Oseltamivir Stada

Leaflet accompanying the packaging: information for the user

Oseltamivir Stada, 75 mg, hard capsules

Oseltamivirum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do 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 not listed in this leaflet, please 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 pack 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 neonates) for the treatment of influenza. It can be used when flu symptoms appear and when it is known that the influenza virus is circulating in the environment.
• Oseltamivir Stada may also be prescribed for adults, adolescents, children, and infants over 1 year of age for the prevention of influenza. Each case is considered individually - for example, if the patient has had contact with a person sick with influenza.
• Oseltamivir Stada may be prescribed for adults, adolescents, children, and infants (including full-term neonates) as prophylactic treatmentin exceptional circumstances, such as during a global influenza epidemic (influenza pandemic), when the seasonal influenza vaccine does not provide sufficient protection.

Oseltamivir Stada contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body. They help to alleviate symptoms or prevent their occurrence in the event of influenza virus infection.
Influenza is an infectious disease caused by a virus. Influenza 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 influenza infection occurs only during annual outbreaks of the disease (epidemics), when the influenza 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, contact a doctor. Do not take Oseltamivir Stada.

Warnings and precautions

Before taking Oseltamivir Stada, 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 adjustment may be necessary
• if the patient has 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, immediately inform the 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 an influenza vaccine

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

Other medicines and Oseltamivir Stada

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently. 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 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. Inform your doctor if you are breastfeeding, so that they can decide whether Oseltamivir Stada is a suitable medicine for you.
Consult your 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, i.e., the medicine is considered "sodium-free".

3. How to take Oseltamivir Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Oseltamivir Stada should be taken as soon as possible, preferably within the first two days of the onset of influenza symptoms.

Recommended dosage

For the treatment of influenza, 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.
For the prevention of influenza or after contact with an infected person, take one dose a day for 10 days, preferably in the morning during breakfast.
In special situations, such as the spread of influenza or if the patient has a weakened immune system, treatment will last up to 6 weeks or 12 weeks.
The recommended dose is calculated based on the patient's body weight. Take the number of capsules or oral suspension prescribed by your doctor.

Adults and adolescents aged 13 and over

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

Children aged 1 to 12 years

*In children with weakened immune systems, treatment lasts 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 an influenza pandemic should be made after evaluating the potential benefits and risks for the infant.

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

Method of administration

Swallow the capsules whole with water. Do not divide or crush the capsules.
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

Stop taking Oseltamivir Stada and contact a doctor or pharmacist immediately.
In most cases of overdose, no adverse reactions have been reported. If they were reported, they were similar to adverse reactions 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. Caution should be exercised 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

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

Stopping treatment with Oseltamivir Stada

There are no adverse reactions if treatment with Oseltamivir Stada is stopped.
However, if treatment with Oseltamivir Stada is stopped earlier than recommended by the doctor, influenza symptoms may return. Always complete the treatment as recommended by the doctor.
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.
The cause of many of the following side effects may also be influenza itself.
The following serious side effects have been reported rarely after oseltamivir was approved:

• 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
• 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, beginning with fever, sore throat, and fatigue, skin rash, 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, seek medical help immediately.

The most common (very common and common) adverse reactions to 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 further use of the medicine. The frequency of these adverse reactions decreases if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately

(may occur in up to 1 in 1000 people)
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-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with influenza who did not take oseltamivir.

• Patient, 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, seek medical help immediately.

Adults and adolescents aged 13 and over

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 labialis
• cough
• dizziness
• fever
• pain
• limb pain
• runny nose
• sleep disturbances
• 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 aged 1 to 12 years

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 media 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 under 1 year of age (0-12 months) are mostly similar to adverse reactions reported in older children (1 year of age or older). Additionally, diarrhea and diaper rash have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 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 not listed in this leaflet, please tell your doctor. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration 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

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 stated.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Oseltamivir Stada contains

• Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir
• The other ingredients are: capsule core: maize starch, talc, povidone K-30, sodium stearyl fumarate; capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171); capsule body: gelatin, iron oxide black (E 172), titanium dioxide (E 171); printing ink: shellac (E 904), iron oxide black (E 172)

What Oseltamivir Stada looks like and contents of the pack

The Oseltamivir Stada 75 mg hard capsule (size "2") consists of a gray, opaque body with a black band and the imprint "M" and a light yellow, opaque cap with the imprint "75 mg".
Oseltamivir Stada 75 mg hard capsules are available in blisters containing 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, please 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, including very young children, there is a liquid form of the medicine, oseltamivir oral suspension.
If the patient needs a liquid form that is not available, a suspension can be prepared from Oseltamivir Stada capsules (see Information intended only for healthcare professionals).
The preferred product is the one prepared in the pharmacy.
If the pharmacy-prepared product is also not available, it is possible to prepare a liquid form of Oseltamivir Stada from capsules at home.
The doses are the same for both the treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparing a liquid form of Oseltamivir Stada at home

• If the patient has the appropriate capsulesfor the required dose (75 mg dose), open the capsule and mix its contents with a spoonful (or less) of an appropriate 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 dose of Oseltamivir Stada smaller than 30 mg. See the bottom of the instructions.

Adults, adolescents aged 13 and over, and children with a body weight of 40 kg or more To prepare 75 mg, you will need:

• One Oseltamivir Stada 75 mg capsule
• Sharp scissors
• One small bowl
• A 5 mL spoon
• Water
• Sweetened food productto neutralize the bitter taste of the Oseltamivir Stada powder, e.g., 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 the correct dose

Find the patient's weight in the left column of the table.
The right column of the table indicates the number of capsules needed to administer one dose.
The amount is the same for both treatment and prevention of influenza.

Dose 75 mg

To prepare a 75 mg dose, use only 75 mg capsules. Do not prepare a 75 mg dose using the contents of a 30 mg or 45 mg capsule.

Do not use in children with a body weight of less than 40 kg.

Prepare a dose smaller than 75 mg for children with a body weight of less than 40 kg. See below.

Step 2: Pour the powder into the bowl

Hold the 75 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 administer the dose

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

Immediately administer 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 administer it to the patient to drink all of it. Repeat the above steps each time you give the medicine.

Infants under 1 year of age and children with a body weight of less than 40 kg

To prepare a smaller dose, you will need:

• One Oseltamivir Stada 75 mg capsule
• Sharp scissors
• Two small bowls(use a separate pair of bowls for each child)
• A large oral dosing syringeto measure water - 5 or 10 mL syringe
• A small oral dosing syringeshowing a measurement of 0.1 mL, for administering the dose
• A 5 mL spoon
• Water
• Sweetened food productto neutralize the bitter taste of Oseltamivir Stada, e.g., 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 75 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 treatment and prevention of influenza.

Step 2: Add water to dissolve the medicine

Use the larger syringe to draw 12.5 mL of water.
Add the water to the powder in the bowl.

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

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 neonates)

Children aged 1 year or older with a body weight of less than 40 kg

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 administer to the child

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

Immediately administer 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 administer it to the child to drink all of it. For children who are unable to drink from a bowl, use a spoon or a baby bottle to administer 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.

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 for adult patients who have difficulty swallowing capsules or require smaller doses. If oseltamivir oral suspension is not available on the market, the pharmacist can prepare a suspension (6 mg/mL) from Oseltamivir Stada capsules. If the pharmacy-prepared suspension is also not available, patients can prepare a suspension from capsules at home.
Ensure that oral dosing syringes(oral syringes) of suitable 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 syringes are marked with the correct volumes. When preparing the solution at home, use separate syringes to draw the correct amount of water and to measure the Oseltamivir Stada mixture with water.
To measure 5.0 mL of water, use 5 mL or 10 mL syringes.
The suitable volume 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 neonates)

Children aged 1 year or older with a body weight of less than 40 kg