Segosana

Leaflet accompanying the packaging: information for the user

Segosana, 75 mg, hard capsules

Oseltamivir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of 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) to treat flu. It can be used when flu symptoms appear and when it is known that the flu virus is circulating in the environment.
• Segosana may also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent flu, on a case-by-case basis, for example, if the patient has been in contact with someone with the flu.
• Segosana may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as preventive treatmentin exceptional cases, for example, during a global flu epidemic (flu 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 flu virus from spreading in the body. They help alleviate symptoms or prevent them from occurring in case of flu virus infection.
Flu 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 flu infection occurs only during annual outbreaks of the disease (epidemics), when flu viruses spread in the local environment. Outside of epidemic periods, flu-like symptoms are usually the result of other types of infection or disease.

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 their doctor:

• 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 systemis not working properly.
• if the patient has chronic heart diseaseor 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 flu 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 plan to 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 the medicine is considered "sodium-free".

3. How to take Segosana

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Segosana should be taken as soon as possible, preferably within the first two days of flu symptoms appearing.

Recommended doses

To treat flu, 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.
To prevent flu 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 a flu 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. The patient should take the number of capsules or oral suspension prescribed by their doctor.

Adults and adolescents from 13 years of age

*For patients with weakened immune systems, treatment lasts 10 days.
**A 75 mg dose may consist of a 30 mg capsule and a 45 mg capsule

Children from 1 year of age to 12 years

*For children with weakened immune systems, treatment lasts 10 days.
**A 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 a flu pandemic should be made after evaluating the potential benefits and risks to the infant by the attending physician.

*For 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. 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 in the form of powder for oral suspension, but under a different trade name. If the patient needs an oral suspension and it is not available at 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 side effects have been reported. If they have been reported, they were similar to side effects that occur after taking the recommended doses, as described in section 4.
Overdose has been reported more frequently after administration of oseltamivir 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 side effects if treatment with Segosana is stopped. However, if the patient stops taking Segosana earlier than their doctor recommended, flu symptoms may return. The patient should always complete treatment as directed by their doctor.
If the patient has any further doubts about taking this medicine, they should consult 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 side effects listed below may also be the flu itself.
The following serious side effects have been reported rarely after oseltamivir was approved:

• Anaphylactic and pseudoanaphylactic reactions: severe allergic reactions with facial and skin edema, pruritus, 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, beginning 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) side effects of oseltamivir are: nausea (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 use of the medicine. The frequency of these side effects decreases if the medicine is taken with food.

Rare but serious side effects: the patient should see a doctor (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. The above events, which had a sudden onset and resolution, were observed mainly in children and adolescents. In rare cases, they were the cause of self-injury, sometimes resulting in death. Similar neuropsychiatric events have also been observed in patients with the flu who did not take oseltamivir.
• Patients, 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 see a doctor 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 level of consciousness;
• Seizures;
• Arrhythmias;
• Mild to moderate liver function disorders;
• Skin reactions (dermatitis, erythematous and pruritic rash, skin peeling).

Rare side effects

(may affect up to 1 in 1,000 patients)

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

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 under 1 year of age (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 get worse or if the patient experiences 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 those not listed in this leaflet, they should tell their doctor or 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 gather more information on the safety of this medicine.

5. How to store Segosana

Store out of 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 at 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 75 mg of oseltamivir.
• The other ingredients are: maize starch, corn starch, 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), black iron oxide (E 172); ink for printing (black TEK SW 9008): shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide

What Segosana looks like and what the pack contains

Hard capsules, gelatin, size "2", gray, opaque body with a black band, with "M" printed on one side and "75 mg" on the other, and a light yellow, opaque cap with "75 mg" printed on it.
The capsule size is approximately 17.66 mm.
Segosana 75 mg hard capsules are available in a blister pack of 10 capsules.

Marketing authorization 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 authorized 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 in the form of 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 can be prepared from Segosana capsules (see Information intended only for healthcare professionals). A product prepared in a pharmacy is preferred.
If preparation in a pharmacy is not possible, the patient can prepare an oseltamivir suspension from available capsules at home.
The dose is the same for treatment and prevention of flu. The difference is how often the medicine is given.

Preparing oseltamivir suspension at home

• If capsules of the appropriate doses are available(75 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 dose of Segosana smaller than 30 mg. See the bottom set of instructions.

Adults, adolescents from 13 years of age, and children with a body weight of 40 kg or more

To prepare a 75 mg dose, the following are needed:

• One Segosana 75 mg capsule
• Sharp scissors
• One small bowl
• One teaspoon (5 ml)
• Water
• Sweetened 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 sugar water 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, the patient should find their body weight in the left column of the table.
Then, they should check the right column for the number of capsules needed for one dose.
The amount is the same for both treatment and prevention of flu.

75 mg dose

To prepare a 75 mg dose, the patient should use only 75 mg capsules. They should not attempt to prepare a 75 mg dose using the contents of a 30 mg or 45 mg capsule.

Do not use in children with a body weight of less than 40 kg.

The patient should prepare a dose smaller than 75 mg for children with a body weight of less than 40 kg.
See below.

Step 2: Pour the powder into the bowl

The patient should hold the 75 mg capsuleupright over the bowl and carefully cut off the rounded end with scissors.
They should pour the entire powder into the bowl.
The patient should handle the powder carefully, as it may be irritating to the skin and eyes.

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

The patient should add a small amount of sweetened 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.
They should give the patient the entire contentsof the bowl immediately.
If anything remains in the bowl, the patient should rinse the bowl with a small amount of water and give the patient the remaining mixture to drink. The patient should repeat these steps each time they take the medicine.

Infants under 1 year of age and children with a body weight of less than 40 kg

To prepare smaller single doses, the following are needed:

• One Segosana 75 mg capsule
• Sharp scissors
• Two small bowls(use a separate pair of bowls for each child)
• One large oral syringefor measuring the amount of water - a 10 ml or 5 ml syringe
• One small oral syringewith a 0.1 ml scale for administering the dose
• One teaspoon (5 ml)
• Water
• Sweetened 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 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.
The patient should hold the 75 mg capsuleupright over one bowl and carefully cut off the rounded end with scissors. They should handle the powder carefully, as it may be irritating to the skin and eyes. The patient should pour the entire powder into the bowl, regardless of the dose being prepared.
The amount is the same regardless of whether the patient is treating or preventing flu.

Step 2: Add water to dissolve the medicine

The patient should use the larger syringe to draw 12.5 ml of water.
They should add the water to the powder in the bowl.
The patient should 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 body weight

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

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

Children from 1 year of age, with a body weight of less than 40 kg

Step 4: Draw the suspension into the syringe

The patient should ensure that they are using a syringe with the correct volume.
They should carefully draw the correct amount of suspension from the first bowl.
The patient should draw the suspension carefully to avoid air bubbles.
They should gently squeeze the mixture from the syringe into the second bowl.

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

The patient should add a small amount of sweetened food - no more than one teaspoon - to the second bowl.
This will neutralize the bitter taste of the Segosana medicine.
The patient should mix the sweetened food with the Segosana medicine well.
They should give the entire contentsof the second bowl (Segosana medicine with sweetened food) to the child immediately.
If anything remains in the second bowl, the patient should rinse the bowl with a small amount of water and give the child the remaining mixture to drink. For children who are unable to drink from a bowl, the patient should use a teaspoon or a baby bottle to administer the remaining mixture.
The patient should give the child something to drink.

Discard any unused suspension that remains in the first bowl.

The patient should repeat these steps each time they give the medicine.

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Information intended only for healthcare professionals

Patients who have difficulty swallowing capsules:

Commercially available oseltamivir in the form of 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 in the form of 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 can prepare a suspension from capsules at home.
The patient should be provided with oral syringes(syringes) of suitable volume and scale to administer 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, the patient should use separate syringes to draw the correct amount of water and to measure the oseltamivir mixture with water. To measure 12.5 ml of water, the patient should use a 10 ml syringe.
The patient should check below for the suitable syringe volume that should be used to draw the correct volume of oseltamivir suspension (6 mg/ml).

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

Children from 1 year of age, with a body weight of less than 40 kg: