Package Insert:Information for the User

Tamiflu 45mg Hard Capsules

oseltamivir

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

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

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

?This medication 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 know before starting to take Tamiflu

3.How to take Tamiflu

4.Possible 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 ofthe 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 also to adults, adolescents, children, and infants over 1 year of age forpreventing the fluon 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 epidemic (aflu pandemic) and when the seasonal flu vaccine is not enough to provide 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 symptoms of the flu virus infection.

The flu is an infection caused by a virus. Flu symptoms 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 infection typically occurs during annual outbreaks (epidemics), when flu viruses are disseminated in the population. Outside of epidemic periods, pseudoflu-like symptoms are generally caused by another type of illness.

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 taking Tamiflu, make sure your doctor is informed

?if you areallergic to other medications

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

?if you have anyserious illnessrequiring immediate hospitalization.

?if yourimmune systemdoes not function properly.

?if you havechronic heart disease or respiratory disease.

During treatment with Tamifluinform your doctor immediately

?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 doctor orpharmacist if you are using any other medication, or have recently used one. This includes even medications obtained without a prescription.

The following medications are particularly important:

?chlorpropamide (used to treatdiabetes)

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

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

For flu prevention 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 outbreaks or patients with a weakened immune system, treatment may continue for up to 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 immunocompromised patients, treatment is for 10 days.

**You can get 75 mg with one 30 mg capsule plus one 45 mg capsule.

Children 1 to 12 years old

*For immunocompromised children, treatment is for 10 days.

**You can get 75 mg with one 30 mg capsule plus one 45 mg capsule.

Children under 1 year (0 to 12 months)

Tamiflu administration to children under 1 year of age for flu prevention during a pandemic should be done based on the doctor's criteria after considering the potential benefit versus any potential risk to the child.

*For immunocompromised children, treatment is for 10 days.

**mg per kg =mg per each kilogram of the child's body weight. For example:

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

8 kg x 3 mg per 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 feeling or experiencing 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 Tamiflu capsules or liquid 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, 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 serious side effects have rarely been reported:

?Anaphylactic and anaphylactoid reactions: severe allergic reactions, facial and skin swelling, itchy rash, low blood pressure, and difficulty breathing.

?Liver disorders (fulminant hepatitis, liver function disorder and jaundice): yellowing of the skin and eyes, change in stool color, and 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 severe allergic reaction that can be life-threatening, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rash, blister formation, peeling, and large areas of skin peeled, possible respiratory difficulty and low blood pressure.

?Gastrointestinal bleeding: 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 are:

?Unpleasant feeling or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain.

Seek medical help immediately if you notice any of these symptoms.

Adults and adolescents 13 years and older

Very common side effects

(can affect more than 1 in 10 people)

?Headache

?Nausea

Common side effects

(can affect up to 1 in 10 people)

?Bronchitis

?Fever

?Cough

?Dizziness

?Fever

?Pain

?Pain in the extremities

?Runny nose

?Difficulty sleeping

?Sore throat

?Stomach pain

?Tiredness

?Fullness in the upper abdomen

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

?Stomach discomfort

?Vomiting

Uncommon side effects

(can affect up to 1 in 100 people)

?Allergic reactions

?Altered level of consciousness

?Convulsion

?Alterations in heart rhythm

?Mild to severe liver function disorder

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

Rare side effects

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

?Thrombocytopenia (reduced platelet count)

?Eye disorders

Children 1 to 12 years old

Very common side effects

(can affect more than 1 in 10 people)

?Cough

?Runny nose

?Vomiting

Common side effects

(can affect up to 1 in 10 people)

?Conjunctivitis (red, watery, or painful eyes)

?Ear inflammation and other ear disorders

?Headache

?Nausea

?Runny nose

?Stomach pain

?Fullness in the upper abdomen

?Stomach discomfort

Uncommon side effects

(can affect up to 1 in 100 people)

?Skin inflammation

?Middle ear disorder (tympanic membrane)

Infants under 1 year old

The side effects reported in children aged 0 to 12 months are mostly similar to those reported in older children (over 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 effect not 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 about the safety of this medicine.

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 on the 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 45 mg of oseltamivir.

?The other components are:

capsule content: pregelatinized starch, talc, povidone, sodium croscarmellose and sodium stearyl fumarate

capsule coating: gelatin, iron oxide black (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 hard capsules of 45mg are formed by a grey opaque body with the inscription “ROCHE” and a grey opaque cap with the inscription “45mg”. The inscriptions are blue.

Tamiflu 45mg hard capsules are available in blisters of 10 capsules.

Marketing Authorization Holder and Responsible Person for Manufacturing

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Roche Pharma AG

Emil-Barell-Str. 1,

D-79639 Grenzach-Wyhlen

Germany

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

*

Last update of this leaflet:

The detailed information on 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 young children, there is a liquid medication,Tamiflu oral suspension.

If you need a liquid medication, but it is not available, you can prepare a suspension from Tamiflu capsules (seeInformation for healthcare professionals).The preparation made by 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 capsulefor the required dose (dose of 45 mg), open the capsule and shake its contents in a spoon (or less) of suitable sweet food.

This is usually suitable for children over 1 year old.See the top section of the instructions..

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

This is suitable for young children, children who weigh little and babies: they usually need a smaller dose of Tamiflu than 45mg.See the lower section of the instructions..

Children aged 1 to 12 years

To make a dose of 45 mg,you need:

?One Tamiflu capsule of 45mg

?Sharp scissors

?A small container

?Spoon (5ml spoon)

?Water

?Sweet food to mask the bitter taste of Tamiflu.

Examples:sweet chocolate syrup or cherry syrup and dessert sauce, such as caramel or condensed milk.

You can also prepare a sweet water: mix 1 spoonful of water with 3/4 of a spoonful of sugar.

Step 1: Check the correct dose

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

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

Only use the 45mg capsules for doses of 45mg. Do not try to prepare doses of 30mg, 60mg or 75mg using the contents of the 45mg capsules. Instead, use the capsule with the appropriate dose.

Step 2: Pour all the powder into the container

Take one45mg Tamiflu capsulein a vertical position 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: Add sweet food to mask the bitter taste and give the dose

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

This is tomaskthe bitter taste of the Tamiflu powder.

Shake the mixture well.

Give the patient immediately all the contentsof the container.

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

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

Newborns under 1 year

To make a smaller dose,you will need:

?OneTamiflu capsule of 45mg

?Sharp scissors

?Two small containers(use different containers for each child)

?Large oral dosing dispenserto measure the water –a 5ml or 10ml dispenser

?Small oral dosing dispenserthat shows 0.1 ml measurements to give the dose

?Spoon (5ml spoon)

?Water

?Sweet food to mask the bitter taste of Tamiflu.

Examples:sweet chocolate syrup or cherry syrup and dessert sauce, such as caramel or condensed milk.

You can also prepare a sweet water: mix 1 spoonful of water with 3/4 of a spoonful of sugar.

Step 1: Pour all the powder into a container

Take one45mg Tamiflu capsulein a vertical position 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 medication

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

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

Look at the left column of the table for the child's weight.

Theright column of the table shows how much of the liquid mixture you need to prepare.

Newborns under 1 year (including term newborns)

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: Add sweet food to mask the bitter taste and give the dose

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

This is tomaskthe bitter taste of the Tamiflu suspension.

Shake the sweet food well with the Tamiflu liquid.

Give the patient immediately all the contentsof the second container (sweet food mixed with the Tamiflu liquid).

If there is anything left in the second container, rinse the container with a small amount of water and give it to the patient to drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use a suitable bottle to give them the remaining liquid.

Give the child something to drink.

Dispose of any remaining liquid from the first container.

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

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Information for healthcare professionals only

Patients who cannot swallow the capsules:

The commercially available Tamiflu oral suspension (6 mg/ml) is the preferred medication for pediatric and adult patients who have difficulty swallowing the capsules or who need lower doses. If Tamiflu powder for oral suspension is not available, the pharmacist can prepare a suspension (6 mg/ml) from Tamiflu capsules. If the pharmacy preparation is not available, patients can prepare the suspension at home from the capsules.

Provide theoral dosing dispenserswith the correct volume and graduation for administering the suspension prepared by the pharmacy and for the procedures to follow for preparation at home. In both cases, the volumes needed should preferably be marked on the dispensers.For home preparation, providethe dispensersfor taking the correct volume of water and for measuring the Tamiflu mixture with water. To measure 5.0 ml of water, use dispensers of 5 ml or 10 ml.

Below is the correct size of dispenser to use for extracting the correct volume of Tamiflu suspension (6mg/ml).

Newborns under 1 year (including term newborns):