Segosana

Leaflet accompanying the packaging: information for the user

Segosana, 30 mg, hard capsules

Oseltamivir

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, as 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 inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Segosana and what is it used for
• 2. Important information 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 is Segosana and what is it used for

• Segosana is used in adults, adolescents, children, and infants (including full-term newborns) for the treatment of influenza. It can be used when flu symptoms appear and when it is known that the influenza virus is circulating in the environment.
• Segosana may also be prescribed for adults, adolescents, children, and infants over 1 year of age for the prevention of influenza, on an individual basis, for example, if the patient has had contact with someone with the flu.
• Segosana may be prescribed for adults, adolescents, children, and infants (including full-term newborns) as preventive treatmentin exceptional cases, for example, during a global influenza epidemic (influenza pandemic), when the seasonal flu 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 alleviate symptoms or
prevent their occurrence in case of influenza virus infection.
Influenza is an infectious disease caused by a virus. Flu symptoms often include sudden onset of
fever (above 37.8°C), cough, runny nose or nasal congestion, headache, muscle pain, and extreme fatigue. Such symptoms can also be caused by other infections.
True influenza infection occurs only during annual outbreaks of the disease (epidemics),
when influenza viruses spread in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of other types of infections or other diseases.

2. Important information before taking Segosana

When not to take Segosana

• If the patient is allergic(hypersensitive) to oseltamivir or any of the other ingredients of this medicine listed in section 6.

If this applies to the patient, they should contact their doctor. Do not take Segosana.

Warnings and precautions

Before taking Segosana, the patient should 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 severe illnessthat may require immediate hospital treatment.
• If the patient's immune system is not working properly.
• If the patient has chronic heart disease or respiratory disease.

During treatment with Segosana, the patient should immediately inform their doctor

• If the patient notices changes in behavior or mood(neuropsychiatric events), especially in children and adolescents. These may be symptoms of rare but serious side effects.

Segosana is not a flu vaccine

Segosana 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. Segosana does not affect the effectiveness of flu vaccination, and the doctor may prescribe both products to the patient.

Segosana and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those 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

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should inform their doctor so that they can decide whether Segosana is suitable.
The effect of oseltamivir on breastfed infants is unknown. If the patient is breastfeeding, they should inform their doctor so that they can decide whether Segosana is suitable.
The patient should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Segosana does not affect the ability to drive or use machines.

Segosana contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that it is essentially 'sodium-free'.

3. How to take Segosana

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
Segosana should be taken as soon as possible, preferably within the first two days of the onset of flu symptoms.

Recommended doses

For the treatment of influenza, the patient should take two doses a day. It is usually best to take one dose in the morning and one in the evening. It is essential to complete the entire 5-day treatment cycle, even if the patient's condition improves quickly.
In patients with a weakened immune system, treatment will be continued for 10 days.
For the prevention of influenza or after contact with an infected person, the patient should take one dose a day for 10 days. It is best to take the medicine in the morning with breakfast.
In special situations, such as the spread of influenza 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.The patient should take the amount of capsules or oral suspension prescribed by their doctor.

Adults and adolescents from 13 years of age

*In patients with weakened immune systems, treatment lasts 10 days.
**The 75 mg dose may consist of a 30 mg capsule and a 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 a 30 mg capsule and a 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 after assessing the potential benefits and risks for the infant.

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

Method of administration

Capsules should be swallowed whole, with water. The capsules should not be broken or chewed.
Segosana can be taken with or without food, although taking the medicine with food reduces the risk of nausea or vomiting.
Patients who have difficulty swallowing capsulesmay use liquid forms of the medicine; oseltamivir may be available as a powder for oral suspension, but under a different trade name. If the patient needs an oral suspension and it is not available in the pharmacy, the patient may prepare a liquid form of Segosana from capsules. Seethe Preparation of oseltamivir suspension at homeinstructions, which are included in this leaflet.

Taking a higher dose of Segosana than recommended.

The patient should stop taking Segosana and contact their doctor or pharmacist immediately.
In most cases of overdose, no adverse reactions have been reported. If they have been reported, they were similar to adverse reactions after taking the recommended doses, as described in section 4.
Overdose has been reported more frequently after administration of oseltamivir to children than to adults and adolescents.
Care should be taken when preparing a liquid form of Segosana for children and when administering Segosana to children in capsule or liquid form.

Missing a dose of Segosana

The patient should not take a double dose to make up for a missed capsule.

Stopping treatment with Segosana

There are no adverse reactions if the patient stops taking Segosana. However, if the patient stops taking Segosana earlier than their doctor recommended, flu symptoms may return. The patient should always complete the treatment as recommended by their doctor.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Segosana can cause side effects, although not everybody gets them.
The cause of many of the following side effects may also be the flu itself.
The following serious side effects have been reported rarely after oseltamivir was made available:

• Anaphylactic and pseudoanaphylactic 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 head and neck area, 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, and 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 the patient notices any of these symptoms, they should seek medical help immediately.

The most common (very common and common) adverse reactions to oseltamivir are: feeling sick (nausea, vomiting), stomach pain, indigestion, headache, and pain. These symptoms usually occur only after the first dose of the medicine and usually disappear during continued treatment. The frequency of these adverse reactions decreases if the medicine is taken with food.

Rare but serious side effects: the patient should seek medical help immediately

(may affect up to 1 in 1,000 patients)
During treatment with oseltamivir, rare cases have been reported, including

• Seizures and hallucinations, including changes in consciousness;
• Confusion, unusual behavior;
• Delusions, hallucinations, agitation, anxiety, nightmares. These events, which had a sudden onset and resolution, were mostly observed 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.
• Patient, especially children and adolescents, should be closely monitored for changes in behavior as described above. If the patient notices any of these symptoms, especially in young people, they should seek medical help immediately.

Adults and adolescents from 13 years of age

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;
• Cough;
• Dizziness;
• Fever;
• Pain;
• Limb pain;
• Runny nose;
• 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 side effects

(may affect up to 1 in 100 patients)

• Allergic reactions;
• Altered 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);
• Vision disorders.

Children from 1 year of age 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 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;
• 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 from 0 to 12 months are mostly similar to those reported in older children (from 1 year of age). Additionally, diarrhea and diaper rash have been reported.
If any of the side effects gets serious, or if the patient notices any side effects not listed in this leaflet, they should tell their doctor or pharmacist. However,

• If the patient or their child vomits repeatedly, or
• .

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this 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 month.
Store in a temperature below 30°C.
Storage of the suspension prepared in the pharmacy
The shelf-life is 10 days if the suspension is stored at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 30 mg of oseltamivir.
• The other ingredients are: maize starch, maize starch pregelatinised, povidone K30, croscarmellose sodium, talc, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172); printing ink (black TEK SW 9008): shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide.

What Segosana looks like and contents of the pack

Hard gelatin capsules, size 4, with a light yellow, opaque body with a black band and a light yellow, opaque cap with the imprint 'M' and '30 mg'.
The capsule size is approximately 14.37 mm.
Segosana 30 mg hard capsules are available in a blister pack of 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 in the Member States of the European Economic Area under the following names:

Netherlands, Czech Republic, Hungary, Poland, Romania, Slovakia:
Segosana
Bulgaria:
Сегосана
Date of last revision of the leaflet:December 2023
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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 trade name.
If the patient needs a liquid form of the medicine and it is not available, an oral suspension may be prepared from Segosana capsules (see Information intended for healthcare professionals only). A product prepared in a pharmacy is preferred.
If preparation in a pharmacy is not possible, the patient may prepare an oseltamivir suspension from available capsules at home.
The dose is the same for treatment and prevention of influenza. The difference is how often the medicine is given.

Preparing oseltamivir suspension at home

• If capsules of the appropriate strength are available(30 mg or 60 mg dose), the patient should open the capsule and mix its contents with no more than one teaspoon of an appropriate sweetened food product. This dose is usually suitable for children over 1 year of age. See the top set of instructions.
• If smaller doses are needed, preparing an oseltamivir suspension from capsules involves additional steps. The dose is suitable for younger children with relatively low body weight and infants who usually require a smaller dose of Segosana than 30 mg. See the bottom set of instructions.

Children from 1 year of age to 12 years

To prepare a 30 mg or 60 mg dose, the following are needed:

• One Segosana 30 mg capsule
• Sharp scissors
• A small bowl
• A teaspoon (5 ml)
• Water
• A sweet foodto neutralize the bitter taste of the medicine. For example: chocolate syrup or cherry syrup and dessert toppings such as caramel or nougat sauce. The patient can also prepare a sugar water by mixing one teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check the correct dose

To determine the correct dose, the patient should find their weight in the left column of the table.
The right column of the table shows how many capsules are needed for one dose.
The amount is the same for treatment and prevention of influenza.

Step 2: Pour the powder into the bowl

The patient should hold the 30 mg capsulevertically over the bowl and carefully cut off the rounded end with scissors.
Pour the entire contents of the capsule into the bowl.
If a 60 mg dose is needed, the patient should open a second capsule and pour its contents into the bowl.
The patient should handle the powder carefully, as it may be irritating to the skin and eyes.

Step 3: Sweeten the mixture and give it to the patient

The patient should add a small amount of sweet food - no more than one teaspoon - to the powder in the bowl.
This will neutralize the bitter taste of the Segosana powder.
The patient should mix the mixture well.
The patient should give the entire contents of the bowl to the patient immediately.
If there is any residue left in the bowl, the patient should rinse the bowl with a small amount of water and give the residue to the patient to drink. The patient should repeat these steps for each dose of the medicine.

The patient should not attempt to prepare a 45 mg or 75 mg dose using the contents of a 30 mg capsule.
In such a case, the patient should use a capsule of the appropriate strength.

Infants under 1 year of age

To prepare smaller single doses, the following are needed:

• One Segosana 30 mg capsule
• Sharp scissors
• Two small bowls(use a separate pair of bowls for each child)
• A large oral syringefor measuring the amount of water - a 5 ml or 10 ml syringe
• A small oral syringewith 0.1 ml gradations for administering the dose
• A teaspoon (5 ml)
• Water
• A sweet foodto neutralize the bitter taste of the medicine. For example: chocolate syrup or cherry syrup and dessert toppings such as caramel or nougat sauce. The patient can also prepare a sugar water by mixing one teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour the powder into the bowl.
Hold the 30 mg capsulevertically over one bowl and carefully cut off the rounded end with scissors.
Pour the entire contents of the capsule into the bowl, regardless of the dose being prepared.
The amount is the same regardless of whether the patient is treating or preventing influenza.

Step 2: Add water to dissolve the medicine

The patient should use the larger syringe to draw 5 ml of water.
Add the water to the powder in the bowl.
Mix the mixture for about 2 minutes with a teaspoon.

The patient should not worry if the powder does not dissolve completely. Undissolved powder consists of inactive ingredients.

Step 3: Adjust the amount of suspension according to the child's weight

The patient should find the child's weight in the left column of the table.
The right column of the table shows how much suspension to draw.

Step 4: Draw the suspension into the syringe

The patient should make sure to use a syringe with the correct volume.
Draw the correct amount of suspension from the first bowl.
Draw the suspension carefully to avoid air bubbles.
Gently squeeze the mixture from the syringe into the second bowl.

Step 5: Sweeten the suspension and give it to the child

Add a small amount of sweet food - no more than one teaspoon - to the second bowl.
This will neutralize the bitter taste of the Segosana medicine.
Mix the sweet food with the Segosana medicine well.

Give the entire contents of the second bowl (Segosana suspension with sweet food) to the child immediately.
If anything is left in the second bowl, rinse the bowl with a small amount of water and give the residue to the child to drink. For children who are unable to drink from a bowl, use a teaspoon or a baby bottle to administer the remaining mixture.
Give the child something to drink.

Discard any unused suspension that remains in the first bowl.

Repeat the above steps for each dose of the medicine.

Information intended for healthcare professionals only

Patients who have difficulty swallowing capsules:

Commercially available oseltamivir as a powder for oral suspension (6 mg/ml) is the preferred product for children and adolescents and for adult patients who have difficulty swallowing capsules or require smaller doses. If a product containing oseltamivir as a powder for oral suspension is not available on the market, the pharmacist may prepare a suspension (6 mg/ml) from capsules. If a suspension prepared in a pharmacy is also not available, patients may prepare a suspension from capsules at home.
Oral syringes (dosing syringes) of appropriate volume and gradation should be provided for administration of the suspension prepared in a pharmacy, as well as for procedures related to preparing the suspension 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 mixture. To measure 5.0 ml of water, syringes with a capacity of 5 ml or 10 ml should be used.
The patient should check below the appropriate capacity of the syringe to be used to draw the correct volume of oseltamivir suspension (6 mg/ml).

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