Segosana

Package Leaflet: Information for the User

Segosana, 45 mg, Hard Capsules

Oseltamivir

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• 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. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any of the Following Symptoms, or Those Listed in Section 4, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack and Other Information

• 1. What Segosana Is and What It Is Used For
• 2. Before You Take 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) 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 for 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 for Adults, Adolescents, Children, and Infants (Including Full-Term Newborns) as Preventive Treatmentin Exceptional Cases, for Example, During a Global Flu Epidemic (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 to Relieve Symptoms or
Prevent Them from Occurring in the Case of Flu Virus Infection.
Flu Is an Infectious Disease Caused by a Virus. Flu Symptoms Often Include a 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 Only Occurs During Annual Outbreaks of the Disease ( Epidemics),
When Flu Viruses Spread in the Local Environment. Outside of Epidemic Periods, Flu-Like Symptoms Are Generally the Result of Other Types of Infection or Another Disease.

2. Before You Take Segosana

When Not to Take Segosana

• If You Are Allergic( Hypersensitive) to Oseltamivir or Any of the Other Ingredients of This Medicine Listed in Section 6. If This Applies to You, Consult a Doctor. Do Not Take Segosana.

Warnings and Precautions

Before Taking Segosana, Tell Your Doctor

• If You Are Allergic to Other Medicines.
• If You Have Kidney Disease. If So, a Dose Adjustment May Be Necessary.
• If You Have a Severe IllnessThat May Require Immediate Hospital Treatment.
• If Your Immune System Is Not Working Properly.
• If You Have Chronic Heart Disease or Respiratory Disease.

During Treatment with Segosana, Immediately Inform Your Doctor

• If You Notice 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 Infection or Prevent the Spread of the Flu Virus. A Vaccine Provides Antibodies Against the Virus. Segosana Does Not Affect the Effectiveness of Flu Vaccination, and Your Doctor May Prescribe Both Products to You.

Segosana and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking Now or Have Recently Taken, as Well as Any Medicines You Plan to Take. This Includes Medicines Available 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 You Are Pregnant, Think You May Be Pregnant, or Plan to Have a Child, Consult Your Doctor to Decide Whether Segosana Is Suitable for You.
The Effect of Oseltamivir on Breastfed Infants Is Unknown. If You Are Breastfeeding, Consult Your Doctor to Decide Whether Segosana Is Suitable for You.
Consult a Doctor or Pharmacist Before Taking This Medicine.

Driving and Using Machines

Segosana Does Not Affect the Ability to Drive and Use Machines.

Segosana Contains Sodium

The Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Capsule, Which Means It Is Essentially "Sodium-Free".

3. How to Take Segosana

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Consult Your Doctor or Pharmacist.
Take Segosana as Soon as Possible, Preferably Within the First Two Days of the Onset of Flu Symptoms.

Recommended Doses

To Treat Flu, Take Two Doses a 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 Cycle, Even If Your 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, 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 Flu 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 Your Doctor.

Adults and Adolescents from 13 Years

*In Patients with Weakened Immune System, Treatment Lasts 10 Days.
**The 75 Mg Dose May Consist of a 30 Mg Capsule and a 45 Mg Capsule

Children from 1 Year to 12 Years

*In Children with Weakened Immune System, Treatment Lasts 10 Days.
**The 75 Mg Dose May Consist of a 30 Mg Capsule and a 45 Mg Capsule

Infants Under 1 Year (0 to 12 Months)

The Decision to Administer Segosana to Infants Under 1 Year for Prophylaxis During a Flu Pandemic Should Be Made After Evaluating the Potential Benefits and Risks for the Infant.

*In Infants with Weakened Immune System, 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

Swallow the Capsules Whole with Water. Do Not Break or Chew the Capsules.
Segosana Can Be Taken with or Without Food, Although Taking It with Food Reduces the Risk of Nausea or Vomiting.
For Patients Who Have Difficulty Swallowing Capsules, a Liquid Form of the Medicine May Be Available, Oseltamivir May Be Available as a Powder for Oral Suspension, but Under a Different Brand Name. If the Patient Needs an Oral Suspension and It Is Not Available in the Pharmacy, the Patient Can Prepare a Liquid Form of Segosana from Capsules. Seethe Instructions for Preparing Oseltamivir Suspensionat Home, Which Are Included in This Leaflet.

Taking More Than the Recommended Dose of Segosana

Stop Taking Segosana and Contact Your Doctor or Pharmacist Immediately.
In Most Cases of Overdose, No Adverse Reactions Were Reported. If They Were Reported, They Were Similar to Adverse Reactions After Taking the 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 a Liquid Form of Segosana for Children and When Administering Segosana to Children in Capsule or Liquid Form.

Missing a Dose of Segosana

Do Not Take a Double Dose to Make Up for a Missed Capsule.

Stopping Treatment with Segosana

There Are No Adverse Reactions If Treatment with Segosana Is Stopped. However, If Stopping Treatment with Segosana Occurs Earlier Than Your Doctor Advised, Flu Symptoms May Return. Always Complete Treatment as Advised by Your Doctor.
If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine 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 Rarely Reported After the Marketing Authorization of Oseltamivir:

• Anaphylactic and Anaphylactoid Reactions: Severe Allergic Reactions with Swelling of the Face and Skin, Itching, Hives, 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, Significant Swelling of the Skin, Mainly in the Head and Neck Area, Including the Eyes and Tongue, Accompanied by Difficulty Breathing.
• Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Complex, Life-Threatening Allergic Reaction, Severe Inflammation of the Outer and Sometimes Inner Layers of the Skin, Beginning with Fever, Sore Throat, and Fatigue, Skin Rashes, Blisters, Peeling, and Shedding of Large Areas of Skin, Which May Be Accompanied by Difficulty Breathing and Low Blood Pressure.

Oddychaniu i niskie ciśnienie krwi.

• Gastrointestinal Bleeding: Prolonged Bleeding from the Colon or Hematemesis
• Neuropsychiatric Disorders, as Described Below.

If You Notice Any of These Symptoms, 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 Further Use of the Medicine. The Frequency of These Adverse Reactions Decreases If the Medicine Is Taken with Food.

Rare but Serious Side Effects: Consult a Doctor Immediately

( May Occur in 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, Abnormal 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 Any of These Symptoms Are Noticed, Especially in Young People, Seek Medical Help Immediately.

Adults and Adolescents from 13 Years

Very Common Side Effects

( May Occur in More Than 1 in 10 Patients)

• Headache;
• Nausea.

Common Side Effects

( May Occur in Up to 1 in 10 Patients)

• Bronchitis;
• Herpes Virus;
• Cough;
• Dizziness;
• Fever;
• Pain;
• Limb Pain;
• Runny Nose;
• Sleep Disorders;
• Sore Throat;
• Stomach Pain;
• Fatigue;
• Feeling of Fullness in the Upper Abdomen;
• Upper Respiratory Tract Infections (Nasal, Throat, and Sinus Infections);
• Indigestion;
• Vomiting.

Uncommon Side Effects

( May Occur in 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, Peeling Skin).

Rare Side Effects

( May Occur in Up to 1 in 1,000 Patients)

• Thrombocytopenia (Low Platelet Count);
• Vision Disorders.

Children from 1 Year to 12 Years

Very Common Side Effects

( May Occur in More Than 1 in 10 Patients)

• Cough;
• Rhinitis;
• Vomiting.

Common Side Effects

( May Occur in 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 Occur in Up to 1 in 100 Patients)

• Dermatitis;
• Tympanic Membrane Disorders.

Infants Under 1 Year

Adverse Reactions Reported in Infants from 0 to 12 Months Are Generally Similar to Those Reported in Older Children (from 1 Year). Additionally, Diarrhea and Diaper Rash Have Been Reported.
If Any of the Side Effects Get Serious, or If You Notice Any Side Effects Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. However,

• If the Patient or Their Child Vomits Repeatedly, or
• If Flu Symptoms Worsen or Fever Persists, Inform Your Doctor Immediately.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your 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, Tel.: +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 Expiration Date Stated on the Packaging and Blister After "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Specified 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.
Medicines Should Not Be Disposed of 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.
• The Other Ingredients Are:
• Cornstarch, Povidone K30, Croscarmellose Sodium, Talc, Sodium Stearate Fumarate;
• Capsule Shell: Gelatin, Titanium Dioxide (E 171), Iron Oxide Black (E 172);
• Ink for Printing (Black Ink TEK SW 9008): Shellac, Propylene Glycol, Ammonium Hydroxide Concentrate, Iron Oxide Black (E 172), Potassium Hydroxide.

What Segosana Looks Like and Contents of the Pack

Hard Capsules, Size 4, Gray, Opaque Body with a Black Stripe, with "M" Printed on One Side and "45 Mg" on the Other. The Capsule Size Is Approximately 14.37 Mm.
Segosana 45 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 a Liquid Form, but Under a Different Brand Name. If the Patient Needs a Liquid Form and It Is Not Available in the Pharmacy, an Oral Suspension Can Be Prepared from Segosana Capsules (See Information Intended for Healthcare Professionals Only). A Pharmacy-Prepared Product Is Preferred. If Pharmacy Preparation 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 Strength Are Available(45 Mg Dose), Use Only the Contents of a 45 Mg Capsule and Mix It with No More Than One Teaspoon of an Appropriate Sweetened Food Product. This Dose Is Generally 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 a Relatively Low Body Weight and Infants Who Typically Require a Lower Dose of Segosana Than 45 Mg. See the Lower Set of Instructions.

Children from 1 Year to 12 Years

To Prepare a 45 Mg Dose, You Will Need:

• One Segosana 45 Mg Capsule
• Sharp Scissors
• One Small Bowl
• A Teaspoon (5 Ml)
• Water
• A Sweetened Food Productto Counteract the Bitter Taste of the Medicine. For Example: Chocolate Syrup or Cherry Syrup and Dessert Toppings, Such as Caramel or Nougat Sauce. You 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, Find the Patient's Weight in the Left Column of the Table.
Then 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.

45 Mg Dose

To Prepare a 45 Mg Dose, Use Only a 45 Mg Capsule.
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 of the Appropriate Strength.

Step 2: Pour the Entire Powder into the Bowl.
Hold the 45 Mg CapsuleUpright Over the Bowl and Carefully Cut Off the Rounded End with Scissors.
Pour the Entire Powder into the Bowl.
Be Careful When Handling the Powder, as It May Be Irritating to the Skin and Eyes.

Step 3: Sweeten the Suspension and Give It to the Patient

Add a Small Amount of Sweetened Food Product - No More Than One Teaspoon - to the Powder in the Bowl.
This Will Counteract the Bitter Taste of the Segosana Powder.
Mix the Mixture Well.
Give the Entire Contentsof the Bowl to the Patient Immediately.
If Anything Remains in the Bowl, Rinse the Bowl with a Small Amount of Water and Give the Patient the Remaining Mixture to Drink. Repeat the Above Steps for Each Dose.

Infants Under 1 Year

To Prepare Smaller Single Doses, You Will Need:

• One Segosana 45 Mg Capsule
• Sharp Scissors
• Two Small Bowls(Use a Separate Pair of Bowls for Each Child)
• One Large Oral Syringefor Measuring the Water - a 5 Ml or 10 Ml Syringe
• One Small Oral Syringewith a 0.1 Ml Gradation for Administering the Dose
• A Teaspoon (5 Ml)
• Water
• A Sweetened Food Productto Counteract the Bitter Taste of Segosana. For Example: Chocolate Syrup or Cherry Syrup and Dessert Toppings, Such as Caramel or Nougat Sauce. You 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 Entire Powder into the Bowl.

Hold the 45 Mg CapsuleUpright Over One Bowl and Carefully Cut Off the Rounded End with Scissors. Be Careful When Handling the Powder, as It May Be Irritating to the Skin and Eyes. Pour the Entire Powder into the Bowl, Regardless of the Dose Being Prepared.

Step 2: Add Water to Dissolve the Medicine.

Use the Larger Syringe to Draw 7.5 Ml of Water.
Add Water to the Powder in the Bowl.
Mix the Mixture with a Teaspoon for About 2 Minutes.

Do 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

Find the Child's Weight in the Left Column of the Table.
The Right Column of the Table Shows How Much Suspension to Draw.

Infants Under 1 Year (Including Full-Term Newborns)

Step 4: Draw the Suspension into the Syringe.

Make Sure to Use a Syringe of 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 Sweetened Food Product - No More Than One Teaspoon - to the Second Bowl.
This Will Counteract the Bitter Taste of Segosana.
Mix the Sweetened Food Product with Segosana Well.
Give the Entire Contentsof the Second Bowl (Segosana Suspension with Sweetened Food Product) to the Child Immediately.
If Anything Remains in the Second Bowl, Rinse the Bowl with a Small Amount of Water and Give the Child the Remaining Mixture to Drink. For Children 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 Remaining in the First Bowl.

Repeat the Above Steps for Each Dose.

Information Intended for Healthcare Professionals Only

Patients Who Have Difficulty Swallowing Capsules:

A Commercially Available Oseltamivir Powder for Oral Suspension (6 Mg/Ml) Is the Preferred Product for Children and Adolescents and for Adults Who Have Difficulty Swallowing Capsules or Require Smaller Doses. If This Product Is Not Available on the Market, a Pharmacist Can Prepare a Suspension (6 Mg/Ml) from Capsules. If a Pharmacy-Prepared Suspension Is Also Not Available, Patients Can Prepare a Suspension from Capsules at Home.
Ensure That Oral Syringes(Oral Syringes) of the Correct Volume and Gradation Are Available for Administering the Suspension Prepared in the Pharmacy, as Well as for the Procedures Involved in Preparing the Suspension at Home. In Both Cases, It Is Best If the Syringes Are Marked with the Correct Volumes. When Preparing the Solution at Home, Use Separate Syringes to Draw the Correct Amount of Water and to Measure the Oseltamivir Mixture. To Measure 5 Ml of Water, Use a 5 Ml or 10 Ml Syringe.
Check Below for the Correct Syringe Volume That Should Be Used to Draw the Correct Volume of Oseltamivir Suspension (6 Mg/Ml).

Infants Under 1 Year (Including Full-Term Newborns):