30 mg hard capsules
oseltamivir
What Tamiflu is and what it is used for
- Tamiflu is used in adults, adolescents, children, and infants (including full-term newborns) to treat influenza. It can be used if you have flu symptoms and if the flu virus is known to be spreading in the community.
- Tamiflu can also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent influenza, on a case-by-case basis – for example if you have been in contact with someone who has influenza.
- Tamiflu can be prescribed to adults, adolescents, children, and infants (including full-term newborns) as a preventive treatment in exceptional cases – for example when there is a global influenza epidemic (an influenza pandemic ) and the seasonal influenza vaccine does not 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 thus help to alleviate or prevent the symptoms of the influenza virus infection.
Influenza is an infection caused by a virus. Signs of the flu often include a sudden onset of fever (more than 37.8ºC), cough, runny nose, headache, muscle aches, and extreme fatigue. These symptoms can also be caused by other infections. A real flu infection only occurs during the annual epidemics when the flu virus spreads in society. In periods other than during influenza epidemics, these flu-like symptoms are usually caused by other types of illness.
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 in Tamiflu listed in section 6.
Talk to your doctor if this applies to you. Do not take Tamiflu.
Warnings and precautions:
Before taking Tamiflu, you should inform the doctor
- if you are allergic to other medicines
- or if you have problems with your kidneys. If so, your dose may need to be adjusted.
- if you have a serious illness that may require immediate hospital care
- if your immune system is not working
- if you have chronic heart disease or lung disease.
During treatment with Tamiflu, tell a doctor immediately:
- if you notice any changes in behavior or mood (neuropsychiatric events), especially in children and adolescents. This may be a sign of rare but serious side effects.
Tamiflu is not a flu vaccine
Tamiflu is not a vaccine: it treats infection or stops the flu virus from spreading. A vaccine gives you antibodies against viruses et. Tamiflu does not affect the effectiveness of a flu vaccine and you can be prescribed both by your doctor.
Other medicines and Tamiflu
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to over-the-counter medicines.
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 breastfeeding
You must tell your doctor if you are pregnant if you think you are pregnant or if you are trying to become pregnant so that your doctor can decide whether Tamiflu is suitable for you.
The effects on breastfed babies are not known. You must tell your doctor if you are breastfeeding, so that your doctor can decide whether Tamiflu is suitable for you.
Consult your doctor or pharmacist before taking this medicine.
Driving ability and use of machinery
Tamiflu does not affect your ability to drive or use machines.
Information about some of the ingredients in Tamiflu
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost ‘sodium-free’.
How to take Tamiflu
Take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Take Tamiflu as soon as possible, preferably within two days of the onset of flu symptoms.
Recommended dose you
For the treatment of influenza, take two doses per day. Usually, it is practical to take one dose in the morning and one in the evening. It is important to complete the entire course of treatment in 5 days, even if you start to feel better sooner.
For patients with a weak immune system, the treatment will last for 10 days.
To prevent influenza or after being exposed to the risk of infection from an infected person, take one dose once a day for 10 days. It is best to take this dose in the morning with breakfast.
In special situations such as widespread influenza or for patients with a weak immune system, the treatment can be continued for up to 6 or 12 weeks.
The recommended dose is based on the patient’s body weight.
You must take the number of capsules or oral suspension prescribed by the doctor.
Adults and youth from 13 years of age
| Body weight | Treatment of influenza: dosage for 5 days | Treatment of influenza (patients with a weakened immune system):dosage for 10 days * | Prevention of influenza: dosage for 10 days |
|---|---|---|---|
| More than 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
* For patients with a weak immune system, the treatment period is 10 days.
** 75 mg can be obtained from a 30 mg capsule plus a 45 mg capsule
Children from 1 to 12 years
| Body weight | Treatment of influenza:dosage for 5 days | Treatment of influenza (patients with a weakened immune system):dosage for 10 days * | Prevention of influenza:dosage for 10 days |
|---|---|---|---|
| 10 to 15 kg | 30 mg twice daily | 30 mg twice daily | 30 mg once daily |
| More than 15 kg and up to 23 kg | 45 mg twice daily | 45 mg twice daily | 45 mg once daily |
| More than 23 kg and up to 40 kg | 60 mg twice daily | 60 mg twice daily | 60 mg once daily |
| More than 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
* For children with a weak immune system, the treatment period is 10 days.
** 75 mg can be obtained from a 30 mg capsule plus a 45 mg capsule
Infants under 1 year (0 to 12 months)
Giving Tamiflu to infants less than 1 year of age to prevent influenza during pandemic influenza should be based on the judgment of the treating physician after weighing the potential benefit of treatment against the potential risk to the infant.
| Body weight | Treatment of influenza:dosage for 5 days | Treatment of influenza (patients with a weakened immune system):dosage for 10 days * | Prevention of influenza:dosage for 10 days |
|---|---|---|---|
| 3 kg to 10+ kg | 3 mg per kg of body weight,** twice daily | 3 mg per kg of body weight**, twice daily | 3 mg per kg,**once daily |
* For infants with a weak immune system, the treatment period is 10 days.
** mg per kg = mg for each kilogram of the infant’s body weight. For example: If a 6-month-old infant 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 split or chew the capsules.
Tamiflu can be taken with or without food, but taking it with food can reduce the risk of nausea or vomiting.
Those who have difficulty swallowing capsules can use a liquid medicine, Tamiflu oral suspension. If you need Tamiflu oral suspension but it is not available at your pharmacy, you can prepare a Tamiflu solution from these capsules. For instructions, see Bereda Tamiflu solution at home.
If you have taken too much Tamiflu
Stop taking Tamiflu and contact your doctor or pharmacist immediately.
In most cases of overdose, no side effects have been reported. When side effects have been reported, they have been similar to those reported at normal doses, as shown in section 4.
Overdose has been reported more often when Tamiflu was given to children than to adults and adolescents. Caution must be exercised when preparing Tamiflu solution for children and when administering Tamiflu capsules or Tamiflu solution for 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
No side effects occur when you stop taking Tamiflu. However, if you stop taking Tamiflu sooner than your doctor recommends, your flu symptoms may return. Always complete the full course of treatment prescribed by your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Several of the side effects listed below can also be caused by the flu.
The following serious side effects have been reported in rare cases since the introduction of oseltamivir on the market:
- Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, itchy rash, low blood pressure, and difficulty breathing
- Liver disease ( acute hepatitis, impaired liver function, and jaundice): yellowing of the skin and whites of the eyes, change in the color of the stool, behavioral changes
- Angioneurotic edema: sudden and severe swelling of the skin mainly in the area around the head and neck, including the eyes and tongue, with difficulty breathing
- Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-threatening allergic reaction, severe inflammation of the outer and possibly the inner part of the skin, initially with fever, sore throat, and fatigue, skin rash, leading to blisters, scaling, detachment of large areas of the skin, possible breathing difficulties and low blood pressure
- Gastrointestinal bleeding: prolonged bleeding from the colon or blood when coughing up
- Neuropsychiatric disorders, as described below.
If you notice any of these symptoms, be sure to get medical help right away.
The most common (very common and common) reported side effects of Tamiflu are nausea, vomiting, stomach ache, upset stomach, headache, and pain. These side effects usually occur after the first dose of the drug and usually stop as the treatment continues. The frequency of these side effects decreases if the medicine is taken with food.
Rare but serious side effects: get medical help right away
(may affect up to 1 in 1,000 people)
During treatment with Tamiflu, rare side effects have been reported which include:
- Convulsions and confusional states, including the altered level of consciousness
- Confusion, abnormal behavior
- Delusions, hallucinations, agitation, restlessness, nightmares
These have mainly been reported in children and adolescents and often started suddenly and then disappeared quickly. A few cases resulted in self-harm, some fatal. Such neuropsychiatric symptoms have also been reported in patients with influenza who did not take Tamiflu. - Patients, especially children, and adolescents should be closely monitored for behavioral changes described above.
If you notice any of these symptoms, especially in younger people, be sure to get medical help right away.
Adults and adolescents from 13 years of age
Very common side effects are
(may affect more than 1 in 10 people)
- Headache
- Nausea.
Common side effects are
(may affect up to 1 in 10 people)
- Bronchitis
- Viral cold sores
- Cough
- Dizziness
- Fever
- Pain
- Pain in arms and legs
- Runny nose
- Difficulty sleeping
- Sore throat
- Stomachache
- Fatigue
- The feeling of fullness in the upper part of the abdomen
- Upper respiratory infection ( inflammation of the nose, throat, and sinuses)
- Stomach upset
- Vomiting.
Less common side effects are
(may affect up to 1 in 100 people)
- Allergic reactions
- Altered level of consciousness
- Cramp
- Altered heart rhythm
- Mild to severe liver function disorders
- Skin reactions ( inflammation of the skin, red and itchy rashes, scaly skin).
Rare side effects ar
(may affect up to 1 in 1,000 people)
- Thrombocytopenia (low platelet count )
- Vision changes.
Children from 1 to 12 years
Very common side effects are
(may affect more than 1 in 10 people)
- Cough
- Nasal congestion
- Vomiting.
Common side effects are
(may affect up to 1 in 10 people)
- Conjunctivitis (red eyes and discharge or pain in the eye)
- Ear infections and other ear diseases
- Headache
- Nausea
- Runny nose
- Stomachache
- The feeling of fullness in the upper part of the abdomen
- Stomach upset.
Less common side effects are
(may affect up to 1 in 100 people)
- Inflammation of the skin
- Impact on the eardrum.
Infants younger than 1 year
The reported side effects in infants from 0 to 12 months of age are mainly comparable to the side effects reported in older children (from 1 year of age). In addition, diarrhea and diaper rash have been reported.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist. But,
- if you or your child vomits repeatedly, or
- if the flu symptoms get worse or the fever persists
Contact a doctor as soon as possible.
How to store Tamiflu
Store out of sight and reach of children.
Use before the expiry date which is stated on the carton after EXP and on the blister after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- Each hard capsule contains oseltamivir equivalent to 30 mg of oseltamivir.
- Other ingredients are:
capsule contents: pregelatinized 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 FD and C Blue 2 (indigo carmine, E132).
Appearance and package sizes of the medicine
The 30 mg hard capsule consists of a pale yellow opaque body imprinted with “ROCHE” and a pale yellow opaque cap imprinted with “30 mg”. The print color is blue.
Tamiflu 30 mg hard capsules are available as blister packs of 10 capsules.
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Pharma AG
Emil-Barell-Str. 1,
79639 Grenzach-Wyhlen
Germany
For further information about this medicine, contact the representative of the marketing authorization holder:
| België/Belgique/BelgienNV Roche SATel/Tel: +32 (0) 2 525 82 11 | LithuaniaUAB “Roche Lietuva” Phone: +370 5 2546799 |
| BulgariaРош Булгария ЕООДPhone: +359 2 818 44 44 | Luxembourg/Luxembourg(Voir/siehe Belgique/Belgium) |
| Czech RepublicRoche s.r.oPhone: +420 – 2 20382111 | MagyarországRoche (Magyarország) Kft.Phone: +36 – 1 279 4500 |
| DenmarkRoche a/sPhone: +45 – 36 39 99 99 | Malta(See Ireland) |
| DeutschlandRoche Pharma AGPhone: +49 (0) 7624 140 | The NetherlandsRoche Netherlands BVPhone: +31 (0) 348 438050 |
| EstoniaRoche Eesti OÜPhone: + 372 – 6 177 380 | NorwayRoche Norway iPhone: +47 – 22 78 90 00 |
| GreeceRoche (Greece) AETel: +30 210 61 66 100 | AustriaRoche Austria GmbHPhone: +43 (0) 1 27739 |
| SpainRoche Pharma SAPhone: +34 – 91 324 81 00 | PolishRoche Polska Sp. z o. iPhone: +48 – 22 608 18 88 |
| FranceRocheTel: +33 (0) 1 47 61 40 00 | PortugalRoche Farmacêutica Química, LdaPhone: +351 – 21 425 70 00 |
| HrvatskaRoche d.o.oPhone: +385 1 4722 333 | RomaniaRoche România SRLPhone: +40 21 206 47 01 |
| IrelandRoche Products (Ireland) Ltd.Phone: +353 (0) 1 469 0700 | SlovenijaRoche farmacevtska družba dooPhone: +386 – 1 360 26 00 |
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| ItalyRoche S.p.iPhone: +39 – 039 2471 | Finland/FinlandRoche OyTel: +358 (0) 10 554 500 |
| CyprusΓ.Α.Σταμάτης & Σια Λτδ.Tel: +357 – 22 76 62 76 | SwedenRoche phone: +46 (0) 8 726 1200 |
| LatviaRoche Latvija SIAPhone: +371 – 6 7039831 | United Kingdom (Northern Ireland)Roche Products (Ireland) Ltd.Phone: +44 (0) 1707 366000 |