Package Insert: Information for the User

Tamiflu 75mg Hard Capsules

oseltamivir

Read this package insert carefully before starting to take the medicine, because it contains important information for you.

?Keep this package insert, as you may need to read it again.

?If you have any questions, consult your doctor or pharmacist.

?This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

?If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this package insert.See section 4.

1.What is Tamiflu and what it is used for

2.What you need to knowbeforestarting totake Tamiflu

3.How to take Tamiflu

4.Adverse effects

5.Storage of Tamiflu

6.Contents of the package and additional information

?Tamiflu is used in adults, adolescents, children, and infants (including newborns at term) for the treatment ofinfluenza (the flu)(influenza). It can be used when you have flu symptoms and it is known that the flu virus ispresent in the population.

?Tamiflu can be prescribed to adults, adolescents, children, and infants over 1 year of age forprophylactic treatment of the flu on a case-by-case basis, for example, if you have been in contact with someone who has the flu.

?Tamiflu may be prescribed to adults, adolescents, children, and infants (including newborns at term) aspreventive treatmentin exceptional circumstances, for example, if there is a global flu pandemic and when the seasonal flu vaccine is not sufficient for protection.

Tamiflu contains oseltamivir, which belongs to a group of medications called neuraminidase inhibitors. These medications prevent the spread of the flu virus within the body. They help to alleviate or prevent the symptoms of the flu virus infection.

The flu is a viral infection. Common signs of the flu often include sudden fever (over37.8°C), cough, runny or stuffy nose, headaches, muscle aches, and extreme fatigue. These symptoms can also be caused by other infections. A true flu infectiononly occurs during annual outbreaks (epidemics), when the flu viruses are disseminated in the population. Outside of epidemic periods, pseudoflu-like symptoms are generally caused by another type of disease.

Do not take Tamiflu:

?if you are allergic(hypersensitive) to oseltamivir or to any of the other components of Tamifluincluded in section 6.

If this happens to you,consult your doctor. Do not take Tamiflu.

Warnings and precautions

Before takingTamiflu, ensure your doctor is informed

?if you areallergic to other medications

?if you have any kidney disease. If so, your dose may need to be adjusted.

?if you have a serious condition that requires immediate hospitalization.

?if your immune system does not function properly.

?if you havechronic heart disease or respiratory disease.

During treatment with Tamifluimmediately inform your doctor

?if you notice changes in your behavior or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Tamiflu is not a flu vaccine

Tamiflu is not a vaccine: it is used to treat the infection or prevent the spread of the flu virus. A vaccine provides antibodies against the virus. Tamiflu does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both.

Use of Tamiflu with other medications

Inform your doctoror pharmacist if you are using any other medication, or have recently used one. This includes even medications purchased without a prescription.

The following medications are particularly important:

?chlorpropamide (used to treat diabetes)

?methotrexate (used to treat, for example, rheumatoid arthritis)

?phenylbutazone (used to treat pain and inflammation)

?probencid (used to treat gout)

Pregnancy and breastfeeding

You must inform your doctor if you are pregnant, think you may be pregnantor intend to become pregnantso that your doctor can decide if Tamiflu is suitable for you.

The effects on breastfeeding are unknown. You must inform your doctor if you are breastfeeding so that they can decide if Tamiflu is suitable for you.

Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Tamiflu has no effect on your ability to drive or operate machinery.

Information on some of the ingredients of Tamiflu

This medication contains less than 1 mmol of sodium (23 mg) per capsule, that is, it is essentially "sodium-free".

Follow the Tamiflu administration instructions exactly as indicated by your doctor.Consult your doctor or pharmacist if you have any doubts.

Take Tamiflu as soon as possible, ideally within two days of starting to experience flu symptoms.

Recommended Doses

For the treatment of the flu, take two doses daily. It is generally recommended to take one dose in the morning and another in the evening.It is essential to complete the entire 5-day treatment, even if you start to feel better quickly.

For patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of the flu or after being in contact with an infected person, take one dose daily for 10 days. It is best to take this dose in the morning with breakfast.

In special cases, such as widespread flu or patients with a weakened immune system, treatment will continue for 6 or 12 weeks.

The recommended dose depends on the patient's body weight.You should use the amount of capsules or oral suspension prescribed by your doctor.

Adults and adolescents 13 years or older

*For patients with a weakened immune system, treatment is for 10 days.

You can get 75 mg with a 30 mg capsule plus a 45 mg capsule.

Children 1 to 12 years

*For children with a weakened immune system, treatment is for 10 days.

**mg/kg = mg per kilogram of body weight. For example:

If a 6-month-old child weighs 8 kg, the dose is

8 kg x 3 mg/kg = 24 mg

Administration Form

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

Tamiflu can be taken with or without food, although taking it with food may reduce the likelihood of experiencing discomfort (nausea or vomiting).

People who may have difficulty swallowing the capsulescan use a liquid medication,Tamiflu oral suspension, but if this is not available at your pharmacy, you can prepare a liquid form of Tamiflu from the capsules.See the page onPreparing Tamiflu liquid at home.

If you take more Tamiflu than you should

Stop taking Tamiflu and consult a doctor or pharmacist immediately.

In many cases of overdose, no adverse effects were reported. When adverse effects were reported, they were similar to those that occurred with normal doses and are included in section 4.

More frequent cases of overdose with Tamiflu have been reported in children than in adults and adolescents. Be cautious when preparing Tamiflu liquid for children and when administering the capsules or liquid Tamiflu to children.

If you forget to take Tamiflu

Do not take a double dose to make up for the missed doses.

If you interrupt treatment withTamiflu

No adverse effects occur when stopping Tamiflu. However, if you stop taking Tamiflu before completing the treatment as prescribed by your doctor, the flu symptoms may reappear. Always complete the treatment prescribed by your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Many of these side effects can be caused by the flu.

Since the marketing of oseltamivir, the following severe side effects have rarely been reported:

?Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, itchy rash, low blood pressure, and difficulty breathing.

?Liver disorders (fulminant hepatitis, liver function disorder and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior

?Angioneuritic edema: severe sudden swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulty breathing.

?Stevens-Johnson syndrome and toxic epidermal necrolysis: a complex allergic reaction that may be life-threatening, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rash, with blister formation, peeling, and large areas of skin peeled, possible respiratory difficulty and low blood pressure

?Gastrointestinal hemorrhage: prolonged bleeding of the large intestine or vomiting blood

?Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, seek medical help immediately.

The most frequently reported side effects (very common and common) for Tamiflu areunpleasant feeling or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These side effects usually occur after the first dose of the medication and generally disappear during treatment. The frequency of these side effects decreases if the medication is taken with food.

Severe side effects: seek medical help immediately

(These may affect up to 1 in 1,000 people)

During treatment with Tamiflu, rare but severe side effects have been reported that include

?Seizures and delirium, including altered levels of consciousness

?Confusion, abnormal behavior

?Delirious disorders, hallucinations, agitation, anxiety, nightmares

Thiss events were mainly reported in children and adolescents and often began suddenly and had a rapid resolution. In very rare cases, these events had resulted in self-harm, some with fatal outcome. These neuropsychiatric events have also been reported in patients with flu who were not taking Tamiflu.

?Patients, especially children and adolescents, should be closely monitored to detect changes in behavior described above.

If you notice any of these symptoms, especially in younger patients,seek medical help immediately.

Adults and adolescents 13 years and older

Very common side effects

(may affect more than 1 in 10 people)

?Headache

?Nausea

Common side effects

(may affect up to 1 in 10 people)

?Bronchitis

?Fever

?Cough

?Dizziness

?Fever

?Pain

?Pain in the limbs

?Coughing

?Difficulty sleeping

?Sore throat

?Stomach pain

?Fatigue

?Feeling of fullness in the upper abdomen

?Upper respiratory tract infections (inflammation of the nose, throat, and sinuses)

?Stomach discomfort

?Vomiting

Uncommon side effects

(may affect up to 1 in 100 people)

?Allergic reactions

?Altered level of consciousness

?Seizure

?Alterations in heart rhythm

?Mild to severe liver function disorders

?Dermatological reactions (inflammation of the skin, red itchy rash, scaly skin)

Rare side effects

(may affect up to 1 in 1,000 people)

?Thrombocytopenia (reduced platelet count)

?Visual disorders

Children 1 to 12 years

Very common side effects

(may affect more than 1 in 10 people)

?Cough

?Runny nose

?Vomiting

Common side effects

(may affect up to 1 in 10 people)

?Conjunctivitis (red, watery, or painful eyes)

?Inflammation of the ears and other ear disorders

?Headache

?Nausea

?Coughing

?Stomach pain

?Feeling of fullness in the upper abdomen

?Stomach discomfort

Uncommon side effects

(may affect up to 1 in 100 people)

?Dermatitis

?Middle ear disorder (tympanic membrane)

Infants under 1 year

The side effects reported in children aged 0 to 12 months are mostly similar to the side effects reported in older children (from 1 year). Additionally, diarrhea and diaper dermatitis have been reported.

If you consider that any of the side effects you are experiencing are severe or if you appreciate any side effectnot mentioned in this leaflet,inform your doctor or pharmacist. However,

?if you or your child are ill several times, or

?if the flu symptoms worsen or the fever continues

Inform your doctor as soon as possible..

Reporting of side effects

If you experience any type of side effect, consult your doctor,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theAppendix Vincluded in the

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Tamiflu

? Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir.

? The other components are:

filling of the capsule: pregelatinized starch, talc, povidone, sodium croscarmellose and sodium stearyl fumarate

capsule coating: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171)

printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine, E132)

Appearance of the product and contents of the pack

The 75 mg hard capsules are formed by a grey opaque body with the inscription “ROCHE” and a clear yellow opaque cap with the inscription “75 mg”. The inscriptions are blue.

Tamiflu 75 mg hard capsules are available in blisters of 10 capsules.

Marketing authorization holder and responsible manufacturer

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Roche Pharma AG

Emil-Barell-Str. 1,

D-79639 Grenzach-Wyhlen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

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Information for the user

For people who find it difficult to swallow the capsules, including small children, there is a liquid medicine, Tamiflu oral suspension.

If you need a liquid medicine, but it is not available, it can be prepared from Tamiflu capsules (see Information for healthcare professionals). The preparation made in the pharmacy is the recommended option.

If the pharmacy preparation is not available, you can prepare Tamiflu liquid at home from these capsules.

The dose is the same for treatment as for prevention of influenza. The difference is the frequency with which it is administered.

Preparing Tamiflu liquid at home

? If you have the right capsule for the required dose (a dose of 75 mg), open the capsule and shake its contents in a spoon (or less) of suitable sweet food.

This is normally suitable for children over 1 year old. See the upper section of the instructions.

? If you need smaller doses , preparing Tamiflu liquid from the capsules requires more steps.

This is suitable for small children and babies: they need a Tamiflu dose of less than 30 mg. See the lower section of the instructions.

Adults, adolescents aged 13 years and over, and children weighing 40 kg or more

To prepare a dose of 75 mg, you need:

? One Tamiflu capsule of 75 mg

? Sharp scissors

? Small container

? Spoon (5 ml spoon)

? Water

? Sweet food to mask the bitter taste of the powder

Examples: chocolate syrup or cherry syrup and dessert sauce, like caramel or condensed milk.

Or you can prepare sugar water: mix 1 teaspoon of water with 3/4 of a teaspoon of sugar.

Step 1: Check the correct dose

To know the correct amount to use, look at the patient's weight on the left of the table.

Look at the right-hand column to check the number of capsules you need to give the patient for a single dose. The dose is the same for treatment as for prevention of influenza.

Only the 75 mg capsules should be used for doses of 75 mg. Do not try to prepare doses of 75 mg using the contents of the 30 mg or 45 mg capsules.

Not for children weighing less than 40 kg

If you need to prepare a smaller dose of less than 75 mg for children weighing less than 40 kg. See below

Step 2: Pour all the powder into the container

Take one 75 mg capsule and place it vertically over a container and carefully cut off the rounded end with scissors.

Pour all the powder into the container.

Be careful with the powder, as it can be irritating to the skin and eyes.

Step 3: Mask the powder with sweet food and give the dose

Add a small amount –no more than a spoonful- of sweet food to the powder in the container.

This is to mask the bitter taste of the Tamiflu powder.

Shake the mixture well.

Give the patient immediately all the contents of the container .

If there is any mixture left in the container, rinse the container with a small amount of water and give it to the patient to drink all of it.

Repeat this procedure every time you need to give the medicine.

Babies under 1 year and children weighing less than 40 kg

To prepare a smaller dose , you will need:

? One Tamiflu capsule of 75 mg

? Sharp scissors

? Two small containers

? Large oral dosing dispenser to measure the water - a 5 or 10 ml dispenser

? Small oral dispenser that shows 0.1 ml measurements, to give the dose

? Spoon (5 ml spoon)

? Water

? Sweet food to mask the bitter taste of Tamiflu

Examples: chocolate syrup or cherry syrup and dessert sauce, like caramel or condensed milk.

Or you can prepare sugar water: mix 1 teaspoon of water with 3/4 of a teaspoon of sugar.

Step 1: Pour all the powder into a container

Take one 75 mg capsule and place it vertically over one of the containers and carefully cut off the rounded end with scissors.

Pour all the powder into the container, regardless of the dose you are preparing.

The amount is the same for treatment as for prevention of influenza.

Step 2: Add water to dilute the medicine

Do not worry if not all the powder dissolves. The undissolved powder corresponds to inactive ingredients.

Step 3: Choose the correct dose for the child's weight

Look at the patient's weight on the left-hand side of the table.

The right-hand column of the table shows how much of the liquid mixture you need to prepare.

Babies under 1 year (including full-term newborns)

Children aged 1 year or over weighing less than 40 kg

Step 4: Prepare the liquid mixture

Make sure you have the right size of dispenser.

Prepare the correct amount of liquid mixture from the first container.

Prepare it carefully to avoid getting air bubbles.

Add the correct dose to the second container.

Step 5 : Mask the mixture with sweet food and give it to the child

Add a small amount –no more than a spoonful- of sweet food to the second container.

This is to