Label:information for the user

Pegasys 90micrograms injectable solution in pre-filled syringe

Pegasys 135micrograms injectable solution in pre-filled syringe

Pegasys 180micrograms injectable solution in pre-filled syringe

peginterferon alfa-2a

Read this label carefully before starting to use this medication,because it contains important information for you.

?Keep this label, as you may need to read it again.

?If you have any questions, consult your doctor, pharmacist, or nurse.

?This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

?If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Pegasys and for what it is used

2.What you need to know before starting to use Pegasys

3.How to use Pegasys

4.Possible adverse effects

5.Storage of Pegasys

6.Contents of the package and additional information

Pegasys contains the active ingredient peginterferón alfa-2a, which is a long-acting interferon. Interferon is a protein that modifies the immune system's response to help combat infections and serious diseasesand to prevent the growth of cancer cells.

Pegasys is used to treat polycythemia vera and essential thrombocytosis in adults.

Polycythemia vera and essential thrombocytosis are rare types of cancer in which the bone marrow produces too many red blood cells, white blood cells, and platelets (cells that facilitate blood clotting).

Polycythemia vera and essential thrombocytosis:Pegasys is used alone.

Pegasys is also used to treat chronic hepatitis B or chronic hepatitis C in adults. It is also used to treat chronic hepatitis B in children and adolescents aged 3 years and older and chronic hepatitis C in children and adolescents aged 5 years and older, who have not been treated before. Both hepatitis B and C are viral infections that affect the liver.

Chronic hepatitis B:Pegasys is usually used alone.

Chronic hepatitis C:Pegasys is used in combination with other medications, for the treatment of chronic hepatitis C (HCC).

You should also consult the prospectus of the medications used in combination with Pegasys.

No use Pegasys

?if you are allergic to peginterferon alfa-2a, any interferon, or any of the other components of this medication (listed in section 6).

?if you have had a heart attack or have been hospitalized for severe chest pain in the last six months.

?if you have or have had an autoimmune disease (such as rheumatoid arthritis, psoriasis, or inflammatory bowel disease).

?if you have an uncontrolled thyroid disease.

?if you have advanced liver disease and your liver does not function properly (e.g., your skin has turned yellow).

?if the patient is under 3 years old.

?if the patient is a child who has had a history of severe psychiatric disorders such as severe depression or suicidal thoughts.

?if you are infected with the hepatitis C virus and the human immunodeficiency virus, and your liver does not function properly (e.g., your skin has turned yellow).

?if you are receiving treatment with telbivudine, a medication for hepatitis B infection (see “Other medications and Pegasys”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Pegasys

?if you have had a severe nervous or mental disorder.

?if you have ever had depression or symptoms related to depression (e.g., feeling sad, discouraged, etc.).

?if you are an adult with a history of substance abuse (e.g., alcohol or drugs).

?if you have psoriasis, it may worsen during treatment with Pegasys.

?if you have other liver problems, apart from hepatitis B or C.

?if you have diabetes or high blood pressure, your doctor may request an eye examination.

?if you have VKH syndrome.

?if you have an uncontrolled thyroid disease.

?if you have had anemia at any time.

?if you have had an organ transplant (liver or kidney) or have one planned in the near future.

?if you are co-infected with the human immunodeficiency virus (HIV) and are receiving antiretroviral medication.

?if you were previously treated for hepatitis C due to anemia or low blood counts.

Once you have started treatment with Pegasys, talk to your doctor, nurse, or pharmacist:

?if you develop symptoms related to depression (e.g., feeling sad, discouraged, etc.) (see section 4).

?if you notice any changes in your vision.

?if you experience symptoms associated with a cold or other respiratory infection (such as cough, fever, or difficulty breathing).

?if you think you are getting an infection (such as pneumonia) since you may have a temporarily increased risk of getting infections while on treatment with Pegasys.

?if you have any signs of bleeding or experience unusual bruising, consult your doctor immediately.

?if you experience severe allergic reactions (such as difficulty breathing, wheezing, or hives) while on treatment with this medication, seek medical help immediately.

?if you experience symptoms of Vogt-Koyanagi-Harada syndrome; combination of symptoms such as neck stiffness, headache, loss of skin or hair color, eye changes (such as blurred vision), and/or hearing changes (such as a ringing in the ears).

During treatment, your doctor will take blood samples periodically to check for changes in your white blood cells (cells that fight infections), red blood cells (cells that transport oxygen), platelets (cells that clot blood), liver function, glucose (blood sugar levels), or other laboratory values.

There have been reports of dental and gum disorders that may lead to tooth loss in patients treated with Pegasys in combination with ribavirin. Additionally, dry mouth may have adverse effects on teeth and mouth mucosa in long-term treatments with Pegasys in combination with ribavirin. You should brush your teeth properly twice a day and have regular dental check-ups. Some patients may also experience vomiting. If you experience this reaction, you should rinse your mouth properly.

Children and adolescents

Indication for polycythemia vera and essential thrombocytosis:

Pegasys should not be administered to children and adolescents due to the lack of information on the use of Pegasys in this age group for these indications.

Indication for chronic hepatitis B and chronic hepatitis C:

Pegasys is limited to children and adolescents with chronic hepatitis C from 5 years old or children and adolescents with chronic hepatitis B from 3 years old.Pegasys should not be administered to children under 3 years of age because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.

?If your child has or has had any history of psychiatric disorders, consult your doctor, who will monitor your child for signs and symptoms of depression (see section 4).

?While on treatment with Pegasys, your child may experience slower growth and development (see section 4).

Other medications and Pegasys

Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medications increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensation in the arms and/or legs). Therefore, the combination of Pegasys with telbivudine is contraindicated. Inform your doctor or pharmacist if you are receiving treatment with telbivudine.

Inform your doctor if you are taking any medication for asthma, as you may need to adjust the dose of the antiasma medication.

Patients who are also infected with HIV: Inform your doctor if you are taking antiretroviral medication. Lactic acidosis and worsening liver function are adverse effects associated with highly active antiretroviral therapy (HAART), a treatment for HIV. If you are receiving HAART, the addition of Pegasys + ribavirin may increase the risk of lactic acidosis or liver failure. Your doctor will monitor you for signs and symptoms of these conditions.Patients who have received zidovudine in combination with ribavirin and interferons alpha may have an increased risk of developing anemia.Patients who are receiving azathioprine in combination with ribavirin and peginterferon have a higher risk of developing severe blood disorders. Please also read the package insert for ribavirin.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

When Pegasys is used in combination with ribavirin, both male and female patients should exercise special caution in their sexual relations if there is a risk of pregnancy since ribavirin can be very harmful to the fetus.

• If you are apotentially fertile womanand are taking Pegasys in combination with ribavirin, you should have a pregnancy test and it should be negative before starting treatment, every month during treatment, and for 4 months after completing treatment. You should use effective contraceptive methods during treatment and for 4 months after completing treatment. You can discuss this with your doctor.
• If you are amanand are taking Pegasys in combination with ribavirin, you should not have sexual relations with a pregnant woman unless you use a condom. This will reduce the likelihood of ribavirin being released into the woman's body. If your partner is not pregnant but is potentially fertile, you or your partner should have a pregnancy test every month during treatment and for 7 months after completing treatment. You or your partner should use effective contraceptive methods during the time you are using the treatment and for 7 months after completing treatment. You can discuss this with your doctor.

Consult your doctor or pharmacist before taking any medication. It is unknown whether this product is present in human milk. Therefore, do not breastfeed your baby if you are being treated with Pegasys. In combination therapy with ribavirin, please also refer to the relevant information for the medications that contain ribavirin.

You should also read the package insert for the medications used in combination with Pegasys.

Driving and operating machines

Do not drive or operate machines if you feel drowsy, tired, or confused while on treatment with Pegasys.

Pegasys containsbenzyl alcohol, polysorbate80, and sodium

This medicationcontains 5 mg of benzyl alcohol in each pre-filled syringe, which is equivalent to 10 mg/ml.

Benzyl alcohol maycauseallergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems (called “breathing difficulty”) in young children. Pegasys should not be administered to premature newborns, full-term newborns, or children under 3 years of age.

Ask your doctor or pharmacist if you are pregnant or breastfeeding, or if you have any liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (called “metabolic acidosis”).

This medication contains 0.025mg of polysorbate80 in eachjeringa precargada, which is equivalent to 0.05mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

This medicationcontains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Pegasys Dosage

Your doctor has established the exact dose of Pegasys, and will tell you how often to use it. If necessary, your doctor will change the dose during treatment. Do not exceed the dose recommended.

Polycthemia vera and essential thrombocytopenia in adults

Pegasys for treating polycthemia vera and essential thrombocytopenia is administered only with the recommended initial dose of 45 micrograms once a week subcutaneously and is usually adjusted in increments of 45 micrograms once a month up to a maximum of 180 micrograms once a week subcutaneously.

Your doctor may adapt the dose and/or prolong the administration interval.

Hepatitis B and hepatitis C in adults

Pegasys is used only (as a single treatment), only if for some reason you cannot take ribavirin.

Pegasys, either alone or in combination with ribavirin, is usually administered in doses of 180 micrograms once a week. See also the sections for combined treatments.The duration of combined treatment varies from 4 to 18 months depending on the type of virus with which you are infected, your response during treatment, and if you have been treated previously.

Please consult your doctor and follow the recommended treatment duration.

The Pegasys injection is usually administered at bedtime.

Use in children and adolescents

Hepatitis B (from 3 years of age) and hepatitis C (from 5 years of age)

Your doctor has determined the exact dose of Pegasys for your child and will inform you how often to use it. The usual dose of Pegasys is based on your child's height and weight. If necessary, the dose may be changed during treatment. For children and adolescents, it is recommended to use Pegasys pre-filled syringes, as these allow for dose adjustment. Do not exceed the recommended dose.

The duration of combined treatment in children with chronic hepatitis C varies from 6 to 12 months, depending on the type of virus with which your child is infected and their response to treatment. The duration of Pegasys treatment in chronic hepatitis B is 48 weeks. Consult your doctor and follow the recommended treatment duration. The Pegasys injection is usually administered at bedtime.

Pegasys is administered subcutaneously (under the skin). This means that Pegasys is injected with a short needle into the fatty tissue under the skin of the abdomen or thigh. If you are going to inject this medication yourself, you must be instructed on how to do it. Detailed instructions are attached at the end of the package insert (see "How to inject Pegasys").

Use Pegasys exactly as your doctor has told you and for the time they have indicated. If you estimate that the action of Pegasys is too strong or too weak, inform your doctor or pharmacist.

Combined treatment with ribavirin in chronic hepatitis C(all patients from 5 years of age)

In the case of combination treatment of Pegasys and ribavirin, please follow the recommended dosing regimen as indicated by your doctor.

Combined treatment with other medications in chronic hepatitis C(all patients from 5 years of age)

In the case of combination treatment with Pegasys, please follow the recommended dosing regimen as indicated by your doctor and also consult the package insert of the medications used in combination with Pegasys.

If you use more Pegasys than you should

Contact your doctor or pharmacist as soon as possible.

If you forget to use Pegasys

If you realize you have forgotten the injection 1 or 2 days after the scheduled time,inject the recommended dose as soon as possible. Continue with the next injection following the planned schedule.

If you realize you have forgotten the injection 3 to 5 days after the scheduled time, inject the recommended dose as soon as possible and inject the following doses at 5-day intervals until you recover the planned weekly schedule.

Example: you inject Pegasys every Monday. However, on Friday you realize you forgot the injection corresponding to the previous Monday (4-day delay). You must inject the regular dose immediately on the same Friday and the next one on Wednesday of the following week (5 days after the Friday dose). The next injection will take place on Monday, 5 days after Wednesday. You have now recovered the old weekly schedule and will be able to continue injecting every Monday.

If you realize you have forgotten the injection 6 days after the scheduled time,you must wait and inject the dose the next day to maintain the usual schedule.

Consult your doctor or pharmacist if you need more detailed information, in case you forget some dose of Pegasys.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Speak immediately with your doctor if you experience any of these adverse reactions: severe chest pain, persistent cough, irregular heartbeats, breathing problems, confusion, depression, severe stomach pain, blood in stool (or black, tar-like stools), severe nasal bleeding, fever, or chills. These side effects can be serious and you may need urgent medical attention.

The very common side effects of Pegasys in combination with ribavirin (can affect more than 1 in 10 people) are:

Metabolic disorders: loss of appetite

Psychiatric and nervous system disorders: feeling depressed (feeling sad, low mood, pessimism), anxiety, insomnia, headache, difficulty concentrating, and dizziness

Respiratory disorders: cough, difficulty breathing

Digestive disorders: diarrhea, nausea, abdominal pain

Skin disorders: hair loss and skin reactions (including itching, dermatitis, and dry skin)

Musculoskeletal and bone disorders: joint pain and muscle pain

General disorders: fever, weakness, fatigue, tremors, chills, pain, and irritability (easily irritable)

The common side effects of Pegasys in combination with ribavirin (can affect up to 1 in 10 people) are:

Infections: fungal, viral, and bacterial infections. Upper respiratory tract infections, bronchitis, fungal infections in the mouth, and herpes (common and recurrent viral infection affecting lips and mouth)

Blood disorders: low platelet count (affects blood clotting), anemia (low red blood cell count), and lymph node inflammation

Endocrine disorders: high and low thyroid activity

Psychiatric and nervous system disorders: mood changes/emotional, aggression, nervousness, decreased libido, memory loss, fainting, decreased muscle tone, migraine, numbness, tingling, feeling hot, tremors, altered sense of taste, nightmares, drowsiness

Eye disorders: blurred vision, eye pain, eye inflammation, and dry eyes

Ear disorders: ear pain

Cardiovascular and vascular disorders: rapid heartbeat, palpitations, limb inflammation, flushing

Respiratory disorders: difficulty breathing during exercise, nasal bleeding, nasal and throat inflammation, nasal and sinus infections, nasal secretion, throat pain

Digestive disorders: vomiting, indigestion, difficulty swallowing, mouth ulcers, gum bleeding, tongue and mouth inflammation, flatulence (excess air or gas), dry mouth, and weight loss

Skin disorders: rash, increased sweating, psoriasis, skin redness and itching (urticaria), eczema, light sensitivity, night sweats

Musculoskeletal and bone disorders: back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps

Reproductive disorders: impotence (inability to maintain an erection)

General disorders: chest pain, flu-like symptoms, discomfort, lethargy, hot flashes, thirst

The uncommon side effects of Pegasys in combination with ribavirin (can affect up to 1 in 100 people) are:

Infections: pulmonary infection, skin infections

Benign and malignant neoplasms: liver tumor

Immune system disorders: sarcoidosis (inflammation of tissue throughout the body), thyroid inflammation

Endocrine disorders: diabetes (high blood sugar levels)

Metabolic disorders: dehydration

Psychiatric and nervous system disorders: suicidal thoughts, hallucinations, peripheral neuropathy (nervous system disorders affecting extremities)

Eye disorders: retinal hemorrhage (posterior part of the eye)

Ear disorders: hearing loss

Cardiovascular and vascular disorders: high blood pressure

Respiratory disorders: wheezing sounds when breathing (sibilance)

Digestive disorders: gastrointestinal bleeding

Hepatic disorders: liver dysfunction

The rare side effects of Pegasys in combination with ribavirin (can affect up to 1 in 1,000 people) are:

Infections: heart infection, external ear infection

Blood disorders: severe decrease in red blood cells, white blood cells, and platelets

Immune system disorders: severe allergic reactions, systemic lupus erythematosus (body attacking its own cells), rheumatoid arthritis (autoimmune disease)

Endocrine disorders: diabetic ketoacidosis, a complication of uncontrolled diabetes

Psychiatric and nervous system disorders: suicide, psychotic disorders (serious personality problems and deterioration in normal social functioning), coma (profound and prolonged unconsciousness), convulsions, facial paralysis (muscle weakness in the face)

Eye disorders: optic nerve inflammation, retinal inflammation, corneal ulcer

Cardiovascular and vascular disorders: heart attack, heart failure, chest pain, rapid heartbeat, altered heart rhythm, or heart and muscle inflammation, cerebral hemorrhage, and vascular inflammation

Respiratory disorders: interstitial pneumonia (lung inflammation including fatal outcome), pulmonary embolism (blood clots in the lungs)

Digestive disorders: gastric ulcer, pancreatitis (inflammation of the pancreas)

Hepatic disorders: liver failure, bile duct inflammation, fatty liver

Musculoskeletal and bone disorders: muscle inflammation

Renal disorders: kidney failure

Accidents or poisonings: overdose

The very rare side effects of Pegasys in combination with ribavirin (can affect up to 1 in 10,000 people) are:

Blood disorders: aplastic anemia (failure of the bone marrow to produce red blood cells, white blood cells, and platelets)

Immune system disorders: idiopathic or thrombotic thrombocytopenic purpura (increased hematomas, bleeding, decreased platelets, anemia, and extreme weakness)

Eye disorders: vision loss

Skin disorders: toxic epidermal necrolysis/Stevens-Johnson syndrome/erythema multiforme (range of rashes with varying degrees of severity that may be associated with blisters in the mouth, nose, eyes, and other mucous membranes, and skin detachment)

Erythema multiforme is a skin condition that can cause blisters, rashes, and other skin problems. It can be life-threatening and may require hospitalization.

Angioedema (inflammation of the skin and mucous membranes)

Unknown frequency of side effects:

Blood disorders: pure red cell aplasia (a type of severe anemia in which the production of red blood cells is severely decreased or stopped), which can cause symptoms such as feeling extremely tired and lacking energy

Immune system disorders: Vogt-Koyanagi-Harada disease, a rare disease characterized by vision loss, hearing loss, and skin pigmentation; rejection of liver and kidney transplants

Psychiatric and nervous system disorders: mania (episodes of excessive excitement of mood) and bipolar disorders (episodes of excessive excitement of mood alternating with sadness and despair); thoughts of harming others, stroke (lack of blood flow to the brain)

Eye disorders: rare form of retinal detachment with fluid in the retina

Cardiovascular and vascular disorders: peripheral ischemia (insufficient blood flow to the extremities)

Digestive disorders: ischemic colitis (insufficient blood flow to the intestine), changes in the color of the tongue

Musculoskeletal and bone disorders: severe muscle damage and pain

Pulmonary hypertension is a disease in which there is a severe narrowing of the blood vessels in the lungs, causing an increase in blood pressure in the vessels that transport blood from the heart to the lungs. This can occur especially in patients with risk factors such as HIV infection or severe liver disease (cirrhosis). Episodes have been reported at different times, even several months after starting treatment with Pegasys.

If Pegasys is only administered to patients with hepatitis B or C, the probability of these effects is reduced.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly (see details below).

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Keep the pre-filled syringe in the original packaging to protect it from light.

Do not use this medication if you observe that the syringe or the needle container are damaged, if the solution is cloudy, has particles floating or if it has another color that is not between colorless to light yellow.

Medicines should not be thrown down the drains or in the trash..Ask your pharmacist how to dispose ofthe packaging and the medications thatyou no longer need.This way, you will help protect the environment.

Composition of Pegasys

?The active ingredient is peginterferon alfa-2a. Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms of peginterferon alfa-2a.

?The other components are sodium chloride, polisorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injection.

Appearance of the product and contents of the pack

Pegasys is presented as a solution for injection contained in a pre-filled syringe (0.5 ml) with a separate injection needle.

Pegasys 90 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 90 micrograms (µg), 65 µg, 45 µg, 30 µg, 20 µg and 10 µg.It is available in packs of 1 pre-filled syringe.

Pegasys 135 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 135 micrograms (µg), 90 µg and 45 µg. It is available in packs of 1, 4 or a multiple pack containing 12 (2 packs of 6) pre-filled syringes. Only some pack sizes may be marketed.

Pegasys 180 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 180 micrograms (µg), 135 µg and 90 µg. It is available in packs of 1, 4 or a multiple pack containing 12 (2 packs of 6) pre-filled syringes. Only some pack sizes may be marketed.

Marketing authorisation holder

pharmaand GmbH

Taborstrasse 1

1020 Wien

Austria

Manufacturer responsible

Loba biotech GmbH

Fehrgasse 7

2401 Fischamend

Austria

Last update of the summary of product characteristics:

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

How to inject Pegasys

The following instructions explain how to use the pre-filled syringes of Pegasys for self-injection or injection by a caregiver. Please read the instructions carefully and follow them step by step. Your doctor or other healthcare professional will give you instructions on how to administer the injections.

Initial preparation

Wash your hands thoroughly before handling any of the materials.

Have everything you need available before starting:

Included in the pack:

?a pre-filled syringe of Pegasys

?a needle for injection

Not included in the pack:

?an alcohol swab

?a small piece of gauze or sterile gauze

?a adhesive bandage

?a disposal container

Preparing the syringe and needle for injection

?Remove the protective cap from the end of the needle (1-2).

?Remove the rubber cap from the syringe (3). Do not touch the tip of the syringe.

?Insert the needle firmly into the tip of the syringe (4).

?Remove the needle protection (5).

?To remove air bubbles from the syringe, hold it vertically with the needle pointing upwards. Tap the syringe with your finger several times to move the air bubbles to the top of the liquid. Push the plunger slowly until you reach the correct dose, where the edge of the plunger enters the syringe. Replace the needle protection and place the syringe in a horizontal position until you are ready to use it.

?Allow the solution to reach room temperature before injection or warm the syringe by holding it in your hands.

?Visually inspect the solution before administration: do not use it if it has changed color or if you see particles.

You are now ready to inject the dose.

Injecting the solution

?Select the abdomen or thigh for injection (except the navel or waist area). Change the injection site each time you administer it.

?Clean and disinfect the skin at the injection site with an alcohol swab.

?Wait for the area to dry.

?Remove the needle protection.

?With one hand, pinch the skin and with the other hand, hold the syringe like a pen.

?Insert the needle completely at a 45° to 90° angle into the skin you are holding with the other hand (6).

?Inject the solution by pushing the plunger downwards from the correct graduation mark.

?Remove the needle from the skin.

?If necessary, press the injection site with a small piece of gauze or sterile gauze for a few seconds.

Do not massage the injection site. If it bleeds, cover it with an adhesive bandage.

Disposal of injection materials

The syringe, needle and all injection materials are for single use and must be disposed of after injection. Dispose of the syringe and needle safely in a closed container. Ask your doctor, hospital or pharmacist for an appropriate container.