Ebilfumin
oseltamivir
oseltamivir
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Ebilfumin is and what it is used for
What you need to know before you take Ebilfumin
How to take Ebilfumin
Possible side effects
How to store Ebilfumin
Contents of the pack and other information
Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there
is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide
sufficient protection.
Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
Talk to your doctor or pharmacist before taking Ebilfumin.
Before you take Ebilfumin, make sure the prescribing doctor knows
if you are allergic to other medicines
if you have problems with your kidneys. If so, your dose may need adjustment
if you have a severe medical condition, which may require immediate hospitalisation
if your immune system is not working
if you have chronic heart disease or respiratory disease.
During treatment with Ebilfumin, tell a doctor immediately:
if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.
Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The following medicines are particularly important:
chlorpropamide (used to treat diabetes)
methotrexate (used to treat e.g. rheumatoid arthritis)
phenylbutazone (used to treat pain and inflammation)
probenecid (used to treat gout)
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.
Ask your doctor or pharmacist for advice before taking this medicine.
Ebilfumin has no effect on your ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Ebilfumin as soon as possible, ideally within two days of the flu symptoms starting.
For patients with a weak immune system, treatment will continue for 10 days.
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
Body weight | Treating flu: dose for 5 days | Treating flu (Immunocompromise d Patients): dose for 10 days* | Preventing flu: dose for 10 days |
40 kg or more | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
For patients with a weak immune system, treatment is for 10 days
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Body weight | Treating flu: dose for 5 days | Treating flu (Immunocompromise d Patients): dose for 10 days* | Preventing flu: dose for 10 days |
10 to 15 kg | 30 mg twice daily | 30 mg twice daily | 30 mg once daily |
More than 15 kg and up to 23 kg | 45 mg twice daily | 45 mg twice daily | 45 mg once daily |
More than 23 kg and up to 40 kg | 60 mg twice daily | 60 mg twice daily | 60 mg once daily |
More than 40 kg | 75 mg** twice daily | 75 mg** twice daily | 75 mg** once daily |
For children with a weak immune system, treatment is for 10 days
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
Body weight | Treating flu: dose for 5 days | Treating flu (Immunocompromised Patients): dose for 10 days* | Preventing flu: dose for 10 days |
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**, once daily |
For infants with a weak immune system, treatment is for 10 days.
** mg per kg = mg for each kilogram of the infant’s body weight. For example: If a 6-month-old weighs 8 kg, the dose is8 kg x 3mg per kg = 24 mg
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 can reduce the chance of feeling or being sick (nausea or vomiting).
People who find it hard to take capsules can use a liquid form of this medicine (oral suspension). If you need an oral suspension but it’s not available from your pharmacy, you can make a liquid form of Ebilfumin from these capsules. See Making Liquid Ebilfumin at home for instructions.
Stop taking Ebilfumin and contact a doctor or pharmacist immediately.
In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.
Do not take a double dose to make up for a forgotten capsule.
There are no side effects when you stop Ebilfumin. But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.
The following serious side effects have been rarely reported since oseltamivir has been marketed:
Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
Neuropsychiatric disorders, as described below.
The most frequently (very common and common) reported side effects of Ebilfumin are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects
mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.
(These may affect up to 1 in 1,000 people)
During oseltamivir treatment, rare events have been reported that include
Convulsions and delirium, including altered level of consciousness
Confusion, abnormal behaviour
Delusions, hallucinations, agitation, anxiety, nightmares
These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.
Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.
(may affect more than 1 in 10 people)
Headache
Nausea.
(may affect up to 1 in 10 people)
Bronchitis
Cold sore virus
Cough
Dizziness
Fever
Pain
Pain in limb
Runny nose
Sleeping difficulties
Sore throat
Stomach ache
Tiredness
Upper abdominal fullness
Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
Upset stomach
Vomiting.
(may affect up to 1 in 100 people)
Allergic reactions
Altered level of consciousness
Convulsion
Heart rhythm abnormalities
Mild to severe liver function disorders
Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
(may affect up to 1 in 1,000 people)
Thrombocytopenia (low platelet count)
Visual disturbances.
(may affect more than 1 in 10 people)
Cough
Nasal congestion
Vomiting.
(may affect up to 1 in 10 people)
Conjunctivitis (red eyes and discharge or pain in the eye)
Ear inflammation and other ear disorders
Headache
Nausea
Runny nose
Stomach ache
Upper abdominal fullness
Upset stomach.
(may affect up to 1 in 100 people)
Inflammation of the skin
Tympanic membrane (eardrum) disorder.
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and nappy rash have been reported.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. However,
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
The other ingredients are:
capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), croscarmellose sodium, sodium stearyl fumarate
capsule shell: gelatin, yellow iron oxide (E172) and titanium dioxide (E171)
printing ink: shellac glaze-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)
The hard capsule consists of a rich yellow body and cap bearing the black imprint “OS 30”. Capsule size: 4.
Ebilfumin 30 mg hard capsules are available in blister packs or tablet containers of 10.
220 Hafnarfjörður Iceland
Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Teл: +359 24899585
TEVA GmbH
Tel: +49 73140208
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
TEVA GmbH
Tel: +49 73140208
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar Α.Β.Ε.Ε. Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117
---------------------------------------------------------------------------------------
If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.
If the pharmacy preparation is not available either, you can make Ebilfumin suspension from these capsules at home.
The dose is the same for treating or preventing flu. The difference is how often it is given.
This is suitable for younger children and babies: they usually need an Ebilfumin dose of less than 30 mg. See the lower set of instructions.
Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
To find the correct amount to use, find the patient’s weight on the left of the table.
Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.
You should use only 30 mg capsules for 30 mg and 60 mg doses. Do not try to make a 45 mg or 75 mg dose by using the contents of 30 mg capsules. Use the appropriate size capsule instead.
Weight | Dose of Ebilfumin | Number of capsules |
Up to 15 kg | 30 mg | 1 capsule |
15 kg up to 23 kg | 45 mg | Do not use 30 mg capsules |
23 kg up to 40 kg | 60 mg | 2 capsules |
Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.
Open a second capsule for a 60 mg dose. Pour all of the powder into the bowl. Be careful with the powder, because it may irritate your skin and eyes.
Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Ebilfumin powder.
Stir the mixture well.
Repeat this procedure every time you need to give the medicine.
Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
Hold a 30 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.
Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.
Use the larger dispenser to draw up 5 ml water.
Add the water to the powder in the bowl.
Stir the mixture with the teaspoon for about 2 minutes.
Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.
Look up the child’s weight on the left side of the table.
The column on the right of the table shows how much of the liquid mixture you will need to draw up.
Child’s weight (nearest) | How much 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 |
Make sure you have the right size dispenser.
Draw up the correct amount of liquid mixture from the first bowl. Draw it up carefully so as not to include air bubbles.
Gently squirt the correct dose into the second bowl.
Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. This is to hide the bitter taste of the Ebilfumin.
Mix the sweet food and Ebilfumin suspension well.
Give the child something to drink.
Repeat this procedure every time you need to give the medicine.
---------------------------------------------------------------------------------------
Commercially manufactured oseltamivir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed. In the event that oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules. If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.
10 ml should be used.
The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.
Dose of Ebilfumin | Amount of Ebilfumin suspension | Dispenser size to use (grading 0.1 ml) |
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 |