Tamiflu 45 mg Hard Capsules

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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.

Before you take Tamiflu, make sure the prescribing doctor knows

• if you are allergic to other medicines
• if you have problems with your kidneys. If so, your dose may need adjustment
• if you have a severe medical condition, which may require immediate hospitalisation
• if your immune system is not working
• if you have chronic heart disease or respiratory disease.

During treatment with Tamiflu, tell a doctor immediately:

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

Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Tell your doctor or pharmacist if you are taking any 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 e.g. rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu is right for you.

The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.

Ask your doctor or pharmacist for advice before taking this medicine.

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

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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 start to feel better quickly.

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

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient's body weight. You must use the amount of oral capsules or suspension prescribed by the doctor.

Adults, and adolescents 13 years and over

For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for treating flu is 75 mg twice daily for 5 days.

For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for treating flu in patients with a weak immune system is 75 mg twice daily for 10 days.

For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for preventing flu is 75 mg once daily for 10 days.

A 75 mg dose can be made up of a 30 mg capsule plus a 45 mg capsule.

Children 1 to 12 years

For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu is 30 mg twice daily for 5 days.

For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu in children with a weak immune system is 30 mg twice daily for 10 days.

For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for preventing flu is 30 mg once daily for 10 days.

For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu is 45 mg twice daily for 5 days.

For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu in children with a weak immune system is 45 mg twice daily for 10 days.

For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for preventing flu is 45 mg once daily for 10 days.

For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu is 60 mg twice daily for 5 days.

For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu in children with a weak immune system is 60 mg twice daily for 10 days.

For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for preventing flu is 60 mg once daily for 10 days.

For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 75 mg twice daily for 5 days.

For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu in children with a weak immune system is 75 mg twice daily for 10 days.

For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 75 mg once daily for 10 days.

A 75 mg dose can be made up of a 30 mg capsule plus a 45 mg capsule.

Infants less than 1 year (0 to 12 months)

Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

For infants aged between 0 and 12 months and weighing between 3 kg to 10 kg and above, the recommended dose for treating flu is 3 mg per kg of body weight, twice daily for 5 days.

For infants aged between 0 and 12 months and weighing between 3 kg to 10 kg and above, the recommended dose for treating flu in infants with a weak immune system is 3 mg per kg of body weight, twice daily for 10 days.

For infants aged between 0 and 12 months and weighing between 3 kg to 10 kg and above, the recommended dose for preventing flu is 3 mg per kg of body weight, once daily for 10 days.

mg per kg equals mg for each kilogram of the infant’s body weight. For example if a 6 month old weighs 8 kg then the dose is 8 kg x 3 mg per kg = 24 mg.

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 can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension. If you need Tamiflu oral suspension, but it's not available from your pharmacy, you can make a liquid form of Tamiflu from these capsules. See Making liquid Tamiflu at home, over the page.

Stop taking Tamiflu and contact a doctor or pharmacist immediately.

In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.

Overdose has been reported to have occurred more frequently when Tamiflu was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for children and when administering Tamiflu capsules or liquid Tamiflu to children.

Do not take a double dose to make up for a forgotten capsule.

There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

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

Rare but serious effects: get medical help at once

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

During Tamiflu treatment, rare events have been reported that include

• Convulsions and delirium, including altered level of consciousness
• Confusion, abnormal behaviour
• Delusions, hallucinations, agitation, anxiety, nightmares

These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases 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 closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger people, get medical help immediately.

Adults and adolescents 13 and over

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 sore virus
• Cough
• Dizziness
• Fever
• Pain
• Pain in limb
• Runny nose
• Sleeping difficulties
• Sore throat
• Stomach ache
• Tiredness
• Upper abdominal fullness
• Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
• Upset stomach
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsion
• Heart rhythm abnormalities
• Mild to severe liver function disorders
• Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

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

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children 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 (red eyes and discharge or pain in the eye)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Upper abdominal fullness
• Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

• Inflammation of the skin
• Tympanic membrane (eardrum) disorder.

Infants less than 1 year

The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,

• if you or your child are repeatedly sick, or
• if the influenza symptoms get worse or the fever continues

Tell your doctor as soon as possible.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

• Each hard capsule contains oseltamivir equivalent to 45 mg of oseltamivir
• The other ingredients are:
  capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate
  capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171)
  printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).

The 45 mg hard capsule consists of a grey opaque body bearing the imprint "ROCHE" and a grey opaque cap bearing the imprint "45 mg". Imprints are blue.

Tamiflu 45 mg hard capsules are available in blister packs of 10.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

• If you have the right capsule for the dose needed (a 45 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.
• If you need smaller doses, making liquid Tamiflu from capsules involves extra steps. This is suitable for younger, lighter children and babies: they usually need a Tamiflu dose of less than 45 mg. See the lower set of instructions.

To make a 45 mg dose, you need:

• One 45 mg Tamiflu capsule
• Sharp scissors
• One small bowl
• Teaspoon (5 ml spoon)
• Water
• Sweet food to hide the bitter taste of the powder.
  Examples are chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

To find the correct amount to use, find the patient’s weight below to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

A 45 mg dose should be made from Tamiflu 45 mg hard capsules. The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue.

You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45 mg capsules. Use the appropriate size capsule instead.

For patients weighing up to 15 kg, the recommended dose of Tamiflu is 30 mg. However, please do not use Tamiflu 45 mg capsules to make this dose.

For patients weighing more than 15 kg and up to 23 kg, the recommended dose of Tamiflu is 45 mg and to make this dose you should use 1 capsule of Tamiflu 45 mg.

For patients weighing more than 23 kg and up to 40 kg, the recommended dose of Tamiflu is 60 mg. However, please do not use Tamiflu 45 mg capsules to make this dose.

Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.

Pour all of the powder into the bowl.

Be careful with the powder, because it may irritate your skin and eyes.

Add a small amount - no more than one teaspoonful - of sweet food to the powder in the bowl.

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

Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

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

Infants less than 1 year

To make a smaller single dose, you need:

• One 45 mg Tamiflu capsule
• Sharp scissors
• Two small bowls (use separate pairs of bowls for each child)
• One large oral dose dispenser to measure out water - a 5 ml dispenser or 10 ml dispenser
• One small oral dose dispenser showing measurements of 0.1 ml, to give the dose
• Teaspoon (5 ml spoon)
• Water
• Sweet food to hide the bitter taste of the Tamiflu.
  Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.
  Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Hold a 45 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 your skin and eyes.

Pour all of the powder into the bowl, whatever the dose you are making.

The amount is the same whether you are treating or preventing flu.

Use the larger dispenser draw up 7.5 ml water.

Add the water to the powder in the bowl.

Stir the mixture with the teaspoon for about 2 minutes.

Don't worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.

Look up the child’s weight in the text below to find how much of the liquid mixture you will need to draw up.

Infants less than 1 year (including full-term newborn babies)

If the child’s weight is nearest 3 kg, you will need to draw up 1.5 ml of the liquid mixture.

If the child’s weight is nearest 3.5 kg, you will need to draw up 1.8 ml of the liquid mixture.

If the child’s weight is nearest 4 kg, you will need to draw up 2.0 ml of the liquid mixture.

If the child’s weight is nearest 4.5 kg, you will need to draw up 2.3 ml of the liquid mixture.

If the child’s weight is nearest 5 kg, you will need to draw up 2.5 ml of the liquid mixture.

If the child’s weight is nearest 5.5 kg, you will need to draw up 2.8 ml of the liquid mixture.

If the child’s weight is nearest 6 kg, you will need to draw up 3.0 ml of the liquid mixture.

If the child’s weight is nearest 6.5 kg, you will need to draw up 3.3 ml of the liquid mixture.

If the child’s weight is nearest 7 kg, you will need to draw up 3.5 ml of the liquid mixture.

If the child’s weight is nearest 7.5 kg, you will need to draw up 3.8 ml of the liquid mixture.

If the child’s weight is nearest 8 kg, you will need to draw up 4.0 ml of the liquid mixture.

If the child’s weight is nearest 8.5 kg, you will need to draw up 4.3 ml of the liquid mixture.

If the child’s weight is nearest 9 kg, you will need to draw up 4.5 ml of the liquid mixture.

If the child’s weight is nearest 9.5 kg, you will need to draw up 4.8 ml of the liquid mixture.

If the child’s weight is nearest 10 kg or more, you will need to draw up 5.0 ml of the liquid mixture.

Make sure you have the right size dispenser.

Draw up the correct amount of liquid mixture from the first bowl.

Draw it up carefully so as not to include air bubbles.

Gently squirt the correct dose into the second bowl.

Add a small amount - no more than one teaspoonful - of a sweet food to the second bowl.

This is to hide the bitter taste of the Tamiflu.

Mix the sweet food and Tamiflu liquid well.

Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

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