Segosana

Package leaflet: Information for the user

Segosana, 45 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it 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, tell your doctor or pharmacist. See section 4.

Package leaflet contents:

1. What Segosana is and what it is used for
2. What you need to know before taking Segosana
3. How to take Segosana
4. Possible side effects
5. How to store Segosana
6. Contents of the pack and other information

1. What Segosana is and what it is used for

• Segosana 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.
• Segosana may also be prescribed to adults, adolescents, children and infants over 1 year of age for prevention of influenza, on an individual basis, for example, if the patient has been in close contact with someone who has influenza.
• Segosana may be prescribed to adults, adolescents, children and infants (including full-term newborns) as prophylactic treatment in exceptional circumstances, for example, during a global influenza epidemic (influenza pandemic), when seasonal influenza vaccine does not provide adequate protection.

Segosana 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 reduce the severity of symptoms or prevent their occurrence if infected 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, watery nasal discharge or nasal congestion, headache, muscle aches and extreme fatigue. These symptoms may also be caused by other infections.
True influenza infection occurs only during seasonal outbreaks (epidemics), when influenza viruses are circulating in the local community. Outside epidemic periods, flu-like symptoms are usually due to other types of infection or illness.

2. Important information before using Segosana

When not to take Segosana

• if the patient is allergic ( hypersensitive ) to oseltamivir or to any of the other ingredients of this medicine listed in section 6. If this applies to the patient, the patient should contact a doctor. Do not take Segosana.

Warnings and precautions
Before taking Segosana, inform the doctor who prescribed the medicine

• if the patient has an allergy to other medicines.
• if the patient has kidney disease. If so, a dose adjustment may be required.
• 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 Segosana, the patient should inform the doctor immediately

• if behavioral or mood changes ( neuropsychiatric events ) occur, especially in children and adolescents. These may be symptoms of rare but serious adverse reactions.

Segosana is not an influenza vaccine
Segosana is not a vaccine: it is used to treat influenza infection or to prevent the spread of
influenza virus. A vaccine provides antibodies against the virus. Segosana does not affect
the effectiveness of influenza vaccination, and the doctor may prescribe both products.
Segosana and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This also includes medicines available without a prescription. The following medicines are particularly important:

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

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
inform the doctor so that he or she can decide whether Segosana is appropriate.
The effect of oseltamivir on breastfed infants is unknown. If the patient is breastfeeding, she should
inform the doctor so that he or she can decide whether Segosana is appropriate.
Consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Segosana has no influence on the ability to drive or operate machinery.
Segosana contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use the medicine Segosana

This medicine should always be taken exactly as directed by the physician. If in doubt, consult a
physician or pharmacist.
The medicine Segosana should be taken as soon as possible, preferably within the first two days after
the onset of flu symptoms.
Recommended doses
For treatment of influenza, two doses per day should be taken. It is generally best to take one
dose 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 rapidly.
In patients with weakened immune systems, treatment will continue for 10 days.
For prevention of influenza or after contact with an infected person, one dose per day should be
taken for 10 days. It is best to take the medicine in the morning with breakfast.
In special situations, such as widespread influenza outbreaks or in patients with compromised immune
systems, treatment may last up to 6 or 12 weeks.
The recommended dose is calculated based on the patient's body weight. The number of capsules
or oral suspension prescribed by the physician should be taken.
Adults and adolescents aged 13 years and older

*In patients with a weakened immune system, treatment lasts 10 days.
**The 75 mg dose may consist of one 30 mg capsule and one 45 mg capsule
Children from 1 year of age 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 to 12 months)
The decision to administer Segosana to infants under 1 year of age for prophylaxis during an influenza pandemic should be made by the attending physician after evaluating the potential benefits against the potential risks for the infant.

In infants with a weakened immune system, treatment lasts 10 days.
mg per kg = mg per each kilogram of the infant's body weight. For example:
if a 6-month-old infant weighs 8 kg, the dose is
8 kg x 3 mg per kg = 24 mg

Instructions for use
Capsules must be swallowed whole with water. Capsules must not be broken or chewed.

Segosana may be taken with food or independently of meals; however, taking the medicine with food reduces the risk of nausea or vomiting.

Patients who have difficulty swallowing capsules may use liquid formulations of the medicine. Oseltamivir oral suspension powder may be available under a different brand name. If a patient requires oral suspension and it is not available at the pharmacy, the patient may prepare a liquid formulation of Segosana capsules at home. See the instructions titled Preparing oseltamivir suspension at home included in this leaflet.

Accidental overdose of Segosana
Stop taking Segosana and contact your doctor or pharmacist immediately.

In most cases of overdose, no adverse effects were reported. When adverse effects did occur, 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. Caution should be exercised when preparing the liquid formulation of Segosana for children, as well as when administering Segosana in capsule or liquid form to children.

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

Stopping treatment with Segosana
There are no adverse effects associated with stopping treatment with Segosana. However, if treatment is stopped earlier than recommended by the doctor, flu symptoms may return. Treatment should always be completed according to the doctor's instructions.

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 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 since 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, liver function abnormalities, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior.
• Angioedema: sudden, significant 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 skin layers, beginning with fever, sore throat, and fatigue, progressing to skin rashes, blisters, peeling, and shedding of large areas of skin, which may be accompanied by

breathing difficulties and low blood pressure.

• Gastrointestinal bleeding: prolonged bleeding from the large intestine or hemoptysis.
• Neuropsychiatric disorders, as described below.

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

• seizures and delirium, including cases of altered consciousness;
• confusion, unusual behavior;
• hallucinations, illusions, agitation, anxiety, nightmares. These events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In sporadic 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 behavioral changes described above. If any of these symptoms occur, particularly in young individuals, seek immediate medical attention.

Adults and adolescents aged 13 years and older
Very common side effects
(may affect more than 1 in 10 patients)

• headache;
• nausea.

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

• bronchitis;
• herpes virus infection;
• 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 (rhinitis, pharyngitis, sinusitis);
• indigestion;
• vomiting.

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

• allergic reactions;
• altered level of consciousness;
• seizures;
• heart rhythm disorders;
• 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 patients)

• thrombocytopenia (low platelet count);
• visual disturbances.

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

• cough;
• rhinitis;
• vomiting.

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

• conjunctivitis (red eyes with discharge or eye pain);
• otitis 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 patients)

• dermatitis;
• tympanic membrane disorders.

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

• 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 effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, phone: +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 Segosana

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister labeled
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 30°C.
Storage of the suspension prepared in the pharmacy
The shelf life is 10 days if the suspension is stored below 25°C.
Do not dispose of medicines 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 Segosana contains

• Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
• Other ingredients:
• pregelatinized maize starch, povidone K30, sodium croscarmellose, talc, sodium stearyl fumarate;
• capsule shell: gelatin, titanium dioxide (E 171), iron oxide black (E 172);
• printing ink (black ink TEK SW 9008): shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

What Segosana looks like and contents of the pack
Hard, gelatinous capsules, size “4”, with a grey, opaque body with a black band and printed with “M”, and a grey, opaque cap printed with “45 mg”. The capsule size is approximately 14.37 mm.
Segosana 45 mg hard capsules are available in blister packs containing 10 capsules.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA3000 Paola
Malta

This medicinal product is authorised for marketing in the European Economic Area under the following trade names:
Netherlands, Czech Republic, Hungary, Poland, Romania, Slovakia: Segosana
Bulgaria: Сегосана

Information for the user
For patients who have difficulty swallowing capsules, including very young children, oseltamivir may be available as an oral suspension powder, but under a different brand name.
If the patient requires the medicine in liquid form and this is not available, an oral suspension may be prepared from Segosana capsules (see Information intended exclusively for healthcare professionals).
A pharmacy-prepared product is preferred.
If pharmacy preparation is not possible, the patient may prepare an oseltamivir suspension at home using available capsules.
The dose is the same for both treatment and prevention of influenza. The difference lies in how frequently the medicine is administered.

Preparation of oseltamivir suspension at home:

• If capsules with the appropriate dose are available (45 mg dose), open the capsule and mix its contents with no more than one teaspoon of a suitable sweetened food product. This dose is generally suitable for children above 1 year of age. See the upper set of instructions.
• If smaller doses are required, preparing an oseltamivir suspension from capsules involves additional steps. The dose is appropriate for younger children with relatively low body weight and infants who usually require a dose of Segosana lower than 45 mg. See the lower set of instructions.

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

• One Segosana 45 mg capsule
• Sharp scissors
• One small bowl
• One teaspoon (5 ml capacity)
• Water
• Sweet food to mask the bitter taste, for example: chocolate syrup or cherry syrup, dessert toppings such as caramel or nougat sauce. Alternatively, prepare a sugar-water solution by mixing 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, locate the patient's body weight in the left column of the table. Then check the right column for the number of capsules required for a single dose. The amount is the same for both treatment and prevention of influenza.
45 mg dose

Only use 45 mg capsules to prepare a 45 mg dose.
Do not attempt to prepare a 30 mg, 60 mg, or 75 mg dose using the contents of a 45 mg capsule.
In such cases, use a capsule with the appropriate strength.

Step 2: Pour the entire powder into a bowl
Hold the 45 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 suspension and administer it to the patient
Add a small amount of sweet food – no more than one teaspoon – to the powder poured into the bowl.
This will neutralize the bitter taste of Segosana powder.
Mix the mixture 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 the remaining liquid to the patient to drink.
Repeat the above steps with each administration of the medicine.

Infants under 1 year of age
To prepare smaller individual doses, the following are required:

• One 45 mg Segosana capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral syringe for measuring water volume – a 5 ml or 10 ml syringe
• One small oral syringe with 0.1 ml graduations for administering the dose
• One teaspoon (5 ml capacity)
• Water
• Sweet food to neutralize the bitter taste of Segosana medicine. For example: chocolate syrup or cherry syrup, dessert toppings such as caramel or nougat sauce. Sugar water can also be prepared by mixing 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 45 mg capsule vertically over one bowl 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 whether the patient is being treated for influenza or receiving it for influenza prevention.

Step 2: Add water to dissolve the medicine
Use the larger syringe to measure 7.5 ml of water.
Add the water to the powder in the bowl.

Mix the mixture for approximately 2 minutes using a teaspoon.

Do not be concerned if the powder does not completely dissolve. The undissolved particles consist of inactive ingredients.

Step 3: Adjust the volume of suspension according to the child's body weight
Locate the child's body weight in the left column of the table.
The right column of the table indicates the volume of suspension to be administered.

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

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

Step 5: Sweeten the suspension and administer the suspension to the child.
Add a small amount of sweet food – no more than one teaspoon – to the second container.
This will neutralize the bitter taste of Segosana.
Mix the sweet food with Segosana thoroughly.

Immediately administer the entire contents of the second container (Segosana suspension mixed 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 the rinse water to drink. In children unable to drink from a container, use a spoon or a baby feeding bottle to administer the remaining mixture.
Give the child something to drink.
Discard all unused suspension remaining in the first container.
Repeat the above steps with each dose of the medicine.

Information intended exclusively for healthcare professionals

Patients who have difficulty swallowing capsules:
Manufactured oseltamivir in the form of a powder 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. When the commercially available product containing
oseltamivir as a powder for oral suspension is not accessible on the market, a pharmacist may
compound an oral suspension (6 mg/ml) from capsules. If pharmacy-compounded suspension is
also unavailable, patients may prepare such a suspension at home from capsules.
Oral dosing syringes (oral syringes) of appropriate volume and graduations should be provided to
administer the pharmacy-prepared suspension, as well as for procedures related to home preparation
of the suspension. In both cases, it is best if the syringes are clearly marked with the correct volumes.
When preparing the suspension at home, separate syringes should be used to measure the correct
amount of water and to measure the oseltamivir-water mixture. To measure 5 ml of water, use
syringes with a capacity of 5 ml or 10 ml.
Please check below the appropriate syringe volume to be used to measure the correct volume of
oseltamivir suspension (6 mg/ml).
Infants under 1 year of age (including full-term newborns):