Oseltamivir stada

Package leaflet: Information for the user

Oseltamivir Stada, 75 mg, hard capsules
Oseltamivirum
Please read 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 consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience 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 occur and when it is known that influenza virus is circulating in the community.
• Oseltamivir Stada may also be prescribed for prophylaxis (prevention) of influenza in adults, adolescents, children and infants over 1 year of age. Each case is considered individually – for example, if the patient has had close contact with someone suffering from influenza.
• Oseltamivir Stada may be prescribed to adults, adolescents, children and infants (including full-term newborns) as preventive treatment in exceptional circumstances, such as during a global influenza epidemic (influenza pandemic), when seasonal influenza vaccine does not provide sufficient protection.

Oseltamivir Stada contains oseltamivir, which belongs to a group of medicines known as neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body. They help to relieve symptoms or prevent their occurrence in case of infection with the influenza virus.
Influenza 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 aches and extreme fatigue. Such symptoms may also be caused by other infections. True influenza infection occurs only during seasonal outbreaks (epidemics), when the influenza virus is spreading within the local community. Outside epidemic periods, flu-like symptoms are usually due to other illnesses.

2. 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 immediately. Do not take
Oseltamivir Stada.
Warnings and precautions
Before taking Oseltamivir Stada, inform the prescribing doctor:

• if the patient is allergic to other medicines
• if the patient has kidney disease. If so, the dose may need to be adjusted
• 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. Vaccines provide antibodies against the virus. Oseltamivir Stada does not reduce the effectiveness of influenza vaccination, and the doctor may prescribe both products.

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

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

Pregnancy and breastfeeding
Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans 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 the doctor if the patient is breastfeeding, so that the doctor can decide whether Oseltamivir Stada is appropriate.
Consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery
Oseltamivir Stada has no influence on the ability to drive or 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. In case of doubt, consult the doctor or pharmacist.
Oseltamivir Stada should be taken as soon as possible, preferably within the first two days after onset of influenza symptoms.

Recommended dosage
For treatment of influenza, take two doses per day, usually one in the morning and one in the evening. It is important to complete the full 5-day treatment course, even if the patient's condition improves quickly.
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 situations, such as widespread influenza outbreaks or in patients with weakened immune systems, treatment may last up to 6 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 older

• In patients with weakened immune systems, treatment lasts 10 days.
  **The 75 mg dose may consist of one 30 mg capsule and one 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 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
Method of administration
Swallow the capsules whole with water. Do not divide or chew the capsules.
Oseltamivir Stada may be taken with food or on an empty stomach. Taking the medicine with food
may reduce the risk of nausea or vomiting.
Patients who have difficulty swallowing capsules may use oseltamivir in the form of an oral
liquid suspension. If a patient requires the liquid formulation but it is not available at the pharmacy,
a liquid form of Oseltamivir Stada can be prepared from the capsules. Instructions, see Preparation
of the liquid form 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 effects were reported. When adverse effects occurred, they
were similar to those observed after recommended doses, as described in section 4.
Overdose has been reported more frequently in children than in 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 Oseltamivir Stada. However, if treatment is
discontinued earlier than recommended by the doctor, flu symptoms may return. Always complete
the full course of treatment as advised by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects listed below may also be caused by influenza itself.
The following serious side effects have been reported rarely after oseltamivir has been marketed:

• 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 behaviour
• 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 inflammation of external and even internal skin layers, 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 commonly reported side effects of oseltamivir (very common and common) are: nausea,
vomiting, stomach pain, diarrhoea, headache, and pain. These symptoms usually occur only after
the first dose and typically resolve during continued treatment. The frequency of these side
effects decreases if the medicine is taken with food.
Rare but serious side effects: 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 behaviour
• hallucinations, illusions, agitation, restlessness, nightmares

These events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In isolated 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 the behavioural changes described above.

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

• headache
• nausea

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

• bronchitis
• cold sores (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 infections)
• indigestion
• vomiting

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

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

Rare side effects (may affect up to 1 in 1,000 people)

• thrombocytopenia (low platelet count)
• visual disturbances.

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

• cough
• nasal mucosal congestion
• vomiting.

Common side effects (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 side effects (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). In addition, diarrhoea 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 side effects
If any adverse reactions occur, including any not listed in this leaflet, tell 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 may also be reported to the marketing authorisation holder or its representative. Reporting adverse reactions helps provide more information on the safety of the 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 cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of 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 75 mg of oseltamivir
• Other ingredients are:
  Capsule core: pregelatinized starch, talc, povidone K-30, sodium croscarmellose, sodium stearyl fumarate
  Capsule cap: 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 75 mg hard gelatin capsule (size "2") consists of a grey, opaque body with a black band printed with the letter "M" and a light yellow, opaque cap printed with "75 mg".
Oseltamivir Stada 75 mg hard capsules are available in blisters containing 10 capsules, packed in a cardboard box.

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 further 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 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

Information for the user
For patients who have difficulty swallowing capsules, including very young children, the medicine is available as a liquid formulation, oseltamivir oral suspension.
If the liquid formulation is required but not available, the suspension can be prepared at the 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 can 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 (75 mg dose), 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 a lower dose is required, 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 lower than 30 mg. See the bottom part of the instructions.

Adults, adolescents aged 13 years and older, and children weighing 40 kg or more
To prepare a dose of 75 mg, you will need:

• One Oseltamivir Stada 75 mg capsule
• Sharp scissors
• One small bowl
• One teaspoon (5 mL)
• 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 whether the dose is correct
To determine the correct dose, locate 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.

Dose 75 mg

To prepare the 75 mg dose, only 75 mg capsules should be used.
The 75 mg dose should not be prepared using the contents of a 30 mg or 45 mg capsule.

Do not use in children weighing less than 40 kg.
A dose lower than 75 mg must be prepared for children weighing less than 40 kg. See below.

Step 2: Pour the entire powder into a bowl
Hold the 75 mg capsule vertically over the bowl and carefully cut off the rounded end with scissors.
Pour 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 sweet food to the
powder in the bowl.
This is to neutralize the bitter taste of Oseltamivir Stada powder.
Mix well.

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 the patient all of it to drink.
Repeat the above steps each time the medicine is administered.

Infants under 1 year of age and children weighing less than 40 kg
To prepare a smaller dose, the following are required:

• One 75 mg Oseltamivir Stada capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral dosing syringe to measure water – a 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
• Sweet food to mask the bitter taste of Oseltamivir Stada, e.g., chocolate syrup, cherry syrup, or dessert topping (caramel). Alternatively, sugar water may be prepared: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Pour the entire powder into a bowl
Hold the 75 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.
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 dosing syringe to draw up 12.5 mL of water.
Add the water to the powder in the bowl.

Mix the contents of the bowl for about 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 drawn up.

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

Children aged 1 year or above, with body weight less than 40 kg

Step 4: Draw up the liquid mixture
Ensure that a dosing device of the correct volume is used.
Draw up the correct amount of liquid mixture from the first container.
Do this carefully to avoid air bubbles.
Gently squeeze the correct dose into the second container.

Step 5: Sweeten and administer to the child
Add a small amount – no more than one teaspoon – of sweet food to the second container.
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 container (the liquid mixture of Oseltamivir Stada with sweet food) to the child.
If any amount remains in the second container, rinse the container with a small amount of water and give the child all of it to drink. For children unable to drink from a cup, use a spoon or baby bottle to administer the remaining liquid.
Give the child something to drink.
Discard any unused liquid remaining in the first container.
Repeat the above steps each time the medicine is administered.

Information intended exclusively for healthcare professionals

Patients who are unable to swallow capsules:
Manufactured oseltamivir 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. When oseltamivir powder for oral suspension is not commercially available, the 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 from capsules at home. Oral dosing devices (oral syringes) of appropriate volume and graduations should be provided for administering both pharmacy-prepared suspension and for use in home preparation procedures. In both cases, dosing devices should ideally be 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 with water. To measure 5.0 mL of water, a 5 mL or 10 mL dosing device should be used. The appropriate dosing device capacity to be used for measuring the correct amount of Oseltamivir Stada suspension (6 mg/mL) is shown below.
Infants under 1 year of age (including full-term newborns)

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