Oseltamivir stada

Package leaflet: Information for the user

Oseltamivir Stada 30 mg hard capsules
Oseltamivirum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Please talk to your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Oseltamivir Stada is and what it is used for
2. What you need to know 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 Oseltamivir Stada is and what it is used for

• Oseltamivir Stada is used in adults, adolescents, children and infants (including full-term newborns) for the treatment of influenza (flu). It may be used when flu symptoms are present and when it is known that the influenza virus is circulating in the community.
• Oseltamivir Stada may also be prescribed to adults, adolescents, children and infants over 1 year of age for prevention of influenza (flu). Each case is considered individually – for example, if the patient has been in close contact with someone who has the flu.
• Oseltamivir Stada may be prescribed to adults, adolescents, children and infants (including full-term newborns) as prophylactic treatment in exceptional circumstances, such as during a global influenza epidemic (influenza pandemic), when seasonal influenza vaccine does not provide adequate protection.

Oseltamivir Stada contains the active substance 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 reduce symptoms or prevent their occurrence in case of infection with the influenza virus.
Influenza (flu) is an infectious disease caused by a virus. Flu symptoms often include sudden onset of fever (above 37.8 °C), cough, runny or blocked nose, headache, muscle pain and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during seasonal outbreaks (epidemics), when the influenza virus is spreading in the local community. Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. Important information before taking Oseltamivir Stada

When NOT to take Oseltamivir Stada

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

In such a case, contact a doctor. Do not take the medicine
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 a serious illness that may require immediate hospital treatment
• if the patient's immune system is not functioning properly
• if the patient has chronic heart disease or respiratory disease.

During treatment with Oseltamivir Stada, inform the doctor immediately:

• if the patient notices changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These symptoms may be rare but serious adverse reactions.

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

Other medicines and Oseltamivir Stada
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription. The following medicines are particularly important:

• chlorpropamide (used in the treatment of diabetes)
• methotrexate (used in the treatment, for example, of rheumatoid arthritis)
• phenylbutazone (used in the treatment of pain and inflammatory conditions)
• probenecid (used in the treatment of gout)

Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that the doctor can decide whether Oseltamivir Stada is an appropriate medicine.
The effect of Oseltamivir Stada on breastfed infants is unknown. Inform your doctor if you are breastfeeding, so that he or she can decide whether Oseltamivir Stada is appropriate.
Before taking this medicine, consult a doctor or pharmacist.
Driving and operating machinery
Oseltamivir Stada has no effect on the ability to drive and operate machinery.
Information about certain 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
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Oseltamivir Stada should be taken as soon as possible, preferably within the first two days after the onset of influenza symptoms.
Recommended dosage
For the treatment of influenza, take two doses per day, usually one in the morning and one in the evening. It is important to complete the entire 5-day treatment course, even if the patient's condition improves rapidly.
In patients with weakened immune systems, treatment will continue for 10 days.
For prevention of influenza or after contact with an infected person, take one dose per day for 10 days, preferably in the morning with breakfast.
In special circumstances, such as widespread influenza or if the patient has a weakened immune system, treatment may 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 the doctor.
Adults and adolescents aged 13 years and above

• In patients with weakened immune systems, treatment lasts for 10 days.
  **The 75 mg dose may consist of one 30 mg capsule and one 45 mg capsule.
  Children from 1 to 12 years of age

*In children with weakened immune systems, treatment lasts 10 days.
**The 75 mg dose may consist of one 30 mg capsule and one 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 by a physician after evaluating the potential benefits against the potential risks for the infant.

In infants with weakened immune systems, treatment lasts 10 days.
**mg per kg = mg per each kilogram of the infant's body weight. For example:
in a six-month-old infant weighing 8 kg, the dose is 8 kg x 3 mg per kg = 24 mg
Instructions for use
Swallow the capsules whole with water. Do not divide or chew the capsules.
Oseltamivir Stada may be taken with or without food. Taking the medicine with food
reduces the risk of nausea or vomiting.
Patients who have difficulty swallowing capsules may use oseltamivir in the form of an
oral liquid suspension. If the patient requires the suspension but it is not available at the pharmacy,
a liquid formulation of Oseltamivir Stada can be prepared from the capsules. Instructions: see Preparation
of the liquid formulation of Oseltamivir Stada at home.
Taking more than the recommended dose of Oseltamivir Stada
Stop taking Oseltamivir Stada and contact your doctor or pharmacist immediately.
In most cases of overdose, no adverse reactions were reported. When they occurred, they were similar to
the adverse reactions occurring after administration of 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. Exercise caution when preparing the liquid formulation of Oseltamivir Stada for children and when
administering Oseltamivir Stada in capsule or liquid form to children.
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 effects associated with stopping treatment with Oseltamivir Stada.
However, if treatment with Oseltamivir Stada is stopped earlier than recommended by the doctor,
flu symptoms may return. Always complete the treatment course as advised by your doctor.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Many of the adverse reactions listed below may also be caused by influenza itself.
The following serious adverse reactions have been reported rarely after oseltamivir was approved for use:

• anaphylactic and anaphylactoid reactions: severe allergic reactions with facial and skin swelling, itchy rash, low blood pressure, and breathing difficulties
• liver disorders (fulminant hepatitis, hepatic dysfunction, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior
• angioedema: sudden, pronounced swelling of the skin, mainly affecting the head and neck area, including eyes and tongue, accompanied by breathing difficulties
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complex, potentially life-threatening allergic reactions, severe inflammatory conditions affecting external and even internal layers of the skin, beginning with fever, sore throat, and fatigue, skin rashes progressing to blisters, peeling, shedding of large areas of skin, possibly accompanied by breathing difficulties and low blood pressure
• gastrointestinal bleeding: prolonged bleeding from the large intestine or haemoptysis
• neuropsychiatric disorders, as described below.

If any of these symptoms occur, seek immediate medical help.
The most frequently reported adverse reactions of oseltamivir (very common and common) are: nausea, vomiting, stomach pain, indigestion, headache, and pain. These symptoms usually occur only after the first dose and typically resolve during continued treatment. The frequency of these adverse reactions decreases if the medicine is taken with food.
Rare but serious adverse reactions: consult a doctor immediately
(may occur in no more than 1 in 1,000 people)
Rare cases have been reported during oseltamivir use:

• seizures and delirium, including disturbances of consciousness
• confusion, unusual behavior
• hallucinations, illusions, agitation, restlessness, nightmares

These events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In rare cases, they led to self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with influenza who did not take oseltamivir.

• Patients, especially children and adolescents, should be closely monitored for any of the behavioral changes described above.

If any of these symptoms occur , especially in young individuals, seek immediate medical advice.
Adults and adolescents aged 13 years and older
Very common adverse reactions (may affect more than 1 in 10 people)

• headache
• nausea

Common adverse reactions (may affect up to 1 in 10 people)

• bronchitis
• herpes labialis
• cough
• dizziness
• fever
• pain
• limb pain
• watery nasal discharge
• sleep disturbances
• sore throat
• stomach pain
• fatigue
• feeling of fullness in the upper abdomen
• upper respiratory tract infections (nasal, throat, and sinus inflammation)
• indigestion
• vomiting

Uncommon adverse reactions (may affect up to 1 in 100 people)

• allergic reactions
• disturbances of consciousness
• seizures
• cardiac rhythm disorders
• mild to severe liver function disorders
• skin reactions (dermatitis, red and itchy rash, skin peeling)

Rare adverse reactions (may affect up to 1 in 1,000 people)

• thrombocytopenia (low platelet count)
• visual disturbances

Children aged 1 to 12 years
Very common adverse reactions (may affect more than 1 in 10 people)

• cough
• nasal mucosal congestion
• vomiting

Common adverse reactions (may affect up to 1 in 10 people)

• conjunctivitis (red eyes with discharge or eye pain)
• otitis media and other ear disorders
• headache
• nausea
• watery nasal discharge
• stomach pain
• feeling of fullness in the upper abdomen
• indigestion

Uncommon adverse reactions (may affect up to 1 in 100 people)

• skin inflammation
• tympanic membrane disorders

Infants under 1 year of age
Adverse reactions observed in infants aged 0 to 12 months are usually similar to those reported in older children (aged 1 year or above). Additionally, diarrhea and diaper rash have been reported.
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

• if the patient or their child vomits repeatedly, or
• if flu symptoms worsen or fever persists, inform the doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative. Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Oseltamivir Stada
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Oseltamivir Stada contains

• Each hard capsule contains oseltamivir equivalent to 30 mg of oseltamivir.
• Other ingredients are:
  Capsule core: pregelatinised starch, talc, povidone K-30, sodium croscarmellose, and sodium stearyl fumarate
  Capsule cap: gelatine, yellow iron oxide (E 172), red iron oxide (E 172), and titanium dioxide (E 171)
  Capsule body: gelatine, yellow iron oxide (E 172), red iron oxide (E 172), and titanium dioxide (E 171)
  Printing ink: shellac (E 904), black iron oxide (E 172)

What Oseltamivir Stada looks like and contents of the pack
Oseltamivir Stada 30 mg hard capsules are size "4" hard gelatine capsules consisting of a light yellow, opaque body with a black band, printed with "M", and a light yellow, opaque cap printed with "30 mg".
Oseltamivir Stada 30 mg hard capsules are available in blister packs containing 10 capsules, packed in a cardboard carton.

Marketing Authorisation 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

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Poland
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Oseltamivir Stada
Germany: Oseltamivir STADA 30 mg Hartkapseln
Oseltamivir STADA 45 mg Hartkapseln
Oseltamivir STADA 75 mg Hartkapseln

Information for the user
For patients who have difficulty swallowing capsules, including very young children, an oral liquid formulation of this medicine is available: oseltamivir oral suspension.
If the patient requires an oral liquid formulation which is not available, the suspension may be prepared in a pharmacy from Oseltamivir Stada capsules (see Information intended exclusively for healthcare professionals). The pharmacy-prepared product is preferred.
If the pharmacy-prepared product is also unavailable, a liquid formulation of Oseltamivir Stada may be prepared at home from the capsules.
The doses are the same for both treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparing a liquid formulation of Oseltamivir Stada at home

• If the patient has the appropriate capsules for the required dose (a dose of 30 mg or 60 mg), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food product. This dose is generally appropriate for children over 1 year of age. See the top part of the instructions.
• If the patient requires a smaller dose, preparing a liquid formulation of Oseltamivir Stada from capsules involves additional steps. These are suitable for younger children and infants who usually require a dose of Oseltamivir Stada less than 30 mg. See the bottom part of the instructions.

Children aged 1 to 12 years
To prepare a dose of 30 mg or 60 mg, you will need:

• One or two Oseltamivir Stada 30 mg capsules
• Sharp scissors
• One small bowl
• Teaspoon (5 mL volume)
• Water
• Sweet food to mask the bitter taste of the powder, e.g., chocolate syrup, cherry syrup, or dessert toppings (caramel). Alternatively, prepare sugar water: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Check if the dose is correct
To determine the correct dose, find the patient's body weight in the left column of the table. Then check the number of capsules required for a single dose in the right column. The amount is the same for both treatment and prevention of influenza.

Dosage 30 mg
Dosage 60 mg

For preparing the 30 mg and 60 mg doses, only 30 mg capsules should be used. The 45 mg or 75 mg doses should not be prepared using the contents of a 30 mg capsule. In such cases, a capsule with the appropriate strength should be used.

Step 2: Empty the entire powder into a bowl
Hold the 30 mg capsule vertically over the bowl and carefully cut off the rounded end with scissors.
Empty the entire powder into the bowl.
Open a second capsule if a 60 mg dose is required. Empty the entire powder into the bowl.
Handle the powder carefully, 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 teaspoon – of a sweet food to the
powder in the bowl.
This helps neutralize the bitter taste of Oseltamivir Stada medication.
Mix thoroughly.

Immediately administer the entire contents of the bowl to the patient.
If any residue remains in the bowl, rinse the bowl with a small amount of water
and give all of it to the patient to drink.
Repeat these steps each time the medication is administered.

Infants under 1 year of age
To prepare a smaller dose, the following are required:

• One 30 mg capsule of Oseltamivir Stada
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral dosing syringe to measure water – 5 or 10 mL syringe
• One small oral dosing syringe marked in 0.1 mL increments for administering the dose
• One teaspoon (5 mL volume)
• Water
• A sweet food to neutralize the bitter taste of Oseltamivir Stada, e.g., chocolate syrup, cherry syrup, or dessert topping (caramel). Alternatively, sugar water can be prepared: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Empty the entire powder into a bowl
Hold the 30 mg capsule vertically over one of the bowls and carefully cut off the rounded end
with scissors. Handle the powder carefully, as it may be irritating to the skin and
eyes.
Empty 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 medication
Use the larger syringe to measure 5 mL of water.
Add the water to the powder in the bowl.

Mix the contents of the bowl for approximately 2 minutes using a spoon.

Do not be concerned if some of the powder does not dissolve. The undissolved
powder is inactive substance.
Step 3: Select the volume appropriate for the child's body weight
Find the child's body weight in the left column of the table.
The right column indicates the volume of the liquid mixture to be administered.
Infants under 1 year of age (including full-term newborns)

Step 4: Draw up the liquid mixture
Ensure that the dosing device of the correct volume is used.
Draw up the correct amount of liquid mixture from the first bowl.
Do this carefully to avoid creating 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 teaspoon – of sweet food to the second bowl.
This helps neutralize the bitter taste of Oseltamivir Stada.
Mix the sweet food well with the liquid form of Oseltamivir Stada.

Immediately administer the entire contents of the second bowl (the liquid mixture of Oseltamivir Stada with the sweet food) to the child.
If any mixture remains in the second bowl, rinse the bowl with a small amount of water and give the child all of it to drink. For children unable to drink from a bowl, use a spoon or a baby feeding bottle to administer the remaining liquid.
Give the child something to drink.
Discard any unused liquid remaining in the first bowl.
Repeat the above steps each time the medicine is administered.

Information intended exclusively for healthcare professionals

Patients who are unable to swallow capsules:
Commercially manufactured oseltamivir for oral suspension (6 mg/mL) is the preferred product for children, adolescents, and adult patients who have difficulty swallowing capsules or when lower doses are required. If oseltamivir oral suspension (6 mg/mL) is not commercially available, a pharmacist may prepare an oral suspension (6 mg/mL) from Oseltamivir Stada capsules. If pharmacy-prepared suspension is also unavailable, patients may prepare the suspension at home using the capsules. Oral dosing devices (oral syringes) of appropriate volume and graduations should be provided to administer the pharmacy-prepared suspension and for procedures related to home preparation of the product. In both cases, the dosing devices should be clearly marked to indicate the correct volumes. When preparing the suspension at home, separate dosing devices should be used to measure the correct amount of water and to measure the mixture of Oseltamivir Stada suspension with water. To measure 5.0 mL of water, use a 5 mL or 10 mL dosing device.
The appropriate dosing device capacity to be used for measuring the correct amount of Oseltamivir Stada suspension (6 mg/mL) is indicated below.
Infants under 1 year of age (including full-term newborns)