Ebilfumin 30 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebilfumin 30 mg hard capsules EFG

oseltamivir

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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ebilfumin is and what it is used for
2. What you need to know before taking Ebilfumin
3. How to take Ebilfumin
4. Possible side effects
5. How to store Ebilfumin
6. 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 newborn babies) for the treatment of influenza (influenza). It may be used when you have symptoms of the flu and it is known that the influenza virus is circulating in the community.
• Ebilfumin may also be prescribed to adults, adolescents, children, and infants over 1 year of age for prevention of influenza on a case-by-case basis, for example, if you have been in close contact with someone who has the flu.
• Ebilfumin may be prescribed to adults, adolescents, children, and infants (including full-term newborn babies) as prophylactic treatment under exceptional circumstances, for example, during a global influenza outbreak (an influenza pandemic) when the seasonal influenza vaccine may 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 within the body. They help to relieve or prevent symptoms caused by infection with the influenza virus.

Influenza is a viral infection. Signs of influenza 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 in the population. Outside epidemic periods, influenza-like symptoms are usually due to other types 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).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebilfumin.

Before taking Ebilfumin, make sure your doctor knows

• if you are allergic to other medicines
• if you have any kidney disease. If so, your dose may need to be adjusted.
• if you have any serious illness requiring immediate hospitalization.
• if your immune system is not functioning properly.
• if you have chronic heart disease or chronic respiratory disease.

During treatment with Ebilfumin, contact a doctor immediately

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

Ebilfumin is not a vaccine

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

Taking Ebilfumin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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

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 infants are unknown. Inform your doctor if you are breastfeeding, so that they can decide whether 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 operate machinery.

Ebilfumin contains sodium

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

3. How to take Ebilfumin

Follow exactly the instructions for use of this medicine given by your doctor.

If in doubt, consult your doctor or pharmacist again.

Take Ebilfumin as soon as possible, ideally within two days after starting to have flu symptoms.

Recommended doses

For the treatment of influenza, take two doses daily. It is generally advisable to take one dose in the morning and one in the evening. It is important to complete the full 5-day treatment course, even if you start feeling better quickly.

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

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

In special situations, such as widespread influenza outbreaks or in patients with weakened immune systems, treatment may continue for up to 6 or 12 weeks.

The recommended dose depends on the patient's body weight. Use the number of capsules or oral suspension volume prescribed by your doctor.

Adults and adolescents aged 13 years and older

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

Children from 1 to 12 years of age

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

Infants under 1 year of age (0 to 12 months)

The administration of Ebilfumin to infants under 1 year of age for influenza prophylaxis during a pandemic should be carried out at the physician's discretion, after considering the potential benefit against 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 instructions

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 experiencing gastrointestinal discomfort (nausea and vomiting).

For individuals who have difficulty swallowing capsules, an oral liquid formulation (oral suspension) may be used. If this is not available at your pharmacy, a liquid form of Ebilfumin can be prepared from the capsules. See instructions in the sectionPreparation of 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 observed with normal doses and listed in section 4.

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

If you forget to take a dose

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

If you stop taking Ebilfumin

No adverse effects occur when you stop taking Ebilfumin. However, if you stop taking Ebilfumin before the time prescribed by your doctor, flu symptoms may return. Always complete the full course of treatment prescribed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Since oseltamivir has been marketed, the following serious adverse effects have rarely been reported:

• Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, itchy rash, low blood pressure, and difficulty breathing
• Liver disorders (fulminant hepatitis, liver function disorder, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior
• Angioedema: sudden, severe 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 complex, potentially life-threatening allergic reaction causing severe inflammation of the outer skin and possibly internal surfaces, initially presenting with fever, sore throat, fatigue, skin rash, blistering, peeling, and large areas of skin shedding, possible breathing difficulty 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 adverse effects (very common and common) for Ebilfumin are malaise or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These adverse effects usually occur after the first dose of the medicine and generally resolve during treatment. The frequency of these effects is reduced if the medicine is taken with food.

Rare but serious adverse effects: seek medical help immediately

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

Rare adverse effects have been reported during treatment with oseltamivir, 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 resolved quickly. In very rare cases, these events resulted in self-harm, some with fatal outcomes. These 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 behavioral changes described above.

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

Adults and adolescents aged 13 years and older

Very common adverse effects

(may affect more than 1 in 10 people)

• Headache
• Nausea

Common adverse effects

(may affect up to 1 in 10 people)

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

Uncommon adverse effects

(may affect up to 1 in 100 people)

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

Rare adverse effects

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

• Thrombocytopenia (reduced number of platelets)
• Vision disorders

Children aged 1 to 12 years

Very common adverse effects:

(may affect 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common adverse effects:

(may affect up to 1 in 10 people)

• Conjunctivitis (red, watery, or painful eyes)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach discomfort

Uncommon adverse effects:

(may affect up to 1 in 100 people)

• Skin inflammation
• Tympanic membrane disorder (eardrum)

Infants under 1 year of age

Adverse effects observed in infants aged 0 to 12 months are mostly similar to those reported in older children (aged 1 year and above). In addition, diarrhea and diaper dermatitis have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist. However,

• if you or your child have repeated episodes of illness, or
• if flu symptoms worsen or fever persists, inform your doctor as soon as possible.

Reporting of adverse effects

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

5. Storage of 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 the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebilfumin

• Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
• The other components are:

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

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

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

Appearance of the product and contents of the pack

The hard capsule consists of a body and cap, both strong yellow in colour, with a black print "OS 30". Capsule size: 4.

Ebilfumin 30 mg hard capsules EFG is available in blisters of 10 capsules.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjördur

Iceland

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {MM/YYYY} {month YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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Patient Information

For people who have difficulty swallowing capsules, including very young children, a liquid formulation of this medicine may be available.

If you need a liquid medicine but it is not available, a suspension can be prepared at 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 unavailable, you may prepare an Ebilfumin suspension at home from these capsules.

The dose is the same for treatment and for prevention of influenza. The difference lies in the frequency of administration.

Preparation of Ebilfumin liquid at home

• If you have the correct capsule for the required dose (a 30 mg or 60 mg dose), open the capsule and mix its contents with a teaspoon (or less) of suitable sweetened food. This is usually appropriate for children over 1 year of age. See the upper section of these instructions.

• If smaller doses are needed, preparing the Ebilfumin suspension from capsules requires additional steps. This is suitable for young children and infants: they generally require an Ebilfumin dose of less than 30 mg. See the lower section of these instructions.

Children from 1 to 12 years of age

To prepare a 30 mg or 60 mg dose, you will need:

• One or two Ebilfumin 30 mg capsule(s)
• Sharp scissors
• A small container
• Measuring spoon (5 ml spoon)
• Water
• Sweetened food to mask the bitter taste of the powder.

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

Step 1: Check the correct dose

To determine the correct amount to use, find the patient's weight in the left column of the table.

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

Use only the 30 mg capsules for 30 mg and 60 mg doses. Do not attempt to prepare 45 mg or 75 mg doses using the contents of 30 mg capsules. Instead, use the capsule with the appropriate dose.

Step 2: Pour all the powder into the container

Hold a 30 mg capsule vertically over a container and carefully cut off the rounded end with scissors.

Pour all the powder into the container.

For a 60 mg dose, open a second capsule. Pour all the powder into the container.

Take care with the powder, as it may be irritating to the skin and eyes.

Step 3: Sweeten the powder and administer the dose

Add a small amount—no more than a teaspoon—of sweetened food to the powder in the container.

This is to mask the bitter taste of Ebilfumin powder.

Mix well.

Give the patient immediately the entire contents of the container.

If any of the mixture remains in the container, rinse the container with a small amount of water and give it to the patient to ensure complete dosing.

Repeat this procedure each time the medication needs to be administered.

Infants under 1 year of age

To prepare a smaller single dose, you will need:

• One capsule of Ebilfumin 30 mg
• A pair of sharp scissors
• Two small containers (use separate pairs of containers for each child)
• A large oral dosing dispenser to measure water—a 5 or 10 ml dispenser
• A small oral dosing dispenser showing 0.1 ml increments to administer the dose
• A teaspoon (5 ml spoon)
• Water
• Sweetened food to mask the bitter taste of Ebilfumin.

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

Alternatively, prepare sweetened water: mix one teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a container

Hold a 30 mg capsule vertically over one of the containers and carefully cut off the rounded end with scissors. Take care with the powder, as it may be irritating to the skin and eyes.

Pour all the powder into the container, regardless of the dose being prepared.

The amount is the same for both treatment and prevention of influenza.

Step 2: Add water to dilute the medication

Do not worry if not all of the powder dissolves. The undissolved powder consists of inactive ingredients.

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

Find 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 need to prepare.

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

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 introducing air bubbles.

Gently add the correct dose to the second container.

Step 5: Sweeten and administer to the child

Add a small amount—no more than a teaspoon—of sweetened food to the second container.

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

Mix the sweetened food well with the Ebilfumin liquid.

Immediately give the child the entire contents of the second container (sweetened food mixed with Ebilfumin suspension).

If any remains in the second container, rinse the container with a small amount of water and ensure the child consumes it all. For children unable to drink directly from the container, administer the remaining liquid with a spoon or use an appropriate bottle.

Give the child something to drink afterward.

Discard any remaining liquid left in the first container.

Repeat this procedure each time the medication needs to be administered.

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Information for healthcare professionals only:

Patients unable to swallow capsules:

The marketed formulation of oseltamivir powder for oral suspension (6 mg/mL) is the preferred medication for pediatric and adult patients who have difficulty swallowing capsules or require lower doses. If oseltamivir powder for oral suspension is not available, the pharmacist may prepare a suspension (6 mg/mL) from Ebilfumin capsules. If pharmacy-prepared suspension is also unavailable, patients may prepare the suspension at home from the capsules.

Oral dosing dispensers (oral syringes) with appropriate volume and graduations must be provided to administer the pharmacy-prepared suspension and for use in home preparation procedures. In both cases, the required volumes should preferably be marked on the dispensers. For home preparation, separate dispensers must be provided to measure the correct volume of water and to measure the Ebilfumin mixture with water. To measure 5.0 mL of water, dispensers of 5 mL or 10 mL capacity should be used.

Below is the appropriate dispenser size to withdraw the correct volume of Ebilfumin suspension (6 mg/mL).

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