Oseltamivir Stada

Leaflet attached to the packaging: information for the user

Oseltamivir Stada, 45 mg, hard capsules

Oseltamivirum

You should carefully read the contents of the leaflet before taking the medicine because it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Oseltamivir Stada and what is it used for
• 2. Important information before taking Oseltamivir Stada
• 3. How to take Oseltamivir Stada
• 4. Possible side effects
• 5. How to store Oseltamivir Stada
• 6. Contents of the packaging and other information

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

• Oseltamivir Stada is used in adults, adolescents, children, and infants (including full-term newborns) to treat flu. It can be used when flu symptoms appear and when it is known that the flu virus is circulating in the environment.
• Oseltamivir Stada may also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent flu. Each case is considered individually - for example, if the patient has had contact with a person with flu.
• Oseltamivir Stada may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as preventive treatmentin exceptional circumstances, such as during a global flu epidemic (flu pandemic), when the seasonal flu vaccine does not provide sufficient protection.

Oseltamivir Stada 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 symptoms or prevent them from occurring in the case of flu virus infection.
Flu is an infectious disease caused by a virus. Flu symptoms often include sudden onset of fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle pain, and extreme fatigue. Such symptoms can also be caused by other infections. True flu infection only occurs during annual outbreaks of the disease (epidemics), when the flu virus spreads in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of other diseases.

2. Important information before taking Oseltamivir Stada

When NOT to take Oseltamivir Stada

• If the patient is allergic(hypersensitive) to oseltamivir or any of the other ingredients of Oseltamivir Stada listed in section 6.

In such a situation, you should contact a doctor. Do not take Oseltamivir Stada.

Warnings and precautions

Before taking Oseltamivir Stada, you should inform the doctor who prescribed the medicine:

• if the patient is allergic to other medicines
• if the patient has kidney disease. If so, a dose change may be necessary
• if the patient has a severe diseasethat may require immediate hospital treatment
• if the immune systemis not working properly
• if the patient has chronic heart diseaseor respiratory disease.

During treatment with Oseltamivir Stada, you should immediately inform your doctor:

• if the patient notices changes in behavior or mood (neuropsychiatric events), especially in children and adolescents. These symptoms can be rare but serious side effects.

Oseltamivir Stada is not a flu vaccine

Oseltamivir Stada is not a vaccine: it is used to treat or prevent the spread of the flu virus. The vaccine provides antibodies against the virus. Oseltamivir Stada does not affect the effectiveness of flu vaccination, and the doctor may prescribe both products to the patient.

Other medicines and Oseltamivir Stada

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. This includes medicines that are available 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 that your doctor can decide whether Oseltamivir Stada is a suitable medicine for you.
The effect of Oseltamivir Stada on breastfed infants is unknown. You should inform your doctor if you are breastfeeding, so that your doctor can decide whether Oseltamivir Stada is a suitable medicine for you.
You should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Oseltamivir Stada does not affect the ability to drive and use machines.

Information about some ingredients of Oseltamivir Stada

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Oseltamivir Stada

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Oseltamivir Stada should be taken as soon as possible, preferably within the first two days of the onset of flu symptoms.

Recommended dosage

To treat flu, you should take two doses a day, usually one in the morning and one in the evening. It is essential to complete the entire 5-day treatment cycle, even if the patient's condition improves quickly.
In patients with weakened immune systems, treatment will be continued for 10 days.
To prevent flu or after contact with a person with flu, you should take one dose a day for 10 days, preferably in the morning during breakfast.
In special situations, such as the spread of flu or if the patient has a weakened immune system, treatment will last for 6 weeks or 12 weeks.
The recommended dose is calculated based on the patient's body weight. You should take the number of capsules or oral suspension prescribed by your doctor.

Adults and adolescents over 13 years of age

*In patients with weakened immune systems, treatment lasts for 10 days.
** The 75 mg dose may consist of a 30 mg capsule and a 45 mg capsule.

Children from 1 year to 12 years of age

* In children with weakened immune systems, treatment lasts for 10 days.
** The 75 mg dose may consist of a 30 mg capsule and a 45 mg capsule.

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

The decision to administer Oseltamivir Stada to infants under 1 year of age for prophylaxis during a flu pandemic should be made after evaluating the potential benefits and risks to the infant.

In infants with weakened immune systems, treatment lasts for 10 days.
** mg/kg = mg per kilogram of infant body weight. For example:
in a 6-month-old infant weighing 8 kg, the dose is 8 kg x 3 mg/kg = 24 mg

Method of administration

Capsules should be swallowed whole, with water. Capsules should not be divided or crushed.
Oseltamivir Stada can be taken with or without food. Taking the medicine with food reduces the risk of nausea or vomiting.
Patients who have difficulty swallowing capsulesmay use oseltamivir in the form of an oral suspension. If the patient requires a suspension but it is not available at the pharmacy, it is possible to prepare a liquid form of Oseltamivir Stada from capsules. Instructions, see Preparing a liquid form of Oseltamivir Stada at home.

Taking a higher dose of Oseltamivir Stada than recommended

You should stop taking Oseltamivir Stada and contact your doctor or pharmacist immediately.
In most cases of overdose, no side effects have been reported. If they have been reported, they were similar to side effects that occur after taking the recommended doses, as described in section 4.
Overdose has been reported more frequently after administration of Oseltamivir Stada to children than to adults and adolescents. You should be careful when preparing a liquid form of Oseltamivir Stada for children and when administering Oseltamivir Stada to children in the form of capsules or liquid.

Missing a dose of Oseltamivir Stada

You should not take a double dose to make up for a missed capsule.

Stopping treatment with Oseltamivir Stada

There are no side effects if treatment with Oseltamivir Stada is stopped.
However, if treatment with Oseltamivir Stada is stopped earlier than recommended by your doctor, flu symptoms may return. You should always complete treatment as recommended by your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The cause of many of the following side effects may also be the flu itself.
The following serious side effects have been reported rarely after oseltamivir was approved for use:

• anaphylactic and pseudo-anaphylactic reactions: severe allergic reactions with swelling of the face and skin, itching rash, low blood pressure, and difficulty breathing
• liver disorders (fulminant hepatitis, liver function disorders, 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 in the head and neck area, including the eyes and tongue, with difficulty breathing

If you notice any of these symptoms, you should seek medical help immediately.

• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complex, potentially life-threatening allergic reaction, severe inflammation of the outer and sometimes inner layers of the skin, starting with fever, sore throat, and fatigue, skin rash, progressing to blisters, peeling, and shedding of large areas of skin, which may be accompanied by difficulty breathing and low blood pressure
• gastrointestinal bleeding: prolonged bleeding from the colon or hematemesis
• neuropsychiatric disorders, as described below.

If you notice any of these symptoms, you should seek medical help immediately.

The most common (very common and common) side effects of oseltamivir are: nausea, vomiting, stomach pain, stomach upset, headache, and pain. These symptoms usually occur only after the first dose of the medicine and usually disappear during continued use of the medicine. The frequency of these side effects decreases if the medicine is taken with food.

Rare but serious side effects: you should see a doctor immediately

(may occur in up to 1 in 100 people)
During the use of oseltamivir, rare cases of

• seizures and hallucinations, including cases of altered consciousness
• confusion, abnormal behavior
• delusions, hallucinations, agitation, anxiety, nightmares

These events, which had a sudden onset and resolution, were observed mainly in children and adolescents. In rare cases, they were the cause of self-injury, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with flu who did not take oseltamivir.

• Patients, especially children and adolescents, should be closely monitored for changes in behavior as described above.

If you notice any of these symptoms, especially in young people, you should see a doctor immediately.

Adults and adolescents over 13 years of age

Very common side effects(may occur in more than 1 in 10 people)

• headache
• nausea

Common side effects(may occur in up to 1 in 10 people)

• bronchitis
• herpes simplex
• cough
• dizziness
• fever
• pain
• limb pain
• runny nose
• sleep disorders
• sore throat
• stomach pain
• fatigue
• feeling of fullness in the upper abdomen
• upper respiratory tract infections (rhinitis, pharyngitis, and sinusitis)
• nausea
• vomiting

Uncommon side effects(may occur in up to 1 in 100 people)

• allergic reactions
• altered consciousness
• seizures
• heart rhythm disorders
• mild to severe liver function disorders
• skin reactions (dermatitis, red and itchy rash, peeling skin).

Rare side effects(may occur in up to 1 in 1000 people)

• thrombocytopenia (low platelet count)
• vision disorders.

Children from 1 year to 12 years of age

Very common side effects(may occur in more than 1 in 10 people)

• cough
• nasal congestion
• vomiting.

Common side effects(may occur in up to 1 in 10 people)

• conjunctivitis (red eyes and discharge or pain in the eye)
• otitis and other ear diseases
• headache
• nausea
• runny nose
• stomach pain
• feeling of fullness in the upper abdomen
• nausea

Uncommon side effects(may occur in up to 1 in 100 people)

• dermatitis
• eardrum disorders.

Infants under 1 year of age

Adverse reactions reported in infants from 0 to 12 months of age are mostly similar to those reported in older children (over 1 year of age). Additionally, diarrhea and diaper rash have been reported.
If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

• If the patient or their child vomits repeatedly, or
• .

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oseltamivir Stada

The medicine should be stored out of 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.
Store at a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oseltamivir Stada contains

• Each hard capsule contains oseltamivir in an amount equivalent to 45 mg of oseltamivir.
• The other ingredients are: capsule core: cornstarch, talc, povidone K-30, sodium croscarmellose, and sodium stearyl fumarate; capsule shell: gelatin, iron oxide black (E 172), and titanium dioxide (E 171); capsule body: gelatin, iron oxide black (E 172), and titanium dioxide (E 171); ink for printing: shellac (E 904), iron oxide black (E 172)

What Oseltamivir Stada looks like and what the pack contains

The 45 mg hard gelatin capsule consists of a gray, opaque body with a black band and the imprint "M" and a gray, opaque cap with the imprint "45 mg".
Oseltamivir Stada 45 mg hard capsules are available in a blister pack of 10 capsules, in a cardboard box.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

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

Poland:
Oseltamivir Stada
Germany:
Oseltamivir STADA 30 mg hard capsules
Oseltamivir STADA 45 mg hard capsules
Oseltamivir STADA 75 mg hard capsules

Date of last revision of the leaflet:

Information for the user

For patients who have difficulty swallowing capsules, there is a medicine in a liquid form, oseltamivir oral suspension.
If the patient needs a liquid form that is not available, a suspension can be prepared from Oseltamivir Stada capsules. See Preparing a liquid form of Oseltamivir Stada at home.

Preparing a liquid form of Oseltamivir Stada at home

• If the patient has the appropriate capsulesfor the required dose (45 mg dose), the contents of the capsule should be mixed with a spoonful (or less) of a suitable sweetened food product. This dose is usually suitable for children over 1 year of age. See the top of the instructions.
• If the patient requires a smaller dose, preparing a liquid form of Oseltamivir Stada from capsules involves additional steps. These are suitable for younger children and infants who usually require a smaller dose of Oseltamivir Stada than 45 mg. See the bottom of the instructions.

Children from 1 year to 12 years of age To prepare a 45 mg dose, you will need:

• One Oseltamivir Stada 45 mg capsule
• Sharp scissors
• One small bowl
• A 5 mL spoon
• Water
• A sweet food productto neutralize the bitter taste of the Oseltamivir Stada powder, such as chocolate syrup, cherry syrup, or dessert toppings (caramel). You can also prepare sugar water: mix 1 spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Check if the dose is correct

To determine the correct dose, find the patient's weight in the left column of the table.
Then check the right column to see how many capsules are needed to give one dose.
The amount is the same for both treating and preventing flu.

Dose of 45 mg

To prepare a 45 mg dose, only 45 mg capsules should be used. Do not prepare a 30 mg, 60 mg, or 75 mg dose using the contents of a 45 mg capsule. In such a case, use a capsule of the appropriate strength.

Step 2: Pour the powder into the bowl

Hold the 45 mg capsulevertically over the bowl and carefully cut off the rounded end with scissors.
Pour the entire powder into the bowl.
Be careful when handling the powder, as it may be irritating to the skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount - no more than one spoonful - of sweetened food product to the powder in the bowl.
This is to neutralize the bitter taste of the Oseltamivir Stada powder.
Mix well.

Immediately give the entire contentsof the bowl to the patient.
If any mixture remains in the bowl, rinse the bowl with a small amount of water and give the patient everything to drink. Repeat the above steps each time you give the medicine.

Infants under 1 year of age

To prepare a smaller dose, you will need:

• One Oseltamivir Stada 45 mg capsule
• Sharp scissors
• Two small bowls(use a separate pair of bowls for each child)
• A large oral syringeto measure water - 5 or 10 mL syringe
• A small oral syringeshowing a dose measurement of 0.1 mL, for administering the dose
• A 5 mL spoon
• Water
• A sweet food productto neutralize the bitter taste of Oseltamivir Stada, such as chocolate syrup, cherry syrup, or dessert toppings (caramel). You can also prepare sugar water: mix 1 spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Pour the powder into the bowl

Hold the 45 mg capsulevertically over one of the bowls and carefully cut off the rounded end with scissors. Be careful when handling the powder, as it may be irritating to the skin and eyes.
Pour the entire powder into the bowl, regardless of the dose being prepared. The amount is the same for both treating and preventing flu.

Step 2: Add water to dissolve the medicine

Use a larger syringe to draw 7.5 mL of water.
Add the water to the powder in the bowl.

Mix the contents of the bowl for about 2 minutes with a spoon.

Do not worry if some of the powder does not dissolve. The undissolved powder is an inactive substance.

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

Find the child's weight in the left column of the table.
The right column of the table indicates the volume of the liquid mixture to be drawn.

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

Step 4: Draw the liquid mixture

Make sure to use a syringe of the correct volume.
Draw the correct amount of liquid mixture from the first bowl.
Draw carefully to avoid air bubbles.
Gently squeeze the correct dose into the second bowl.

Step 5: Sweeten and give to the child

Add a small amount - no more than one spoonful - of sweetened food product to the second bowl.
This is to neutralize the bitter taste of Oseltamivir Stada.
Mix the sweetened food product well with the liquid form of Oseltamivir Stada.

Immediately give the entire contentsof the second bowl (Oseltamivir Stada liquid mixture with sweetened food product) to the child.
If anything remains in the second bowl, rinse the bowl with a small amount of water and give the child everything to drink. For children who are unable to drink from a bowl, use a spoon or baby bottle to give the remaining liquid. Give the child something to drink.
Discard any unused liquid that remains in the first bowl.

Repeat the above steps each time you give the medicine.
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Information intended only for healthcare professionals

Patients who are unable to swallow capsules:

Commercially available oseltamivir in the form of an oral suspension (6 mg/mL) is the preferred product for children and adolescents and adult patients who have difficulty swallowing capsules or require smaller doses. In the event that oseltamivir oral suspension is not available on the market, a pharmacist can prepare a suspension (6 mg/mL) from Oseltamivir Stada capsules. If the suspension prepared in the pharmacy is also not available, patients can prepare a suspension from capsules at home. You should ensure that oral syringes(oral syringes) of the correct volume and graduation are available for administering the suspension prepared in the pharmacy and for the procedures related to preparing the product at home. In both cases, it is best if the correct volumes are marked on the syringes. When preparing the solution at home, separate syringes should be used to draw the correct amount of water and to measure the Oseltamivir Stada mixture with water. To measure 5.0 mL of water, use a 5 mL or 10 mL syringe. The suitable capacity of the syringe to be used to draw the correct amount of Oseltamivir Stada suspension (6 mg/mL) is presented below.

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