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Tamiflu 75mg hard capsule

Last Updated on eMC 15-May-2015 View changes  | Roche Products Limited Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/02/222/001.



Tamiflu 75mg hard capsule

Package Leaflet: Information for the user

Tamiflu 75 mg hard capsules

oseltamivir

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

  • 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.

What is in this leaflet

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

1. What Tamiflu is and what it is used for

  • Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
  • Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
  • Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

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

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

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 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 flu vaccine

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.

Other medicines and Tamiflu

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)

Pregnancy and breast-feeding

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.

Driving and using machines

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

3. How to take Tamiflu

Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

The 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 start to feel better quickly.

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.

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

For adults and adolescents 13 years and over and weighing 40 kg or more, 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.

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 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 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 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 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 less than 12 months, the recommended dose for treating flu is 3 mg per kg of body weight, twice daily for 5 days.

For infants aged less than 12 months, the recommended dose for preventing flu is 3 mg per kg of body weight, once daily for 10 days.

mg/kg equals mg per kilogram of infant body weight. For example if a 6 month-old weighs 8 kg then the dose is 8kg 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 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.

If you take more Tamiflu than you should

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.

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 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.

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 side effects have been rarely reported since oseltamivir has been marketed:

  • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
  • Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
  • Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
  • Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
  • Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
  • Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, get medical help immediately.

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.

Reporting of side effects

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.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Malta

ADR Reporting
Website:www.medicinesauthority.gov.mt/adrportal

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Tamiflu

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tamiflu contains

  • Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir
  • The 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), black iron oxide (E172) and titanium dioxide (E171)
    printing ink: shellac (E904), titanium dioxide (E171) FD and C Blue 2 (indigo carmine E132).

What Tamiflu looks like and contents of the pack

The 75 mg hard capsule consists of a grey 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
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany

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

United Kingdom
Roche Products Ltd.
Tel: +44 (0) 1707 366000

This leaflet was last revised in May 2015.

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

Information for the user

For people who find it hard to take capsules, including very young children, there’s a liquid medicine, Tamiflu oral suspension.

If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Tamiflu capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.

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

The dose is the same for treating or preventing flu. The difference is how often it is given.

Making liquid Tamiflu at home

  • If you have the right capsule strength for the dose needed (a 75 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 children and babies: they usually need a Tamiflu dose of less than 30 mg. See the lower set of instructions.

Adults, adolescents 13 years and over, and children weighing 40 kg and over

To make a 75 mg dose, you need:

  • One 75 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.

Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.

Look at the right column 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.

You should use only 75 mg capsules for 75 mg doses. Do not try to make a 75 mg dose by using the contents of 30 mg or 45 mg capsules.

For patients weighing 40 kg and over, 75 mg dose of Tamiflu, use 1 capsule.

Not for children who weigh less than 40 kg

You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg. See below.

Step 2: Pour all the powder into 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 into the bowl.

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

Step 3: Sweeten the powder and give the dose

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, and children weighing less than 40 kg

To make a smaller single dose, you need:

  • One 75 mg Tamiflu capsule
  • Sharp scissors
  • Two small bowls
  • One large oral dose dispenser to measure out water – a 5 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.

Step 1: Pour all the powder into 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 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.

Step 2: Add water to dilute the medicine

Use the larger dispenser to draw up 12.5 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.

Step 3: Choose the correct amount for your child’s weight

Look up the child’s weight on the left side of the table.

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

For an infant less than 12 months old, weighing around 3 kg, draw up 1.5 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 3.5 kg, draw up 1.8 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 4 kg, draw up 2.0 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 4.5 kg, draw up 2.3 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 5 kg, draw up 2.5 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 5.5 kg, draw up 2.8 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 6 kg, draw up 3.0 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 6.5 kg, draw up 3.3 ml of Tamiflu mixture.

For an infant less than 12 months old, weighing around 7 kg, draw up 3.5 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 7.5 kg, draw up 3.8 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 8 kg, draw up 4.0 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 8.5 kg, draw up 4.3 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 9 kg, draw up 4.5 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing around 9.5 kg, draw up 4.8 ml of Tamiflu mixture.

For an infant less than 12 month old, weighing 10 kg or more, draw up 5 ml of Tamiflu mixture.

Step 4: Draw up 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.

Step 5: Sweeten and give to the child

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.

Company contact details

Roche Products Limited

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Address

Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW

Fax

+44 (0)1707 338 297

Medical Information e-mail
Medical Information Fax

+44 (0)1707 384555

Telephone

+44 (0)1707 366 000

Medical Information Direct Line

+44 (0)800 328 1629

Customer Care direct line

+44 (0)800 731 5711

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

oseltamivir phosphate

Legal categories

POM - Prescription Only Medicine

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