Tamiflu 75 mg. 10 capsules

What Tamiflu is and what it is used
Tamiflu is commonly used in adults, adolescents, infants and children aged 1 year and older:
Tamiflu is prescribed to treat flu (influenza). It can be used when you have flu symptoms and it is known that influenza virus is circulating in the community;
Tamiflu can also be prescribed for prevention of influenza, as the case for example, if you have been in contact with someone who has the flu;
Tamiflu can be prescribed as preventive treatment in exceptional circumstances - for example, if a global flu epidemic (pandemic flu) and seasonal flu vaccine does not provide sufficient protection.
During a flu pandemic, Tamiflu can also be used for prevention of influenza in infants less than 1 year. Doctors must decide whether to use Tamiflu in babies of this age based on the severity of the illness caused by the influenza virus, and the health of the baby, to make sure that the baby will benefit from the drug.
Tamiflu contains oseltamivir, which belongs to the group of medicines called neuraminidase inhibitors. These drugs prevent the proliferation of influenza virus in the body. They help to relieve or prevent the symptoms of influenza virus infection.
Influenza, commonly known as flu, is an infection caused by a virus. The signs of flu often include a sudden fever (over 37,8 ° C), cough, runny nose, headache, muscle aches and often extreme fatigue. These symptoms may be caused by other infections. True influenza infection only occurs during annual outbreaks when flu viruses spread in society. Outside epidemic periods, flu-like symptoms are usually caused by a different type of disease.

2. What you need to know before you take Tamiflu
Do not take Tamiflu
if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu, listed in Section 6.
Talk to your doctor if this applies to you. Do not take Tamiflu.

Warnings and Precautions
Before you take Tamiflu, make sure tell the doctor who prescribes it:
if you are allergic to other drugs;
if you have kidney problems. In that case, you may need your dosage to be adjusted;
If you have severe illness that requires immediate hospitalization;
if your immune system is not working;
if you have chronic heart disease or respiratory disease.
During treatment with Tamiflu, tell your doctor immediately:
if you notice changes in behavior or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of a rare but serious side effects.
Tamiflu is not a vaccine against flu
Tamiflu is not a vaccine: it treats infection, or prevents the spread of the flu virus. The vaccine gives you antibodies against the virus. Tamiflu will not change the effectiveness of the flu vaccine, and your doctor may prescribe both.

Other medicines and Tamiflu
Tell your doctor or pharmacist if you are taking other medicines or have recently taken any. This includes medicines obtained without a prescription.
The following medicines are particularly important:
chlorpropamide (used to treat diabetes);
methotrexate (used to treat eg. rheumatoid arthritis);
phenylbutazone (used to treat pain and inflammation);
probenecid (used to treat gout).
Pregnancy and lactation
You should tell your doctor if you are pregnant, you think you might be pregnant or planning pregnancy to your doctor can decide if Tamiflu is right for you.
The effects on infants of breastfeeding are not known. You should tell your doctor if you are breast-feeding to your doctor can decide if Tamiflu is right for you.
Ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Tamiflu has no effect on the ability to drive or operate machinery.

3. How to take Tamiflu
Take this medication exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
Take Tamiflu as soon as possible, ideally within two days of flu symptoms.

Recommended doses
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5 day course, even if you quickly start to feel better.
For preventing flu or after being in contact with an infected person, take one dose daily for 10 days. It is best to take the morning with breakfast.
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue until 6 or 12 weeks.
The recommended dose is based on patient body weight.
Adults and adolescents 13 years and older
Body weight Treating flu:
dose for 5 days Preventing flu:
dose for 10 days
40 kg or more 75 mg BID 75 mg QD
75 mg can be made from a capsule of 30 mg plus capsule of 45 mg.

Children from 1 to 12 years
Body weight Treating flu:
dose for 5 days Preventing flu:
dose for 10 days
10 to 15 kg 30 mg BID 30 mg QD
15 kg to 23 kg and 45 mg BID 45 mg QD
More than 23 kg and 40 kg to 60 mg BID 60 mg QD
More than 40 kg 75 mg BID 75 mg QD
75 mg can be made from a capsule of 30 mg plus 45 mg capsule

Infants under 1 year
Use of Tamiflu in infants younger than one year should be based on judgment of the physician after taking into account the potential benefits against the potential risks for the infant. There is only limited data on infants younger than 2 years and no data for infants under the age of one month.
Body weight, age Treatment of influenza:
dose for 5 days Preventing flu:
dose for 10 days
3 kg to 4,5 kg, less than 1 month 2 mg per kg body weight, twice daily, 2 mg per kg, once a day
4 kg to 6,5 kg, 1 to 3 months 2,5 mg per kg body weight, twice a day 2,5 mg per kg, once a day
6 kg to 10+ kg, 3 to 12 months
3 mg per kg of body weight twice daily 3 mg per kg, once a day
mg per kg = mg per kilogram of body weight of the infant.
For example: If a 6-month-old infant weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg.

Method of administration
Swallow the capsules whole with water. Do not crush or chew the capsules.
Tamiflu can be taken with or without food, though acceptance of food may reduce the likelihood of nausea or vomiting.
People who find it difficult to swallow capsules may use liquid medicine Tamiflu oral suspension. If you need Tamiflu oral suspension, but do not have one, you can make a liquid form of Tamiflu from these capsules. See "Making Tamiflu liquid at home" on the other page.

If you take more Tamiflu,
Stop taking Tamiflu and contact your doctor immediately or pharmacist.
In most cases of overdose, patients reported no side effects.
When reported adverse reactions, they were similar to those as in normal doses, which are described in Section 4.
More often reports of overdose in children than in adults and adolescents.
The preparation of liquid Tamiflu should be approached cautiously, and the application of Tamiflu capsules or liquid Tamiflu in children.

If you forget 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 you stop taking Tamiflu. But if Tamiflu is stopped earlier than your doctor told you, the symptoms of influenza may return. Always complete the course of treatment prescribed by your doctor.

If you have any further questions on 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 the side effects listed below may also be caused by influenza.

The following serious adverse reactions have been reported rarely since, Tamiflu has been on the market:
Anaphylactic and anaphylactoid reactions, severe anaphylactic reactions with swelling of the face and skin, itchy rash, low blood pressure and difficulty breathing;
Liver disorders (fulminant hepatitis, hepatic dysfunction and jaundice): yellowing of the skin and whites of the eyes, discoloration of feces, behavior change;
Angioneurotic edema, severe sudden swelling of the skin primarily in the area of ​​head and neck, including eye and tongue, with difficulty breathing;
Stevens-Johnson and toxic epidermal necrolysis: severe life-threatening allergic reaction, severe inflammation of the skin and mucous membranes, begins with fever, sore throat, fatigue, skin rashes that lead to the appearance of skin blistering, peeling, sliding of large surfaces the skin, difficulty breathing and low blood pressure;
Bleeding from the gastrointestinal tract, prolonged bleeding from the colon or spitting blood;
Neuropsychiatric disorders described below.
If you notice any of these symptoms, seek medical advice immediately.

The most frequently (very common and common) reported side effects of Tamiflu are nausea or vomiting, stomach pain, stomach upset, headache and pain. These side effects occur predominantly after the first dose of the medicine and will usually stop the continuation of treatment. The frequency of these effects is reduced if the medicinal product is taken with food.

Rare but serious effects: get medical advice immediately (These may affect up to 1 in 1000 people)
During treatment with Tamiflu, is Rare events include:
Convulsions and delirium, including altered level of consciousness;
Confusion, unusual behavior;
Delusions, hallucinations, agitation, anxiety, nightmares.
These events were reported primarily among children and adolescents and often started suddenly and resolved rapidly. Several cases have resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
Patients, especially children and adolescents should be monitored carefully for occurrence of the above changes in behavior.
If you notice any of these symptoms, especially in younger people, get 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;
Cold sores;
cough;
dizziness;
Fever;
pain;
Pain in extremity;
fever;
insomnia;
Sore throat;
Stomachache;
fatigue;
Fullness in the upper abdomen;
Infections of the upper respiratory tract (inflammation of the nose, throat and sinuses);
Indigestion;
Vomiting.
Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions;
Altered level of consciousness;
convulsion;
Heart rhythm disturbances;
Mild to severe liver dysfunction;
Skin reactions (inflammation of the skin red and itchy rash sliding of the skin).
Rare side effects (may affect up to 1 in 1000 people):
Thrombocytopenia (low platelet count);
Visual disturbances.
Children from 1 to 12 years
Very common side effects (may affect more than 1 in 10 people):
cough;
Nasal congestion;
Vomiting.
Common side effects (may affect up to 1 in 10 people):
Conjunctivitis (eye redness and discharge or pain in the eye);
Ear infections and other disorders of the ear;
Headache;
nausea;
fever;
Stomachache;
Fullness in the upper abdomen;
Indigestion.
Uncommon side effects (may affect more than 1 in 100 people):
Skin irritation;
Violation of the tympanic membrane (eardrum).
Infants under 1 year
Reported side effects in infants 1 to 12 months are similar to adverse events reported in older children (aged 1 year or older).

Infants under 1 month
No information on the use of Tamiflu in infants less than 1 month.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, tell your doctor or pharmacist. however:
if you or your child vomit repeatedly;
if symptoms of influenza worsen, or fever continues.
Tell your doctor as soon as possible.

If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can do your bit for getting more information on the safety of this medicine.

5. How to store Tamiflu
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP / EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Tamiflu contains
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.

Other ingredients are:
Capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate;
Capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171);
Printing ink: shellac (E904), titanium dioxide (E171) and the FD and C Blue 2 (indigo carmine, E132).
What Tamiflu looks like and contents of the pack
Hard 75 mg capsule consists of a gray opaque body bearing the imprint "ROCHE" and a light yellow opaque cap bearing the imprint "75 mg". Imprints are blue.
Tamiflu 75 mg hard capsules are available in blister packs of 10.

Marketing Authorisation Holder and Manufacturer:
Roche Registration Limited, United Kingdom;
Roche Pharma AG, Germany.

User Information
For people who find it difficult to swallow capsules, including very young children, there is a liquid medicine Tamiflu oral suspension.
If you need a liquid medicine, but do not have such suspension can be prepared at the pharmacy from Tamiflu capsules (see Information for healthcare professionals). This preparation prepared in pharmacy is the best alternative for infants aged under 1 year.
If there is no preparation prepared in the pharmacy can make liquid Tamiflu capsules from those at home.
The dosage for treatment and prevention of influenza is the same. The difference is in how often apply.
Preparation of liquid Tamiflu at home
If you have the right capsule for the required dose (dose of 75 mg), will open the capsule and mix its contents in a teaspoon (or less) suitable sweetened food product. This is usually suitable for children over 1 year. See instructions above;
If you need a smaller dose, formulation of liquid Tamiflu from capsules involves additional steps. This is suitable for small children and babies: they usually need Tamiflu, less than 30 mg. See instructions below.
Adults, adolescents 13 years and older and children weighing over 40 kg:
To prepare the dose of 75 mg, you need:
One or two of Tamiflu capsules of 75 mg;
Sharp scissors;
A small bowl;
Tsp (teaspoon of 5 ml);
water;
Sweet food to hide the bitter taste of dust. For example, chocolate syrup or cherry syrup and dessert toppings such as caramel or nougat. Or you can cook sugar water: mix a teaspoon of water with three-fourths (3/4) teaspoon sugar.
Step 1: Make sure the dose is correct
To find the exact amount you need to use, find the patient's weight on the left of the table.
Look at the right column to see the number of capsules that should give the patient as a single dose. The amount is the same, whether it is for the treatment or prevention of influenza.

75 mg dose
You should use only 75 mg capsules for doses of 75 mg. Do not attempt to prepare a dose of 75 mg, and use the contents of the capsules 30 and 45 mg.
Weight dose of Tamiflu Number of capsules
40 kg or more
75 mg of 1 capsule
Step 2: Pour all of the powder in a bowl
Hold a 75 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Pour all of the powder in the bowl.
Beware of dust because it can irritate the skin and eyes.

Step 3: Sweeten the dust and give the dose
Add a small amount - no more than a teaspoon - sweet food to the powder in the bowl.
This is to mask the bitter taste of the Tamiflu powder.
Stir the mixture well.
Give the entire contents of the bowl to the patient immediately.
If left little of the mixture in the bowl, rinse it with some water and give the patient to drink it all.
Repeat this procedure every time you need to give your medicine.

Infants under 1 year and children weighing less than 40 kg
To prepare smaller single dose you need:
One Tamiflu capsule of 75 mg;
Sharp scissors;
Two small bowls (use separate pair of bowls for each child);
A large oral dispenser for measuring water - dispenser of 5 or 10 ml;
A small oral dispenser with divisions of 0,1 ml of dosing;
Tsp (teaspoon of 5 ml);
water;
Sweet food to hide the bitter taste of Tamiflu. For example, chocolate syrup or cherry syrup and dessert toppings such as caramel or nougat. Or you can cook sugar water: mix a teaspoon of water with three-fourths (3/4) teaspoon sugar.
Step 1: Pour all of the powder in a bowl
Hold a 75 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate the skin and eyes.
Pour all of the powder in the bowl, whatever the dose to cook.
The amount is the same, whether it is for the treatment or prevention of influenza.

Step 2: Add water to dilute the drug
Use the larger dispenser to download 12,5 ml water.
Add water to the powder in the bowl.
Stir the mixture with a teaspoon for about 2 minutes.
Do not worry if the powder is completely dissolved. The undissolved powder contains only inactive ingredients.

Step 3: Select the correct amount for your child's age and weight
Find the table for the age of your child.
Look for the child's weight on the left side of the table.
The column to the right of the table shows how the liquid mixture should download.

Infants under 1 month
Weight of the child (closest) How mixture should download
3 kg 1,0 ml
3,5 kg 1,2 ml
4 kg 1,3 ml
4,5 kg 1,5 ml

Infants from 1 month to 3 months
Weight of the child (closest) How mixture should download
4 kg 1,7 ml
4,5 kg 1,9 ml
5 kg 2,1 ml
5,5 kg 2,3 ml
6 kg 2,5 ml
6,5 kg 2,7 ml

Infants from 3 months to 12 months
Weight of the child (closest) How mixture should download
6 kg 3,0 ml
6,5 kg 3,3 ml
7 kg 3,5 ml
7,5 kg 3,8 ml
8 kg 4,0 ml
8,5 kg 4,3 ml
9 kg 4,5 ml
9,5 kg 4,8 ml
10 kg or more 5,0 ml
Children over 1 year and weighing less than 40 kg
Weight of the child How mixture should download
15 kg 5,0 ml
15 to 23 kg 7,5 ml
23 to 40 kg 10,0 ml
Step 4: Download the liquid mixture
Make sure you have the correct size dispenser.
Get the exact amount of liquid mixture from the first bowl.
Download it carefully so as not to insert air bubbles.
Carefully infuse the correct dose into the second bowl.

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