EBILFUMIN 30 mg Hard Capsules

Зміст інструкції

1. Ebilfumin 30 mg hard capsules
   1. What Ebilfumin is and what it is used for
   2. What you need to know before taking Ebilfumin
   3. How to take Ebilfumin
   4. Possible side effects
   5. How to store Ebilfumin
   6. Content of the pack and other information
2. Ebilfumin 45 mg hard capsules
   1. What is Ebilfumin and what is it used for
   2. What you need to know before taking Ebilfumin
   3. How to take Ebilfumin
   4. Possible side effects
   5. How to store Ebilfumin
   6. Content of the pack and other information
3. Ebilfumin 75 mg hard capsules
   1. What Ebilfumin is and what it is used for
   2. What you need to know before taking Ebilfumin
   3. How to take Ebilfumin
   4. Possible side effects
   5. How to store Ebilfumin
   6. Content of the pack and other information

Ebilfumin 30 mg hard capsules

oseltamivir

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 pack 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 newborns) to treat influenza. It can be used when you feel the symptoms and when the influenza virus is circulating in the community.
• Ebilfumin can also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, to prevent influenza, for example if you have been in contact with someone who has the flu.
• Ebilfumin can be prescribed in adults, adolescents, children and infants (including full-term newborns) as preventive treatmentin exceptional circumstances - for example, if there is a global influenza epidemic (influenza pandemic) and the seasonal influenza vaccine fails to provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines called Neuraminidase Inhibitors.

These medicines prevent the spread of the influenza virus in the body and thus
help to relieve or prevent the symptoms of infection caused by the influenza virus.
Influenza is an infection caused by a virus. Symptoms of influenza often include sudden fever (above 37.8 °C), cough, runny or stuffy nose, headache, muscle aches and extreme
fatigue. These symptoms can also be caused by other infections. True influenza infection
only occurs during annual outbreaks (epidemics) when the influenza virus spreads in the
local community. Outside the epidemic period, flu-like symptoms are generally caused by a
different type of illness.

2. What you need to know before taking Ebilfumin

Do not takeEbilfumin

• if you are allergicto oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctorif this applies to you. Do not take Ebilfumin

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebilfumin.
Before taking Ebilfumin, make sure your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary.
• if you have a serious health condition, which may require immediate hospitalization
• if your immune systemis not functioning
• if you have heart diseaseor chronic respiratory diseases.

During treatment with Ebilfumin, tell your doctor immediately

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

Ebilfumin is not an influenza vaccine
Ebilfumin is not a vaccine: it treats the infection, or prevents the spread of the influenza virus.
A vaccine provides antibodies against the virus. Ebilfumin does not alter the effectiveness of an influenza vaccine, and
your doctor may prescribe both.

Other medicines and Ebilfumin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines without a prescription.
The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding
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 suitable for you.
The effects on breastfed babies are unknown. If you are breastfeeding, tell your doctor, so that
he/she can decide if Ebilfumin is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ebilfumin does not affect your ability to drive vehicles or use machines.

Ebilfumin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Ebilfumin

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Take Ebilfumin as soon as possible, ideally within two days of the onset of flu symptoms.

Recommended doses
For the treatment of influenza, take two doses a day. It is usually convenient to take one dose in the
morning and one in the evening. It is important that you complete the entire 5-day cycle, even if you quickly begin to
feel better.
In patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of influenza or after contact with an infected person,take one dose a day
for 10 days. The best thing is to take this dose in the morning with breakfast.
In particular situations, such as widespread influenza or for patients with a weakened immune system, the
treatment will continue for a maximum of 6 or 12 weeks.

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

Adults and adolescents starting from 13 years

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Children from 1 to 12 years

*In children with a weakened immune system, treatment lasts 10 days.

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Infants under 1 year of age (0-12 months)
The administration of Ebilfumin in infants under 1 year of age for the prevention of influenza in
case of an influenza pandemic must be based on the doctor's judgment after considering the potential benefit
and any possible risks to the child.

*In infants with a weakened immune system, treatment lasts 10 days

**mg per kg = mg per each kilogram of the child's body weight. For example

if a 6-month-old child 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 break or chew the capsules.
Ebilfumin can be taken with or without food, although taking it with food may reduce the possibility of
feeling or being unwell (nausea or vomiting).

People who have difficulty swallowing capsulescan use a liquid form of the medicine
( oral suspension). If you need the oral suspension, but it is not available at the pharmacy, you can
prepare the liquid form of Ebilfumin from the capsules. SeePreparation of Ebilfumin in liquid
form at homefor instructions.

If you take more Ebilfumin than you should
Stop taking Ebilfumin and consult your doctor or pharmacist immediately.
In most cases of overdose, people have not reported any adverse effects.
When adverse effects have been reported, they were similar to those observed with normal doses
as indicated in paragraph 4.
Cases of overdose have been reported more frequently when oseltamivir was administered to
children compared to adults and adolescents. Caution is needed when preparing the solution of
Ebilfumin for children and when Ebilfumin capsules or Ebilfumin in liquid form are administered to
children.

If you forget to take Ebilfumin
Do not take a double dose to make up for the forgotten capsule.

If you stop taking Ebilfumin
There are no adverse effects when the administration of Ebilfumin is stopped. If Ebilfumin
is stopped before when your doctor told you, the symptoms of the flu may reappear.
Always complete the therapy prescribed by your doctor.
If you have any doubts about 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 can also be caused by the flu.
The following serious side effects have been reported rarely since oseltamivir was placed on the
market:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, low blood pressure and difficulty breathing;
• Liver disorders (fulminant hepatitis, liver function disorders and jaundice): yellowing of the skin and the white of the eye, change in stool color, changes in behavior.
• Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including the eyes and tongue, with difficulty breathing
• Stevens-Johnson Syndrome and toxic epidermal necrolysis: a complicated allergic reaction, which can lead to death, manifesting with severe skin and internal mucous membrane inflammation, initially accompanied by fever, sore throat, feeling tired, rash and subsequent blisters, skin peeling with large areas of dermal-epidermal detachment, possible difficulty breathing and low blood pressure.
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or expulsion of blood from the mouth
• Neuro-psychiatric disorders, as described below. If you notice any of these symptoms, seek immediate medical help.

The most frequently reported side effects (very common and common) with Ebilfumin are
feeling unwell or sick (nausea, vomiting), stomach pain, stomach discomfort, headache and
pain. These side effects mostly appear after the first dose of the medicine and
generally disappear with continued treatment. The frequency of these effects is reduced if the
medicine is taken with food.

Rare but serious effects: require immediate medical attention
( may affect up to 1 in 1,000 people)
Rare events have been reported during treatment with oseltamivir including

• Convulsions and delirium including altered level of consciousness
• Confusion, abnormal behaviour
• Delirium, hallucinations, agitation, anxiety, nightmares These events have been reported mainly in children and adolescents and often occurred suddenly and resolved rapidly. Only a few cases have progressed to self-harm, which in some cases has led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken oseltamivir.
• Patients, especially children and adolescents, should be carefully monitored for the behavioral changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical attention.

Adults and adolescents aged 13 years 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 sores
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disturbances
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat and nasal cavities)
• Stomach discomfort
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsions
• Abnormal heart rhythm
• Liver function abnormalities of mild to severe degree
• Skin reactions (skin inflammation, red and itchy rash, skin peeling)

Rare side effects:

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

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children aged 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 secretion or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach discomfort

Uncommon side effects

(may affect up to 1 in 100 people)

• Skin inflammation
• Ear drum disorders

Infants under 1 year of age
The side effects reported in children from 1 to 12 months of age are similar to the side effects reported
for older children (1 year and older). Diarrhea and diaper rash have also been reported.
If any of the side effects worsen, or if you notice any side effect

• if you or the child becomes frequently ill,or
• if the symptoms of the flu worsen or if the fever persistsInform your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system indicated in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

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 package and blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ebilfumin contains

• Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
• The excipients are: capsule content: pregelatinized starch (derived from corn starch), talc, povidone (K-29/32), sodium croscarmellose and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (E172) and titanium dioxide (E171) printing ink: shellac-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520) and 28% ammonium hydroxide (E527).

Description of the appearance of Ebilfumin and content of the pack
The hard capsule consists of a body and a cap of intense yellow color with the black inscription "OS
30". Capsule size: 4
Ebilfumin 30 mg hard capsules are available in blisters or in tablet containers in packs of 10
capsules.

Marketing authorization holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
TEVA GmbH
Tel: +49 73140208

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar Α.Β.Ε.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
---------------------------------------------------------------------------------------------------------------------------

Information for the user
For people who have difficulty swallowing capsules, including very young children, a liquid
medicinal product may be available. If you need a liquid medicinal product, but it is not available, you can use an
oral suspension prepared in a pharmacy from Ebilfumin capsules (see Information addressed to
healthcare professionals). Pharmacy preparation is the preferred option.
If the liquid preparation prepared in a pharmacy is also not available, you can prepare Ebilfumin
suspension at home from these capsules.
The dose is the same for the treatment and prevention of influenza. The difference is in the frequency of
administration.

Preparation of Ebilfumin in liquid form at home

• If you have the correct capsulesfor the required dosage (a 30 mg or 60 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sugary food. This procedure is usually suitable for children over 1 year of age. See the top of the instructions.
• If you need a lower dose, preparing Ebilfumin suspension from the capsules requires additional steps. This procedure is suitable for younger children, and infants who usually need a dose of Ebilfumin less than 30 mg. See the bottom of the instructions.

Children from 1 to 12 years
To prepare a 30 mg or 60 mg dose,
you will need:

• One or two Ebilfumin 30 mg capsules
• Sharp scissors
• A small bowl
• Teaspoon (5 ml spoon)
• Water
• A sweet foodto mask the bitter taste of the powder. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can prepare sugar water by mixing a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, find the patient's weight in the left column.
Find the number of capsules to administer to the patient for each dose in the right column. The amount is
the same for both treatment and prevention of influenza.
You must use 30 mg capsules only for 30 mg and 60 mg doses. Do not try to prepare a 45 mg or 75 mg dose using the contents of 30 mg capsules. Instead, use capsules of the appropriate dosage.

Step 2: Pour all the powder into a bowl
Hold the 30 mg capsuleupright over a bowl and carefully cut the rounded end
with scissors.
Pour all the powder into the bowl.
Open a second capsule for a 60 mg dose. Pour all the powder into the bowl.
Be careful with the powder, as it can irritate the skin and eyes.

Step 3: Sweeten the powder and administer it to the patient
Add a small amount - no more than a teaspoon - of sugary food to the powder in the
bowl.
This masks the bitter taste of Ebilfumin powder.
Mix the mixture well.

Administerimmediately to the patient all the contentsof the bowl.

If some of the mixtureremains in the bowl, rinse the bowl with a small amount of water and
give all the contents to drink to the patient.
Repeat this procedure each time you administer the medicine.

Children under 1 year of age
To prepare a single smaller dose, you will need:

• One Ebilfumin 30 mg capsule
• Sharp scissors
• Two small bowls(use a different pair of bowls for each child)
• A large oral dispenserfor measuring water - a 5 or 10 ml dispenser
• A small oral dispenser that allows measurement of 0.1 ml,to give the dose
• Teaspoon (5 ml spoon)
• Water
• Sweet foodsto mask the bitter taste of Ebilfumin. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can prepare sugar water by mixing 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 30 mg capsuleupright over one of the bowls and carefully cut the end
rounded with scissors. Be careful with the powder: it can irritate the skin and eyes.
Pour all the powder into the bowl, whatever the dose you are preparing.
The amount is the same whether you are treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger dispenser
to take 5 ml of
water.
Add the water to the
powder in the bowl.

Mix the compound
with a teaspoon
for about 2 minutes.

Do not worry if not all the powder dissolves. The powder that does not dissolve consists only of
excipients.

Step 3: Choose the correct amount based on the child's weight
Find the weight on the left side of the table.
The right column of the table shows the amount of liquid mixture to be drawn.

Infants under 1 year of age (including full-term newborns)

Step 4: Draw the liquid mixture
Make sure you have the correct size dispenser (oral syringe).
Draw the correct amount of liquid mixture from the first bowl.
Draw up carefully, making sure not to include air bubbles.
Gently pour the correct dose into the second bowl.

Step 5: Sweeten and administer it to the child
Add a small amount - no more than a teaspoon - of the sugary food to the second
bowl.
This masks the bitter taste of the Ebilfumin suspension.
Mix the sugary food and Ebilfumin suspension well.

Giveimmediately to the child all the contentsof the second bowl (sugary food with the
liquid Ebilfumin mixture).

If some of the mixtureremains in the bowl, rinse the bowl with a small amount of water and give
to drink to the child all the contents. For children who are unable to drink from the bowl, use
a teaspoon or bottle to administer the remaining liquid mixture to the child.
Give the child something to drink.

Discard any unused liquid remaining in the first bowl.
Repeat this operation each time you administer the medicine.

Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Oseltamivir powder for oral suspension (6mg/ml) represents the preferred formulation for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are required. In the event that oseltamivir powder for oral suspension is not available, the pharmacist can prepare a suspension (6 mg/ml) from Ebilfumin capsules. If even the suspension prepared in the pharmacy is not available, patients can use the capsules to prepare the suspension at home.

Oral dispensers(oral syringes) of appropriate volume and graduated must be provided for both the administration of the suspension prepared in the pharmacy and for the procedures related to preparation at home. In both cases, the correct volume should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for aspirating the correct volume of water and for measuring the mixture of Ebilfumin and water. To measure 5.0 ml of water, 5 ml or 10 ml dispensers should be used.
The appropriate size of the dispenser for aspirating the correct volume of Ebilfumin suspension (6 mg/ml) is shown below.

Infants under 1 year of age (including full-term newborns):

Ebilfumin 45 mg hard capsules

oseltamivir

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 pack and other information

1. What is Ebilfumin and what is it used for

• Ebilfumin is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza. It can be used when you feel the symptoms and when the influenza virus is circulating in the community.
• Ebilfumin can also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, to prevent influenza, 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 newborns) as preventive treatmentin exceptional circumstances - for example, if there is a global influenza epidemic (influenza pandemic) and the seasonal influenza vaccine fails to provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines called Neuraminidase Inhibitors.

These medicines prevent the spread of the influenza virus in the body and thus
help to relieve or prevent the symptoms of infection caused by the influenza virus.
Influenza is an infection caused by a virus. Symptoms of influenza often include sudden fever
(above 37.8 °C), cough, runny or stuffy nose, headache, muscle aches and extreme
fatigue. These symptoms can also be caused by other infections. True influenza infection
only occurs during annual outbreaks (epidemics) when the influenza virus spreads in the
local community. Outside the epidemic period, flu-like symptoms are generally caused by a
different type of illness.

2. What you need to know before taking Ebilfumin

Do not takeEbilfumin

• if you are allergicto oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctorif this applies to you. Do not take Ebilfumin

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebilfumin.
Before taking Ebilfumin make sure your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary.
• if you have a serious health condition, which may require immediate hospitalization
• if your immune systemis not functioning
• if you have heart diseaseor chronic respiratory diseases.

During treatment with Ebilfumin, tell your doctor immediately

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

Ebilfumin is not an influenza vaccine
Ebilfumin is not a vaccine: it treats the infection, or prevents the spread of the influenza virus.
A vaccine provides antibodies against the virus. Ebilfumin does not alter the effectiveness of an influenza vaccine, and
your doctor may prescribe both.

Other medicines and Ebilfumin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines without a prescription.
The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding
Tell your doctor if you are pregnant, think you may be or are trying to become pregnant, so that the doctor
can decide if Ebilfumin is suitable for you.
The effects on breastfed babies are unknown. If you are breastfeeding, tell your doctor, so that
they can decide if Ebilfumin is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ebilfumin does not affect your ability to drive vehicles or use machines.

Ebilfumin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Ebilfumin

Take this medicine following the doctor's instructions exactly. If you have doubts, consult your
doctor or pharmacist.
Take Ebilfumin as soon as possible, ideally within two days of the onset of flu symptoms.

Recommended doses
For the treatment of influenza, take two doses a day. It is usually practical to take one dose in the
morning and one in the evening. It is important to complete the entire 5-day cycle, even if you start to
feel better quickly.
In patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of influenza or after contact with an infected person,take one dose a day
for 10 days. The best thing is to take this dose in the morning with breakfast.
In particular situations, such as widespread influenza or for patients with a weakened immune system, the
treatment will continue for a maximum of 6 or 12 weeks.

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

Adults and adolescents starting from 13 years

*In patients with a weakened immune system, treatment lasts 10 days

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Children from 1 to 12 years

*In children with a weakened immune system, treatment lasts 10 days

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Infants under 1 year of age (0-12 months)
The administration of Ebilfumin in children under 1 year of age for the prevention of influenza in
case of an influenza pandemic must be based on the doctor's judgment after considering the potential benefit
and any possible risks to the child.

*In infants with a weakened immune system, treatment lasts 10 days

**mg per kg = mg per kilogram of the child's body weight. For example

if a 6-month-old child 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 break or chew the capsules.
Ebilfumin can be taken with or without food, although taking it with food may reduce the possibility of
feeling or being unwell (nausea or vomiting).

People who have difficulty swallowing capsulescan use a liquid form of the medicine
( oral suspension). If you need the oral suspension, but it is not available at the pharmacy, you can
prepare the liquid form of Ebilfumin from the capsules. SeePreparation of Ebilfumin in liquid form
at homefor instructions.

If you take more Ebilfumin than you should
Stop taking Ebilfumin and consult your doctor or pharmacist immediately.
In most cases of overdose, people have not reported any adverse effects.
When adverse effects have been reported, they were similar to those observed with normal doses
as indicated in paragraph 4.
Cases of overdose have been reported more frequently when oseltamivir has been administered to
children compared to adults and adolescents. Caution is needed when preparing the solution
of Ebilfumin for children and when Ebilfumin capsules or Ebilfumin in liquid form are administered to
children.

If you forget to take Ebilfumin
Do not take a double dose to make up for the forgotten capsule.

If you stop treatment withEbilfumin
There are no adverse effects when the administration of Ebilfumin is stopped. If Ebilfumin
is stopped before the doctor told you, the symptoms of influenza may reappear.
Always complete the therapy prescribed by your doctor.
If you have any doubts about 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 can also be caused by the flu.
The following serious side effects have been reported rarely since oseltamivir was placed on the
market:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rashes, low blood pressure and difficulty breathing;
• Liver disorders (fulminant hepatitis, liver function disorders and jaundice): yellowing of the skin and the white of the eye, change in stool color, changes in behavior.
• Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including the eyes and tongue, with difficulty breathing
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complicated allergic reaction, which can lead to death, manifesting with severe skin and internal mucous membrane inflammation, initially accompanied by fever, sore throat, feeling tired, skin rashes and subsequent blisters, skin peeling with large areas of dermal-epidermal detachment, possible breathing difficulties and low blood pressure.
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or expulsion of blood from the mouth
• Neuro-psychiatric disorders, as described below. If you notice any of these symptoms, seek immediate medical help.

The most frequently reported side effects (very common and common) with Ebilfumin are feeling
unwell or sick (nausea, vomiting), stomach pain, stomach discomfort, headache and pain.
These side effects mostly appear after the first dose of the medicine and generally
disappear with continued treatment. The frequency of these effects is reduced if the medicine is
taken with food.

Rare but serious effects: consult a doctor immediately
( may affect up to 1 in 1,000 people)
Rare events have been reported during treatment with oseltamivir, including

• Convulsions and delirium including altered level of consciousness
• Confusion, abnormal behavior
• Delirium, hallucinations, agitation, anxiety, nightmares These events have been reported mainly in children and adolescents and often occurred suddenly and resolved quickly. Only a few cases have progressed to self-harm, which in some cases has led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken oseltamivir.
• Patients, especially children and adolescents, should be carefully monitored for the behavioral changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical attention.

Adults and adolescents aged 13 years 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 sores
• Cough
• Dizziness
• Fever
• Pain
• Pain in the limbs
• Runny nose
• Sleep disorders
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat and nasal cavities)
• Stomach discomfort
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsions
• Abnormal heart rhythm
• Liver function abnormalities of mild to severe severity
• Skin reactions (skin inflammation, red and itchy rash, skin peeling)

Rare side effects:

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

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children aged 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 eye secretion or pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach discomfort

Uncommon side effects

(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic membrane disorders.

Children under 1 year of age
The side effects reported in children from 1 to 12 months of age are mostly similar to the side effects
reported for older children (1 year and older). Diarrhea and diaper rash have also been reported.
If any of these side effects worsen, or if you notice any other side effect

• if you or the child gets frequent illnesses,or
• if the symptoms of the flu worsen or if the fever persistsInform your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

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 package and blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ebilfumin contains

• Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
• The excipients are: capsule content: pregelatinized starch (derived from corn starch), talc, povidone (K-29/32), sodium croscarmellose and sodium stearyl fumarate capsule shell: gelatin and titanium dioxide (E171) printing ink: gum lac-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520) and 28% ammonium hydroxide (E527).

Description of the appearance of Ebilfumin and content of the pack
The hard capsule consists of a body and a cap of opaque white color with the black inscription "OS
45". Capsule size: 4
Ebilfumin 45 mg hard capsules are available in blisters or in tablet containers in packs of 10
capsules.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
TEVA GmbH
Tel: +49 73140208

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar Α.Β.Ε.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
---------------------------------------------------------------------------------------------------------------------------

Information for the user
For people who have difficulty swallowing capsules, including very young children, a liquid
medicinal product may be available. If you need a liquid medicinal product, but it is not available, you can use an
oral suspension prepared by the pharmacy from Ebilfumin capsules (see Information addressed to healthcare
professionals). Pharmacy preparation is the preferred option.
If the preparation prepared in the pharmacy is not available, you can prepare Ebilfumin suspension at home
from these capsules.
The dose is the same for the treatment and prevention of influenza. The difference is in the frequency of
administration.

Preparation of Ebilfumin in liquid form at home

• If you have the correct capsulesfor the required dosage (a 45 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sugary food. This procedure is usually suitable for children over 1 year old. See the topof the instructions.
• If you need a lower dose, preparing Ebilfumin suspension from the capsules requires additional steps. This procedure is suitable for younger children, of lower weight and infants who usually need a dose of Ebilfumin less than 45 mg. See the bottom of theinstructions.

Children from 1 to 12 years old
To prepare a 45 mg dose,
you will need:

• One Ebilfumin 45 mg capsule
• Sharp scissors
• A small bowl
• Teaspoon (5 ml spoon)
• Water
• A sweet foodto mask the bitter taste of the powder. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can make sugar water by mixing a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, look for the patient's weight in the left column.
Look for the number of capsules to administer to the patient for each dose in the right column. The amount is
the same for both treatment and prevention of influenza.
You must use 45 mg capsules only for the 45 mg dose. Do not try to prepare a 30mg, 60 mg
or 75 mg dose using the contents of 45 mg capsules. Instead, use capsules of the appropriate dosage.

Step 2: Pour all the powder into a bowl
Hold the 45 mg capsuleupright over a bowl and carefully cut the rounded end
with scissors.
Pour all the powder into the bowl.
Be careful with the powder, as it can irritate the skin and eyes.

Step 3: Sweeten the powder and administer it to the patient
Add a small amount - no more than a teaspoon - of sugary food to the powder in the
bowl.
This masks the bitter taste of Ebilfumin powder.
Mix the mixture well.

Immediately administerall the contents of the bowl to the patient.

If some of the mixture remainsin the bowl, rinse the bowl with a small amount of water and
give all the contents to drink to the patient.
Repeat this procedure each time you administer the medicine.

Children under 1 year old
To prepare a single smaller dose, you will need:

• One Ebilfumin 45 mg capsule
• Sharp scissors
• Two small bowls(use a different pair of bowls for each child)
• A large oral dispenserfor dispensing water - a 5 or 10 ml dispenser
• A small oral dispenser that allows measurement of 0.1 ml,to give the dose
• Teaspoon (5 ml spoon)
• Water
• A sweet foodto mask the bitter taste of Ebilfumin. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can make sugar water by mixing 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 45 mg capsuleupright over one of the bowls and carefully cut the
rounded end with scissors. Be careful with the powder: it can irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose you are preparing.
The amount is the same whether you are treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger dispenser
to take 7.5 ml of
water.
Add the water to the
powder in the bowl.

Mix the compound
with a teaspoon
for about 2 minutes.

Do not worry if not all the powder dissolves. The powder that does not dissolve consists only of
excipients.

Step 3: Choose the correct amount based on the child's weight
Look for the weight on the left side of the table.
The right column of the table shows the amount of liquid mixture to be drawn up with a
oral syringe.

Infants under 1 year old (including full-term newborns)

Step 4: Draw up the liquid mixture
Make sure you have the right size dispenser (oral syringe).
Draw up the correct amount of liquid mixture from the first bowl.
Draw up carefully, avoiding air bubbles.
Gently pour the correct dose into the second bowl.

Step 5: Sweeten and administer to the child
Add a small amount - no more than a teaspoon - of the sugary food into the second
bowl.
This masks the bitter taste of the Ebilfumin suspension.
Mix the sugary food and Ebilfumin suspension well.

Immediately givethe child the entire contentsof the second bowl (the liquid mixture of Ebilfumin
with the added sugary food).

If any of the mixture remainsin the second bowl, rinse the bowl with a small amount of water and
give all the contents to drink to the child. For children who are unable to drink from the bowl, use a
teaspoon or bottle to administer the remaining liquid mixture to the child.
Give the child something to drink.

Discard any unused liquid remaining in the first bowl.
Repeat this operation each time you administer the medicine.

Information exclusively for healthcare professionals
Patients who are unable to swallow capsules:
Oseltamivir powder for oral suspension (6mg/ml) is the preferred formulation for pediatric and adult patients
who have difficulty swallowing capsules or where lower doses are needed. If oseltamivir powder for oral
suspension is not available, the pharmacist can prepare a suspension (6 mg/ml) from Ebilfumin capsules. If the
pharmacy-prepared suspension is also not available, patients can use the capsules to prepare the suspension at
home.

Oral dispensers(oral syringes) of appropriate volume and graduated must be provided both for the
administration of the suspension prepared in the pharmacy and for the procedures related to the preparation at
home. In both cases, the correct volume should preferably be marked on the dispensers. For the
preparation at home, separate dispensers must be provided for aspirating the correct volume of water and for
measuring the mixture of Ebilfumin and water. To measure 5.0 ml of water, dispensers of
5 ml or 10 ml should be used.
The appropriate size of the dispenser for aspirating the correct volume of Ebilfumin suspension (6
mg/ml) are shown below.

Infants under 1 year of age (including full-term newborns):

Ebilfumin 75 mg hard capsules

oseltamivir

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 pack 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 newborns) for the treatment of influenza. It can be used when you feel the symptoms and when the influenza virus is circulating in the community.
• Ebilfumin may also be prescribed to adults, adolescents, children and infants over 1 year of age, on a case-by-case basis, to prevent influenzafor example if you have been in contact with someone who has the flu.
• Ebilfumin may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatmentin exceptional circumstances - for example, if there is a global influenza epidemic (influenza pandemic) and the seasonal influenza vaccine fails to provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines called Neuraminidase Inhibitors.

These medicines prevent the spread of the influenza virus in the body and thus
help to relieve or prevent the symptoms of infection caused by the influenza virus..
Influenza is an infection caused by a virus. Symptoms of influenza often include sudden fever (above 37.8 °C), cough, runny or blocked nose, headache, muscle aches and extreme
fatigue. These symptoms can also be caused by other infections. True influenza infection
only occurs during annual outbreaks (influenza epidemics) when influenza viruses spread in the
local community. Outside the epidemic period, flu-like symptoms are generally caused by a
different type of illness.

2. What you need to know before taking Ebilfumin

Do not takeEbilfumin

• if you are allergicto oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctorif this applies to you. Do not take Ebilfumin

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebilfumin.
Before taking Ebilfumin, make sure your prescribing doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. In this case, a dose adjustment may be necessary.
• if you have a serious health condition, which may require immediate hospitalisation
• if your immune systemis not functioning
• if you have heart diseaseor chronic respiratory diseases.

During treatment with Ebilfumin, tell your doctor immediately

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

Ebilfumin is not an influenza vaccine
Ebilfumin is not a vaccine: it treats the infection, or prevents the spread of the influenza virus.
A vaccine provides antibodies against the virus. Ebilfumin does not alter the effectiveness of an influenza vaccine, and the
doctor may prescribe both.

Other medicines and Ebilfumin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines without a prescription.
The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding
Tell your doctor if you are pregnant, if you think you might be pregnant or if you are trying to become pregnant, so that the doctor
can decide if Ebilfumin is suitable for you.
The effects on breastfed babies are unknown. If you are breastfeeding, tell your doctor so that
they can decide if Ebilfumin is suitable for you.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ebilfumin does not affect your ability to drive or operate machines.

Ebilfumin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Ebilfumin

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Take Ebilfumin as soon as possible, ideally within two days of the onset of flu symptoms.

Recommended doses
For the treatment of influenza, take two doses per day. It is usually practical to take one dose in the
morning and one in the evening. It is important to complete the entire 5-day cycle, even if you start to
feel better quickly.
In patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of influenza or after contact with an infected person,take one dose per day
for 10 days. The best thing is to take this dose in the morning with breakfast.
In particular situations, such as widespread influenza or for patients with a weakened immune system, the
treatment will continue for a maximum of 6 or 12 weeks.

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

Adults and adolescents starting from 13 years of age

*In patients with a weakened immune system, treatment lasts 10 days

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Children from 1 to 12 years

*In children with a weakened immune system, treatment lasts 10 days

**75 mg can be formed by one 30 mg capsule plus one 45 mg capsule

Infants under 1 year of age (0-12 months)
The administration of Ebilfumin in children under 1 year of age for the prevention of influenza in
case of an influenza pandemic must be based on the doctor's judgment after considering the potential benefit
and any possible risks to the child.

*In infants with a weakened immune system, treatment lasts 10 days

**mg per kg = mg for each kilogram of the child's body weight. For example

if a 6-month-old child 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 break or chew the capsules.
Ebilfumin can be taken with or without food, although taking it with food may reduce the possibility of
feeling or being unwell (nausea or vomiting).

People who have difficulty swallowing capsulescan use a liquid form of the medicine
( oral suspension). If you need the oral suspension, but it is not available at the pharmacy, you can
prepare the liquid form of Ebilfumin from the capsules. SeePreparation of Ebilfumin in liquid
form at homefor instructions.

If you take more Ebilfumin than you should
Stop taking Ebilfumin and consult your doctor or pharmacist immediately.
In most cases of overdose, people have not reported any adverse effects.
When adverse effects have been reported, they were similar to those observed with normal doses
as indicated in paragraph 4.
Cases of overdose have been reported more frequently when oseltamivir was administered to
children compared to adults and adolescents. Caution is needed when preparing the solution of
Ebilfumin for children and when Ebilfumin capsules or Ebilfumin in liquid form are administered to
children.

If you forget to take Ebilfumin
Do not take a double dose to make up for the missed capsule.

If you stop taking Ebilfumin
There are no adverse effects when the administration of Ebilfumin is stopped. If Ebilfumin
is stopped before the time your doctor told you, the symptoms of influenza may return.
Always complete the therapy prescribed by your doctor.
If you have any doubts about 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 everyone gets them.
Many of the side effects listed below can also be caused by the flu.
The following serious side effects have been reported rarely since oseltamivir was placed on the
market:

• Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rashes, low blood pressure and difficulty breathing;
• Liver disorders (fulminant hepatitis, liver function disorders and jaundice): yellowing of the skin and the white of the eye, change in stool color, changes in behavior.
• Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including the eyes and tongue, with difficulty breathing
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complicated allergic reaction, which can be fatal, that manifests with severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling tired, skin rashes and subsequent blisters, skin peeling with large areas of dermal-epidermal detachment, possible difficulty breathing and low blood pressure.
• Gastrointestinal bleeding: prolonged bleeding from the large intestine or expulsion of blood from the mouth
• Neuro-psychiatric disorders, as described below. If you notice any of these symptoms, seek medical help immediately.

The most frequently reported side effects (very common and common) with Ebilfumin are feeling
unwell or sick (nausea, vomiting), stomach pain, stomach upset, headache and pain.
These side effects mostly appear after the first dose of the medicine and generally
disappear with continued treatment. The frequency of these effects is reduced if the medicine is
taken with food.

Rare but serious side effects: consult a doctor immediately
( may affect up to 1 in 1,000 people)
Rare events have been reported during treatment with oseltamivir that include

• Convulsions and delirium including altered level of consciousness
• Confusion, abnormal behavior
• Delirium, hallucinations, agitation, anxiety, nightmares These events have been reported mainly in children and adolescents and often occurred suddenly and resolved quickly. Only a few cases have progressed to self-harm, which in some cases has led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken oseltamivir.
• Patients, especially children and adolescents, should be carefully monitored for the behavioral changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical attention.

Adults and adolescents aged 13 years 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 sores
• Cough
• Dizziness
• Fever
• Pain
• Pain in the limbs
• Runny nose
• Sleep disorders
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat and nasal cavities)
• Stomach upset
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsions
• Abnormal heart rhythm
• Liver function abnormalities of mild to severe severity
• Skin reactions (skin inflammation, red and itchy rash, skin peeling)

Rare side effects:

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

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children aged 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 eye secretion or pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach upset

Uncommon side effects

(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic membrane disorders

Infants under 1 year of age
The side effects reported in children from 0 to 12 months of age are mostly similar to the side effects
reported for older children (1 year and older). ). Diarrhea and diaper rash have also been reported.
If any of the side effects worsen, or if you notice any side effect

• if you or the child gets frequent infections,or
• if the symptoms of the flu worsen or if the fever persistsInform your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

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 pack and blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ebilfumin contains

• Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
• The excipients are: capsule content: pregelatinized starch (derived from corn starch), talc, povidone (K-29/32), sodium croscarmellose and sodium stearyl fumarate capsule shell: cap: gelatin, yellow iron oxide (E172) and titanium dioxide (E171); body: cap: gelatin and titanium dioxide (E171); printing ink: gum lac-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520) and 28% ammonium hydroxide (E527).

Description of the appearance of Ebilfumin and content of the pack
The 75 mg hard capsule consists of an opaque white body and an intense yellow cap
with black writing "OS 75". Capsule size: 2.
Ebilfumin 75 mg hard capsules are available in blisters or in tablet containers in packs of 10
capsules.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
TEVA GmbH
Tel: +49 73140208

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar Α.Β.Ε.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
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Information for the user
For people who have difficulty swallowing capsules, including very young children, a liquid
medicinal product may be available. If you need a liquid medicinal product, but it is not available, you can use an oral
suspension prepared by a pharmacy from Ebilfumin capsules (see Information addressed to healthcare
professionals).Pharmacy preparation is the preferred option.
If pharmacy-prepared preparation is not available, you can prepare Ebilfumin suspension at home
from the capsules.
The dose is the same for the treatment and prevention of influenza. The difference is in the frequency of
administration.

Preparing Ebilfumin in liquid form at home

• If you have the correct capsulesfor the required dosage (a dose of 75 mg), open the capsule and mix its contents with a teaspoon (or less) of a suitable sugary food. This procedure is usually suitable for children over 1 year old. See the topof the instructions.
• If you need a lower dose, preparing Ebilfumin suspension from the capsules requires additional steps. This procedure is suitable for younger children, and infants who usually need a dose of Ebilfumin less than 30 mg. See the bottom of the instructions.

Children from 1 to 12 years
To prepare a 75 mg dose,
you will need:

• One 75 mg Ebilfumin capsule
• Sharp scissors
• A small bowl
• Teaspoon (5 ml spoon)
• Water
• A sweet foodto mask the bitter taste of the powder. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can make sugar water by mixing a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct amount of medicine to use, look for the patient's weight in the left
column of the table.
Look in the right column for the number of capsules to give the patient for each dose. The amount is
the same for both treatment and prevention of influenza.
You should only use 75 mg capsules for the 75 mg dose. Do not try to prepare a 75 mg or
75 mg dose using the contents of 30 mg or 45 mg capsules. Instead, use the appropriate dosage
capsules.

Not suitable for children weighing less than 40 kg.
A lower dose than 75 mg must be prepared for children weighing less than 40 kg. See
below.

Step 2: Pour all the powder into a bowl
Hold the 75 mg capsulevertically over a bowl and carefully cut the rounded end
with scissors.
Pour all the powder into the bowl.
Be careful with the powder, as it can irritate the skin and eyes.

Step 3: Sweeten the powder and administer it to the patient
Add a small amount - no more than a teaspoon - of the sugary food to the powder
in the bowl.
This masks the bitter taste of Ebilfumin powder.
Mix the mixture well.

Administerimmediately to the patient all the contentsof the bowl.

If some of the mixture remainsin the bowl, rinse the bowl with a small amount of water and
give all the contents to drink to the patient.
Repeat this procedure each time you need to administer the medicine.

Infants under 1 year of age, and children with a body weight of less than 40 kg
To prepare a single smaller dose, you will need:

• One 75 mg Ebilfumin capsule
• Sharp scissors
• Two small bowls(use a different pair of bowls for each child)
• A large oral dispenserfor dispensing water - a 5 or 10 ml dispenser
• A small dispenser that allows measurement of 0.1 ml,to give the dose
• Teaspoon (5 ml spoon)
• Water
• Sweet foodsto mask the bitter taste of Ebilfumin. For example: chocolate or cherry syrup and dessert toppings, such as caramel or caramel sauce. Or you can make sugar water by mixing 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 capsulevertically over one of the bowls and carefully cut the rounded end
with scissors. Be careful with the powder: it can irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose you are preparing.
The amount is the same whether you are treating or preventing influenza.

Step 2: Add water to dilute the medicine
Use the larger
dispenser to draw 12.5
ml of water.
Add the water to the
powder in the bowl.

Mix the compound
with a teaspoon
for about 2 minutes.

Do not worry if not all the powder dissolves. The powder that does not dissolve consists only of
excipients.

Step 3: Choose the correct amount based on the child's weight
Look for the weight on the left side of the table.
The right column of the table shows the amount of liquid mixture to be drawn up with a
oral syringe.

Infants under 1 year of age (including full-term newborns

Children aged 1 year or older and weighing less than 40 kg
Step 4: Draw up the liquid mixture
Make sure you have the right size dispenser (oral syringe).
Draw up the correct amount of liquid mixture from the first bowl.
Draw up carefully, avoiding air bubbles.
Gently pour the correct dose into the second bowl.

Step 5: Sweeten and administer to the child
Add a small amount - no more than a teaspoon - of the sugary food to the second
bowl.
This masks the bitter taste of the Ebilfumin suspension.
Mix the sugary food and Ebilfumin suspension well.

Givethe child immediately all the contentsof the second bowl (the liquid mixture of Ebilfumin
with the added sugary food).

If some of the mixture remainsin the second bowl, rinse the bowl with a small amount of water and give
the child all the contents to drink. For children who are unable to drink from the bowl, use a
teaspoon or bottle to administer the remaining liquid mixture to the child.
Give the child something to drink.

Discard any unused liquid remaining in the first bowl.
Repeat this operation each time you need to administer the medicine.

Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Oseltamivir powder for oral suspension (6mg/ml) represents the preferred formulation for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are required. In the event that oseltamivir powder for oral suspension is not available, the pharmacist may prepare a suspension (6 mg/ml) from Ebilfumin capsules. If the suspension prepared in the pharmacy is also unavailable, patients may use the capsules to prepare the suspension at home..
.

Oral dispensers(oral syringes) of appropriate volume and graduated must be provided for both the administration of the suspension prepared in the pharmacy and for the procedures related to preparation at home. In both cases, the correct volume should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for drawing up the correct volume of water and for measuring the mixture of Ebilfumin and water. To measure 12.5 ml of water, a 10 ml dispenser should be used.
The appropriate size of the dispenser for drawing up the correct volume of Ebilfumin suspension (6 mg/ml) is shown below.

Infants under 1 year of age (including full-term newborns):
Children over 1 year of age and weighing less than 40 kg