TAMIFLU 45 mg HARD CAPSULES

Introduction

Leaflet: information for the user

Tamiflu 45mg hard capsules

oseltamivir

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

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

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

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

?If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Tamiflu and what is it used for
2. What you need to know before taking Tamiflu
3. How to take Tamiflu
4. Possible side effects
5. Storage of Tamiflu
6. Contents of the pack and further information

1. What is Tamiflu and what is it used for

?Tamiflu is used in adults, adolescents, children, and infants (including newborn babies) to treat flu(influenza). It can be used when you have flu symptoms and it is known that the flu virus is present in the population.

? Tamiflu can also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent 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 newborn babies) as a preventive treatmentin exceptional circumstances - for example, if there is a global flu epidemic (a flu pandemic) and when the seasonal flu vaccine cannot provide sufficient protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the flu virus from spreading in the body. They help to relieve or prevent the symptoms of flu virus infection.

Flu is an infection caused by a virus. The signs of flu often include sudden fever (over 37.8°C), cough, runny or stuffy nose, headache, muscle pain, and extreme tiredness. These symptoms can also be caused by other infections. A true flu infection only occurs during annual outbreaks (epidemics), when flu viruses are widespread in the population. Outside of epidemic periods, flu-like symptoms are generally caused by another type of illness.

2. What you need to know before taking Tamiflu

Do not take Tamiflu

?if you are allergic(hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu listed 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 medicines

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

? if you have any severe illnessthat requires immediate hospitalization.

? if your immune systemis not working properly.

? if you have chronic heart or respiratory disease.

During treatment with Tamiflu, tell your doctor immediately

? if you notice changes in your behavior or mood (neuropsychiatric events), especially if they occur in children and adolescents. These can 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 you with antibodies against the virus. Tamiflu does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both.

Using Tamiflu with other medicines

Tell your doctor or pharmacist if you are using any other medicines, or have recently used any. This includes medicines obtained without a prescription.

The following medicines are particularly important:

? chlorpropamide (used to treat diabetes)

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

? phenylbutazone (used to treat pain and inflammation)

? probenecid (used to treat gout)

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your doctor can decide if Tamiflu is suitable for you.

The effects on infants are unknown. You should 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 medicine.

Driving and using machines

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

Information on some of the ingredients of Tamiflu

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

3. How to take Tamiflu

Follow the instructions for taking Tamiflu exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

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

Recommended doses

For the treatment of flu, take two doses a day. It is usually convenient to take one dose in the morning and one in the evening. It is important 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 flu or after being in contact with an infected person, take one dose a day for 10 days. It is best to take this dose in the morning with breakfast.

In special situations, 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 and older

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

**You can get 75mg with one 30mg capsule and one 45mg capsule

Children 1 to 12 years

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

**You can get 75mg with one 30mg capsule and one 45mg capsule

Children under 1 year (0 to 12 months)

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

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

**mg per kg =mg per 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

Method of administration

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 possibility of feeling or having discomfort (nausea or vomiting).

People who may have difficulty swallowing the capsulescan use a liquid medicine, 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 side effects were reported. When side effects were reported, they were similar to those that occurred with normal doses and are included in section 4.

Overdose cases with Tamiflu have been reported more frequently 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 forgotten doses.

If you stop takingTamiflu

No side effects occur when you stop taking Tamiflu. But if you stop taking Tamiflu before your doctor told you to, your flu symptoms may come back. Always complete the treatment that your doctor has prescribed.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of these side effects may be caused by the flu.

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

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

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

? Angioedema: 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 complicated 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 with blistering, peeling, and large areas of skin peeled, possible difficulty breathing and low blood pressure.

? Gastrointestinal hemorrhage: prolonged bleeding from 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 feeling unwell or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These side effects usually occur after the first dose of the medicine and generally tend to disappear during treatment. The frequency with which these side effects occur is reduced if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately

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

During treatment with Tamiflu, rare 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 started suddenly and had a rapid resolution. In very rare cases, these events resulted in self-injury, some with a 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 as 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

(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

? Pain

? Limb pain

? Runny nose

? 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

(can affect up to 1 in 100 people)

? Allergic reactions

? Altered consciousness

? Seizure

? Heart rhythm disorders

? Liver function disorders, from mild to severe

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

Rare side effects

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

? Thrombocytopenia (low platelet count)

? Vision disorders

Children 1 to 12 years

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 eyes and tearing or pain in the eyes)

? Ear inflammation and other ear disorders

? Headache

? Nausea

? Runny nose

? Stomach pain

? Feeling of fullness in the upper abdomen

? Stomach discomfort

Uncommon side effects

(can affect up to 1 in 100 people)

? Skin inflammation

? Eardrum disorder (eardrum)

Infants under 1 year

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist. However,

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

?if flu symptoms worsen or fever continues

Tell your doctor as soon as possible.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamiflu

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

Do not use this medicine after the expiration date stated on the packaging and on the blister after EXP. The expiration date is the last day of the month indicated.

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 that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

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 shell: gelatin, black iron oxide (E172), and titanium dioxide (E171)

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

Product Appearance and Container Content

The 45 mg hard capsules are formed by a gray opaque body with the inscription “ROCHE” and a gray opaque cap with the inscription “45 mg”. The inscriptions are blue.

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

Marketing Authorization Holder and Manufacturer

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Roche Pharma AG

Emil-Barell-Str. 1,

D-79639 Grenzach-Wyhlen

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

*

Date of the last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

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Information for the User

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

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

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

The dose is the same for treatment as for prevention of the flu. The difference is the frequency of administration.

Preparing Tamiflu Liquid at Home

? If you have the correct capsulefor the required dose (45 mg dose), open the capsule and mix its contents in a teaspoon (or less) of suitable sweetened food.

This is usually suitable for children over 1 year of age. See the top part of the instructions.

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

This is suitable for small children, children who weigh little, and babies: they generally need a smaller dose of Tamiflu than 45 mg. See the bottom part of the instructions.

Children from 1 to 12 years

To make a 45 mg dose, you need:

?A 45 mg Tamiflu capsule

?Sharp scissors

?A small container

?A 5 ml spoon

?Water

?Sweetened foodto mask the bitter taste of the powder

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

Or you can prepare sugared water by mixing a spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Check the Correct Dose

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

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

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

Step 2: Pour All the Powder into the Container

Hold a 45 mgcapsule upright 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: Sweeten the Powder and Give the Dose

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

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

Mix well.

Give the patient the entire contentsof the container immediately.

If some mixture remainsin the container, rinse the container with a small amount of water and have the patient drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use an appropriate bottle to give the patient the remaining liquid.

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

Infants under 1 year

To make a smaller single dose, you will need:

?A 45 mg Tamiflu capsule

?Sharp scissors

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

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

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

?A 5 ml spoon

?Water

?Sweetened foodto mask the bitter taste of Tamiflu

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

Or you can prepare sugared water: mix a spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Pour All the Powder into a Container

Hold a 45 mgcapsule upright over one of the containers and carefully cut off the rounded end with scissors. Be careful with the powder, as it can be irritating to the skin and eyes.

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 the flu.

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 for the child's weight in the left column of the table.

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

Infants under 1 year (including full-term newborns)

Step 4: Prepare the Liquid Mixture

Make sure you have the correct dispenser size.

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

Prepare it carefully to avoid getting air bubbles.

Gently add the correct dose to the second container.

Step 5: Sweeten and Give to the Child

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

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

Mix well the sweetened food with the Tamiflu liquid.

Give the child the entire contentsof the second container (sweetened food with the Tamiflu liquid mixture) immediately.

If some mixture remainsin the second container, rinse the container with a small amount of water and have the child drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use an appropriate bottle to give the child the remaining liquid.

Give the child something to drink.

Discard any remaining liquidfrom the first container.

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

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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 medicine of choice for pediatric and adult patients who have difficulty swallowing the capsules or who require 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-prepared suspension is also not available, patients can prepare the suspension at home from the capsules.

Oral dosing dispensers(oral syringes) with the correct volume and graduation should be provided to administer the pharmacy-prepared suspension and for the procedures to follow for home preparation. In both cases, the volumes needed should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided to take the correct volume of water and to measure the Tamiflu mixture with water. To measure 5.0 ml of water, 5 ml or 10 ml dispensers should be used.

The following is the suitable dispenser size to draw the correct volume of Tamiflu suspension (6 mg/ml).

Infants under 1 year (including full-term newborns):