RIXIMYO 100 mg Concentrate For Infusion Solution

Зміст інструкції

1. Riximyo 100 mg concentrate for solution for infusion, 500 mg concentrate for solution for infusion
   1. What is Riximyo and what is it used for
   2. What you need to know before you are given Riximyo
   3. How Riximyo is administered
   4. Possible side effects
   5. How to store Riximyo
   6. Package contents and other information

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

rituximab

Read this leaflet carefully before you start this medicine 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Riximyo is and what it is used for
• 2. What you need to know before you are given Riximyo
• 3. How Riximyo is given
• 4. Possible side effects
• 5. How to store Riximyo
• 6. Contents of the pack and other information.

1. What is Riximyo and what is it used for

What is Riximyo
Riximyo contains the active substance “rituximab”, a type of protein called a “monoclonal antibody” that binds to the surface of particular white blood cells, namely B lymphocytes. When rituximab binds to the surface of these cells it causes their death.

What is Riximyo used for
Riximyo can be used for the treatment of many and diverse conditions in adults and children. Your doctor may prescribe Riximyo 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 particular type of white blood cell.
In adults Riximyo can be given as monotherapy (alone) or with other medicines called collectively “chemotherapy”.
In adult patients in whom the treatment proves effective, Riximyo can be used as maintenance therapy for 2 years after completion of the initial treatment.
In children and adolescents rituximab is given in association with “chemotherapy”.

b)Chronic Lymphocytic Leukemia (CLL)
CLL is the most common form of leukemia in adults. CLL involves a particular lymphocyte, the B cell, which originates from the bone marrow and matures in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate especially in the bone marrow and blood. The proliferation of these abnormal B lymphocytes is the cause of the symptoms you may have. Riximyo in association with chemotherapy destroys these cells which are gradually removed from the body by biological processes.

c)Rheumatoid Arthritis
Riximyo is used for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a disease that affects the joints. B lymphocytes are responsible for some of the symptoms you have. Riximyo is used to treat rheumatoid arthritis in people who have already tried other medicines that have stopped working, have not worked well enough or have caused undesirable effects. Riximyo is generally taken with another medicine called methotrexate.
Riximyo slows down the damage to the joints caused by rheumatoid arthritis and increases the ability to perform normal daily activities.
The best response to Riximyo has been observed in those who have a blood test positive for rheumatoid factor (RF) and/or Cyclic Citrullinated Peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and help in confirming the diagnosis.

d)Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Riximyo is used for the treatment of adults and children aged 2 years and over with GPA (previously called Wegener's disease) or MPA, in association with glucocorticoids.
GPA and MPA are two forms of inflammation of the blood vessels that mainly affect the lungs and kidneys, but can also affect other organs. B lymphocytes are involved in the cause of these conditions.

e)Pemphigus Vulgaris (PV)
Riximyo is used for the treatment of patients with moderate to severe pemphigus vulgaris. PV is an autoimmune disease that causes the formation of 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 Riximyo

Do not take Riximyo

• 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 weak;
• if 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 Riximyo if any of the above conditions apply to you. If you have any doubts, ask your doctor, pharmacist or nurse before you are given Riximyo.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Riximyo:

• if you have had a hepatitis infection in the past or might have it now, as in a small number of cases Riximyo may cause reactivation of hepatitis B which, in very rare cases, can lead to death. Patients with a previous hepatitis B infection will be carefully monitored by the doctor to detect any signs of this infection;
• if you have previously suffered from heart problems (such as angina, palpitations or heart failure) or have had breathing problems.

If any of the above conditions apply to you (or if you are unsure), talk to your doctor, pharmacist or nurse before you are given Riximyo. Your doctor may need to pay particular attention to you during treatment with Riximyo.
Talk to your doctor also if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as Riximyo or in the months following the administration of Riximyo. Your doctor will assess whether you can have any vaccines before taking Riximyo.

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 like a cold. The cells that are affected by Riximyo are needed to fight infections and you need to wait until the infection has healed before taking Riximyo. Also, tell your doctor if you have had numerous infections in the past or if you suffer from serious infections.

Children and adolescents

Non-Hodgkin lymphoma
Rituximab can be used for the treatment of children and adolescents aged 6 months or older with non-Hodgkin lymphoma, specifically diffuse large B-cell lymphoma (DLBCL) CD20 positive, Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia; BAL) or Burkitt-like lymphoma (BLL).

Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
Rituximab can be used for the treatment of children and adolescents aged 2 years or older with GPA (previously called Wegener’s disease) or MPA. There is currently limited information available regarding the use of rituximab in children and adolescents with other diseases.
Talk to your doctor, pharmacist or nurse before the administration of this medicine if you or your child is less than 18 years of age.

Other medicines and Riximyo
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal medicines, as Riximyo can affect the way some medicines work and vice versa.
In particular, tell your doctor:

• if you are taking medicines for the treatment of high blood pressure. You may be asked to stop taking these medicines 12 hours before you are given Riximyo, as some people experience a drop in blood pressure during the administration of Riximyo;
• if you have previously taken medicines that affect your immune system - such as chemotherapy or immunosuppressant drugs.

If any of the above conditions apply to you (or if you are unsure), talk to your doctor, pharmacist or nurse before you are given Riximyo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, tell your doctor or nurse. This is because Riximyo can cross the placenta and have effects on the baby.
If there is a possibility that you might become pregnant, you will need to use effective contraception during treatment with Riximyo and for 12 months after the last treatment with Riximyo. This is because Riximyo passes into breast milk in very small amounts. As the long-term effects on breastfed infants are not known, it is not recommended to breastfeed during treatment with Riximyo and for 6 months after treatment.

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

Riximyo contains sodium
This medicine contains 52.6 mg of sodium (the main component of table salt) per 10 mL vial and 263.2 mg of sodium per 50 mL vial.
This is equivalent to 2.6% (in the 10 mL vial) and 13.2% (in the 50 mL vial) of the recommended maximum daily intake of salt with the diet of an adult.

3. How Riximyo is administered

Administration
Riximyo will be administered by a doctor or a nurse experienced in the use of this treatment.
They will monitor you carefully during the administration of the medicine in order to detect
the possible occurrence of undesirable effects.
The administration of Riximyo will always be carried out by intravenous drip infusion
(intravenous infusion).

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

Quantity and frequency with which you will receive therapy
a)If you are being treated for non-Hodgkin's lymphoma

• If you are administered only RiximyoRiximyo will be administered once a week for 4 weeks. Repeated treatment cycles with Riximyo are possible.
• If you are administered Riximyoin combination with chemotherapyYou will receive Riximyo on the same day you receive chemotherapy; their administration generally occurs every 3 weeks for a maximum of 8 times.
• If you respond well to treatment, Riximyo may be administered as maintenance therapy every 2 or 3 months for two years. Based on your response to the medicine, the doctor may modify this administration schedule.
• If you are under 18 years of age, you will be administered Riximyo with chemotherapy. You will receive Riximyo up to 6 times over a period of 3.5-5.5 months.

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

c)If you are being treated for rheumatoid arthritis
Each treatment cycle involves two separate infusions, administered 2 weeks apart.
Repeated treatment cycles with Riximyo are possible. Based on the signs and
symptoms of the disease, the doctor will determine when to administer further cycles. This could
occur several months later.

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

e)If you are being treated for pemphigus vulgaris (PV)
Each treatment cycle involves two separate infusions, administered 2
weeks apart. If you respond well to treatment, Riximyo may be administered
as maintenance therapy at 1 year and 18 months from the initial treatment and, subsequently, if
necessary, every 6 months. Based on your response to the medicine, the doctor may modify this
administration schedule.
If you have any further questions regarding the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Infusion reactions
During or within the first 24 hours of the infusion, you may develop fever, chills and tremor. Less
frequently, some patients may experience pain at the infusion site, blister formation,
itching, nausea, fatigue, headache, difficulty breathing, increased blood
pressure, wheezing, sore throat, swelling of the tongue or throat, irritation or runny nose,
vomiting, a feeling of warmth or palpitations, heart attack or a decrease in the number of platelets. If
you have heart disease or angina, these reactions may worsen. If you or
your child experiences any of these symptoms, immediately inform the person who is
administering the infusion, as it may be necessary to slow down the infusion rate or
stop it. Additional treatment may be necessary, for example with an antihistamine or
paracetamol. When these symptoms resolve or improve, the infusion may be resumed. It
is less likely that these reactions will occur after the second infusion. The doctor may
decide to discontinue treatment with Riximyo if these reactions are severe.

Infections
Immediately inform your doctor if you or your child shows signs of an infection,
including:

• fever, cough, sore throat, burning when urinating, feeling weak or generally unwell;
• memory loss, thinking problems, 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 and stiff neck, lack of coordination (ataxia), altered personality, hallucinations, altered state of consciousness, seizures or coma - these may be due to a serious brain infection (enteroviral meningoencephalitis), which can be fatal.

You may develop infections more easily during treatment with Riximyo.
These are often colds, but cases of pneumonia, urinary tract infections and
serious viral infections have 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 also find this information in the Patient Alert Card that your doctor will give you. It is important that you carry this alert card with you and
show it to family members or anyone who cares for you.

Skin reactions
Very rarely, severe skin reactions with blister formation can occur, which
can 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
may be accompanied by fever. Immediately inform your doctor if any of
these symptoms occur.
Other side effects
a)If you or your child is being treated for non-Hodgkin 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 number of white blood cells, with or without fever, or platelets (blood cells)
• nausea
• areas of baldness on the scalp, chills, headache
• weakened immune defenses - due to a reduction in the amount of certain antibodies called “immunoglobulins” (IgG) in the blood that help the body protect itself from infections.

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

• blood infections (sepsis), pneumonia, herpes zoster, colds, bronchial infection, fungal infections, infections of unknown origin, sinusitis, hepatitis B
• low number of red blood cells (anemia), low number of all blood cells
• allergic reactions (hypersensitivity)
• high blood sugar levels, weight loss, swelling of the face and body, high levels of the enzyme “LDH” in the blood, low levels of calcium in the blood
• abnormal sensations on the skin - such as numbness, tingling, prickling, burning, skin tightness, decreased sense of touch
• feeling restless, difficulty falling asleep
• marked redness on the face and other skin areas as a result of blood vessel dilation
• dizziness or anxiety
• increased tearing, problems with the tear duct, eye inflammation (conjunctivitis)
• ringing in the ears, ear pain
• heart problems - such as heart attack, irregular or accelerated heart rate
• high or low blood pressure (decreased blood pressure especially when standing up)
• constriction of the muscles of the airways causing wheezing (bronchospasm), inflammation, irritation in the lungs, throat and sinuses, shortness of breath, runny nose
• vomiting, diarrhea, stomach pain, irritation or ulceration of the throat and mouth, difficulty swallowing, constipation, indigestion
• eating disorders: insufficient food intake with resulting weight loss
• hives, increased sweating, night sweats
• muscle problems - such as muscle stiffness, joint or muscle pain, back and neck pain
• tumor pain
• general malaise, restlessness or fatigue, tremors, flu-like symptoms
• multi-organ failure.

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

• problems with blood clotting, decreased production of red blood cells and increased destruction of red blood cells (hemolytic and aplastic anemia), swelling or enlargement of the lymph nodes
• low mood and loss of interest or pleasure in doing activities, nervousness
• taste problems - such as altered sense of taste
• heart problems - such as decreased heart rate or chest pain (angina)
• asthma, insufficient oxygen reaching the body's organs
• stomach bloating.

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

• a temporary increase in the amount of certain types of antibodies (immunoglobulins - IgM) in the blood, chemical changes in the blood due to the breakdown of dying tumor cells
• damage to the nerves of the arms and legs, facial paralysis
• heart failure
• inflammation of blood vessels, including those causing symptoms on the skin
• respiratory failure
• damage to the intestinal wall (perforation)
• severe skin reactions with blister formation, which can 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 may be accompanied by fever
• kidney failure
• severe vision loss.

Not known (the frequency with which these side effects occur is not known):

• non-immediate decrease in white blood cells
• decrease in the number of platelets immediately after the infusion - a reversible condition, but potentially fatal in rare cases
• hearing loss, loss of other senses
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Children and adolescents with non-Hodgkin lymphoma (NHL)
In general, the side effects recorded in children and adolescents with non-Hodgkin lymphoma
have been similar to those found 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 sores on 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 urinating (urinary tract infections)
• allergic reactions that likely occur during the infusion but may occur up to 24 hours after the infusion
• changes in blood pressure, nausea, skin rashes, fever, itching, stuffy or runny nose, sneezing, tremor, fast heartbeat and fatigue
• headache
• changes in laboratory tests required by the doctor. These include a reduction in the amount of 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), stomach pain, vomiting and diarrhea, breathing problems
• fungal foot infection (athlete's foot)
• high cholesterol levels in the blood
• abnormal sensations on the skin, such as numbness, tingling, prickling or burning, sciatica, migraine, dizziness
• hair loss
• anxiety, depression
• indigestion, diarrhea, acid reflux, irritation and/or ulceration of the throat and mouth
• pain in the stomach, back, muscles and/or joints.

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

• excess fluid retention in the face and body
• inflammation, irritation and/or tension in the lungs, throat, cough
• skin reactions, including hives, itching, 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 that occur within a few weeks of rituximab infusion including allergic-type reactions such as skin rashes, itching, joint pain, swollen lymph nodes and fever
• severe skin reactions with blister formation that can 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 may be accompanied by fever

Not known (the frequency cannot be defined based on available data):

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

Other side effects rarely reported due to treatment with rituximab include a
reduction in the number of white blood cells in the blood (neutrophils) that fight
infections. Some infections may be serious (please see the information
relating to Infectionswithin this paragraph).

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 that likely occur during the infusion but may occur up to 24 hours after the infusion
• diarrhea
• cough or shortness of breath
• nosebleeds
• increased blood pressure
• joint or back pain
• muscle contractions or agitation
• feeling dizzy
• tremors (often in the hands)
• sleep disorders (insomnia)
• swelling of the hands and ankles.

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

• indigestion
• constipation
• skin rashes, including acne or spots
• flushing or redness of the skin
• fever
• stuffy or runny nose
• muscle stiffness or muscle pain
• pain in the muscles or hands or feet
• low number of red blood cells (anemia)
• low number of platelets in the blood
• increased amount of potassium in the blood
• changes in heart rate or faster heartbeat than normal.

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

• severe skin reactions with blister formation that can 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 may be accompanied by fever
• recurrence of a previous hepatitis B infection.

Not known (the frequency cannot be defined based on available data):

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

Children and adolescents with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
In general, undesirable effects in children and adolescents with GPA or MPA have been found to be similar in type to those observed in adults with GPA or MPA. The undesirable effects observed more frequently were infections, allergic reactions and nausea.

d)If you are being treated for pemphigus vulgaris
Very common undesirable effects (may affect more than 1 in 10 people):

• allergic reactions that likely occur during the infusion but may occur up to 24 hours after the infusion
• headache
• infections, such as chest infections
• persistent depression
• hair loss.

Common undesirable 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 conditions, such as itching, hives and benign cysts
• fatigue or dizziness
• fever
• joint or back pain
• abdominal pain
• muscle pain
• heartbeat faster than normal.

Not known (frequency cannot be estimated based on available data):

• severe viral infections
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Riximyo can also cause changes in laboratory tests requested by your doctor.
If you are taking Riximyo in combination with other medicines, some of the undesirable effects that occur may be due to the other medicines.
Reporting of undesirable effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 Riximyo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the 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 the original carton outside the refrigerator up to a
maximum of 30 °C for a single period of up to 7 days, but not beyond the original expiry
date. In this situation, it must not be returned to the refrigerator. Write the
new expiry date on the carton including day/month/year. Discard this medicine if
not used within the new expiry date or within the expiry date printed on the carton, whichever
comes first.
Do not dispose of any medicine in 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 Riximyo contains

• The active substance of Riximyo 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, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).

Description of the appearance of Riximyo and contents of the pack
Riximyo is a clear solution, from colourless to slightly yellowish, supplied as a concentrate for
infusion solution (sterile concentrate).
10 mL vial - pack of 2 or 3 vials.
50 mL vial - pack of 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, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf/Sími/Tel: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
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.