg twice daily 1 month to 3 months 2.5 mgkg twice daily 0 to 1 month 2 mgkg twice daily

Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of treatment versus any potential risk to the infant.

Prevention

Tamiflu can also be used for prevention of influenza following exposure to an infected individual, such as family members.

Adolescents (13 to 17 years of age) and adults:
30 mg and 45 mg capsules can be used by adults and adolescents as an alternative to 75 mg capsules. Tamiflu should be taken once daily for 10 days. It is best to take this dose in the mornings with breakfast.

Infants 1 year of age and older, and children 2 to 12 years of age: Tamiflu oral suspension can be used instead of capsules.

The usual dose for prevention of influenza in children depends on the body weight of the child (see table below).

Children 1 year of age and older Body Weight Recommended dose for 10 days Prevention Less than or equal to 15 kg 30 mg once daily More than 15 kg and up to 23 kg 45 mg once daily More than 23 kg and up to 40 kg 60 mg once daily More than 40 kg 75 mg once daily 75 mg is made up of a 30 mg dose plus a 45 mg dose

Your doctor will recommend the length of time to continue taking Tamiflu, if it is prescribed to prevent influenza.

Infants below 12 months of age: The recommended prophylaxis dose for infants less than 12 months of age during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in children older than 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza. The following weight-adjusted dosing prophylaxis regimens are recommended for infants below 1 year of age:

Age Recommended dose for 10 days Prevention 3 months to 12 months 3 mgkg once daily 1 month to 3 months 2.5 mgkg once daily 0 to 1 month 2 mgkg once daily

Administration of Tamiflu to infants less than one year of age should be based upon the judgment of the physician after considering the potential benefit of prophylaxis versus any potential risk to the infant.

When Tamiflu oral suspension is not available

When commercially manufactured Tamiflu oral suspension is not available, a pharmacy preparation from Tamiflu capsules can be used (see end of package leaflet, information for medical or healthcare personnel). If the pharmacy preparation is not available either, Tamiflu doses may be prepared at home. The pharmacy preparation is the preferred option in infants below 12 months of age.

When appropriate capsule strengths are available, the dose is given by opening the capsule and mixing its contents with no more than one teaspoon of a suitable sweetened food product. The bitter taste can be masked by products such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce). The mixture should be stirred and given entirely to the patient. The mixture must be swallowed immediately after its preparation.

When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation involves additional steps.

Preparing Tamiflu doses for infants younger than 1 year ? 45 mg capsules

Infants who weigh 10 kg or less need a Tamiflu dose of 30 mg or less. To make doses of Tamiflu for these infants, you will need to open a Tamiflu capsule, prepare a powder-water mixture and mix the correct volume of the mixture with food.

You will need:

1. One 45 mg Tamiflu capsule

2. Dosing chart to determine the correct dosage amount (see Tamiflu dosing chart under step 3 in the next section below)

3. A pair of scissors

4. Two small bowls per child (use separate pairs of bowls for each child)

5. One 3 ml (three millilitre) oral syringe that shows measurements of 0.1 ml (one-tenth of one millilitre)

6. One suitable oral dosing syringe that shows measurements of 0.1 ml (one-tenth of one millilitre). Ask the pharmacist for the correct syringe (1 ml, 2 ml, or 3 ml).

7. One teaspoon

8. One of these foods to hide the bitter taste of the Tamiflu powder:

• Sugar water (If you plan to use sugar water, make this mixture now in a separate bowl or cup. Mix a teaspoon of water with three-fourths [3/4] of a teaspoon of sugar.)
• Chocolate syrup
• Cherry syrup
• Dessert toppings, like caramel or fudge sauce

Making the Tamiflu 10 mg/ml mixture for infants younger than 1 year ? 45 mg capsules These instructions show you how to make one dose of Tamiflu, to be used immediately.

1. Carefully open ONE 45 mg Tamiflu capsule over the first small bowl. To open a capsule, hold the capsule upright and snip off the rounded tip with scissors (see accompanying picture). Pour all of the powder into the bowl. Handle the powder carefully, because it may be irritating to the skin and eyes

2. Follow the chart below. Use the 3 ml dosing syringe to measure first 3.0 ml of water, and add it to the powder in the bowl. Then measure 1.5 ml of water, and add it to the powder in the bowl. Stir for about 2 minutes.

Tamiflu capsule Amount of water to add ONE 45 mg capsule 4.5 ml four and a half millilitres

3. Follow the chart below. Find the child?s weight on the left side of the chart, and then look at the column on the right side of chart to see the amount of the Tamiflu powder-water mixture to draw up into the dosing syringe. Draw up the correct amount of powder-water mixture from the first small bowl into the dosing syringe, and then gently expel it from the dosing syringe into the second bowl.

Tamiflu dosing chart for infants 1 to 12 months of age:

Weight rounded to the Required dosenearest 0.5 kg of Tamiflu Amount of Tamiflu powder-water mixture to be drawn up into the dosing syringe 4 kg 10 mg 1.00 ml 4.5 kg 11.25 mg 1.10 ml 5 kg 12.5 mg 1.30 ml 5.5 kg 13.75 mg 1.40 ml 6 kg 15 mg 1.50 ml 7 kg 21 mg 2.10 ml 8 kg 24 mg 2.40 ml 9 kg 27 mg 2.70 ml 10 kg 30 mg 3.00 ml

Tamiflu dosing chart for infants below 1 month of age:

Weight rounded to the nearest 0.5 kg Required doseof Tamiflu Amount of Tamiflu powder-water mixture to be drawn up into the dosing syringe 3 kg 6 mg 0.60 ml 3.5 kg 7 mg 0.70 ml 4 kg 8 mg 0.80 ml 4.5 kg 9 mg 0.90 ml

4. Add a small amount of one of the sweet foods (use no more than 1 teaspoon) into the second bowl. This will hide the bitter taste of the powder-water mixture.

5. Mix the sweet food and powder-water mixture well.

6 Give the entire contents of the second bowl sweet food with powder-water mixture to the child. 7. Give the child something suitable to drink. 8. Throw out any unused powder-water mixture left in the first bowl.

(Note: Not all capsule contents may dissolve. Do not worry, as the undissolved materials are inactive ingredients.)

If you take more Tamiflu, than you should

Contact your doctor or pharmacist immediately.

If you have forgotten to take Tamiflu

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Tamiflu

There are no side effects when Tamiflu is discontinued prior to advice from your doctor. If Tamiflu is stopped earlier than your doctor told you, the symptoms of influenza may reoccur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Tamiflu can cause side effects, although not everybody gets them.

• Common side effects of Tamiflu

The most common side effects of Tamiflu are nausea, vomiting, diarrhoea, stomach ache and headache. These side effects mostly occur only after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.

• Less common side effects of Tamiflu

During Tamiflu treatment, events like convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares) have been reported, in a very few cases resulting in self-injury, in some instances with fatal outcome. These events were reported primarily among children and adolescents and often had an abrupt onset and rapid resolution. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.

Adults and adolescents (children aged 13 years and older)

Other less common side effects, which may also be caused by influenza, are upper abdominal fullness, bleeding in the gastrointestinal tract, bronchitis, upper respiratory tract infections, dizziness, tiredness, sleeping difficulties, skin reactions, mild to severe liver function disorders, visual disturbances and heart rhythm abnormalities.

Children (aged 1 to 12 years)
Other less common side effects, which may also be caused by influenza, are cough, nasal congestion, ear inflammation, inflammation of the lungs, sinusitis, bronchitis, aggravation of pre-existing asthma, nose bleeding, ear disorders, inflammation of the skin, swelling of the lymph nodes, conjunctivitis, visual disturbances and heart rhythm abnormalities.

Infants (aged 6 to 12 months)

The reported side effects of Tamiflu when used for treatment of influenza in infants 6 to 12 months of age are similar to the side effects reported for older children (1 year and older). Please read the section above for your information.

Infants (aged 0 to 6 months)

The reported side effects of Tamiflu when used for treatment of influenza in infants 1 to 6 months of age are similar to the side effects reported for infants 6 to 12 months of age and older children (1 year and older). There are no data available for the use of Tamiflu in infants less than 1 month of age. Please read the section above for your information.

If you or your child are often sick, you should inform your doctor. You should also tell your doctor if the influenza symptoms get worse or the fever continues.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Tamiflu after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Tamiflu contains

• The active substance is oseltamivir phosphate (45 mg oseltamivir in each hard capsule).
• The other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigocarmine, E132).

What Tamiflu looks like and contents of the pack

45 mg hard capsule consists of a grey opaque body bearing the imprint ?ROCHE? and a grey opaque cap bearing the imprint ?45 mg?. Imprints are blue.

Tamiflu 45 mg hard capsules are available in blister packs of 10.

Marketing Authorisation Holder and Manufacturer

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Roche Pharma AG
Emil-Barell-Str. 1,
D-79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

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Tel: +370 5 2546799

This leaflet was last approved in {MM/YYYY}.

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The following information is intended for medical or healthcare professionals only: When commercially manufactured Tamiflu powder for oral suspension is not available, patients who are unable to swallow capsules may receive appropriate doses of Tamiflu prepared in a pharmacy or prepared at home.

For infants below 12 months, the pharmacy preparation should be preferred to home preparation.

Detailed information on the pharmacy preparation can be found in the SmPC of Tamiflu capsules section 4.2.

Syringes of appropriate volume and grading should be provided for administering the pharmacy compounded suspension as well as for the procedures involved in the home preparation. In both cases, the correct volumes should preferably be marked on the syringes.