InfoCons Consumer Protection informs you – Tamiflu – Package Leaflet

Before anything else

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 the ir 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.

ℹ️ 1. What Tamiflu is and what it is used for

• Tamiflu is use d 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 f or 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 (i ncluding 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 infecti on 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 Tami flu

• 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.

108 Warnings and precautions:

Before you take Tamiflu, make sure the p rescribing 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 b e 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 fl u 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 followi ng 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 -feedi ng 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.

Important i nformation about some of the ingredients of Tamiflu Tamif lu contains sorbitol.

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

Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

5 ml ose ltamivir suspension contains 0.9 g of sorbitol.

7.5 ml ose ltamivir suspension contai ns 1.3 g of sorbitol.

10 ml os eltamivir suspension contains 1 .7 g of sorbitol.

12.5 ml os eltamivir suspension contains 2 .1 g of sorbitol.

Tamiflu contains sodium benzoate .

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

5 ml oseltamivir suspension contains 2.5 mg of sodium benzoate.

7.5 ml oseltamivir suspension conains 3.75 mg of sodium benzoate.

10 ml oseltamivir suspension contains 5.0 mg of sodium benzoate.

12.5 ml oseltamivir sus pension contains 6.25 mg of sodium benzoate.

This medicine contains less than 1 mmol sodium (23 mg) per single dose (based on a maximum dose of 75 mg) , that is to say essentially ‘sodium -free’.

💊 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.

Always use the oral dispenser that is provided in the box and has markings indicating the dose in millilitre s (ml).

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 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 Tamiflu prescribed by the doctor. The oral suspension can be used by people who find it hard to take capsules. See the instructions overleaf to make up and give a dose.

Adults, and adolescents 13 years and over Body weight Treating flu: dose for 5 days Treating flu (Immunocompromised Patie nts): dose for 10 days* Preventing flu: dose for 10 days 40 kg or more 12.5 ml** twice daily 12.5 ml** twice daily 12.5 ml** once daily *For patients with a weak immune system, treatment is for 10 days. **12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose 110 Children 1 to 12 years Body weight Treating flu: dose for 5 days Treating flu (Immunocompromised Patients): dose for 10 days* Preventing flu: dose for 10 days 10 kg to 15 kg 5.0 ml twice daily 5.0 ml twice daily 5.0 ml once daily More than 1 5 kg, up to 23 kg 7.5 ml twice daily 7.5 ml twice daily 7.5 ml once daily More than 23 kg, up to 40 kg 10.0 ml twice daily 10.0 ml twice daily 10.0 ml once daily More than 40 kg 12.5 ml** twice daily 12.5 ml** twice daily 12.5 ml** once daily *For chi ldren with a weak immune system, treatment is for 10 days. **12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose 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 bas ed upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing infants less than 1 year old requiring 1 to 3 ml of Tamiflu oral suspension .

Body weight Treating flu: dose for 5 days Treating flu (Immunocompromised Patients): dose for 10 days* Preventing flu: dose for 10 days Dispenser size to use 3 kg 1.5 ml twice daily 1.5 ml twice daily 1.5 ml once daily 3 ml 3.5 kg 1.8 ml twice daily 1.8 ml twice daily 1.8 ml once daily 3 ml 4 kg 2.0 ml twice daily 2.0 ml twice daily 2.0 ml once daily 3 ml 4.5 kg 2.3 ml twice daily 2.3 ml twice daily 2.3 ml once daily 3 ml 5 kg 2.5 ml twice daily 2.5 ml twice daily 2.5 ml once daily 3 ml 5.5 kg 2.8 ml twice daily 2.8 ml twice daily 2.8 ml once daily 3 ml 6 kg 3.0 ml twice daily 3.0 ml twice daily 3.0 ml once daily 3 ml > 6 to 7 kg 3.5 ml twice daily 3.5 ml twice daily 3.5 ml once daily 10 ml > 7 to 8 kg 4.0 ml twice daily 4.0 ml twice daily 4.0 ml once daily 10 ml > 8 to 9 kg 4.5 ml twice daily 4.5 ml twice daily 4.5 ml once daily 10 ml > 9 to 10 kg 5.0 ml twice daily 5.0 ml twice daily 5.0 ml once daily 10 ml *For patients with a weak immune system, treatment is for 10 days.

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 l isted 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 capsule s or liquid Tamiflu to children.

If you forget to take Tamiflu

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

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 anaphylactoi d 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 nec rolysis: 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, possib le 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 usual ly 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 hav e 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 of ten 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 adoles cents, 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 112 • Pain
• Pain in limb
• Runny nose
• Sleeping difficulties
• Sore throat
• Stomach ache
• Tirednes s
• 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 (ea rdrum) 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, 113 • if you or your child are repeatedly sick, or

• if the influenza symptoms get worse or the fever continues Tell your d octor 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 via the national reporting system listed i n Appendix V .

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

🌡️ 5. How to store Tami flu

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 bottle after EXP. The expiry date refers to the last day of that month.

Powder: Do not store above 30° C.

After reconstitution, store below 25 °C for 10 days.

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

• The active substance is oseltamivir (6 mg/ml oseltamivir after reconstitution).
• The other ingredients are sorbitol (E420) , sodium dihydrogen citrate (E331[a]), xanthan gum (E415) , sodium benzoate (E211), saccharin sodium (E954) , titanium dioxide (E171) and tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).

What Tamiflu looks l ike and contents of the pack Powder for oral suspension The powder is a granulate or clumped granulate with a white to light yellow colour.

Tamiflu 6 mg/ml powder for oral suspension is available in a bottle containing 13 g powder for mixing with 55 ml of water.

The box also contains 1 plastic measuring jug (55 ml), 1 plastic bottle adapter (to help get the drug into the dispenser) ,1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser (to give the correct amount of medicine via the mouth). S hown on the oral dispenser are millilitre (ml) markings of the medicine (see figures in Instructions for the user ).

For details on how to prepare the oral suspension and how to measure and take the medicine, read Instructions for the user, over the page.

Marketing Authorisation Holder and Manufacturer

Roche Registration GmbH Emil -Barell -Strasse 1 79639 Grenzach- Wyhlen Germany 114 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.

België/Belgique/Belgien N.V. Roche S.A.

Tél/Tel: +32 (0) 2 525 82 11 Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799 България Рош България ЕООД Тел: +359 2 818 44 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien) Česká republika Roche s. r. o.

Tel: +420 – 2 20382111 Magyarorsz ág Roche (Magyarország) Kft.

Tel: +36 – 23 446 800 Danmark Roche a/s Tlf: +45 – 36 39 99 99 Malta (See Ireland ) Deutschland Roche Pharma AG Tel: +49 (0) 7624 140 Nederland Roche Nederland B.V.

Tel: +31 ( 0) 348 438050 Eesti Roche Eesti OÜ Tel: + 372 – 6 177 380 Norge Roche Norge AS Tlf: +47 – 22 78 90 00 Ελλάδα Roche (Hellas) A.E.

Τηλ: +30 210 61 66 100 Österreich Roche Austria GmbH Tel: +43 (0) 1 27739 España Roche Farma S.A.

Tel: +34 – 91 324 81 00 Polska Roche Polska Sp.z o.o.

Tel: +48 – 22 345 18 88 France Roche Tél: +33 (0) 1 47 61 40 00 Portugal Roche Farmacêutica Química, Lda Tel: +351 – 21 425 70 00 Hrvatska Roche d.o.o Tel: +385 1 4722 333 România Roche Rom ânia S.R.L.

Tel: +40 21 206 47 01 Ireland Roche Products (Ireland) Ltd.

Tel: +353 (0) 1 469 0700 Slovenija Roche farmacevtska družba d.o.o.

Tel: +386 – 1 360 26 00 Ísland Roche a/s c/o Icepharma hf Sími: +354 540 8000 Slovenská republika Roche Slovensko, s.r.o.

Tel: +421 – 2 52638201 115 Italia Roche S.p.A.

Tel: +39 – 039 2471 Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500 Kύπρος Γ.Α.Σταμάτης & Σια Λτδ.

Τηλ: +357 – 22 76 62 76 Sverige Roche AB Tel: +46 (0) 8 726 1200 Latvija Roche Latvija SIA Tel: +371 – 6 7039831 United Kingdom Roche Products Ltd.

Tel: +44 (0) 1707 366000 This leaflet was last revised in {MM/YYYY}.

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

116 Instructions for the user There are two stages to taking Tamiflu oral suspension .

Stage 1 Prepare a new bottle of the medicine Your pharmacist may have prepar ed the medicine for you when you collected your prescription.

If not, you can do it easily yourself. See the first set of instructions. You only need to do this once , at the beginning of your course.

Stage 2 Measure and give the correct dose Shake the s uspension well and draw the appropriate recommended dose into the dispenser. See the second set of instructions. You will need to do this every time you need a dose.

Stage 1: Prepare a new bottle of the medicine You will need:

• The bottle, containing Ta miflu powder (in the medicine pack)
• The bottle cap (in the medicine pack)
• A plastic measuring jug (in the medicine pack)
• The plastic bottle adapter (in the medicine pack)
• Water
• Tap the bottle to loosen the powder Tap the closed bottle gentl y several times to loosen the powder.
• Use the jug to measure 55 ml of water The measuring jug in the pack has a line marked to show you an exact amount.

Fill it with water to the indicated level.

• Add all the water, close and shake Pour all of the water from the jug into the bottle, onto the powder.

Always use 55 ml of water, whatever the dose you need.

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

• Press in the adapter Open the bottle and press the bottle adapter hard in to the neck of the bottle.
• Close the bottle again Screw the cap tightly onto the top of the bottle, which now includes the adapter.

This will make sure that the bottle adapter fits in the bottle in the right position.

You now have a bottle of Tamiflu oral suspension ready to measure out a dose. You will not need to prepare it again unless you start a new bottle.

Stage 2: Measure and give the correct dose You will need:

• A bottle of prepared Tamiflu oral suspension
• Depending on the required dos e you will need the 3 ml oral dispenser (orange plunger , 0.1 ml graduation ) or the 10 ml oral dispenser (transparent plunger 0.5 ml graduation ) from the medicine pack.
• For doses from 1.0 ml to 3.0 ml, the 3 ml oral dispenser should be used. For doses above 3.0 ml to 10 ml, 10 ml oral dispenser should be used.

Always use the oral dispenser provided with your medicine to measure a correct dose.

• Shake the bottle Check the cap is secure, and then shake the bottle of Tamiflu oral suspension.

Always shake well before use.

• Prepa re the oral dispenser Depending on the required dose, u se the 3 ml dispenser ( orange plunger) or the 10 ml oral dispenser (transparent plunger) provided in the pack.

Push the plunger completely down toward the tip of the dispenser.

• Fill the dispenser with the correct dose Unscrew the cap from the bottle.

Push the tip of the dispenser into the bottle adapter.

Then turn the whole unit upside down (bottle and dispenser together).

Slowly pull out the plunger to draw medicine into the dispenser.

Stop at the mark that shows the dose you need.

Turn the whole unit upright.

Remove the dispenser from the bottle.

• Give the medicine into the mouth Deliver the suspension directly into the mouth by pushing down the plunger of the dispenser.

Make sure the medicine is swallowed.

You may drink and eat something after taking the medicine.

• Close the bottle, keep it safe Put the cap back on the bottle. Keep it out of sight and reach of children.

Store the medicine below 25 º C for up to 10 days. See 5 How to store Tamiflu , overleaf.

Take the dispenser apart straight after dosing , and rinse both parts of the dispenser under running tap water.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Tamiflu (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/02/222).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.