OSELTAMIVIR ACCORD 30 mg HARD CAPSULES

Introduction

Leaflet: information for the user

Oseltamivir Accord 30mg hard capsules EFG

Oseltamivir Accord 45mg hard capsules EFG

Oseltamivir Accord 75mg hard capsules EFG

oseltamivir phosphate

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

?Keep this leaflet, as you may need to read it again.

? If you have any doubts, consult your doctor, pharmacist, or nurse.

?This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

?If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Oseltamivir Accord and what is it used for
2. What you need to know before taking Oseltamivir Accord
3. How to take Oseltamivir Accord
4. Possible side effects
5. Storage of Oseltamivir Accord
6. Package contents and additional information

1. What is Oseltamivir Accord and what is it used for

?Oseltamivir is used in adults, adolescents, children, and infants (including newborn babies) to treat influenza (the flu). It can be used when you have flu symptoms and it is known that the flu virus is present in the population.

? Oseltamivir can also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent the flu, for example, if you have been in contact with someone who has the flu.

?Oseltamivir may be prescribed to adults, adolescents, children, and infants (including newborn babies) as preventive treatment in exceptional circumstances, for example, if there is a global flu epidemic (a flu pandemic) and when the seasonal flu vaccine cannot provide sufficient protection.

Oseltamivir Accord contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the flu virus from spreading in the body. They help to alleviate or prevent the symptoms of flu virus infection.

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

2. What you need to know before taking Oseltamivir Accord

Do not take Oseltamivir Accord:

?if you are allergic (hypersensitive) 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 this medicine.

Warnings and precautions

Consult your doctor before starting to take this medicine:

?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 severe illness that requires immediate hospitalization.

? if your immune system is not working properly.

? if you have chronic heart or respiratory disease.

Tell your doctor immediately during treatment with oseltamivir:

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

Oseltamivir is not a flu vaccine

Oseltamivir 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. Oseltamivir does not change the effectiveness of the flu vaccine, and your doctor may prescribe both.

Other medicines and Oseltamivir

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those 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 oseltamivir is suitable for you.

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

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Oseltamivir Accord contains sodium

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

3. How to take Oseltamivir Accord

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist.

Take this medicine as soon as possible, ideally within 2 days of starting to have flu symptoms.

Recommended doses

For the treatment of flu, take 2 doses a day. It is usually convenient to take one dose 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 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 1 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 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

*For patients with a weakened immune system, treatment is for 10 days.

**75 mg can be obtained with a 30 mg capsule and a 45 mg capsule.

Children 1 to 12 years

*For children with a weakened immune system, treatment is for 10 days.

**75 mg can be obtained with a 30 mg capsule and a 45 mg capsule.

Children under 1 year (0 to 12 months)

The administration of oseltamivir to children under 1 year of age to prevent flu during a pandemic should be done based on the doctor's judgment after considering the potential benefits and risks to the child.

*For children with a weakened immune system, treatment is 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.

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

People who may have difficulty swallowing the capsulescan use a liquid medicine, oseltamivir for oral suspension. If you need a liquid formulation of the medicine, but it is not available at the pharmacy, a liquid formulation can be prepared with oseltamivir capsules. See the page on Preparing Oseltamivir liquid at home.

If you take more oseltamivir than you should

Stop taking oseltamivir andconsult a doctor or pharmacist immediately.

In many cases of overdose, no side effects were reported. When side 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 oseltamivir liquid for children and when administering oseltamivir capsules or liquid to children.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take oseltamivir

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

If you stop taking oseltamivir

No side effects occur when you stop taking oseltamivir. However, if you stop taking oseltamivir before your doctor told you to, your flu symptoms may return. Always complete the treatment prescribed by your doctor.

If you have any other doubts 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 everyone gets them. Many of these side effects may be caused by the flu.

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, rash with itching, low blood pressure, and difficulty breathing.

? Hepatic 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: 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, skin rash, with blistering, peeling, and large areas of skin peeled, 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 commonly reported side effects (very common and common) for oseltamivir 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 generally tend to 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.

? Patients, especially children and adolescents, should be closely monitored 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

? Feverishness

? Cough

? Dizziness

? Fever

? Pain

? Pain in the limbs

? Runny nose

? Difficulty sleeping

? Sore throat

? Stomach pain

? Fatigue

? Feeling of fullness in the upper abdomen

? Infections of the upper respiratory tract (inflammation of the nose, throat, and sinuses)

? Stomach upset

? Vomiting

Uncommon side effects

(can affect up to 1 in 100 people)

? Allergic reactions

? Altered level of consciousness

? Seizure

? Heart rhythm disorders

? Liver function disorders, from mild to severe

? 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 more than 1 in 10 people)

? Cough

? Runny nose

? Vomiting

Common side effects

(can affect up to 1 in 10 people)

? Conjunctivitis (red and watery eyes or eye pain)

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

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

?if you or your child are sick several times, or

? if flu symptoms worsen or fever continues

Tell your doctor as soon as possible.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oseltamivir Accord

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage temperature. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Storage of the pharmaceutical preparation in suspension form: validity period of 10 days when stored below 25 ºC.

6. Container Contents and Additional Information

Composition of Oseltamivir Accord

Oseltamivir Accord 30 mg hard capsules

Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.

The other ingredients are:

Capsule content:

Pregelatinized corn starch,

Sodium croscarmellose,

Povidone,

Talc,

Stearic acid fumarate and sodium.

Capsule shell

Gelatin,

Titanium dioxide (E171),

Yellow iron oxide (E172).

Printing ink

Lacquer (E904), propylene glycol (E1520),

Indigo carmine (E132).

Oseltamivir Accord 45 mg hard capsules

Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.

The other ingredients are:

Capsule content

Pregelatinized corn starch,

Sodium croscarmellose,

Povidone,

Talc,

Stearic acid fumarate and sodium.

Capsule shell

Gelatin,

Titanium dioxide (E171),

Black iron oxide (E172).

Printing ink

Lacquer (E904), propylene glycol (E1520),

Indigo carmine (E132).

Oseltamivir Accord 75 mg hard capsules

Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.

The other ingredients are:

Capsule content

Pregelatinized corn starch,

Sodium croscarmellose,

Povidone,

Talc,

Stearic acid fumarate and sodium.

Capsule shell

Gelatin,

Titanium dioxide (E171),

Yellow iron oxide (E172),

Black iron oxide (E172).

Printing ink

Lacquer (E904), propylene glycol (E1520),

Indigo carmine (E132).

Product Appearance and Container Contents

Oseltamivir Accord 30 mg hard capsules EFG

Hard gelatin capsules of size “4” with a light yellow opaque cap and a light yellow opaque body, with the inscription “IN3” in blue ink on the cap and no inscription on the body, containing white to off-white granules (14.00 mm to 14.80 mm).

Oseltamivir Accord 45 mg hard capsules EFG

Hard gelatin capsules of size “4” with a light gray opaque cap and a light gray opaque body, with the inscription “IN2” in blue ink on the cap and no inscription on the body, containing white to off-white granules (14.00 mm to 14.80 mm).

Oseltamivir Accord 75 mg hard capsules EFG

Hard gelatin capsules of size “2” with a light yellow opaque cap and a light gray opaque body, with the inscription “IN1” in blue ink on the cap and no inscription on the body, containing white to off-white granules (17.40 mm to 18.20 mm).

Oseltamivir Accord hard capsules are available in blisters (PVC/PVDC-Al) or unit-dose precut blisters of 10 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z.o.o.,

ul. Lutomierska 50,

95-200, Pabianice,

Poland

Or

Accord Healthcare B.V.

Winthontlaan 200,

Utrecht, 3526 KV,

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Romania: Oseltamivir Accord 30 mg capsule

Oseltamivir Accord 45 mg capsule

Oseltamivir Accord 75 mg capsule

Spain: Oseltamivir Accord 30 mg hard capsules EFG

Oseltamivir Accord 45 mg hard capsules EFG

Oseltamivir Accord 75 mg hard capsules EFG

Date of Last Revision of this Leaflet: February 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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Information for the User

For people who find it difficult to swallow the capsules, including very young children, there is a liquid medicine, oseltamivir phosphate oral suspension.

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

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

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

Preparing Oseltamivir Phosphate Liquid at Home

? If you have the correct capsule for the required dose (a 30 mg, 60 mg, 45 mg, or 75 mg dose), open the capsule and shake its contents into a teaspoon (or less) of suitable sweetened food. This is usually suitable for children over 1 year of age. See the top section of the instructions.

? If you need smaller doses, preparing oseltamivir phosphate liquid from the capsules requires more steps. This is suitable for young children and babies: they need a dose of oseltamivir phosphate of less than 30 mg or 45 mg. See the lower section of the instructions.

Children from 1 to 12 years

To make a 30 mg, 60 mg, 45 mg, or 75 mg dose, you will need:

? One or two oseltamivir phosphate capsules of 30 mg or one oseltamivir phosphate capsule of 45 mg or one oseltamivir phosphate capsule of 75 mg.

? Sharp scissors

? A small container

? A spoon (5 ml spoon)

? Water

? Sweetened food to mask the bitter taste of the powder

Examples: chocolate syrup or cherry syrup and dessert sauce, such as caramel or condensed milk. Or you can prepare sugared water by mixing one spoon of water with three-quarters (3/4) of a spoon 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 to check the number of capsules you will need to give to the patient for a single dose. The amount is the same for treatment as for prevention of the flu.

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

Step 2: Pour All the Powder into the Container

Hold a 30 mg, 45 mg, or 75 mg capsule upright 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.

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 one spoon - of sweetened food to the powder in the container.

This is to mask the bitter taste of the oseltamivir phosphate 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 medicine.

Infants Under 1 Year

To Make a Smaller Single Dose, You Will Need:

? One oseltamivir phosphate capsule

? Sharp scissors

? Two small containers (use different containers for each child)

? A large oral dosing dispenser to measure the water - a 5 ml or 10 ml dispenser

? A small oral dosing dispenser that shows measurements of 0.1 ml to give the dose

? A spoon (5 ml spoon)

? Water

? Sweetened food to mask the bitter taste of oseltamivir phosphate

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

Step 1: Pour All the Powder into a Container

Hold a 30 mg, 45 mg, or 75 mg capsule upright over one of the containers and carefully cut off the rounded end with scissors. Be careful with the powder, as 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 prevention of the flu.

Step 2: Add Water to Dilute the Medicine

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 Under 1 Year (Including Newborns at Term)

Children 1 Year or Older, Weighing Less than 40 kg

Step 4: Prepare the Liquid Mixture

Make sure you have the correct dispenser size.

Carefully prepare the correct amount of liquid mixture from the first container.

Prepare it carefully to avoid getting 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 one spoon - of sweetened food to the second container.

This is to mask the bitter taste of the oseltamivir phosphate suspension.

Shake the sweetened food well with the oseltamivir phosphate liquid.

Give the child the entire contents of the second container (sweetened food with the oseltamivir phosphate liquid mixture) 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 an appropriate 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 medicine.

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Information Exclusively for Healthcare Professionals

Patients Who Cannot Swallow Capsules:

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

Oral Dosing Dispensers(oral syringes) with the correct volume and graduation should be provided to administer the suspension prepared in the pharmacy 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, separate dispensers should be provided to take the correct volume of water and to measure the oseltamivir phosphate mixture with water. To measure 5.0 ml of water, 5 ml or 10 ml dispensers should be used.

The following is the suitable dispenser size to draw the correct volume of oseltamivir phosphate suspension (6 mg/ml).

Infants Under 1 Year (Including Newborns at Term):