Package Insert: Information for the User

Ebilfumin 75 mg Hard Capsules EFG

oseltamivir

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

• Ebilfumin is used in adults, adolescents, children, and infants (including newborns at term) for the treatment ofthe flu(influenza). It can be used when you have flu symptoms and it is known that the flu virus is present in the population.
• Ebilfumin can also be prescribed to adults, adolescents, children, and infants over 1 year of age forpreventing the fluon a case-by-case basis, for example, if you have been in contact with someone who has the flu.
• Ebilfumin may be prescribed to adults, adolescents, children, and infants (including newborns at term) aspreventive treatmentin exceptional circumstances, for example, if there is a global flu pandemic and the seasonal flu vaccine does not provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medications calledneuraminidase inhibitors. These medications prevent the spread of the flu viruswithin the body. They help to alleviate or prevent symptoms of the flu virus infection.

The flu is an infection caused by a virus. Flu symptoms often include sudden fever (over 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches, and extreme fatigue. These symptoms can also be caused by other infections. A true flu infection only occurs during annual outbreaks (epidemics), when the flu viruses are disseminated in the population. Outside of epidemic periods, pseudoflu-like symptoms are generally caused by another type of illness.

Do not take Ebilfumin

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

If this happens to you,consult your doctor. Do not take Ebilfumin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebilfumin.

Before taking Ebilfumin, make sure your doctor knows

• if you areallergic to other medications
• if you haveany kidney disease. If so, your dose may need to be adjusted.
• if you haveany serious illnessrequiring immediate hospitalization.
• if yourimmune systemdoes not function properly.
• if you haveheart diseaseorchronic respiratory disease.

During treatment with Ebilfumin,inform your doctor immediately

• if you notice changes in your behavior or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Ebilfumin is not a vaccine

Ebilfumin is not a vaccine: it is used to treat the infection or prevent the spread of the flu virus. A vaccine provides antibodies against the virus. Ebilfumin does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both.

Use of Ebilfumin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription. The following medications are particularly important:

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

Pregnancy and breastfeeding

You must inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant so that your doctor can decide if Ebilfumin is suitable for you.

The effects on breastfed infants are unknown. You must inform your doctor if you are breastfeeding so that your doctor can decide if Ebilfumin is suitable for you.

Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Ebilfumin has no effect on your ability to drive or operate machinery.

Ebilfumin contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Take Ebilfumin as soon as possible, ideally within two days of starting to experience flu symptoms.

Dosage recommendations

For the treatment of the flu, take two doses daily. It is generally recommended to take onedose in the morning and another at night.It is essential to complete the entire 5-day treatment, even if you start to feel better quickly.

For adult patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of the flu or after being in contact with an infected person, takeone dose daily for 10 days. It is best to take this dose in the morning with breakfast.

In special cases, such as widespread flu or patients with a weakened immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dosage depends on the patient's body weight.You should use the amount ofcapsules or oral suspension that your doctor has prescribed.

Adults, and adolescents 13 years or older

You can get 75 mg with a 30 mg capsule plus a 45 mg capsule

Children 1 to 12 years old

You can get 75 mg with a 30 mg capsule plus a 45 mg capsule

Infants under 1 year (0 to 12 months)

The administration of Ebilfumin to infants under 1 year of age for the prevention of flu during a pandemic should be done based on the doctor's judgment after considering the potential benefit versus any potential risk to the infant.

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

Administration form

Swallow the capsules whole with water. Do not break or chew the capsules.

Ebilfumin can be taken with or without food, although taking it with food may reduce the possibility of feeling or having discomfort (nausea and vomiting).

People who have difficulty swallowing the capsulesmay use a liquid medication(oral suspension). If this is not available at your pharmacy, you can make a liquid form of Ebilfumin from the capsules.See the instructions in the sectionPreparing Ebilfumin liquid at home.

If you take more Ebilfumin than you should

Stop taking Ebilfumin and consult your doctor or pharmacist immediately.

In most cases of overdose, no adverse effects were reported. When adverse effects were reported, they were similar to those that occurred with normal doses and are included in section 4.

More frequent cases of overdose have been reported with oseltamivir in children than in adults and adolescents. Be cautious when preparing Ebilfumin liquid for children and when administering capsules or Ebilfumin liquid to children.

If you interrupt the taking of Ebilfumin

Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Ebilfumin

No adverse effects occur when stopping Ebilfumin. However, if you stop taking Ebilfumin before completing the treatment period prescribed by your doctor, the flu symptoms may reappear. Always complete the treatment period prescribed by your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Since the marketing of oseltamivir, the following severe side effects have rarely been reported:

• Anaphylactic and anaphylactoid reactions: severe allergic reactions, facial and skin swelling, itchy rash, low blood pressure, and difficulty breathing
• Liver disorders (fulminant hepatitis, liver function disorder, and jaundice): yellowish skin and eyes, change in stool color, and behavioral changes
• Angioneurotic edema: severe sudden skin swelling, mainly around the head and neck area, including eyes and tongue, with difficulty breathing
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complex allergic reaction that may be life-threatening, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, rash on the skin, with blister formation, peeling, and large areas of skin peeled, possible difficulty breathing, and low blood pressure
• Gastrointestinal hemorrhage: prolonged intestinal bleeding or vomiting 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) for Ebilfumin are a feeling of discomfort or unease (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These side effects usually occur after the first dose of the medicine and generally disappear throughout treatment. The frequency of these side effects decreases if the medicine is taken with food.

Severe but rare side effects: seek medical help immediately

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

During treatment with oseltamivir, rare but severe side effects have been reported, including

• Seizures and delirium, including altered levels of consciousness
• Confusion, abnormal behavior
• Delirious disorders, hallucinations, agitation, anxiety, nightmares

These events were mainly reported in children and adolescents and often began suddenly and had a rapid resolution. In very rare cases, these events had a fatal outcome. These neuropsychiatric events have also been reported in patients with flu who were not taking oseltamivir.

• Patients, especially children and adolescents, should be closely monitored to detect the behavioral changes described above.

If you notice any of these symptoms, especially in younger patients, seek medical help immediately.

Adults and adolescents 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
• Fevers
• Cough
• Dizziness
• Fever
• Pain
• Pain in the extremities
• Runny nose
• Difficulty sleeping
• Sore throat
• Stomach pain
• Fatigue
• Fullness in the upper abdomen
• Upper abdominal discomfort
• Upper respiratory tract infections (inflammation of the nose, throat, and sinuses)
• Stomach discomfort
• Vomiting

Rare side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizure
• Cardiac rhythm disorders
• Mild to severe liver function disorders
• Dermatological reactions (skin inflammation, itchy red rash, scaly skin)

Infants under 1 year

The side effects observed in infants from 0 to 12 months of age are mostly similar to the side effects reported in older children (from 1 year). Additionally, diarrhea and diaper dermatitis have been reported.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. However,

• if you or your child are sick several times, or
• if the flu symptoms worsen or the fever continues, inform your doctor as soon as possible.

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through thenational notification system included in theAnexo V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ebilfumin

• Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
• The other components are:

contents of the capsule: pregelatinized starch (derived from cornstarch), talc, povidone (K-29/32), croscarmellose sodium, and sodium stearyl fumarate

capsule coating: cap, gelatin, yellow iron oxide (E172), and titanium dioxide (E171); body: gelatin, titanium dioxide (E171)

printing ink: 45% shellac (20% esterified), black iron oxide (E172), propylene glycol (E1520), and 28% ammonium hydroxide (E527)

Appearance of the product and contents of the package

The hard capsule is formed by an opaque white body and a strong yellow cap with a black print "OS 75". Capsule size: 2.

Ebilfumin 75 mg hard capsules EFG are available in blisters of 10 capsules.

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjördur

Islandia

Responsible for manufacturing

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/AAAA} {month AAAA}.

For more detailed information about this medicine, please visit the website of the European Medicines Agencyhttp://www.ema.europa.eu.

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Information for the user

For people who find it difficult to swallow the capsules, including very small children,there may be a liquid medicine available.

If you need a liquid medicine, but it is not available, it can be prepared in the pharmacy from Ebilfumin capsules (seeInformation for healthcare professionals).The preparation made in the pharmacy is the recommended option.

If the pharmacy preparation is not available, you can prepare Ebilfumin liquid at home from these capsules.

The dose is the same for treatment as for prevention of influenza. The difference is the frequency with which it is administered.

Preparing Ebilfumin liquid at home

• If you have the right capsulefor the required dose (a dose of 75 mg), open thecapsule and shake its contents in a spoon (or less) of suitable sweet food. This is usually suitable for children over 1 year old.See the top section of the instructions.

• If you need smaller doses,preparing the Ebilfumin suspension from thecapsules requires more steps. This is suitable for small children and babies: they usually need a dose of Ebilfumin of less than 30 mg.See the lower section of the instructions.

Adults, adolescents aged 13 years and over,

and children who weigh 40 kg or more

To make a dose of 75 mg, you will need:

• One Ebilfumin 75 mg capsule
• Sharp scissors
• A small container
• Spoon (5 ml spoon)
• Water
• Sweet food to mask the bitter taste of Ebilfumin

Examples: chocolate syrup or cherry syrup and dessert sauces, such as caramel or condensed milk. Or you can prepare a sweet water: mix 1 spoonful of water with 3/4 of a spoonful of sugar.

Step 1: Check the correct dose

To know the correct amount to use, look up the child's weight on the left side of the table.

Look at the right-hand column to see the number of capsules you need to give the child for a single dose. The amount is the same for treatment as for prevention of influenza.

You should only use the 75 mg capsules for doses of 75 mg. Do not try to prepare doses of 75 mg using the contents of the 30 mg or 45 mg capsules.

Not for children who weigh less than 40 kg

You need to prepare a smaller dose for children who weigh less than 40 kg.See below.

Step 2: Pour all the powder into a container

Take one75 mg capsuleand place it vertically over a container and carefully cut off the rounded end with scissors.

Pour all the powder into the container.

Be careful with the powder, as it can be irritating to the skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount -no more than a spoonful- of sweet food to the powder in the container.

This is to mask the bitter taste of Ebilfumin.

Shake the mixture well.

Give the child the entire contentsof the container immediately.

If there is any mixtureleft in the container, rinse the container with a small amount ofwater and get the child to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants under 1 year and children who weigh less than 40 kg

To prepare a single dose of a smaller amount, you will need:

• One Ebilfumin 75 mg capsule
• Sharp scissors
• Two small containers
• Oral syringe for measuring water-a syringe of 5 or 10 ml
• Oral syringe for measuring a small amountto give the dose, showing measurements of 0.1 ml

• Spoon (5 ml spoon)
• Water
• Sweet food to mask the bitter taste of Ebilfumin

Examples: chocolate syrup or cherry syrup and dessert sauces, such as caramel or condensed milk.

Or you can prepare a sweet water: mix 1 spoonful of water with 3/4 of a spoonful of sugar.

Step 1: Pour all the powder into one container

Take one75 mg capsuleand place it vertically over one of the containers and carefully cut off the rounded end with scissors.

Pour all the powder into the container, regardless of the dose you are preparing.

The amount is the same for treatment as for prevention of influenza.

Step 2: Add water to dilute the medicine

Add the water to the powder

in the container.

Shake the suspension with a spoon for 2 minutes.

Do not worry if not all the powder dissolves. The undissolved powder corresponds to inactive ingredients.

Step 3: Choose the correct amount for the child's weight

Look up the child's weight on the left side of the table.

The right-hand column of the table shows how much of the liquid mixture you need to prepare.

Infants under 1 year (including term newborns):

Children aged 1 year or over who weigh less than 40 kg:

Step 4: Prepare the liquid mixture

Make sure you have the right syringe size.

Prepare the correct amount of liquid mixture from the first container.

Prepare it carefully to avoid getting air bubbles.

Add the correct dose to the second container.

Step 5: Sweeten and give to the child

Add a small amount -no more than a spoonful- of sweet food to the second container.

This is to mask the bitter taste of Ebilfumin.

Shake the sweet food well with the Ebilfumin liquid.

Give the child the entire contentsof the second container (sweet food with Ebilfumin liquid) immediately.

If there is any mixtureleft in the second container, rinse the container with a small amount ofwater and get the child to drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use a suitable bottle to give them the remaining liquid.

Give the child something to drink.

Discard any remaining liquid from the first container.

Repeat this procedure every time you need to give the medicine.

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Information for healthcare professionals only:

Patients who cannot swallow the capsules:

The commercially available oseltamivir powder for oral suspension (6 mg/ml) is the preferred option for pediatric and adult patients who have difficulty swallowing the capsules or who require lower doses. If oseltamivir powder for oral suspension is not available, the pharmacist can prepare a suspension (6 mg/ml) from Ebilfumin capsules. If the suspension prepared in the pharmacy is not available, patients can prepare the suspension at home from the capsules.

Provide theoral syringes for dosing(oral syringes) with the appropriate volume and graduation for administering the suspension prepared in the pharmacy and for the procedures to follow for preparation at home. In both cases, the volumes needed should preferably be marked on the syringes. For preparation at home, provide separate syringes for measuring the correct volume of water and for measuring the Ebilfumin mixture with water. To measure 12.5 ml of water, use syringes of 10 ml.

Below is the correct syringe size for measuring the correct volume of the Ebilfumin suspension (6 mg/ml).

Infants under 1 year (including term newborns):

Children aged 1 year or over who weigh less than 40 kg: