Rixathon: detailed information

Patient Information Leaflet: Information for the Patient

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

rituximab
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of this leaflet

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

1. What Rixathon is and what it is used for

What Rixathon is
Rixathon contains the active substance "rituximab", a type of protein called a "monoclonal antibody" that binds to the surface of certain white blood cells, specifically B-lymphocytes. When rituximab binds to the surface of these cells, it causes their death.

What Rixathon is used for
Rixathon can be used to treat a variety of different conditions in adults and children. Your doctor may prescribe Rixathon 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 cell.
In adults, Rixathon may be given alone or in combination with other medicines collectively referred to as "chemotherapy".
In adult patients who respond to treatment, Rixathon can be used as maintenance therapy for 2 years following completion of initial treatment.
In children and adolescents, rituximab is administered in combination with "chemotherapy".

b) Chronic lymphocytic leukaemia (CLL)
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. Rixathon, in combination with chemotherapy, destroys these cells, which are then gradually removed from the body through biological processes.

c) Rheumatoid arthritis
Rixathon 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. Rixathon is used to treat rheumatoid arthritis in people who have already tried other medicines that either stopped working, were not effective enough, or caused unwanted side effects. Rixathon is usually taken together with another medicine called methotrexate.
Rixathon slows down joint damage caused by rheumatoid arthritis and improves the ability to carry out normal daily activities.
The best response to Rixathon has been observed in patients who have positive blood tests for rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP) antibodies. Both tests are commonly positive in rheumatoid arthritis and help confirm the diagnosis.

d) Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)
Rixathon is used to treat adults and children aged 2 years and older with GPA (previously called Wegener’s disease) or MPA, in combination with glucocorticoids.
GPA and MPA 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 (PV)
Rixathon is used to treat patients with moderate to severe pemphigus vulgaris. PV is an autoimmune disease that causes painful blisters on the skin and mucous membranes (lining tissues) of the mouth, nose, throat, and genitals.

2. What you need to know before you are given Rixathon

Do not take Rixathon

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);
if you currently have a serious active infection;
if your immune system is weakened;
if you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris.

Do not take Rixathon if any of the above conditions apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before receiving Rixathon.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Rixathon:

if you have previously had hepatitis infection or may currently have one, as in a small number of cases Rixathon could cause reactivation of hepatitis B, which in very rare cases may lead to death. Patients with a prior history of hepatitis B infection will be closely monitored by the doctor for any signs of this infection;
if you have previously had 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 Rixathon. Your doctor may need to monitor you particularly closely during treatment with Rixathon.
Also speak with your doctor if you think you may need any vaccination in the near future, including vaccinations required for travel to other countries. Some vaccines should not be given at the same time as Rixathon or in the months following Rixathon treatment. Your doctor will assess whether you can receive any vaccine before starting Rixathon.

If you have rheumatoid arthritis, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or pemphigus vulgaris (PV), talk to your doctor

if you think you have an infection, even a mild one such as a cold. The cells affected by Rixathon are involved in fighting infections, and it is necessary to wait until the infection has resolved before taking Rixathon. Also, inform your doctor if you have previously had frequent infections 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 (acute mature B-cell leukemia; BAL), or Burkitt-like lymphoma (BLL).
Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
Rituximab may be used to treat children and adolescents aged 2 years and older with GPA (previously known as Wegener’s disease) or MPA. Currently, limited information is available regarding the use of rituximab in children and adolescents with other diseases.
Talk to your doctor, pharmacist, or nurse before administration of this medicine if you or your child is under 18 years of age.

Other medicines and Rixathon
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 medicines, as Rixathon may affect how some medicines work and vice versa.
Specifically, inform your doctor:

if you are taking medicines for high blood pressure. You may be asked to stop taking these medicines 12 hours before receiving Rixathon, as some people experience a drop in blood pressure during Rixathon 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), talk to your doctor, pharmacist, or nurse before receiving Rixathon.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, inform your doctor or nurse. This is because Rixathon can cross the placenta and may affect the unborn child.
If there is any possibility you could become pregnant, you must use an effective method of contraception during treatment with Rixathon and for 12 months after your last dose of Rixathon.
Breastfeeding is not recommended during treatment with Rixathon and for 6 months after treatment, as rituximab passes into breast milk in very small amounts. Since the long-term effects on breastfed infants are unknown, a precautionary approach is advised.

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

Rixathon contains sodium
This medicine contains 52.6 mg of sodium (a main component of table salt) per 10 mL vial and 263.2 mg of sodium per 50 mL vial.
This corresponds to 2.6% (in the 10 mL vial) and 13.2% (in the 50 mL vial) of the maximum daily dietary intake recommended for an adult.

3. How Rixathon is administered

Administration
Rixathon will be administered to you by a doctor or a nurse experienced in the use of this treatment.
You will be closely monitored during administration of the medicine in order to detect any possible
adverse effects.
Rixathon will always be administered by intravenous infusion (a slow drip into a vein).

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

Dose and frequency of treatment

a) If you are being treated for non-Hodgkin's lymphoma

If you are receiving Rixathon alone
Rixathon will be given once a week for 4 weeks. Repeated cycles of Rixathon treatment may be possible.
If you are receiving Rixathon in combination with chemotherapy
You will receive Rixathon on the same day as your chemotherapy; administration usually occurs every 3 weeks for up to 8 times.
If you respond well to treatment, Rixathon may be given as maintenance therapy every 2 or 3 months for two 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 Rixathon in combination with chemotherapy. You will receive Rixathon up to 6 times over a period of 3.5 to 5.5 months.

b) If you are being treated for chronic lymphocytic leukemia (CLL)
If you are receiving Rixathon in combination with chemotherapy, you will receive Rixathon 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 Rixathon 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 Rixathon treatment may be possible. Based on disease signs and symptoms, your doctor will determine when to administer further cycles. This may occur after several months.

d) If you are being treated for granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
Treatment with Rixathon consists of four separate infusions given at weekly intervals. Corticosteroids will be administered by injection before starting Rixathon treatment. Oral corticosteroids may be started at any time by your doctor to manage your condition.

If you are 18 years of age or older and respond well to treatment, Rixathon may be given 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 Rixathon treatment (up to a maximum duration of 5 years).

e) If you are being treated for pemphigus vulgaris (PV)
Each treatment cycle consists of two separate infusions given 2 weeks apart. If you respond well to treatment, Rixathon may be given as maintenance therapy at 1 year and 18 months after initial treatment, and subsequently, if necessary, every 6 months. Depending on your response to the medicine, your doctor may modify this treatment schedule.

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 everyone gets them.
Most side effects are mild or moderate, but in some cases they can 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, irritation or runny nose, vomiting, feeling of warmth or palpitations, heart attack, or reduced 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 treatment with Rixathon 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 sensation 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);
fever, headache, neck stiffness, lack of coordination (ataxia), personality changes, hallucinations, altered consciousness, seizures, or coma – these may be due to a serious brain infection (enteroviral meningioencephalitis), which can be fatal.

You may be more prone to infections during treatment with Rixathon.
These are often colds, but cases of pneumonia, urinary tract infections, and serious viral infections have occurred. These conditions are listed below under the section “Other side effects”.
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris, you will also find this information 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, which may be life-threatening, can occur. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area, or on the 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 (NHL) or chronic lymphocytic leukemia (CLL)

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 (blood cells)
nausea
areas of hair loss on the scalp, chills, headache
reduced immune defenses – due to a decrease in certain antibodies called “immunoglobulins” (IgG) in the blood, which help the body protect 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, sinusitis, hepatitis B
low red blood cell count (anaemia), low count of all blood cells
allergic reactions (hypersensitivity)
high blood sugar levels, weight loss, facial and body swelling, elevated levels of the enzyme “LDH” in the blood, low blood calcium levels
abnormal skin sensations – such as numbness, tingling, pricking, burning, feeling of stretched skin, reduced sense of touch
restlessness, difficulty falling asleep
marked redness of the face and other skin areas due to blood vessel dilation
dizziness or anxiety
increased tear production, tear duct problems, eye inflammation (conjunctivitis)
continuous ringing in the ears, ear pain
heart problems – such as heart attack, irregular or rapid heartbeat
high or low blood pressure (decreased blood pressure especially when standing)
contraction of respiratory muscles causing wheezing (bronchospasm), inflammation, irritation in the lungs, throat, and sinuses, shortness of breath, runny nose
vomiting, diarrhoea, stomach pain, throat or mouth irritation or ulceration, swallowing difficulties, constipation, indigestion
eating disorders: inadequate food intake leading to weight loss
hives, increased sweating, night sweats
muscle problems – such as muscle stiffness, joint or muscle pain, back and neck pain
tumour pain
general malaise, restlessness or fatigue, 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 and increased destruction of red blood cells (haemolytic and aplastic anaemia), swelling or enlargement of lymph nodes
low mood and loss of interest or pleasure in activities, nervousness
taste-related problems – such as altered sense of taste
heart problems – such as decreased heart rate or chest pain (angina)
asthma, insufficient oxygen supply to the body’s organs
stomach swelling.

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

short-term increase in certain types of antibodies (immunoglobulins – IgM) in the blood, chemical changes in the blood due to the breakdown of dying 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 intestinal wall (perforation)
severe skin problems with blistering, potentially fatal. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area, or on the eyelids, and fever may be present
kidney failure
severe loss of vision.

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

delayed decrease in white blood cells
reduced platelet count immediately after infusion – a reversible condition, but potentially fatal in rare cases
hearing loss, loss of other senses
infection/inflammation of the brain and meninges (enteroviral meningioencephalitis).

Children and adolescents with non-Hodgkin’s lymphoma (NHL)
In general, side effects observed in children and adolescents with non-Hodgkin’s lymphoma have been similar to those seen in adults with NHL or CLL. The most common side effects observed were fever associated with low levels of a type of white blood cells (neutrophils), inflammation or mouth ulcers (aphthae), 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 urinating (urinary tract infections)
allergic reactions likely to occur during the infusion but which may occur up to 24 hours after the infusion
changes in blood pressure, nausea, skin rashes, fever, itching sensation, stuffy or runny nose, sneezing, tremor, rapid heartbeat, and fatigue
headache
changes in laboratory tests required by your doctor. These include a reduction in certain 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)
a feeling of pain and fullness behind the nose, cheeks, and eyes (sinusitis), abdominal pain, vomiting, and diarrhoea, breathing problems
fungal infection of the feet (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, diarrhoea, acid reflux, throat or mouth irritation and/or ulceration
stomach, back, muscle, and/or joint pain.

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

fluid retention in the face and body
inflammation, irritation, and/or tightness in the lungs or throat, cough
skin reactions, including hives, itching, skin rashes
allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse.

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

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

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

serious viral infections
infection/inflammation of the brain and meninges (enteroviral meningioencephalitis).

Other side effects rarely reported with rituximab treatment include a reduced number of white blood cells (neutrophils) in the blood, which are needed to fight infections. Some infections may be serious (please see the information on Infections within this section).

c) If you or your child is being treated for granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

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

infections, such as lung infections, urinary tract infections (pain when urinating), colds, and herpes infections
allergic reactions likely to occur during the infusion but which may occur up to 24 hours after the infusion
diarrhoea
cough or shortness of breath
nosebleeds
increased blood pressure
joint or back pain
muscle contractions or restlessness
dizziness
tremors (often in the hands)
sleep disturbances (insomnia)
swelling of hands and ankles.

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

indigestion
constipation
skin rashes, including acne or spots
hot flushes or skin redness
fever
stuffy or runny nose
muscle stiffness or muscle pain
pain in muscles, hands, or feet
low red blood cell count (anaemia)
low platelet count in the blood
increased potassium levels in the blood
changes in heart rhythm or abnormally rapid heartbeat.

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

severe skin reactions with blistering that may be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area, or on the eyelids, and fever may be present
reactivation of previous hepatitis B infection.

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

serious viral infections
infection/inflammation of the brain and meninges (enteroviral meningioencephalitis).

Children and adolescents with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
In general, the side effects in children and adolescents with GPA or MPA have been similar in type to those observed in adults with GPA or MPA. The most frequently observed side effects were 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 likely to occur during the infusion but which may occur up to 24 hours after the infusion
headache
infections, such as chest infections
persistent depression
hair loss.

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

infections, such as colds, herpes infections, eye infections, oral thrush, and urinary tract infections (pain during urination)
mood disorders, such as irritability and depression
skin disorders, such as itching, hives, and benign cysts
fatigue or dizziness
fever
joint or back pain
abdominal pain
muscle pain
abnormally rapid heartbeat.

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

serious viral infections
infection/inflammation of the brain and meninges (enteroviral meningioencephalitis).

Rixathon may also cause changes in laboratory tests required by your doctor.
If you are taking Rixathon in combination with other medicines, some of the side effects you experience 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 listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rixathon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and label of the vial after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer packaging to protect it from light.
This medicine can also be stored in its original carton outside the refrigerator at a temperature not exceeding 30 °C for a single period of up to 7 days, provided that this period does not extend beyond the original expiry date. In this case, the medicine must not be returned to the refrigerator. Write the new expiry date on the carton, including day/month/year. Dispose of this medicine if not used within the new expiry date or the printed expiry date on the carton, whichever comes first.
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 Rixathon contains

The active substance in Rixathon 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 components are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).

Description of the appearance of Rixathon and contents of the pack
Rixathon is a clear, colourless to slightly yellowish solution supplied as a concentrate for infusion (sterile concentrate).
10 mL vial – pack containing 2 or 3 vials.
50 mL vial – pack containing 1 or 2 vials.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Lek Pharmaceuticals d.d. Ljubljana
Verovškova 57
1526 Ljubljana
Slovenia

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

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf/Sími/Tel: +45 63 95 10 00 Tel: +35699644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
Sandoz Pharmaceuticals d.d. Sandoz GmbH
Τηλ: +357 22 69 0690 Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.