Ebilfumin
Italy
Table of Contents
Package leaflet: Information for the user
Ebilfumin 30 mg hard capsules
oseltamivir
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What Ebilfumin is and what it is used for
- What you need to know before taking Ebilfumin
- How to take Ebilfumin
- Possible side effects
- How to store Ebilfumin
- 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 are experiencing 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 influenza, for example if you have been in contact with someone who has influenza.
- Ebilfumin may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as a preventive treatment in exceptional circumstances – for example, during a global influenza outbreak (influenza pandemic) when the seasonal influenza vaccine does not 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 symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden onset of fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during seasonal outbreaks (epidemics), when the influenza virus is spreading within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.
2. What you need to know before taking Ebilfumin
Do not take Ebilfumin
- if you are allergic to oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor if 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 that your prescribing doctor knows
- if you are allergic to other medicines
- if you have kidney disease. In this case, a dose adjustment may be necessary.
- if you have a serious health condition that may require immediate hospitalization
- if your immune system is not functioning properly
- if you have heart disease or chronic respiratory diseases.
During treatment with Ebilfumin, inform your doctor immediately
- if you notice changes in behaviour or 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 infection or prevents the spread of the influenza virus.
A vaccine provides antibodies against the virus. Ebilfumin does not affect the efficacy 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
Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that
your doctor can decide whether Ebilfumin is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor, so that
he or she can decide whether 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 machinery.
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 exactly as directed by your doctor. 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 daily. It is usually convenient to take one dose in the
morning and one in the evening. It is important that you complete the full 5-day course, even if you
start to feel better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For the prevention of influenza or after contact with an infected person, take one dose daily
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 weakened immune system,
treatment may continue for up to 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 aged 13 years and older
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| 40 kg or more | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In patients with a weakened immune system, treatment lasts for 10 days
**75 mg can be composed of one 30 mg capsule plus one 45 mg capsule
Children from 1 to 12 years old
| Body weight | Influenza treatment: administer for 5 days | Influenza treatment (immunocompromised patients): dose for 10 days* | Influenza prevention: administer for 10 days |
| 10 - 15 kg | 30 mg twice daily | 30 mg twice daily | 30 mg once daily |
| Over 15 kg up to 23 kg | 45 mg twice daily | 45 mg twice daily | 45 mg once daily |
| Over 23 kg up to 40 kg | 60 mg twice daily | 60 mg twice daily | 60 mg once daily |
| Over 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In children with weakened immune systems, treatment lasts for 10 days.
**75 mg can be composed of one 30 mg capsule plus one 45 mg capsule
Infants under 1 year of age (0–12 months)
Administration of Ebilfumin in infants under 1 year of age for influenza prevention during an influenza pandemic should be based on the physician's judgment after considering the potential benefit and any possible risks for the child.
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| from 3 kg to 10 kg | 3 mg per kg body weight** twice daily | 3 mg per kg body weight** twice daily | 3 mg per kg** body weight once daily |
*In infants with weakened immune systems, treatment lasts for 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 may be taken with or without food, although taking it with food may reduce the likelihood of
feeling unwell (nausea or vomiting).
For people who have difficulty swallowing the capsules, a liquid form of the medicine is available
(oral suspension). If you need the oral suspension but it is not available at the pharmacy, it is possible
to prepare a liquid form of Ebilfumin from the capsules. See Preparation of Ebilfumin as a liquid at
home for instructions.
If you take more Ebilfumin than you should
Stop taking Ebilfumin and contact 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 described in section 4.
Overdose cases have been reported more frequently when oseltamivir was administered to
children compared to adults and adolescents. Care must be taken when preparing the Ebilfumin solution for
children and when administering Ebilfumin capsules or Ebilfumin in liquid form 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 administration of Ebilfumin is stopped. If Ebilfumin is stopped
before the time prescribed by your doctor, influenza symptoms may return.
Always complete the course of treatment prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.
The following serious side effects have been reported rarely since oseltamivir has been marketed:
- Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, low blood pressure, and breathing difficulties;
- Liver disorders (fulminant hepatitis, hepatic function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
- Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including eyes and tongue, with breathing difficulties;
- Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction, which may be fatal, characterised by severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blisters, skin peeling, extensive areas of dermo-epidermal detachment, possible breathing difficulties, and low blood pressure;
- Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
- Neuropsychiatric 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 malaise (nausea, vomiting), stomach ache, stomach disorders, headache, and pain. These side effects mostly occur after the first dose of the medicine and usually disappear with continued treatment. The frequency of these side effects is reduced if the medicine is taken with food.
Rare but serious side effects: seek immediate medical attention
(may affect up to 1 in 1,000 people)
Rare events have been reported during treatment with oseltamivir, including:
- Seizures 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 appeared suddenly and resolved rapidly. Only a few cases progressed to self-harm, which in some cases led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken oseltamivir. - Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical advice.
Adults and adolescents aged 13 years and older
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 (herpes labialis);
- Cough;
- Dizziness;
- Fever;
- Pain;
- Limb pain;
- Runny nose;
- Sleep disorders;
- Sore throat;
- Stomach ache;
- Fatigue;
- Feeling of fullness in the upper abdominal tract;
- Upper respiratory tract infections (inflammation of the nose, throat, and nasal sinuses);
- Stomach disorders;
- Vomiting.
Uncommon side effects
(may affect up to 1 in 100 people)
- Allergic reactions;
- Altered level of consciousness;
- Seizures;
- Abnormal heart rhythm;
- Mild to severe liver function abnormalities;
- Skin reactions (skin inflammation, red 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, eye discharge, or eye pain);
- Ear inflammation and other ear disorders;
- Headache;
- Nausea;
- Runny nose;
- Stomach ache;
- Feeling of fullness in the upper abdominal tract;
- Stomach disorders.
Uncommon side effects
(may affect up to 1 in 100 people)
- Skin inflammation;
- Tympanic disorders.
Infants under 1 year of age
The side effects reported in children aged 1 to 12 months are similar to those reported in older children (aged 1 year and above). Diarrhoea and diaper rash (erythema) have also been reported.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,
- if you or the child become unwell frequently, or
- if influenza symptoms worsen or fever persists,
inform the doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the carton and on the blister after Exp. The expiry
date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Ebilfumin Contains
- Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
- The other components are:
Capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), sodium croscarmellose, sodium stearil fumarate
Capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171)
Printing ink: shellac-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)
Description of the Appearance of Ebilfumin and Contents of the Pack
The hard capsule consists of a body and a cap, both bright yellow, with black printing "OS 30". Capsule size: 4.
Ebilfumin 30 mg hard capsules are available in blisters or 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 about this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД TEVA GmbH
Teл: +359 24899585 Tel: +49 73140208
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117
Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
Specifar A.B.E.E. Greece Teva Sweden AB
Τηλ: +30 2118805000 Tel: +46 42121100
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 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/ .
Information for the User
For people who have difficulty swallowing capsules, including very young children, a liquid formulation of the medicine may be available.
If you need a liquid formulation but it is not available, you may use an oral suspension prepared by a pharmacy from Ebilfumin capsules (see Information for Healthcare Professionals). The pharmacy-prepared formulation is the preferred option.
If the pharmacy-prepared liquid formulation is also unavailable, Ebilfumin suspension can be prepared at home from these capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.
Preparing Ebilfumin Liquid Form at Home
- If you have the correct capsules for the required dose (a 30 mg or 60 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food. This procedure is usually suitable for children over 1 year of age. See the top part of the instructions.
- If you need a lower dose, preparing Ebilfumin suspension from capsules requires additional steps. This procedure is suitable for younger children and infants who usually require a dose of Ebilfumin lower than 30 mg. See the bottom part of the instructions.
Children aged 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 food to mask the bitter taste of the powder. For example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you can prepare sweetened water by mixing one 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-hand column of the table.
In the right-hand column, find the number of capsules to administer to the patient per dose. The amount is the same for both treatment and prevention of influenza.
Use only the 30 mg capsules for 30 mg and 60 mg doses. Do not attempt to prepare a 45 mg or 75 mg dose using the contents of 30 mg capsules. Instead, use capsules of the appropriate strength.
| Weight | Ebilfumin dose | Number of capsules |
| Up to 15 kg | 30 mg | 1 capsule |
| 15 kg up to 23 kg | 45 mg | Do not use the 30 mg capsules |
| 23 kg up to 40 kg | 60 mg | 2 capsules |
Step 2: Pour all the powder into a bowl
Hold the 30 mg capsule upright over a bowl and carefully cut off 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 may irritate the skin and eyes.
Step 3: Sweeten the powder and administer to the patient
Add a small amount—no more than a teaspoon—of sweet food to the powder in the bowl.
This masks the bitter taste of Ebilfumin powder.
Mix the mixture well.
Administer immediately the entire contents of the bowl to the patient.
If any portion of the mixture remains in the bowl, rinse the bowl with a small amount of water and give the patient all the rinse liquid to drink.
Repeat this procedure each time you need to administer the medicine.
Children under 1 year of age
To prepare a smaller single dose, you will need:
- One 30 mg Ebilfumin capsule
- Sharp scissors
- Two small bowls (use a separate pair of bowls for each child)
- A large oral dosing syringe to measure water—a 5 ml or 10 ml syringe
- A small oral dosing syringe capable of measuring 0.1 ml, for administering the dose
- Teaspoon (5 ml spoon)
- Water
- Sweet foods to mask the bitter taste of Ebilfumin. For example: chocolate or cherry syrup, and dessert toppings such as caramel or butterscotch sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.
Step 1: Pour all the powder into a bowl
Hold one 30 mg capsule upright over one of the bowls and carefully cut off the rounded end with scissors. Be careful with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared.
The amount is the same whether treating or preventing influenza.
Step 2: Add water to dilute the medicine
Use the larger dosing syringe
to draw up 5 ml of water.
Add the water to the powder in the bowl.
Mix the mixture
with a teaspoon for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of excipients.
Step 3: Select the correct amount based on the child's weight
Find the weight on the left side of the table.
The column on the right shows the amount of liquid mixture that should be drawn up.
Infants under 1 year of age (including full-term newborns)
| Child's weight (closest) | Amount of mixture to aspirate |
| 3 kg | 1.5 ml |
| 3.5 kg | 1.8 ml |
| 4 kg | 2.0 ml |
| 4.5 kg | 2.3 ml |
| 5 kg | 2.5 ml |
| 5.5 kg | 2.8 ml |
| 6 kg | 3.0 ml |
| 6.5 kg | 3.3 ml |
| 7 kg | 3.5 ml |
| 7.5 kg | 3.8 ml |
| 8 kg | 4.0 ml |
| 8.5 kg | 4.3 ml |
| 9 kg | 4.5 ml |
| 9.5 kg | 4.8 ml |
| 10 kg or more | 5.0 ml |
Step 4: Draw up the liquid mixture
Ensure you have the correct size dispenser (oral syringe).
Draw up the correct amount of liquid mixture from the first bowl.
Draw upwards 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 one teaspoon – of sweetened food to the second bowl.
This masks the bitter taste of Ebilfumin suspension.
Mix the sweetened food and Ebilfumin suspension thoroughly.
Give the child the entire contents of the second bowl (sweetened food with the liquid mixture of Ebilfumin) immediately.
If any residue remains in the second bowl, rinse the bowl with a small amount of water and give the child all the contents to drink. For children unable to drink from a bowl, use a teaspoon or feeding 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 procedure each time the medicine is to be administered.
Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Oseltamivir powder for oral suspension (6 mg/mL) is the preferred formulation for pediatric and adult patients who have difficulty swallowing capsules or when lower doses are required. If oseltamivir powder for oral suspension is not available, the pharmacist may prepare a suspension (6 mg/mL) from Ebilfumin capsules. If even the pharmacist-prepared suspension is unavailable, patients may use the capsules to prepare the suspension at home.
Appropriately sized and graduated oral dosing devices (oral syringes) must be provided for both the administration of the pharmacist-prepared suspension and for the at-home preparation procedures. In both cases, the dosing devices should preferably be marked with the correct volume. For at-home preparation, separate dosing devices must be provided to draw up the correct volume of water and to measure the Ebilfumin-water mixture. To measure 5.0 mL of water, 5 mL or 10 mL dosing devices should be used.
The appropriate doser size to draw up the correct volume of Ebilfumin suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including full-term neonates):
| Ebilfumin dose | Amount of Ebilfumin suspension | Syringe size to use (with 0.1 ml graduations) |
| 9 mg | 1.5 ml | 2.0 ml (or 3.0 ml) |
| 10 mg | 1.7 ml | 2.0 ml (or 3.0 ml) |
| 11.25 mg | 1.9 ml | 2.0 ml (or 3.0 ml) |
| 12.5 mg | 2.1 ml | 3.0 ml |
| 13.75 mg | 2.3 ml | or 3.0 ml |
| 15 mg | 2.5 ml | or 3.0 ml |
| 16.25 mg | 2.7 ml | 3.0 ml |
| 18 mg | 3.0 ml | 3.0 ml (or 5.0 ml) |
| 19.5 mg | 3.3 ml | 5.0 ml |
| 21 mg | 3.5 ml | 5.0 ml |
| 22.5 mg | 3.8 ml | 5.0 ml |
| 24 mg | 4.0 ml | 5.0 ml |
| 25.5 mg | 4.3 ml | 5.0 ml |
| 27 mg | 4.5 ml | 5.0 ml |
| 28.5 mg | 4.8 ml | 5.0 ml |
| 30 mg | 5.0 ml | 5.0 ml |
Package leaflet: Information for the user
Ebilfumin 45 mg hard capsules
oseltamivir
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Ebilfumin is and what it is used for
- What you need to know before taking Ebilfumin
- How to take Ebilfumin
- Possible side effects
- How to store Ebilfumin
- Contents of the package 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 are experiencing 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, for preventing influenza, for example if you have been in contact with someone who has influenza.
- Ebilfumin may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as prophylactic treatment under exceptional circumstances—for example, during a global influenza outbreak (influenza pandemic) when the seasonal influenza vaccine does not 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 symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual outbreaks (epidemics) when the influenza virus is spreading within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.
2. What you need to know before taking Ebilfumin
Do not take Ebilfumin
- if you are allergic to oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor if 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 that 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 that may require immediate hospitalization
- if your immune system is not functioning properly
- if you have heart disease or chronic respiratory diseases.
During treatment with Ebilfumin, inform your doctor immediately
- if you notice changes in behaviour or 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 affect the effectiveness of an influenza vaccine, and
your doctor may prescribe both.
Other medicines and Ebilfumin
Inform 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
Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that the doctor
can decide whether Ebilfumin is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor, so that
they can decide whether 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 machinery.
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 exactly as your doctor has told you. If you are unsure, 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 daily. It is usually convenient to take one dose in the morning and one in the evening. It is important that you complete the full 5-day course, even if you start to feel better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For influenza prevention or after contact with an infected person: Take one dose daily 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 weakened immune system, treatment may continue for up to 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 aged 13 years and older
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| 40 kg or more | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In patients with a weakened immune system, the treatment duration is 10 days
**75 mg can be composed of one 30 mg capsule plus one 45 mg capsule
Children from 1 to 12 years of age
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| 10 - 15 kg | 30 mg twice daily | 30 mg twice daily | 30 mg once daily |
| Over 15 kg up to 23 kg | 45 mg twice daily | 45 mg twice daily | 45 mg once daily |
| Over 23 kg up to 40 kg | 60 mg twice daily | 60 mg twice daily | 60 mg once daily |
| Over 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In children with weakened immune systems, treatment lasts for 10 days
**75 mg can be composed of 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 influenza prevention during an influenza pandemic should be based on the physician's judgment after considering the potential benefit and any possible risks for the child.
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| from 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** of body weight once daily |
*In infants with weakened immune systems, treatment lasts for 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 likelihood of
feeling unwell (nausea or vomiting).
People who have difficulty swallowing capsules can use a liquid form of the medicine
(oral suspension). If you need the oral suspension but it is not available at the pharmacy, it is possible
to prepare the liquid form of Ebilfumin from the capsules. See Preparing Ebilfumin liquid form at home
for instructions.
If you take more Ebilfumin than you should
Stop taking Ebilfumin and contact your doctor or pharmacist immediately.
In most cases of overdose, no adverse effects have been reported.
When adverse effects have been reported, they were similar to those observed with normal doses
as described in section 4.
Overdose cases have been reported more frequently when oseltamivir was administered to
children compared to adults and adolescents. Care must be taken when preparing Ebilfumin solution for
children and when administering Ebilfumin capsules or Ebilfumin liquid form 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 Ebilfumin administration is stopped. However, if Ebilfumin
is stopped before the time indicated by your doctor, influenza symptoms may return.
Always complete the course of treatment prescribed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them. Many of the side effects listed below may also be caused by influenza itself. The following serious side effects have been rarely reported since oseltamivir has been marketed:
- Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, drop in blood pressure, and breathing difficulties;
- Liver disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
- Angioedema: sudden onset of severe swelling of the skin, particularly around the head and neck, including eyes and tongue, with breathing difficulties;
- Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction which may be fatal, characterised by severe inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling of fatigue, skin rash, followed by blistering, skin peeling, extensive areas of dermo-epidermal detachment, possible breathing difficulties and low blood pressure;
- Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
- Neuropsychiatric 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 malaise (nausea, vomiting), stomach ache, stomach discomfort, headache, and pain. These side effects mostly occur after the first dose of the medicine and generally disappear during continued treatment. The frequency of these side 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 reported during treatment with oseltamivir include:
- Seizures 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 appeared suddenly and resolved rapidly. Only a few cases progressed to self-harm, which in some instances led to death. Such neuropsychiatric events have also been reported in patients with influenza who had not taken oseltamivir.
Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger patients, seek medical advice immediately.
Adults and adolescents aged 13 years and older
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 (herpes labialis);
- Cough;
- Dizziness;
- Fever;
- Pain;
- Limb pain;
- Runny nose;
- Sleep disorders;
- Sore throat;
- Stomach ache;
- Fatigue;
- Feeling of fullness in the upper abdominal tract;
- Upper respiratory tract infections (inflammation of the nose, throat and nasal sinuses);
- Stomach discomfort;
- Vomiting.
Uncommon side effects
(may affect up to 1 in 100 people)
- Allergic reactions;
- Altered level of consciousness;
- Seizures;
- Abnormal heart rhythm;
- Mild to severe liver function abnormalities;
- Skin reactions (skin inflammation, red itchy rash, skin peeling).
Rare side effects:
(may affect up to 1 in 1,000 people)
- Thrombocytopenia (low platelet count);
- Visual disturbances.
Children aged between 1 and 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 with discharge or eye pain);
- Ear inflammation and other ear disorders;
- Headache;
- Nausea;
- Runny nose;
- Stomach ache;
- Feeling of fullness in the upper abdominal tract;
- Stomach discomfort.
Uncommon side effects
(may affect up to 1 in 100 people)
- Skin inflammation;
- Tympanic disorders.
Children under 1 year of age
The side effects reported in children aged 1 to 12 months are mostly similar to those reported in older children (1 year and above). Diarrhoea and diaper rash (erythema) have also been reported.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,
- if you or the child become unwell frequently, or
- if influenza symptoms worsen or fever persists,
inform your doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Ebilfumin contains
- Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
- The excipients are:
Capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), sodium croscarmellose, and sodium stearyl fumarate.
Capsule shell: gelatin 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 contents of the pack
The hard capsule consists of a body and a cap, both opaque white, with black printing "OS 45". Capsule size: 4.
Ebilfumin 45 mg hard capsules are available in blisters or 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД TEVA GmbH
Teл: +359 24899585 Tel: +49 73140208
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117
Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
Specifar A.B.E.E. Greece Teva Sweden AB
Tel: +30 2118805000 Tel: +46 42121100
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 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/ .
Information for users
For people who have difficulty swallowing capsules, including very young children, a liquid formulation of the medicine may be available.
If you need a liquid formulation but it is not available, you may use an oral suspension prepared by a pharmacy from Ebilfumin capsules (see Information for healthcare professionals). Pharmacy-prepared suspension is the preferred option.
If a pharmacy-prepared formulation is not available, you may prepare Ebilfumin oral suspension at home from these capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.
Home preparation of liquid Ebilfumin
- If you have the correct capsules for the required dose (a 45 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food. This procedure is usually suitable for children over 1 year of age. See top part of instructions.
- If you need a lower dose, preparing Ebilfumin suspension from capsules requires additional steps. This procedure is suitable for younger, lower-weight children and infants who usually require an Ebilfumin dose lower than 45 mg. See bottom part of instructions.
Children aged 1 to 12 years
To prepare a 45 mg dose,
you will need:
- One 45 mg Ebilfumin capsule
- Sharp scissors
- A small bowl
- Teaspoon (5 ml spoon)
- Water
- A sweet food to mask the bitter taste of the powder. For example: chocolate or cherry syrup, or dessert toppings such as caramel or butterscotch sauce. Alternatively, you can prepare sweetened water by mixing one 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-hand column of the table.
In the right-hand column, find the number of capsules to administer per dose. The amount is the same for both treatment and prevention of influenza.
Use 45 mg capsules only for the 45 mg dose. Do not attempt to prepare doses of 30 mg, 60 mg, or 75 mg by using contents from 45 mg capsules. Instead, use capsules with the appropriate dosage strength.
| Weight | Ebilfumin dose | Number of capsules |
| Up to 15 kg | 30 mg | Do not use the 45 mg capsules |
| 15 kg up to 23 kg | 45 mg | 1 capsule |
| 23 kg up to 40 kg | 60 mg | Do not use the 45 mg capsules |
Step 2: Pour all the powder into a bowl
Hold the 45 mg capsule upright over a bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Take care with the powder, as it may irritate the skin and eyes.
Step 3: Mix the powder with a sweet food and administer to the patient
Add a small amount – no more than one teaspoon – of a sweet food to the powder in the bowl.
This will mask the bitter taste of Ebilfumin powder.
Mix the mixture well.
Immediately administer to the patient the entire contents of the bowl.
If any of the mixture remains in the bowl, rinse the bowl with a small amount of water and give all the contents to the patient to drink.
Repeat this procedure each time you need to administer the medicine.
Children under 1 year of age
To prepare a smaller single dose, you will need:
- One 45 mg Ebilfumin capsule
- Sharp scissors
- Two small bowls (use a separate pair of bowls for each child)
- A large oral dosing device to measure water – a 5 or 10 ml dispenser
- A small oral dosing device capable of measuring 0.1 ml, to administer the dose
- Teaspoon (5 ml teaspoon)
- Water
- A sweet food to mask the bitter taste of Ebilfumin, for example: chocolate or cherry syrup, dessert toppings such as caramel or butterscotch sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.
Step 1: Pour all the powder into a bowl
Hold one 45 mg capsule upright over one of the bowls and carefully cut off the rounded end with scissors. Take care with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared.
The amount is the same whether treating or preventing influenza.
Step 2: Add water to dilute the medicine
Use the larger dosing device
to measure 7.5 ml of water.
Add the water to the powder in the bowl.
Mix the mixture
with a teaspoon for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of excipients.
Step 3: Select the correct dose based on the child's weight
Find the child's weight on the left side of the table.
The column on the right shows the volume of liquid mixture that should be drawn up with an oral syringe.
Infants under 1 year of age (including full-term newborns)
| Child's weight (closest) | Amount of mixture to draw up |
| 3 kg | 1.5 ml |
| 3.5 kg | 1.8 ml |
| 4 kg | 2.0 ml |
| 4.5 kg | 2.3 ml |
| 5 kg | 2.5 ml |
| 5.5 kg | 2.8 ml |
| 6 kg | 3.0 ml |
| 6.5 kg | 3.3 ml |
| 7 kg | 3.5 ml |
| 7.5 kg | 3.8 ml |
| 8 kg | 4.0 ml |
| 8.5 kg | 4.3 ml |
| 9 kg | 4.5 ml |
| 9.5 kg | 4.8 ml |
| 10 kg or more | 5.0 ml |
Step 4: Draw up the liquid mixture
Make sure you have the correct size oral dispenser (oral syringe).
Draw up the correct amount of liquid mixture from the first bowl.
Draw upwards, taking care not to include 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 one teaspoon – of sweetened food to the second bowl.
This will mask the bitter taste of Ebilfumin suspension.
Mix the sweetened food and Ebilfumin suspension thoroughly.
Give the child the entire contents of the second bowl (the liquid mixture of Ebilfumin with added sweetened food) immediately.
If any residue remains in the second bowl, rinse the bowl with a small amount of water and give the child all of the rinse water to drink. For children unable to drink from a bowl, use a teaspoon or feeding 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 procedure each time the medicine needs to be administered.
Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Oseltamivir oral suspension powder (6 mg/mL) is the preferred formulation for pediatric and adult patients who have difficulty swallowing capsules or when lower doses are required. If oseltamivir oral suspension powder is not available, the pharmacist may prepare a suspension (6 mg/mL) from Ebilfumin capsules. If even the pharmacy-prepared suspension is unavailable, patients may use the capsules to prepare the suspension at home.
Oral dosing syringes (oral syringes) of appropriate volume and graduated markings must be provided both for administering the pharmacy-prepared suspension and for the at-home preparation procedure. In both cases, the correct volume should preferably be clearly marked on the dosing syringe. For at-home preparation, separate dosing syringes must be provided to draw up the correct volume of water and to measure the Ebilfumin and water mixture. To measure 5.0 mL of water, 5 mL or 10 mL dosing syringes should be used.
The appropriate size of dosing syringe for drawing up the correct volume of Ebilfumin suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including full-term neonates):
| Dose of Ebilfumin | Quantity of Ebilfumin suspension | Syringe size to use (with 0.1 ml graduations) |
| 9 mg | 1.5 ml | 2.0 ml (or 3.0 ml) |
| 10 mg | 1.7 ml | 2.0 ml (or 3.0 ml) |
| 11.25 mg | 1.9 ml | 2.0 ml (or 3.0 ml) |
| 12.5 mg | 2.1 ml | 3.0 ml |
| 13.75 mg | 2.3 ml | or 3.0 ml |
| 15 mg | 2.5 ml | or 3.0 ml |
| 16.25 mg | 2.7 ml | 3.0 ml |
| 18 mg | 3.0 ml | 3.0 ml (or 5.0 ml) |
| 19.5 mg | 3.3 ml | 5.0 ml |
| 21 mg | 3.5 ml | 5.0 ml |
| 22.5 mg | 3.8 ml | 5.0 ml |
| 24 mg | 4.0 ml | 5.0 ml |
| 25.5 mg | 4.3 ml | 5.0 ml |
| 27 mg | 4.5 ml | 5.0 ml |
| 28.5 mg | 4.8 ml | 5.0 ml |
| 30 mg | 5.0 ml | 5.0 ml |
Package leaflet: Information for the user
Ebilfumin 75 mg hard capsules
oseltamivir
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What Ebilfumin is and what it is used for
- What you need to know before taking Ebilfumin
- How to take Ebilfumin
- Possible side effects
- How to store Ebilfumin
- 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 are experiencing 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, for prevention of influenza, for example if you have been in contact with someone who has influenza.
- Ebilfumin may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as preventive treatment in exceptional circumstances—for example, during a global influenza outbreak (pandemic) when the seasonal influenza vaccine does not provide adequate 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 symptoms caused by influenza virus infection.
Influenza is a viral infection. Influenza symptoms often include sudden fever (above 37.8 °C), cough, runny or stuffy nose, headache, muscle aches, and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during annual outbreaks (epidemics), when influenza viruses are circulating within the local community. Outside the epidemic period, influenza-like symptoms are generally caused by a different type of illness.
2. What you need to know before taking Ebilfumin
Do not take Ebilfumin
- if you are allergic to oseltamivir or to any of the other ingredients of this medicine (listed in section 6). Consult your doctor if 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 that the prescribing doctor knows
- if you are allergic to other medicines
- if you have kidney disease. In this case, a dose adjustment may be necessary.
- if you have a serious health condition that may require immediate hospitalization
- if your immune system is not working properly
- if you have heart diseases or chronic respiratory diseases.
During treatment with Ebilfumin, inform 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 affect the efficacy of an influenza vaccine, and your
doctor may prescribe both.
Other medicines and Ebilfumin
Inform 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
Inform your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant, so that the doctor
can decide whether Ebilfumin is suitable for you.
The effects on breastfed infants are unknown. If you are breastfeeding, inform your doctor, so that
he or she can decide whether 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 machinery.
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 exactly as your doctor has told you. 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 daily. It is usually convenient to take one dose in the
morning and one in the evening. It is important that you complete the full 5-day course, even if you
start feeling better quickly.
In patients with a weakened immune system, treatment will last for 10 days.
For the prevention of influenza or after contact with an infected person, take one dose daily
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 weakened immune system,
treatment may continue for up to 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 aged 13 years and older
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| 40 kg or more | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In patients with a weakened immune system, the treatment lasts for 10 days
**75 mg can be made up of one 30 mg capsule plus one 45 mg capsule
Children from 1 to 12 years
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| 10 - 15 kg | 30 mg twice daily | 30 mg twice daily | 30 mg once daily |
| Over 15 kg up to 23 kg | 45 mg twice daily | 45 mg twice daily | 45 mg once daily |
| Over 23 kg up to 40 kg | 60 mg twice daily | 60 mg twice daily | 60 mg once daily |
| Over 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
*In children with weakened immune systems, treatment lasts for 10 days
**75 mg can be achieved by combining 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 influenza prevention during an influenza pandemic should be based on the physician's judgment after assessing the potential benefit and any possible risks for the child.
| Body weight | Treatment of influenza: administer for 5 days | Treatment of influenza (immunocompromised patients): dose for 10 days* | Prevention of influenza: administer for 10 days |
| from 3 kg to 10 kg less than 1 month | 3 mg per kg of body weight** twice daily | 3 mg per kg of body weight** twice daily | 3 mg per kg** of body weight once daily |
*In infants with weakened immune systems, treatment lasts for 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 may be taken with or without food, although taking it with food may reduce the likelihood of
feeling unwell (nausea or vomiting).
Patients who have difficulty swallowing capsules can use a liquid form of the medicine
(oral suspension). If you need the oral suspension but it is not available at the pharmacy, it is possible
to prepare the liquid form of Ebilfumin from the capsules. See Preparation of Ebilfumin in liquid form at
home for instructions.
If you take more Ebilfumin than you should
Stop taking Ebilfumin and contact your doctor or pharmacist immediately.
In most cases of overdose, no adverse effects have been reported.
When adverse effects have been reported, they were similar to those observed with normal doses
as described in section 4.
Cases of overdose have been reported more frequently when oseltamivir was administered to
children than to adults and adolescents. Care must be taken when preparing Ebilfumin solution for
children and when administering Ebilfumin capsules or Ebilfumin in liquid form 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 Ebilfumin administration is stopped. However, if Ebilfumin
is stopped earlier than instructed by your doctor, influenza symptoms may return.
Always complete the course of treatment prescribed by your doctor.
If you have any doubts about using this medicine, consult 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 may also be caused by influenza itself. The following serious side effects have been reported rarely since oseltamivir has been marketed:
- Anaphylactic or anaphylactoid reactions: severe allergic reactions with swelling of the face and skin, itchy rash, low blood pressure, and breathing difficulties;
- Liver disorders (fulminant hepatitis, disorders of liver function, and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour;
- Angioedema: sudden onset of severe swelling of the skin, especially around the head and neck, including the eyes and tongue, with breathing difficulties;
- Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe allergic reaction that may be fatal, characterised by serious inflammation of the skin and internal mucous membranes, initially accompanied by fever, sore throat, feeling unwell, skin rash, followed by blistering, skin peeling, and extensive areas of dermo-epidermal detachment, possible breathing difficulties, and low blood pressure;
- Gastrointestinal bleeding: prolonged bleeding from the large intestine or vomiting of blood;
- Neuropsychiatric 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 malaise (nausea, vomiting), stomach ache, stomach disorders, headache, and pain. These side effects mostly occur after the first dose of the medicine and usually disappear with continued treatment. The frequency of these side 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, including:
- Seizures 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 appear suddenly and resolve quickly. Only a few cases have progressed to self-harm, which in some instances has led to death. Such neuropsychiatric events have also been reported in patients with influenza who did not take oseltamivir.
Patients, particularly children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger patients, seek immediate medical advice.
Adults and adolescents aged 13 years and older
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 (herpes labialis);
- Cough;
- Dizziness;
- Fever;
- Pain;
- Limb pain;
- Runny nose;
- Sleep disorders;
- Sore throat;
- Stomach discomfort;
- Fatigue;
- Feeling of fullness in the upper abdomen;
- Upper respiratory tract infections (inflammation of the nose, throat, and sinuses);
- Stomach disorders;
- Vomiting.
Uncommon side effects
(may affect up to 1 in 100 people)
- Allergic reactions;
- Altered level of consciousness;
- Seizures;
- Abnormal heart rhythm;
- Mild to severe abnormalities in liver function;
- Skin reactions (skin inflammation, red 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 with discharge or eye pain);
- Ear inflammation and other ear disorders;
- Headache;
- Nausea;
- Runny nose;
- Stomach discomfort;
- Feeling of fullness in the upper abdomen;
- Stomach disorders.
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 aged 0 to 12 months are mostly similar to those reported in older children (1 year and above). Diarrhoea and nappy rash (diaper dermatitis) have also been reported.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. In addition,
- if you or the child become unwell frequently, or
- if influenza symptoms worsen or fever persists,
inform your doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the carton and on the blister after "Exp". The
expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Ebilfumin contains
- Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
- The other ingredients are:
Capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), sodium croscarmellose, and sodium stearate fumarate.
Capsule shell:- Cap: gelatin, yellow iron oxide (E172), and titanium dioxide (E171)
- Body: gelatin 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 contents of the pack
The 75 mg hard capsule consists of an opaque white body and an intense yellow cap, printed in black with "OS 75". Capsule size: 2.
Ebilfumin 75 mg hard capsules are available in blisters or 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД TEVA GmbH
Tel: +359 24899585 Tel: +49 73140208
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117
Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Greece Tel: +46 42121100
Tel: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
Information for users
For people who have difficulty swallowing capsules, including very young children, a liquid formulation of the medicine may be available.
If you need a liquid formulation but it is not available, you may use an oral suspension prepared by a pharmacy from Ebilfumin capsules (see Information for healthcare professionals). Pharmacy-prepared suspension is the preferred option.
If a pharmacy-prepared suspension is not available, you may prepare Ebilfumin suspension at home from the capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in the frequency of administration.
Preparation of Ebilfumin liquid formulation at home
- If you have the correct capsules for the required dose (a 75 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food. This procedure is usually suitable for children over 1 year of age. See the top part of the instructions.
- If you need a lower dose, preparing Ebilfumin suspension from capsules requires additional steps. This procedure is suitable for younger children and infants who usually require an Ebilfumin dose below 30 mg. See the bottom part of the instructions.
Children aged 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 food to mask the bitter taste of the powder, such as chocolate or cherry syrup, dessert toppings like caramel or butterscotch sauce. Alternatively, you can prepare sweetened water by mixing one 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 of the table.
In the right column, find the number of capsules to administer to the patient per dose. The amount is the same for both treatment and prevention of influenza.
Use only 75 mg capsules for the 75 mg dose. Do not attempt to prepare a 75 mg dose using the contents of 30 mg or 45 mg capsules. Instead, use capsules of the appropriate strength.
| Weight | Ebilfumin dose | Number of capsules |
| Up to 15 kg | 75 mg | 1 capsule |
Not suitable for children weighing less than 40 kg.
A dose lower 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 capsule vertically over a bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Be careful with the powder, as it may irritate the skin and eyes.
Step 3: Sweeten the powder and administer it to the patient
Add a small amount – no more than one teaspoon – of sweet food to the powder in the bowl.
This will mask the bitter taste of Ebilfumin powder.
Mix the mixture thoroughly.
Administer immediately to the patient the entire contents of the bowl.
If any of the mixture remains in the bowl, rinse the bowl with a small amount of water and give all the contents to the patient to drink.
Repeat this procedure every time you need to administer the medicine.
Infants under 1 year of age, and children with a body weight below 40 kg
To prepare a smaller single dose, you will need:
- One 75 mg Ebilfumin capsule
- Sharp scissors
- Two small bowls (use a separate pair of bowls for each child)
- A large oral dosing device to measure water – a 5 or 10 ml dispenser
- A small oral dosing device capable of measuring 0.1 ml, to administer the dose
- Teaspoon (5 ml spoon)
- Water
- Sweet foods to mask the bitter taste of Ebilfumin. For example: chocolate or cherry syrup, and dessert toppings such as caramel or caramel sauce. Alternatively, you may prepare sweetened water by mixing one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.
Step 1: Pour all the powder into a bowl
Hold one 75 mg capsule vertically over one of the bowls and carefully cut off the rounded end with scissors. Be cautious with the powder: it may irritate the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared.
The amount is the same whether treating or preventing influenza.
Step 2: Add water to dilute the medicine
Use the larger dispenser to draw up 12.5 ml of water.
Add the water to the powder in the bowl.
Mix the mixture with a teaspoon for about 2 minutes.
Do not worry if not all the powder dissolves. The undissolved powder consists only of excipients.
Step 3: Select the correct amount based on the child's weight
Find the weight on the left side of the table.
The column on the right side of the table shows the amount of liquid mixture that should be drawn up with an oral syringe.
Infants under 1 year of age (including full-term newborns)
| Child's weight (closest) | Amount of mixture to aspirate |
| 3 kg | 1.5 ml |
| 3.5 kg | 1.8 ml |
| 4 kg | 2.0 ml |
| 4.5 kg | 2.3 ml |
| 5 kg | 2.5 ml |
| 5.5 kg | 2.8 ml |
| 6 kg | 3.0 ml |
| 6.5 kg | 3.3 ml |
| 7 kg | 3.5 ml |
| 7.5 kg | 3.8 ml |
| 8 kg | 4.0 ml |
| 8.5 kg | 4.3 ml |
| 9 kg | 4.5 ml |
| 9.5 kg | 4.8 ml |
| 10 kg or more | 5.0 ml |
Children aged 1 year and older and weighing less than 40 kg
| Child's weight (closest) | Amount of liquid suspension to be taken |
| Up to 15 kg | 5.0 ml |
| From 15 to 23 kg | 7.5 ml |
| From 23 to 40 kg | 10.0 ml |
Step 4: Draw up the liquid mixture
Make sure you have an oral dispenser (oral syringe) of the correct size.
Draw up the correct amount of liquid mixture from the first bowl.
Draw upwards, taking care not to include 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 one teaspoon – of sweetened food into the second bowl.
This will mask the bitter taste of Ebilfumin suspension.
Mix the sweetened food and Ebilfumin suspension thoroughly.
Give the child the entire contents of the second bowl immediately (the liquid mixture of Ebilfumin with the added sweetened food).
If any residue remains in the second bowl, rinse the bowl with a small amount of water and give the child all the rinse water to drink. For children unable to drink from a bowl, use a teaspoon or feeding bottle to administer the remaining liquid mixture.
Give the child something to drink.
Discard any unused liquid left in the first bowl.
Repeat this procedure each time the medicine needs to be administered.
Information intended exclusively for healthcare professionals
Patients unable to swallow capsules:
Oseltamivir oral suspension powder (6 mg/mL) is the preferred formulation for paediatric and adult patients who have difficulty swallowing capsules or when lower doses are required. If oseltamivir oral suspension powder is not available, the pharmacist may prepare a suspension (6 mg/mL) from Ebilfumin capsules. If even the pharmacy-prepared suspension is unavailable, patients may use the capsules to prepare the suspension at home.
Oral dosing devices (oral syringes) of appropriate volume and graduations must be provided both for administering the pharmacy-prepared suspension and for the procedures related to at-home preparation. In both cases, the correct volume should preferably be clearly marked on the dosing device. For at-home preparation, separate dosing devices must be provided to draw up the correct volume of water and to measure the Ebilfumin and water mixture. A 10 mL dosing device should be used to measure 12.5 mL of water.
The appropriate size of dosing device for drawing up the correct volume of Ebilfumin suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including full-term neonates):
| Dose of Ebilfumin | Volume of Ebilfumin suspension | Syringe size to use (with 0.1 ml graduations) |
| 9 mg | 1.5 ml | 2.0 ml (or 3.0 ml) |
| 10 mg | 1.7 ml | 2.0 ml (or 3.0 ml) |
| 11.25 mg | 1.9 ml | 2.0 ml (or 3.0 ml) |
| 12.5 mg | 2.1 ml | 3.0 ml |
| 13.75 mg | 2.3 ml | 3.0 ml |
| 15 mg | 2.5 ml | 3.0 ml |
| 16.25 mg | 2.7 ml | 3.0 ml |
| 18 mg | 3.0 ml | 3.0 ml (or 5.0 ml) |
| 19.5 mg | 3.3 ml | 5.0 ml |
| 21 mg | 3.5 ml | 5.0 ml |
| 22.5 mg | 3.8 ml | 5.0 ml |
| 24 mg | 4.0 ml | 5.0 ml |
| 25.5 mg | 4.3 ml | 5.0 ml |
| 27 mg | 4.5 ml | 5.0 ml |
| 28.5 mg | 4.8 ml | 5.0 ml |
| 30 mg | 5.0 ml | 5.0 ml |
Children over 1 year of age and weighing less than 40 kg
| Dose of Ebilfumin | Quantity of Ebilfumin suspension | Dispenser measure to use (graduated 0.1 ml) |
| 30 mg | 5.0 ml | 5.0 ml (or 10.0 ml) |
| 45 mg | 7.5 ml | 10.0 ml |
| 60 mg | 10.0 ml | 10.0 ml |