EBILFUMIN 75 mg HARD CAPSULES

2. What you need to know before you take Ebilfumin

Do not take Ebilfumin

• to oseltamivir or any of the other ingredients of this medicine (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 so, your dose may need to be adjusted.
• that requires immediate hospitalization.
• is not working properly.
• or chronic respiratory disease.

During treatment with Ebilfumin, tell your doctor immediately

• (neuropsychiatric events), especially if they occur in children and adolescents. These can 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 you with antibodies against the virus. Ebilfumin does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both.

Using Ebilfumin with other medicines

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

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ebilfumin has no effect on your ability to drive or use machines.

Ebilfumin contains sodium

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

3. How to take Ebilfumin

Follow the instructions for taking this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist again.

Take Ebilfumin as soon as possible, ideally within 2 days of the onset of flu symptoms.

Recommended doses

For the treatment of flu, take two doses a day. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the entire 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 flu or after being in contact with an infected person, take one dose a day for 10 days. It is best to take this dose in the morning with breakfast.

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

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

Adults and adolescents 13 years and older

75 mg can be obtained with one 30 mg capsule and one 45 mg capsule

Children 1 to 12 years

75 mg can be obtained with one 30 mg capsule and one 45 mg capsule

Infants under 1 year (0 to 12 months)

The administration of Ebilfumin to infants under 1 year of age to prevent 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 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 chance of feeling or having discomfort (nausea and vomiting).

People who have difficulty swallowing the capsulescan use a liquid medicine (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.

Overdose cases with oseltamivir have been reported more frequently in children than in adults and adolescents. Caution should be exercised when preparing Ebilfumin liquid for children and when administering the capsules or Ebilfumin liquid to children.

If you stop taking Ebilfumin

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

If you stop treatment with Ebilfumin

No adverse effects occur when you stop taking Ebilfumin. However, if you stop taking Ebilfumin before your doctor told you to, the flu symptoms may return. Always complete the treatment period that your doctor has prescribed.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, itchy rash, low blood pressure, and difficulty breathing
• Hepatic disorders (fulminant hepatitis, hepatic function disorder, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior
• Angioedema: severe, sudden swelling of the skin, mainly around the head and neck area, including eyes and tongue, with difficulty breathing.
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complicated allergic reaction with possible life-threatening, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, rash on the skin, with blistering, peeling, and large areas of skin peeled off, possible difficulty breathing and low blood pressure
• Gastrointestinal hemorrhage: prolonged bleeding from the large intestine 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 discomfort (nausea, vomiting), stomach pain, stomach upset, headache, and pain. These side effects usually occur after the first dose of the medicine and usually disappear during treatment. The frequency with which these effects occur is reduced if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately

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

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

• Seizures and delirium, including altered levels of consciousness
• Confusion, abnormal behavior
• Delusional 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 resulted in self-harm, some with a fatal outcome. These neuropsychiatric events have also been reported in patients with flu who were not taking oseltamivir.

• Patient monitoring, especially children and adolescents, should be done closely to detect changes in behavior 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:

(can affect more than 1 in 10 people)

• Headache
• Nausea

Common side effects:

(can affect up to 1 in 10 people)

• Bronchitis
• Fever
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Sleep disturbance
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat, and sinuses)
• Stomach upset
• Vomiting

Uncommon side effects:

(can affect up to 1 in 100 people)

• Allergic reactions
• Altered consciousness
• Seizure
• Abnormal heart rhythm
• Mild to severe liver function changes
• Skin reactions (skin inflammation, red and itchy rash, scaly skin)

Rare side effects:

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

• Thrombocytopenia (low platelet count)
• Vision disorders

Children 1 to 12 years

Very common side effects:

(can affect 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects:

(can affect up to 1 in 10 people)

• Conjunctivitis (red and watery eyes or eye pain)
• Ear infections and other ear disorders

• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach upset

Uncommon side effects:

(can affect up to 1 in 100 people)

• Skin inflammation
• Eardrum disorder (eardrum)

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 onwards). Additionally, diarrhea and diaper dermatitis have been reported.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist. However,

• , or
• .

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ebilfumin

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

6. Container Content and Additional Information

Ebilfumin Composition

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

capsule content: pregelatinized starch (derived from corn starch), talc, povidone (K-29/32), sodium croscarmellose, and sodium stearyl fumarate

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

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

Product Appearance and Container Content

The hard capsule is formed by a white opaque body and a strong yellow cap, with 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

Iceland

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus: {MM/AAAA} {Month AAAA}.

Detailed information about this medication is available on the European Medicines Agency website http://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, a liquid medication may be available.

If you need a liquid medication, but it is not available, a suspension can be prepared in the pharmacy from Ebilfumin capsules (see Information for Healthcare Professionals). The pharmacy-prepared formulation is the recommended option.

If the pharmacy-prepared formulation is also not available, you can prepare Ebilfumin liquid at home from these capsules.

The dose is the same for treatment as for flu prevention. The difference is the frequency of administration.

Preparing Ebilfumin Liquid at Home

• If you have the correct capsulefor the required dose (a 75 mg dose), open the capsule and shake its contents in a spoonful (or less) of suitable sweetened 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 the capsules requires more steps. This is suitable for small children and babies: they generally need a dose of Ebilfumin of less than 30 mg. See the lower section of the instructions.

Adults, Adolescents 13 Years and Older, and Children Weighing 40 kg or More

To Prepare a 75 mg Dose, You Will Need:

• Ebilfumin 75 mg capsule(s)
• Sharp scissors
• A small container
• A spoon (5 ml spoon)
• Water
• Sweetened foodto mask the bitter taste of the powder.

Examples: chocolate syrup or cherry syrup and dessert sauces, such as caramel or condensed milk. Or you can prepare sugared water by mixing a spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Check the Correct Dose

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

Look at the right column of the table to see the number of capsules you will need to give the patient for a single dose. The amount is the same for treatment as for flu prevention.

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

Not for Children Weighing Less Than 40 kg

A smaller dose than 75 mg needs to be prepared for children weighing less than 40 kg. See below.

Step 2: Pour All the Powder into the Container

Hold a 75 mg capsulevertically 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 sweetened food to the powder in the container.

This is to mask the bitter taste of the Ebilfumin powder.

Shake the mixture well.

Give the Patient the Entire Contents of the Container Immediately.

If Some Mixture Remains in the Container, rinse the container with a small amount of water and have the patient drink it all. Repeat this procedure each time you need to give the medication.

Infants Less Than 1 Year Old and Children Weighing Less Than 40 kg

To Prepare a Smaller Single Dose, You Will Need:

• Ebilfumin 75 mg capsule
• Sharp scissors
• Two small containers
• An oral dose dispenserto measure the water - a 5 or 10 ml dispenser
• A small oral dose dispenserthat shows 0.1 ml measurements to give the dose

• A spoon (5 ml spoon)
• Water
• Sweetened foodto 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 sugared water: mix a spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Pour All the Powder into a Container

Hold a 75 mg capsulevertically over one of the containers and carefully cut off the rounded end with scissors. Be careful with the powder: it can be irritating to the skin and eyes.

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

The amount is the same for treatment as for flu prevention.

Step 2: Add Water to Dilute the Medication

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 for the child's weight in the left column of the table.

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

Infants Less Than 1 Year Old (Including Full-Term Newborns)

Children 1 Year or Older Who Weigh Less Than 40 kg

Step 4: Prepare the Liquid Mixture

Make sure you have the correct dispenser size.

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

Prepare it carefully to avoid air bubbles.

Gently 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 sweetened food to the second container.

This is to mask the bitter taste of the Ebilfumin suspension.

Shake the sweetened food well with the Ebilfumin liquid.

Give the Child the Entire Contents of the Second Container Immediately.

If Some Mixture Remains in the Second Container, rinse the container with a small amount of water and have the child 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 the child the remaining liquid. Give the child something to drink.

Discard any remaining liquid from the first container.

Repeat this procedure each time you need to give the medication.

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Information Exclusively for Healthcare Professionals:

Patients Who Cannot Swallow the Capsules:

The commercially available oseltamivir powder for oral suspension (6 mg/ml) is the medication of choice 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 pharmacy-prepared suspension is also not available, patients can prepare the suspension at home from the capsules.

Oral dose dispensers(oral syringes) with the correct volume and graduation should be provided to administer the pharmacy-prepared suspension and for the procedures to follow for home preparation. In both cases, the volumes needed should preferably be marked on the dispensers. For home preparation, the dispensers to take the correct volume of water and to measure the Ebilfumin mixture with water should be provided separately. For measuring 12.5 ml of water, 10 ml dispensers should be used.

The following shows the correct dispenser size to take the correct volume of the Ebilfumin suspension (6 mg/ml).

Infants Less Than 1 Year Old (Including Full-Term Newborns):

Children 1 Year or Older Who Weigh Less Than 40 kg: