Oseltamivir Stada

Leaflet accompanying the packaging: information for the user

Oseltamivir Stada, 30 mg, hard capsules

Oseltamivirum

Read the leaflet carefully before taking the medicine because it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 for the treatment of influenza in adults, adolescents, children and infants (including full-term neonates). It can be used when flu symptoms have appeared 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 to prevent influenza. Each case is considered individually - for example, if the patient has had contact with a person with influenza.
• Oseltamivir Stada may be prescribed for adults, adolescents, children and infants (including full-term neonates) as preventive treatment in 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 them from occurring in case 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 only occurs 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 you are allergic(hypersensitive) to oseltamivir or any of the other ingredients of Oseltamivir Stada listed in section 6.

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

Warnings and precautions

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

• if you are allergic to other medicines
• if you have kidney disease. If so, a dose adjustment may be necessary
• if you have a severe diseasethat may require immediate hospital treatment
• if your immune system is not working properly
• if you have chronic heart disease or respiratory disease.

While taking Oseltamivir Stada, you should immediately inform your doctor:

• if you notice 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 your doctor may prescribe both products to you.

Other medicines and Oseltamivir Stada

You should tell your doctor or pharmacist about all the 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

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 the right medicine for you.
The effect of Oseltamivir Stada on breastfed infants is not known. You should inform your doctor if you are breastfeeding, so that he can decide whether Oseltamivir Stada is the right medicine for you.
Before taking this medicine, consult your doctor or pharmacist.

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

This medicine should always be taken as directed by your doctor. If you are unsure, 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

For the treatment of influenza, the recommended dose is two doses per day, usually one in the morning and one in the evening. It is important to complete the entire 5-day treatment cycle, even if the patient's condition improves quickly.
In patients with impaired immune system, treatment will be continued for 10 days.
For the prevention of influenza or after contact with a person with influenza, the recommended dose is one dose per day for 10 days, preferably in the morning during breakfast.
In special situations, such as the spread of influenza or if the patient has an impaired immune system, treatment will last up to 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 impaired immune system, treatment lasts 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 impaired immune system, 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 assessing the potential benefits and risks to the infant.

In infants with impaired immune system, 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

Capsules should be swallowed whole, with a glass of water. The 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 were 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. 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

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 you stop taking Oseltamivir Stada earlier than your doctor recommended, flu symptoms may return. You should always complete the treatment as recommended by your 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, Oseltamivir Stada can cause side effects, although not everybody gets them.
The cause of many of the side effects listed below 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 area of the head and neck, 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, starting with fever, sore throat and fatigue, skin rash, progressing to blisters, peeling, 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 further 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)
The following rare cases have been reported during the use of oseltamivir:

• 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 influenza 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 labialis
• 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 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 from 0 to 12 months of age are mostly similar to adverse reactions reported in older children (over 1 year of age). 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
• if flu symptoms worsen or fever persists, you should see a doctor as soon as possible.

Reporting side effects

If you experience any side effects, including any 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 Biocides,
Al. Jerozolimskie 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 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.
Store in a temperature 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. This will help protect the environment.

6. Contents of the pack and other information

What Oseltamivir Stada contains

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

What Oseltamivir Stada looks like and contents of the pack

The 30 mg hard gelatin capsule (size "4") consists of a light yellow, opaque body with a black band and a light yellow, opaque cap with the imprint "M" and "30 mg".
Oseltamivir Stada 30 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, please contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. 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 Hartkapseln
Oseltamivir STADA 45 mg Hartkapseln
Oseltamivir STADA 75 mg Hartkapseln

Date of last revision of the leaflet:

Information for the user

For patients who have difficulty swallowing capsules, 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).
Preferably, a product prepared in a pharmacy should be used.
If the product prepared in a pharmacy is also not available, patients can prepare a liquid form of Oseltamivir Stada from capsules at home.
Doses are the same for both flu treatment and prevention. The difference is in the frequency of administration.

Preparing a liquid form of Oseltamivir Stada at home

• If the patient has the appropriate capsulesfor the required dose (30 mg or 60 mg dose), the capsule should be opened and its contents mixed with a spoonful (or less) of a suitable sweet 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 30 mg. See the bottom of the instructions.

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

• One or two Oseltamivir Stada 30 mg capsules
• Sharp scissors
• A small bowl
• A spoon (5 mL)
• Water
• A sweet foodto 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 and three-quarters (3/4) of a spoonful of sugar.

Step 1: Check the correct dose

To determine 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 flu treatment and prevention.

Dose 30 mg
Dose 60 mg

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

Step 2: Pour the powder into a bowl

Hold the 30 mg capsuleupright over the bowl and carefully cut off the rounded end with scissors.
Pour the entire powder into the bowl.
Open the second capsule if a 60 mg dose is needed. 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 sweet food 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 anything 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 30 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 dose measurement of 0.1 mL, for administering the dose
• A spoon (5 mL)
• Water
• A sweet foodto 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 and three-quarters (3/4) of a spoonful of sugar.

Step 1: Pour the powder into a bowl

Hold the 30 mg capsuleupright 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 flu treatment and prevention.

Step 2: Add water to dissolve the medicine

Use a larger syringe to draw 5 mLof water.
Add 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. Undissolved powder is an inactive substance.
Step 3: Choose the correct amount for the child's body 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)

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 sweet food to the second bowl.
This is to neutralize the bitter taste of Oseltamivir Stada.
Mix the sweet food well with the liquid form of Oseltamivir Stada.

Immediately give the entire contentsof the second bowl (Oseltamivir Stada liquid mixture with sweet food) 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 a 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 as well as 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 a pharmacy is also not available, patients can prepare a liquid form of Oseltamivir Stada from capsules at home.
Oral dosing syringes(oral syringes) of appropriate volume and graduation should be provided for administration of the suspension prepared in a 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 a 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 neonates)