Package Leaflet:Information for the User

Tamiflu 6mg/ml Powder for Oral Suspension

oseltamivir

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

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

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

?If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 side effects

5.Storage of Tamiflu

6.Contents of the pack 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 the symptoms of the flu virus infection.

The flu is a viral infection. The 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 any of the other components of Tamiflulisted 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 are allergic to other medications

?you have any kidney 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 diseaseorrespiratory 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 or pharmacist 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 pregnant, so that your doctor can decide if Tamiflu is suitable for you.

The effects on breastfed infants are unknown. You must inform your doctor if you are breastfeeding so that your doctor 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.

Important information about some of the ingredients in Tamiflu

Tamiflu contains sorbitol.

Sorbitol is a source of fructose. If your doctor has told you that you have intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, speak with your doctor before taking or receiving this medicine.

Sorbitol may cause gastrointestinal discomfort and a moderate laxative effect.

5 ml of oseltamivir suspension contain 0.9 g of sorbitol.

7.5 ml of oseltamivir suspension contain 1.3 g of sorbitol.

10 ml of oseltamivir suspension contain 1.7 g of sorbitol.

12.5 ml of oseltamivir suspension contain 2.1 g of sorbitol.

Tamiflu contains sodium benzoate.

Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

5 ml of oseltamivir suspension contain 2.5 mg of sodium benzoate.

7.5 ml of oseltamivir suspension contain 3.75 mg of sodium benzoate.

10 ml of oseltamivir suspension contain 5.0 mg of sodium benzoate.

12.5 ml of oseltamivir suspension contain 6.25 mg of sodium benzoate.

This medicine contains less than 1 mmol of sodium (23 mg) per single dose (based on a maximum dose of 75 mg), i.e., it is essentially "sodium-free".

Tamiflu contains fructose

Before taking Tamiflu, make sure your doctor knows if you have hereditary fructose intolerance.

This medicine contains sorbitol, which is a type of fructose.

Sorbitol may have a moderate laxative effect.

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

Always use the oral dispenser included in the box and marked with dosing indications in milliliters (ml).

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

Recommended dosages

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 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 may continue for 6 or 12 weeks.

The recommended dosage depends on the patient's body weight.You should use the amount of Tamiflu prescribed by your doctor. Tamiflu oral suspension can be used in people who cannot swallow capsules.See the instructions later to prepare and administer the dose.

Adults and adolescents 13 years or older

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

**12.5ml can be prepared with a 5ml dose and a 7.5ml dose

Children 1 to 12 years old

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

**12.5 ml can be prepared with a 5 ml dose and a 7.5 ml dose

Infants under 1 year old (0 to 12 months)

The administration of Tamiflu to children under 1 year of age for flu prevention during a pandemic should be done on a medical basis after considering the potential benefit versus any potential risk to the child.

A 3ml oral dispenser (graduated with 0.1ml markings) should be used for the dosing in infants under 1 year of age who require 1 to 3ml of the Tamiflu oral suspension.

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

If you take more Tamiflu than you should

Stop taking Tamiflu and consult your 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. Caution should be exercised 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 dose.

If you interrupt treatment withTamiflu

No adverse effects occur when stopping Tamiflu. However, if you stop taking Tamiflu before completing the treatment prescribed by your doctor, flu symptoms may recur. 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, 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 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 severe allergic reaction that can be life-threatening, with severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, itchy rash, with blistering, peeling, and large areas of skin peeled, possible difficulty breathing and low blood pressure.

?Gastrointestinal bleeding: prolonged bleeding of the 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

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

During treatment with Tamiflu, rare but serious side effects have been reported, including:

?Seizures and delirium, including altered levels of consciousness.

?Confusion, abnormal behavior.

?Delirious disorders, hallucinations, agitation, anxiety, nightmares.

These 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 the 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)

?Cough

?Fever

?Coughing

?Dizziness

?Fever

?Pain

?Pain in the limbs

?Coughing up mucus

?Difficulty sleeping

?Sore throat

?Stomach pain

?Tiredness

?Feeling full 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

?Skin 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)

?Eye disorders

Children 1 to 12 years old

Very common side effects

(may affect more than 1 in 10 people)

?Cough

?Stuffy 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 full in the upper abdomen

?Stomach discomfort

Uncommon side effects

(may 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 the side effects reported in older children (from 1 year). In addition, 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, orif 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 thenational reporting system included in theAppendix V.

By reporting side effects, you can contribute to providing more information on 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 bottle after CAD. The expiration date is the last day of the month indicated.

Powder: Do not store above 30°C.

After reconstitution, the suspension can be stored at room temperature (below 25°C) for 10 days.

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

Composition of Tamiflu

?The active ingredient is oseltamivir(6mg/ml of oseltamivir after reconstitution)

?The other components are: sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), sodium saccharin (E954), titanium dioxide (E171), and tutti frutti aroma (including corn maltodextrins, propylene glycol, arabic gum E414, and natural-like flavoring substances, mainly from banana, pineapple, and peach aromas).

Appearance of the product and contents of the package

Oral suspension powder.

The powder is a white to pale yellow granulated or agglomerated powder.

Tamiflu 6mg/ml oral suspension powder is available in bottles containing 13g of powder to be mixed with 55ml of water.

The package also contains 1 plastic measuring cup (55ml), 1 plastic bottle adapter (to help introduce the product into the dispenser), 1 3ml oral dispenser, and 1 10ml oral dispenser (to administer the correct dose of the medication orally). The oral dispenser has milliliter (ml) markings for the medication (see figures inUser Instructions).

For more details on how to prepare the oral suspension and how to measure and take the medication, please read the page onUser Instructions.”

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 more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of thisleaflet:

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

User Instructions

There are two steps to take the oral suspension.

Step 1 Prepare a new bottle of the medication

You may have prepared the medication when you picked up your prescription. If not, you can prepare it easily yourself. See the first group of instructions.You only need to do this once, when you start treatment.

Step 2 Measure and give the correct dose

Shake the suspension well and extract the recommended dose with the dispenser. See the second group of instructions. You will need to do this every time you need to take a dose.

Step 1 Prepare a new bottle of the medication

You will need:

?The bottle containing the Tamiflu powder (in the medication package)

?The bottle cap (in the medication package)

?A plastic measuring cup (in the medication package)

?The plastic bottle adapter (in the medication package)

?Water

?Tap the bottle to loosen the powder

Gently tap the closed bottle several times to loosen the powder.

?Use the measuring cup to measure 55ml of water

The measuring cup that comes with the package has a line marked to show you the exact amount.

Fill it with water up to the indicated level.

?Add the water, close and shakePour all the water from the measuring cup into the bottle, over the powder

You must always use 55ml of water, regardless of the dose you need.

Put the cap on the bottle. Shake the bottle well for 15 seconds.

?Press the adapter

Open the bottle and press the bottle adapter well into the neck of the bottle.

?Close the bottle again

Twist the cap tightly onto the top of the bottle, which now includes the adapter. This will ensure that the adapter fits into the bottle in the correct position.

You now have a bottle ofTamiflu oral suspension ready to measure and administer a dose. You will not need to prepare it again until you start a new bottle.

Step 2: Measure and give the correct dose

You will need:

?A prepared Tamiflu oral suspension bottle

?Depending on the dose needed, you will need a 3ml oral dispenser (orange plunger, 0.1ml graduation) or a 10ml oral dispenser (transparent plunger, 0.5ml graduation) included in the package.

?For doses of 1.0ml to 3.0ml, the 3ml oral dispenser should be used. For doses above 3.0ml to 10ml, the 10ml oral dispenser should be used.

Always use the oral dispenser provided in the package to measure the correct dose.

?Shake the bottle

Make sure the bottle is tightly closed and then shake the Tamiflu oral suspension bottle.

Always shake well before use.

?Prepare the oral dispenser

Depending on the dose needed, use the 3ml oral dispenser (orange plunger) or the 10ml oral dispenser (transparent plunger) that comes with the package.

Pullthe plunger all the way down to the bottom of the dispenser.

?Fill the dispenser with the correct dose

Remove the cap from the bottle.

Push the tip of the dispenser into the adapter of the bottle.

Turn the combination(bottle and dispenser together)until the topis inverted.

Slowly pull the plunger to extract the medication into the dispenser.

Stop at the graduation mark corresponding to the dose you need.

Turn the combination back to the right.

Remove the dispenser from the bottle.

?Administer the medication orally

Insert the suspension directly into the mouth, pushing the plunger of the dispenser. Make sure the medication is swallowed. After taking the medication, you can drink and eat some food.

?Close the bottle, keep in a safe place

Put the cap back on the bottle. Keep out of the sight and reach of children.

Store the medication below 25°C for a maximum of 10 days. See section 5.Storage of Tamiflu,in this leaflet.

Immediately after administration, separate the parts of the dispenser and wash both under running water.