30 mg hard capsules 
oseltamivir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ebilfumin is and what it is used for 
2. What you need to know before you take Ebilfumin 
3. How to take Ebilfumin 
4. Possible side effects 
5. How to store Ebilfumin 
6. Contents of the packaging and other information 

1. What Ebilfumin is and what it is used for

  • Ebilfumin is used in adults, adolescents, children, and infants (including full-term neonates) to treat the flu. It can be used if you have flu symptoms and if it is known that the flu virus is circulating in the community.
  • Ebilfumin can also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent flu. This is decided on a case-by-case basis, for example, if you have been in contact with someone who has the flu 
  • Ebilfumin can be prescribed to adults, adolescents, children, and infants (including full-term neonates) as an emergency treatment in exceptional cases. For example, it can be used in global influenza epidemics ( pandemics ) and the seasonal flu vaccine does not provide adequate protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These drugs prevent the flu virus from spreading in the body. They thus help to alleviate or prevent the symptoms of the flu virus infection.

Influenza is an infection caused by a virus. Signs of flu often include sudden fever (more than 37.8 ° C), 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 flu epidemics, these flu-like symptoms are most often caused by other types of diseases.

2. What you need to know before you take Ebilfumin

Do not take Ebilfumin:

  • if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6.)

Tell your doctor if this applies to you. Do not take Ebilfumin.

Warnings and cautions

Talk to your doctor or pharmacist before taking Ebilfumin.

Before taking Ebilfumin you should tell your doctor

  • if you are  allergic to other medicines
  • if you have kidney problems. In this case, your dose may need to be adjusted
  • if you have a  serious illness  that may require immediate hospitalization
  • if your  immune system is  not working
  • if you have chronic heart disease or lung disease.

During treatment with Ebilfumin, tell your doctor immediately:

  • if you notice any changes in behavior or mood ( neuropsychiatric events ), especially in children and adolescents. This can be a sign of unusual but serious side effects.

Ebilfumin is not a flu vaccine

Ebilfumin is not a vaccine: it treats infection or prevents the flu virus from spreading. A vaccine gives you antibodies against the virus. Ebilfumin does not affect the effect of a flu vaccine and you can be prescribed both by your doctor.

Other medicines and Ebilfumin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 eg rheumatoid arthritis )
  • phenylbutazone (used to treat pain and inflammation )
  • probenecid (used to treat gout )

Pregnancy and breastfeeding

You need to tell your doctor if you are pregnant, if you think you may be pregnant or if you are trying to become pregnant so that your doctor can decide if Ebilfumin is right for you.

The effects on breast-fed infants are not known. You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.

Talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

Ebilfumin does not affect your ability to drive and use machines

Ebilfumin contains sodium

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

3. How to take Ebilfumin

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Take Ebilfumin as soon as possible, preferably within the first two days of the onset of flu symptoms.

Recommended dose you

To treat the flu, take two doses a day. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the entire treatment course in 5 days, even if you start to feel better earlier.

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

To prevent flu or after being exposed to the risk of infection from an infected person, take a dose once a day for 10 days. It is best to take this dose in the morning for breakfast.

In special situations such as widespread flu and for patients with a weak immune system, 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 your doctor.

Adults and adolescents from 13 years of age and older

Bodyweight Treatment of influenza: dosage for 5 days Prevention of influenza: dosage for  1 0 days
40 kg or more 75 mg twice daily 75 mg once daily

75 mg can be obtained from a 30 mg capsule plus a 45 mg capsule

Children from 1 to 12 years of age

Bodyweight Treatment of influenza: dosage for  5 days Prevention of influenza: dosage for  1 0 days
10 to 15 kg 30 mg twice daily 30 mg once daily
More than 15 kg and up to 23 kg 45 mg twice daily 45 mg once daily
More than 23 kg and up to 40 kg 60 mg twice daily 60 mg once daily
More than 40 kg 75 mg twice daily 75 mg once daily

75 mg can be obtained from a 30 mg capsule plus a 45 mg capsule

Infants younger than 1 year (0 to 12 months)

Giving Ebilfumin to infants under 1 year of age to prevent influenza during an influenza pandemic should be based on the assessment of the treating physician after considering the potential benefit of treatment compared to the potential risk to the infant.

Bodyweight Treatment of influenza: dosage for 5 days Prevention of influenza: dosage for 10 days
3 kg to 10+ kg 3 mg per kg body weight, twice daily 3 mg per kg, 
once daily

mg per kg = mg per kilogram of infant body weight. For example: 
If a 6-month-old infant weighs 8 kg, the dose is 8 kg 
3 mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not divide or chew on the capsules.

Ebilfumin can be taken with or without food, but taking it with food can reduce the risk of nausea or vomiting.

Patients who have difficulty taking capsules may use a solution ( oral suspension ) of this medicine. If you need an oral suspension but it is not available at your pharmacy, you can prepare an Ebilfumin suspension from these capsules. For instructions, see Prepare Ebilfumin solution at home.

If you take more Ebilfumin then you should

Stop taking Ebilfumin and contact your doctor or pharmacist immediately.

In most cases of overdose, no side effects have been reported. When adverse reactions have been reported, they have been similar to those reported at normal doses, as shown in section 4.

Overdose has been reported more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparingEbilfumin solution for children and when administering Ebilfumin capsules or Ebilfumin solution to children.

If you forget to take Ebilfumin

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

If you stop taking Ebilfumin

No side effects occur when you stop taking Ebilfumin. However, if you stop taking Ebilfumin earlier than your doctor advised, your flu symptoms may return. Always complete the treatment prescribed by your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. 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 adverse reactions have been reported rarely since the introduction of oseltamivir in 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, hepatic dysfunction, and jaundice): yellowing of the skin and whites of the eyes, discoloration of the stool, behavioral changes
  • Angioneurotic edema: sudden and severe swelling of the skin, mainly in the area around the head and neck, including 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, flaking, discharge of large areas of skin, possible breathing difficulties and low blood pressure
  • Gastrointestinal bleeding: prolonged bleeding from the colon or blood on cough
  • Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, be sure to seek medical attention immediately.

The most common (very common and common) side effects reported with Ebilfumin are nausea, vomiting, stomach pain, upset stomach, headache, and pain. These side effects usually occur after the first dose of one of the medicines and usually stop when treatment is continued. The frequency of these side effects decreases if the medicine is taken with food.

Rare but serious side effects: be sure to seek medical attention immediately

(Can affect up to 1 in 1000 people)

During treatment with oseltamivir, rare side effects have been reported that include

  • Seizures and confusion, including altered levels of consciousness
  • Confusion, abnormal behavior
  • Delusions, hallucinations, agitation, anxiety, nightmares

These have mainly been reported among children and adolescents and often started suddenly and then quickly disappeared. A few cases resulted in self-harm, some with fatal outcomes. Such neuropsychiatric symptoms have also been reported in patients with influenza who have not taken oseltamivir.

  • Patients, especially children, and adolescents should be closely monitored for behavioral changes as described above.

If you notice any of these symptoms, especially in younger people, be sure to seek medical attention immediately.

Adults and adolescents from 13 years and older

Very common side effects are

(may affect more than 1 in 10 people)

• Headache

• Nausea.

Common side effects are

(can affect up to 1 in 10 people)

• Bronchitis

• Viral cold sores

• Hosta

• Dizziness

• Fever

• Pain

• Pain in arms and legs

• Runny nose

• Difficulty sleeping

• Sore throat

• Stomach pain

• Fatigue

• Feeling full in the upper abdomen

• Upper respiratory tract infection ( inflammation of the nose, throat, and sinuses)

• Stomach upset

• Vomiting.

Uncommon side effects are

(can affect up to 1 in 100 people)

• Allergic reactions

• Changed level of consciousness

• Cramps

• Altered heart rhythm

Mild to severe liver disease

Skin reactions ( inflammation of the skin, red and itchy rash, scaly skin).

Rare side effects are

(can affect up to 1 in 1000 people)

• Thrombocytopenia (low platelet count )

• Visual changes.

Children from 1 to 12 years

Very common side effects are

(may affect more than 1 in 10 people)

• Hosta

• Nasal congestion

• Vomiting.

Common side effects are

(can affect up to 1 in 10 people)

• Conjunctivitis (red eyes and discharge or pain in the eye)

• Ear inflammation and other ear diseases

• Headache

• Nausea

• Runny nose

• Stomach pain

• Feeling full in the upper abdomen

• Stomach upset.

Uncommon side effects are

(can affect up to 1 in 100 people)

• Inflammation of the skin

• Effect on the eardrum.

Infants younger than 1 year

The reported side effects were in infants 0-12 months of age are generally comparable to adverse events were reported for older children (1 year of age). Also, diarrhea and diaper rash have been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes possible side effects not mentioned in this information. 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.

5. How to store Ebilfumin

Keep this medicine 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 expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • Each hard capsule contains oseltamivir phosphate equivalent to 30 mg oseltamivir
  • Other ingredients are: Capsule content: pregelatinized starch (derived from maize starch), talc, povidone (K-29/30), croscarmellose sodium, sodium stearyl fumarate capsules shell: gelatin, yellow iron oxide (E172), and titanium dioxide (E171)printing ink: shellac glaze 45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527) 

What the medicine looks like and the contents of the pack

The hard capsule consists of a deep yellow lower part and upper part embossed with “OS 30” in black print.

Capsule size: 4.

Ebilfumin 30 mg hard capsules are available as blister packs or jars of 10 capsules

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78,

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienActavis Group PTC ehf.Iceland / Iceland / IcelandTel: +354 5503300 LithuaniaUAB Teva BalticsTel: +370 52660203
BulgariaOctavis FADTel: +359 24899585 Luxembourg / LuxemburgActavis Group PTC ehf.IcelandTel: +354 5503300
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400
DenmarkTeva Denmark A / STel: +45 44985511 MaltaActavis Ltd.Tel: +356 21693533
GermanyTEVA GmbHTel: +49 73140208 The NetherlandsTeva Nederland BVTel: +31 8000228400
EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 NorwayTeva Norway ASTel: +47 66775590
GreeceSpecifar Α.Β.Ε.Ε.:Ηλ: +30 2118805000 Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070
SpainTeva Pharma, SLTel: +34 913873280 PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300
FranceTeva HealthTel: +33 155917800 PortugalActavis Group PTC ehf.IcelandTel: +354 5503300
CroatiaPliva Hrvatska dooTel: +385 13720000 RomaniaTeva Pharmaceuticals SRLTel: +40 212306524
IrelandTeva Pharmaceuticals IrelandTel: +353 19127700 SloveniaPliva Ljubljana dooTel: +386 15890390
IcelandActavis Group PTC ehf.Phone: +354 5503300 Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911
ItalyActavis Group PTC ehf.IcelandTel: +354 5503300 Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900
LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 United KingdomTeva UK LimitedTel: +44 1977628500

Muhammad Nadeem

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