Segosana

Package leaflet: Information for the user

Segosana, 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, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• 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 adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 the 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 contact with someone who has the flu.
• 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 sufficient 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 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, watery nasal discharge or nasal congestion, 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 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 taking 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, contact a doctor. Do not take Segosana.

Warnings and precautions

Before taking Segosana, 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 Segosana, the patient should immediately inform the doctor

• if behavioral or mood changes occur ( neuropsychiatric events ), 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 the
influenza virus. Vaccines provide 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 includes also 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 the doctor 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 the doctor can decide whether Segosana is appropriate.
Before taking this medicine, consult a doctor or pharmacist.

Driving and operating machinery
Segosana has no influence on the ability to drive and operate machinery.

Segosana contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".

3. How to use Segosana

This medicine should always be taken according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
Segosana should be taken as soon as possible, preferably within the first two days after the onset of
flu symptoms.
Recommended doses
For the treatment of influenza, take two doses per day. It is usually 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 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. It is best to take the medicine in the morning with breakfast.
In special situations, such as during an influenza outbreak or if the patient has a weakened immune system, 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

For 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 weakened immune systems, 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
Administration method
Capsules should be swallowed whole with water. Capsules must not be broken or chewed.
Segosana may be taken with food or independently of meals, although 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 may be available as an oral suspension powder, but under a different brand name. If a patient requires an oral suspension and it is not available at the pharmacy, the patient may prepare a liquid formulation of Segosana from the capsules. See the instructions Preparing oseltamivir suspension at home included in this leaflet.
Taking more Segosana than recommended.
Stop taking Segosana and contact your doctor or pharmacist immediately.
In most cases, no adverse effects were reported following overdose. If symptoms occurred, they were similar to the adverse effects 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 and 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. Always complete the full course of treatment as directed by your doctor.
If you have any further questions about 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 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, possibly 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 reported adverse reactions of oseltamivir (very common and common) are: nausea (feeling sick, 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 reactions decreases if the medicine is taken with food.
Rare but serious adverse reactions: seek immediate medical advice (may occur in up to 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 rare cases, they led to self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in influenza patients who did not receive oseltamivir.

Patients, especially children and adolescents, should be closely monitored for 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 occur in more than 1 in 10 patients)

• Headache;
• Nausea.

Common adverse reactions
(may occur in 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, and sinusitis);
• Indigestion;
• Vomiting.

Uncommon adverse reactions
(may occur in up to 1 in 100 patients)

• Allergic reactions;
• Altered level of consciousness;
• Seizures;
• Heart rhythm disturbances;
• Mild to severe liver function disorders;
• Skin reactions (dermatitis, red and itchy rash, skin peeling).

Rare adverse reactions
(may occur in up to 1 in 1,000 patients)

• Thrombocytopenia (low platelet count);
• Visual disturbances.

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

• Cough;
• Rhinitis;
• Vomiting.

Common adverse reactions
(may occur in 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 adverse reactions
(may occur in up to 1 in 100 patients)

• Dermatitis;
• 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 and above). In addition, 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. 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 reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 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 after
"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 0 days if the suspension is stored below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Segosana contains

• Each hard capsule contains oseltamivir phosphate, equivalent to 30 mg of oseltamivir.
• Other ingredients: pregelatinized corn starch, povidone K30, sodium croscarmellose, talc, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172); printing ink (black ink TEK SW 9008): shellac, propylene glycol, concentrated ammonium hydroxide, black iron oxide (E 172), potassium hydroxide.

What Segosana looks like and contents of the pack
Hard, gelatinous capsules of size "4", with a light yellow, opaque body with a black band and printed with "M", and a light yellow, opaque cap printed with "30 mg".
The capsule size is approximately 14.37 mm.
Segosana 30 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 Member States of the European Economic Area under the following 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 a powder for oral suspension, but under a different
brand name.
If the patient requires the medicine in liquid form and this product is not available, an oral suspension may be prepared from Segosana capsules (see Information intended exclusively for healthcare professionals).
The pharmacy-prepared product is preferred.
If preparation in the pharmacy is not possible, the patient may prepare the oseltamivir suspension at home from available capsules.
The dose is the same for treatment and prevention of influenza. The difference lies in how frequently the medicine is administered.
Preparing oseltamivir suspension at home

• If capsules with appropriate doses (30 mg or 60 mg) are available, 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 over 1 year of age. See upper set of instructions.
• If smaller doses are required, preparing 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 less than 30 mg. See lower set of instructions.

Children from 1 year to 12 years of age
To prepare a 30 mg or 60 mg dose, the following are needed:

• One or two Segosana 30 mg capsules
• 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, and dessert toppings such as caramel or nougat sauce. Alternatively, sugar water can be prepared 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 to administer one dose.
The amount is the same for treatment and prevention of influenza.
30 mg dose

60 mg dose

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

Step 2: Pour the entire powder into a bowl
Hold the 30 mg capsule vertically over the bowl and carefully cut off the rounded end with scissors.
Pour the entire powder into the bowl.
Open a second capsule if a 60 mg dose is required. 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 (5 ml) – 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 these steps each time the medicine is administered.

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

• One 30 mg Segosana capsule
• Sharp scissors
• Two small bowls (use a separate pair of bowls for each child)
• One large oral dosing syringe for measuring water volume – a 5 ml or 10 ml syringe
• One small oral dosing 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. Alternatively, prepare sugar water 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 30 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 prophylaxis against influenza.

Step 2: Add water to dissolve the medicine
Use the larger dosing syringe to measure 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
Find the child's body weight in the left column of the table.
The right column 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 well with the Segosana suspension.

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 rinse water to the child to drink. In children unable to drink from a container, use a spoon or feeding bottle to administer the remaining mixture.
Give the child something to drink.
Discard any 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:
Commercially manufactured oseltamivir 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 an oral suspension powder is not accessible on the market,
a pharmacist may compound an oral suspension (6 mg/ml) from capsules. If a pharmacy-compounded 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 the pharmacy-prepared suspension, as well as for procedures related to home preparation of the suspension. In both cases, it is best if the dosing devices are clearly marked with 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 oseltamivir-water mixture. To measure 5.0 ml of water, use dosing devices with a capacity of 5 ml or 10 ml.
Please check below the appropriate dosing device volume to be used to withdraw the correct volume of oseltamivir suspension (6 mg/ml).
Infants under 1 year of age (including full-term newborns):