Package leaflet: Information for the patient

Ituxredi 100 mg concentrate for solution for infusion, 500 mg concentrate for solution for infusion

rituximab
Generic medicine
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4.8 for information on how to report side effects.
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Ituxredi is and what it is used for
What you need to know before Ituxredi is administered to you
How Ituxredi is administered
Possible side effects
How to store Ituxredi
Contents of the pack and other information

1. What Ituxredi is and what it is used for

What Ituxredi is
Ituxredi contains the active substance "rituximab". This is a type of protein called a "monoclonal antibody". It binds to the surface of a type of white blood cells known as "B-lymphocytes". When rituximab binds to the surface of these cells, the cell dies.

What Ituxredi is used for
Ituxredi may be used to treat several conditions in adults and children. Your doctor may prescribe rituximab for the treatment of:

a) Non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma is a disease of the lymphatic tissue (part of the immune system) that involves B-lymphocytes, a specific type of white blood cells.
In adults, rituximab can be given alone (monotherapy) or in combination with other medicines collectively called "chemotherapy".
In adult patients who respond to treatment, rituximab can be used as maintenance therapy for 2 years after completion of initial treatment.
In children and adolescents, rituximab is administered in combination with "chemotherapy".

b) Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common form of leukaemia in adults. CLL involves a specific type of lymphocyte, the B-cell, which originates in the bone marrow and matures in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood.
The proliferation of these abnormal B-lymphocytes causes the symptoms you may experience. Rituximab, in combination with chemotherapy, destroys these cells, which are then gradually removed from the body by biological processes.

c) Rheumatoid arthritis
Rituximab is used to treat rheumatoid arthritis. Rheumatoid arthritis is a disease that affects the joints. B-lymphocytes are responsible for some of the symptoms you have. Rituximab is used to treat rheumatoid arthritis in people who have already tried other medicines that either stopped working, were not effective enough, or caused undesirable side effects. Rituximab is usually taken together with another medicine called methotrexate.
Rituximab slows down joint damage caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
The best response to rituximab has been observed in patients who have tested positive in blood tests for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and help confirm the diagnosis.

d) Granulomatosis with polyangiitis and microscopic polyangiitis
Rituximab is used to treat adults and children aged 2 years and older with granulomatosis with polyangiitis (previously called Wegener’s granulomatosis) or microscopic polyangiitis, in combination with glucocorticoids.
Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of blood vessel inflammation that primarily affect the lungs and kidneys, but may also involve other organs. B-lymphocytes are involved in the cause of these conditions.

e) Pemphigus vulgaris
Rituximab is used to treat patients with moderate to severe pemphigus vulgaris. Pemphigus vulgaris is an autoimmune disease that causes painful blisters on the skin and mucous membranes of the mouth, nose, throat, and genitals.

2. What you should know before using Ituxredi

Do not take Ituxredi if:

you are allergic to rituximab, to other proteins similar to rituximab, or to any of the other ingredients of this medicine (listed in section 6)
you currently have a serious active infection
your immune system is weakened
you suffer from severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris.

Do not take rituximab if any of the above conditions apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before receiving rituximab.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving rituximab if:

you have previously had hepatitis infection or suspect you may currently have it. In a small number of cases, rituximab may cause reactivation of hepatitis B, which in very rare cases can lead to death. Patients with a prior history of hepatitis B infection will be closely monitored by the doctor for any signs of reactivation.
you have previously experienced heart problems (such as angina, palpitations, or heart failure) or respiratory problems.

If any of the above conditions apply to you (or if you have any doubts), speak with your doctor, pharmacist, or nurse before receiving rituximab. Your doctor may need to monitor you more closely during treatment with rituximab.

Also talk to your doctor if you think you may need any vaccinations in the near future, including those required for travel to other countries. Some vaccines should not be administered at the same time as, or in the months following, rituximab treatment. Your doctor will assess whether you can receive any vaccine before starting rituximab.

If you have rheumatoid arthritis, granulomatosis with polyangi inflammatoria, microscopic polyangiitis, or pemphigus vulgaris, talk to your doctor

if you suspect you have an infection, even a mild one such as a cold. The cells affected by rituximab play a role in fighting infections, so it is necessary to wait until the infection has resolved before taking rituximab. Additionally, inform your doctor if you have had frequent infections in the past or suffer from serious infections.

Children and adolescents
Non-Hodgkin’s lymphoma
Rituximab may be used to treat children and adolescents aged 6 months and older with non-Hodgkin’s lymphoma, specifically CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukemia (mature B-cell acute leukemia; BAL), or Burkitt-like lymphoma (BLL).
Talk to your doctor, pharmacist, or nurse before administering this medicine if you or your child is under 18 years of age.

Granulomatosis with polyangiitis or microscopic polyangiitis
Rituximab may be used to treat children and adolescents aged 2 years and older with granulomatosis with polyangiitis (previously known as Wegener’s granulomatosis) or microscopic polyangiitis. Currently, limited information is available on the use of rituximab in children and adolescents with other diseases.
Talk to your doctor, pharmacist, or nurse before administering this medicine if you or your child is under 18 years of age.

Other medicines and Ituxredi
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal products. This is because rituximab may affect how some medicines work and vice versa. Other medicines may also influence how rituximab works.

In particular, inform your doctor:

if you are taking medicines for high blood pressure. You may be asked to stop taking these medicines for 12 hours before receiving rituximab. This is because some people experience a drop in blood pressure during rituximab infusion.
if you have previously taken medicines that affect the immune system—such as chemotherapy or immunosuppressive drugs.

If any of the above conditions apply to you (or if you have any doubts), speak with your doctor, pharmacist, or nurse before receiving rituximab.

Pregnancy and breastfeeding
You must inform your doctor or nurse if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. This is because rituximab can cross the placenta and may affect the unborn baby.
If there is a possibility that you could become pregnant, you and your partner must use an effective method of contraception during treatment with rituximab and for 12 months after the last dose of treatment.

Rituximab passes into breast milk in very small amounts. Since the long-term effects on breastfed infants are unknown, as a precautionary measure, breastfeeding is not recommended during treatment with rituximab and for 6 months after treatment ends.

Driving and using machines
It is not known whether rituximab affects the ability to drive or use tools or machinery.

Ituxredi contains sodium
This medicine contains 52.2 mg of sodium (the main component of table salt) per 10 ml vial and 261.2 mg per 50 ml vial.
This corresponds to 2.6% (for the 10 ml vial) and 13.2% (for the 50 ml vial) of the maximum daily recommended dietary intake of sodium for an adult.

3. How Ituxredi is administered

Ituxredi will be administered to you by a doctor or nurse experienced in the use of this treatment.
They will monitor you closely during administration of the medicine, in case any adverse reactions occur.
Ituxredi is always administered as an intravenous infusion (IV infusion).

Medicines given before each Ituxredi infusion
Before each Ituxredi infusion, you will be given other medicines (premedication) to prevent or reduce the occurrence of possible side effects.

Dose and frequency of treatment
a) If you are being treated for non-Hodgkin’s lymphoma

If you are receiving Ituxredi as a single treatment, Ituxredi will be administered once a week for 4 weeks. Repeated cycles of rituximab treatment may be possible.
If you are receiving Ituxredi in combination with chemotherapy, you will receive Ituxredi on the same day as your chemotherapy. These are usually given every 3 weeks for up to 8 cycles.
If you respond well to treatment, Ituxredi may be given as maintenance therapy every 2 or 3 months for 2 years. Depending on your response to the medicine, your doctor may adjust this treatment schedule.
If you are under 18 years of age, you will receive Ituxredi in combination with chemotherapy. You will receive Ituxredi up to 6 times over a period of 3.5 to 5.5 months.

b) If you are being treated for chronic lymphocytic leukemia
If you are receiving rituximab in combination with chemotherapy, you will receive Ituxredi infusions together with chemotherapy: rituximab infusions on day 0 of cycle 1, then on day 1 of each cycle for a total of 6 cycles. Each cycle lasts 28 days. Chemotherapy must be administered after the rituximab infusion. Your doctor will decide whether you need concomitant supportive therapy.

c) If you are being treated for rheumatoid arthritis
Each treatment cycle consists of two separate infusions given 2 weeks apart. Repeated cycles of rituximab treatment may be possible. Based on the signs and symptoms of your disease, your doctor will determine when to administer further cycles of rituximab. This may occur after several months.

d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Treatment with rituximab consists of four separate weekly infusions. Corticosteroids will be administered by injection before starting rituximab treatment. Oral corticosteroids may be started at any time, as decided by your doctor, to manage your condition.
If you are 18 years of age or older and respond well to treatment, rituximab may be administered as maintenance therapy. This will consist of two separate infusions given 2 weeks apart, followed by one infusion every 6 months for at least 2 years. Depending on your response to the medicine, your doctor may decide to extend treatment with rituximab (up to a maximum duration of 5 years).

e) If you are being treated for pemphigus vulgaris
Each treatment cycle consists of two separate infusions given 2 weeks apart. If you respond well to treatment, rituximab may be administered as maintenance therapy at 1 year and 18 months after the initial treatment, and subsequently, if necessary, every 6 months, or as modified by your doctor depending on your response to the medicine.

If you have any further questions about the use of this medicine, please ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate, but in some cases they may be severe and require treatment. Rarely, some of these reactions have been fatal.

Infusion reactions
During or within the first 24 hours after the infusion, you may develop fever, chills, and shaking. Less frequently, some patients may experience pain at the infusion site, blistering, skin itching, nausea, fatigue, headache, breathing difficulties, increased blood pressure, wheezing, sore throat, swelling of the tongue or throat, irritated or runny nose, vomiting, feeling of warmth or palpitations, heart attack, or reduction in platelet count. If you have heart disease or angina, these reactions may worsen. If you or your child experiences any of these symptoms, inform immediately the person administering the infusion, as it may be necessary to slow down or stop the infusion rate. Additional treatment may be required, for example with an antihistamine or paracetamol. Once these symptoms have resolved or improved, the infusion may be resumed. These reactions are less likely to occur after the second infusion. Your doctor may decide to discontinue rituximab treatment if these reactions are severe.

Infections
Inform your doctor immediately if you or your child shows signs of infection, including:

fever, cough, sore throat, burning when urinating, feeling weak or generally unwell;
memory loss, thinking disturbances, difficulty walking, or loss of vision – these may be due to a very rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).

You may be more susceptible to infections during treatment with rituximab. These are often colds, but cases of pneumonia, urinary tract infections, and serious viral infections have also occurred. These conditions are listed below in the section “Other side effects”.

If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris, you will find this information also in the Patient Alert Card that will be given to you by your doctor. It is important that you carry this alert card with you and show it to family members or anyone caring for you.

Skin reactions
Very rarely, serious skin reactions with blistering may occur, which can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes such as inside the mouth, genital area, or eyelids, and fever may be present. Inform your doctor immediately if any of these symptoms occur.

Other side effects

a) If you or your child is being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukemia

Very common side effects (may affect more than 1 in 10 people):

bacterial or viral infections, bronchitis
low white blood cell count, with or without fever, or low platelet count
nausea
areas of hair loss on the scalp, chills, headache
weakened immune defenses – due to reduced levels of certain antibodies called “immunoglobulins” (IgG) in the blood, which help protect the body against infections.

Common side effects (may affect up to 1 in 10 people):

blood infections (sepsis), pneumonia, shingles (herpes zoster), colds, bronchial infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
low red blood cell count (anemia) and low counts of all blood cells
allergic reactions (hypersensitivity)
high blood sugar levels, weight loss, facial and body swelling, increased levels of the enzyme “LDH” in the blood, low calcium levels in the blood
abnormal skin sensations – such as numbness, tingling, prickling, burning sensation, tight feeling in the skin, reduced sense of touch
restlessness, difficulty falling asleep
facial flushing and redness in other skin areas due to blood vessel dilation
dizziness or anxiety
increased tear production, tear duct problems, eye inflammation (conjunctivitis)
ringing in the ears, ear pain
heart problems – such as heart attack, rapid or irregular heartbeat
high or low blood pressure (low blood pressure especially when standing up)
airway muscle tightening causing wheezing (bronchospasm), inflammation or irritation of the lungs, throat, or sinuses, shortness of breath, runny nose
vomiting, diarrhea, abdominal pain, throat or mouth irritation or ulceration, difficulty swallowing, constipation, indigestion
difficulty eating, inadequate food intake leading to weight loss
hives, increased sweating, night sweats
muscle problems – such as muscle stiffness, muscle or joint pain, back and neck pain
tumour pain
general feeling of fatigue and malaise, tremors, flu-like symptoms
multi-organ failure

Uncommon side effects (may affect up to 1 in 100 people):

blood clotting problems, reduced red blood cell production, increased destruction of red blood cells (aplastic hemolytic anemia), swelling or enlargement of lymph nodes
low mood and loss of interest or pleasure in usual activities, nervousness
taste disturbances – such as altered taste
heart problems – such as slow heartbeat or chest pain (angina)
asthma, insufficient oxygen supply to body organs
stomach swelling

Very rare side effects (may affect up to 1 in 10,000 people):

temporary increase in certain types of antibodies in the blood (called immunoglobulins – IgM), chemical changes in the blood due to the breakdown of dead tumour cells
nerve damage in arms and legs, facial paralysis
heart failure
inflammation of blood vessels, including those causing skin symptoms
respiratory failure
damage to the gastrointestinal wall (perforation), severe skin problems with blistering that can be fatal. Redness, often associated with blisters, may appear on the skin or mucous membranes such as inside the mouth, genital areas, or eyelids, and fever may be present
kidney failure
severe vision loss (sign of cranial nerve damage)

Not known (frequency cannot be estimated from available data):

delayed reduction in white blood cells
immediate post-infusion decrease in platelet count – reversible, but in rare cases may be fatal
hearing loss, loss of other senses
brain and meningeal infection/inflammation (enteroviral meningoencephalitis)

Children and adolescents with non-Hodgkin’s lymphoma:
In general, side effects in children and adolescents with non-Hodgkin’s lymphoma have been similar to those observed in adults with non-Hodgkin’s lymphoma or chronic lymphocytic leukemia. The most common side effects have been fever associated with low levels of a type of white blood cell (neutrophils), inflammation or sores in the lining of the mouth, and allergic reactions (hypersensitivity).

b) If you are being treated for rheumatoid arthritis

Very common side effects (may affect more than 1 in 10 people):

Infections such as pneumonia (bacterial)
Pain when passing water (urinary tract infection)
Allergic reactions occurring mainly during infusion, but which may occur up to 24 hours after infusion
Blood pressure changes, nausea, rash, fever, itching sensation, stuffy or runny nose and sneezing, tremors, rapid heartbeat, and fatigue
Headache
Changes in laboratory tests performed by your doctor. These include a decrease in specific proteins in the blood (immunoglobulins) that help protect against infections.

Common side effects (may affect up to 1 in 10 people):

Infections such as bronchial inflammation (bronchitis)
Feeling of fullness or throbbing pain in the nose, cheeks, and eyes (sinusitis), abdominal pain, vomiting and diarrhea, breathing problems
Fungal foot infection (athlete’s foot)
High cholesterol levels in the blood
Abnormal skin sensations such as numbness, tingling, pricking, or burning, sciatica, migraine, dizziness
Hair loss
Anxiety, depression
Indigestion, diarrhea, acid reflux, throat or mouth irritation and/or ulceration
Abdominal, back, muscle and/or joint pain

Uncommon side effects (may affect up to 1 in 100 people):

Excessive fluid retention in the face and body
Inflammation, irritation and/or stiffness of the lungs and throat, cough
Skin reactions, including hives, itching, and rashes
Allergic reactions, including shortness of breath, facial and tongue swelling, collapse

Very rare side effects (may affect up to 1 in 10,000 people):

A complex of symptoms occurring within a few weeks after a rituximab infusion, including allergic-type reactions such as rashes, itching, joint pain, swollen lymph glands, and fever.
Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes such as inside the mouth, genital areas, or eyelids, and fever may be present.

Not known (frequency cannot be estimated from available data):

Severe viral infection
brain and meningeal infection/inflammation (enteroviral meningoencephalitis)

Other side effects rarely reported with rituximab include a decrease in the number of white blood cells (neutrophils) in the blood, which help fight infections. Some infections may be severe (see information on Infections in this section).

c) If you or your child are being treated for granulomatosis with polyangiitis or microscopic polyangiitis

Very common side effects (may affect more than 1 in 10 people):

Infections, such as chest infections, urinary tract infections (pain when passing water), colds, and herpes infections
Allergic reactions occurring mainly during infusion, but which may occur up to 24 hours after infusion
Diarrhea
Cough or shortness of breath
Nosebleeds
Increased blood pressure
Joint or back pain
Muscle contractions or tremors
Dizziness
Tremors (often in the hands)
Difficulty sleeping (insomnia)
Swelling of the hands or ankles

Common side effects (may affect up to 1 in 10 people):

Indigestion
Constipation
Skin rashes, including acne or spots
Skin redness or flushing
Fever
Stuffy or runny nose
Tight or painful muscles
Muscle, hand or foot pain
Low red blood cell count (anemia)
Low platelet count in the blood
increased potassium levels in the blood
Changes in heart rhythm or faster than normal heartbeat

Very rare side effects (may affect up to 1 in 10,000 people):

Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes such as inside the mouth, genital areas, or eyelids, and fever may be present
Reactivation of previous hepatitis B infection

Not known (frequency cannot be estimated from available data):

Severe viral infection
brain and meningeal infection/inflammation (enteroviral meningoencephalitis)

Children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis
In general, side effects in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis have been similar to those observed in adults with these conditions. The most common side effects have been infections, allergic reactions, and nausea.

d) If you are being treated for pemphigus vulgaris

Very common side effects (may affect more than 1 in 10 people):

Allergic reactions occurring more likely during infusion, but which may occur up to 24 hours after infusion
Headache
Infections such as chest infections
Long-lasting depression
Hair loss

Common side effects (may affect up to 1 in 10 people):

Infections such as common cold, herpes infections, eye infections, oral thrush, and urinary tract infections (pain during urination)
Mood disturbances such as irritability and depression
Skin disorders such as itching, hives, and benign nodules
Feeling of fatigue or dizziness
Fever
Joint or back pain
Abdominal pain
Muscle pain
Heart beating faster than normal

Not known (frequency cannot be estimated from available data):

Severe viral infection
brain and meningeal infection/inflammation (enteroviral meningoencephalitis)

Rituximab may also cause changes in laboratory tests performed by your doctor.
If rituximab is administered together with other medicines, some of the side effects may be due to these other medicines.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ituxredi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the container in the outer carton to protect it from light.

After aseptic dilution in sodium chloride solution The infusion solution of Ituxredi prepared in 0.9% sodium chloride solution is physically and chemically stable for 60 days at 5±3°C and for 30 days at 25±2°C.
After aseptic dilution in dextrose solution The infusion solution of Ituxredi prepared in 5% dextrose solution is physically and chemically stable for 48 hours at 2°C - 8°C and 25±2°C.

From a microbiological standpoint, the prepared infusion solution should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should generally not exceed 24 hours at 2°C - 8°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ituxredi contains

The active substance in Ituxredi is rituximab. The 10 mL vial contains 100 mg of rituximab (10 mg/mL). The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
The other ingredients are sodium citrate (E331), citric acid (E330), polysorbate 80 (E433), sodium chloride and water for injections.

Description of the appearance of Ituxredi and contents of the pack
Ituxredi is a solution ranging from clear to opalescent, colourless to yellowish, supplied as a concentrate for infusion solution in glass vials.
Each pack contains 1 or 2 vials of Ituxredi.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
Augsburg 86156
Germany

Manufacturer
betapharm Arzneimittel GmbH
Kobelweg 95
Augsburg 86156
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tél/Tel: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

България Luxembourg/Luxemburg
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Teл.: +49 821 74881 0 Tél/Tel: + 49 821 74881 0
[email protected] [email protected]

Česká republika Magyarország
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: +49 821 74881 0 Tel.: + 49 821 74881 0
[email protected] [email protected]

Danmark Malta
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tlf: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Deutschland Nederland
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Kobelweg 95 Tel: + 49 821 74881 0
86156 Augsburg [email protected]
Tel: + 49 821 74881 0
[email protected]

Eesti Norge
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0 Tlf: + 49 821 74881 0
[email protected] [email protected]

Ελλάδα Österreich
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Τηλ: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

España Polska
Reddy Pharma Iberia S.A.U. betapharm Arzneimittel GmbH
Avenida Josep Tarradellas nº 38 Tel.: + 49 821 74881 0
E-08029 Barcelona [email protected]
Tel: + 34 93 355 49 16
[email protected]

France Portugal
Reddy Pharma SAS betapharm Arzneimittel GmbH
9 avenue Edouard Belin Tel: + 49 821 74881 0
F-92500 Rueil-Malmaison [email protected]
Tél: + 33 1 85 78 17 34
[email protected]

Hrvatska România
betapharm Arzneimittel GmbH Dr. Reddy´s Laboratories Romania SRL
Tel: + 49 821 74881 0 Tel: + 4021 224 0032
[email protected] [email protected]

Ireland Slovenija
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Ísland Slovenská republika
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Sími: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Italia Suomi/Finland
Dr. Reddy’s S.r.l. betapharm Arzneimittel GmbH
Piazza Santa Maria Beltrade, 1 Puh/Tel: + 49 821 74881 0
20123 Milano [email protected]
Tel: + 39(0)2 70106808
[email protected]

Κύπρος Sverige
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Τηλ: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Latvija
betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0
[email protected]

Ituxredi contains the same active substance and works in the same way as a reference medicine already authorised in the EU.