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Generated Narrative: Bundle TEST PURPOSES ONLY - riximyo

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Generated Narrative: MedicinalProductDefinition mp496dabc84021ffaf219deb764d02458d

identifier: http://ema.europa.eu/identifier/EU/1/17/1184/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Riximyo 100 mg concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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type: Scientific name part

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-	Country	Jurisdiction	Language
*	EU	EU	en

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Generated Narrative: Composition composition-en-496dabc84021ffaf219deb764d02458d

identifier: http://ema.europa.eu/identifier/EU/1/17/1184/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - riximyo

Attesters

What is in 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

What Riximyo is Riximyo contains the active substance rituximab . This is a type of protein called a monoclonal antibody . It sticks to the surface of a type of white blood cell called B-Lymphocyte . When rituximab sticks to the surface of this cell, the cell dies. What Riximyo is used for Riximyo may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe Riximyo for the treatment of: a) Non-Hodgkin s Lymphoma This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes. In adults Riximyo can be given alone or with other medicines called chemotherapy . In adult patients where the treatment is working, Riximyo may be used as a maintenance treatment for 2 years after completing the initial treatment. In children and adolescents, rituximab is given in combination with chemotherapy . b) Chronic lymphocytic leukaemia (CLL) CLL is the most common form of adult leukaemia. CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops 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 is the cause of symptoms you may have. Riximyo in combination 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 of the joints. B lymphocytes are involved in the cause of some of the symptoms you have. Riximyo is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. Riximyo is usually taken together with another medicine called methotrexate. Riximyo slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities. The best responses to Riximyo are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis. d) Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) Riximyo is used for the treatment of adults and children 2 years of age and older with GPA (formerly called Wegener s granulomatosis) or MPA, taken in combination with corticosteroids. GPA and MPA are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well. 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 condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.

Do not take Riximyo if:

you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6).

you have a severe active infection at the moment.

you have a weak immune system.

you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris. Do not have Riximyo if any of the above apply to you. If you are not sure, talk to 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 ever had or might now have a hepatitis infection. This is because in a few cases, Riximyo could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.

you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Riximyo. Your doctor may need to take special care of you during your treatment with Riximyo. Also talk to your doctor 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 after you receive Riximyo. Your doctor will check if you should have any vaccines before you receive Riximyo. If you have rheumatoid arthritis, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) or pemphigus vulgaris (PV) also tell your doctor

if you think you may have an infection, even a mild one like a cold. The cells that are affected by Riximyo help to fight infection and you should wait until the infection has passed before you are given Riximyo. Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections. Children and adolescents Non-Hodgkin s lymphoma Rituximab can be used for the treatment of children and adolescents, 6 months of age and older, with non-Hodgkin s lymphoma, specifically CD20 positive diffuse large B-cell lymphoma (DLBCL), 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 treatment of children and adolescents, 2 years of age and older, with GPA (formerly called Wegener s granulomatosis) or MPA. There is not much information about the use of rituximab in children and adolescents with other diseases. Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 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. This includes medicines obtained without a prescription and herbal medicines. This is because Riximyo can affect the way some other medicines work. Also some other medicines can affect the way Riximyo works. In particular, tell your doctor:

if you are taking medicines for high blood pressure. You may be asked not to take these other medicines 12 hours before you are given Riximyo. This is because some people have a fall in their blood pressure while they are being given Riximyo.

if you have ever taken medicines which affect your immune system such as chemotherapy or immune-suppressive medicines. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Riximyo. Pregnancy and breast-feeding You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. This is because Riximyo can cross the placenta and may affect your baby. If you can get pregnant, you and your partner must use an effective method of contraception while using Riximyo. You must also do this for 12 months after your last treatment with Riximyo. Riximyo passes into breast milk in very small amounts. As the long-term effects on breastfed infants are not known, for precautionary reasons, breast feeding is not recommended during treatment with Riximyo and for 6 months after the treatment. Driving and using machines It is not known whether rituximab has an effect on you being able to drive or use any tools or machines. Riximyo contains sodium This medicine contains 52.6 mg sodium (main component of the cooking/table salt) in each 10 mL vial and 263.2 mg in each 50 mL vial. This is equivalent to 2.6% (for 10 ml vial) and 13.2% (for 50 ml vial) of the recommended maximum daily dietary intake of sodium for an adult.

How it is given Riximyo will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects. You will always be given Riximyo as a drip (intra-venous infusion). Medicines given before each Riximyo administration Before you are given Riximyo you will be given other medicines (premedication) to prevent or reduce possible side effects. How much and how often you will receive your treatment a) If you are being treated for non-Hodgkin s Lymphoma

If you are having Riximyo alone Riximyo will be given to you once a week for 4 weeks. Repeated treatment courses with Riximyo are possible.

If you are having Riximyo with chemotherapy Riximyo will be given to you on the same day as your chemotherapy. This is usually given every 3 weeks up to 8 times.

If you respond well to treatment you may be given Riximyo as a maintenance treatment every 2 or 3 months for two years. Your doctor may change this, depending on how you respond to the medicine.

If you are less than 18 years of age, you will be given Riximyo with chemotherapy. You will receive Riximyo up to 6 times over a 3.5 5.5 month period. b) If you are being treated for chronic lymphocytic leukaemia (CLL) When you are treated with Riximyo in combination with chemotherapy, you will receive Riximyo infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total. Each cycle has a duration of 28 days. The chemotherapy should be given after the Riximyo infusion. Your doctor will decide if you should receive concomitant supportive therapy. c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart. Repeated courses of treatment with Riximyo are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Riximyo. This may be months from now. d) If you are being treated for granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) Treatment with Riximyo uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of Riximyo treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition. If you are 18 years of age or older and respond well to treatment, you may be given Riximyo as a maintenance treatment. This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with Riximyo (up to 5 years), depending on how you respond to the medicine. e) If you are being treated for pemphigus vulgaris (PV) Each course of treatment is made up of two separate infusions which are given 2 weeks apart. If you respond well to treatment, you may be given Riximyo as a maintenance treatment. This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate but some may 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 shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse. Tell the person giving you the infusion immediately if you or your child develops any of these symptoms, as the infusion may need to be slowed down or stopped. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. Your doctor may decide to stop your Riximyo treatment if these reactions are serious. Infections Tell your doctor immediately if you or your child gets signs of an infection including:

fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell

memory loss, trouble thinking, difficulty walking or sight loss these may be due to a very rare, serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or PML).

fever, headache and stiff neck, incoordination (ataxia), personality change, hallucinations, altered consciousness, seizures or coma these may be due to a serious brain infection (enteroviral meningoencephalitis), which can be fatal. You might get infections more easily during your treatment with Riximyo. These are often colds, but there have been cases of pneumonia, urinary infections and serious viral infections. These are listed below under 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 you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver. Skin reactions Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms. Other side effects include: a) If you or your child are being treated for non-Hodgkin s Lymphoma (NHL) or chronic lymphocytic leukaemia (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 blood cells called platelets

feeling sick (nausea)

bald spots on the scalp, chills, headache

lower immunity because of lower levels of anti-bodies called immunoglobulins (IgG) in the blood which help protect against infection Common side effects (may affect up to 1 in 10 people):

infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B

low number of red blood cells (anaemia), low number of all blood cells

allergic reactions (hypersensitivity)

high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme LDH in the blood, low calcium levels in the blood

unusual feelings of the skin such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch

feeling restless, problems falling asleep

becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels

feeling dizzy or anxious

producing more tears, tear duct problems, inflamed eye (conjunctivitis)

ringing sound in the ears, ear pain

heart problems such as heart attack, uneven or fast heart rate

high or low blood pressure (low blood pressure especially when standing upright)

tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose

being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion

eating disorders, not eating enough, leading to weight loss

hives, increased sweating, night sweats

muscle problems such as tight muscles, joint or muscle pain, back and neck pain

tumour pain

general discomfort or feeling uneasy or tired, shaking, signs of flu

multiple-organ failure. Uncommon side effects (may affect up to 1 in 100 people):

blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes

low mood and loss of interest or enjoyment in doing things, feeling nervous

taste problems such as changes in the way things taste

heart problems such as reduced heart rate or chest pain (angina)

asthma, too little oxygen reaching the body organs

swelling of the stomach. Very rare side effects (may affect up to 1 in 10,000 people):

short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins IgM), chemical disturbances in the blood caused by break-down of dying cancer cells

nerve damage in arms and legs, paralysed face

heart failure

inflammation of blood vessels including those leading to skin symptoms

respiratory failure

damage to the intestinal wall (perforation)

severe skin problems causing blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.

kidney failure

severe vision loss Not known (it is not known how often these side effects happen):

a reduction in white blood cells which does not happen straight away

reduced platelets number just after the infusion this can be reversed, but can be fatal in rare cases

hearing loss, loss of other senses

brain and meningeal infection/inflammation (enteroviral meningoencephalitis) Children and adolescents with non-Hodgkin s lymphoma (NHL): In general, side effects in children and adolescents with non-Hodgkin s lymphoma were similar to those in adults with NHL or CLL. The most common side effects seen were fever associated with low levels of a type of white blood cell (neutrophil), 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 on passing water (urinary tract infection)

Allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion

Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness

Headache

Changes in laboratory tests carried out by your doctor. These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection. Common side effects (may affect up to 1 in 10 people):

Infections such as bronchial tube inflammation (bronchitis)

A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems

Fungal foot infection (athlete s foot)

High cholesterol levels in the blood

Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, migraine, dizziness

Loss of hair

Anxiety, depression

Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth

Pain in the tummy, 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 tightness of the lungs, and throat, coughing

Skin reactions including hives, itching and rash

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 of an infusion of rituximab including allergic like reactions such as rash, 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 on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Not known (frequency cannot be estimated from the available data):

Serious viral infection

Brain and meningeal infection/inflammation (enteroviral meningoencephalitis) Other rarely-reported side-effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection. Some infections may be severe (please see information on Infections within this section). c) If you or your child are 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 chest infections, urinary tract infections (pain on passing water), colds and herpes infections

allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion

diarrhoea

coughing or shortness of breath

nose bleeds

raised blood pressure

painful joints or back

muscle twitches or shakiness

feeling dizzy

tremors (shakiness, 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

flushing or redness of the skin

fever

blocked or runny nose

tight or painful muscles

pain in the muscles or in the hands or feet

low number of red blood cells (anaemia)

low numbers of platelets in the blood

an increase in the amount of potassium in the blood

changes in the rhythm of the heart, or the heart beating faster than normal 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 on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.

recurrence of a previous Hepatitis B infection Not known (frequency cannot be estimated from the available data):

serious viral infection

brain and meningeal infection/inflammation (enteroviral meningoencephalitis) Children and adolescents with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) In general, side effects in children and adolescents with GPA or MPA were of a similar type to those in adults with GPA or MPA. Most common side effects seen were infections, allergic reactions and feeling sick (nausea). d) If you are being treated for pemphigus vulgaris Very common side effects (may affect more than 1 in 10 people):

allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion

headache

infections such as chest infections

long lasting depression

loss of hair Common side effects (may affect up to 1 in 10 people): infections such as common cold, herpes infections, eye infection, oral thrush and urinary tract infections (pain on passing urine)

mood disorders such as irritability and depression

skin disorders such as itching, hives, and benign lumps

feeling tired or dizzy

fever

painful joints or back

pain in the tummy

pain in the muscles

heart beating faster than normal Not known (frequency cannot be estimated from the available data):

Serious viral infection

Brain and meningeal infection/inflammation (enteroviral meningoencephalitis) Riximyo may also cause changes in laboratory tests carried out by your doctor. If you are having Riximyo with other medicines, some of the side effects you may get may be due to the other medicines. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and the vial label 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 carton in order to protect from light. This medicine can also be stored in the original carton outside of refrigerated storage 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, do not return to the refrigerated storage again. Write the new expiry date on the carton including day/month/year. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

What Riximyo contains

The active substance in Riximyo is called 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). What Riximyo looks like and contents of the pack Riximyo is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion (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. 6250 Kundl Austria Manufacturer Sandoz GmbH Schaftenau Biochemiestr. 6336 Langkampfen Austria Lek Pharmaceuticals d.d. Ljubljana Verov kova 1526 Ljubljana Slovenia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Sandoz nv/sa T l/Tel: +32 2 722 97 Lietuva Sandoz Pharmaceuticals d.d filialas Tel: +370 5 2636

.: +359 2 970 47 Luxembourg/Luxemburg Sandoz nv/sa T l/Tel.: +32 2 722 97 esk republika Sandoz s.r.o. Tel: +420 225 775 Magyarorsz g Sandoz Hung ria Kft. Tel.: +36 1 430 2Danmark/Norge/ sland/Sverige Sandoz A/S Tlf: +45 63 95 10 Malta Sandoz Pharmaceuticals d.d. Tel: +35699644Deutschland Hexal AG Tel: +49 8024 908 0 Nederland Sandoz B.V. Tel: +31 36 52 41 Eesti Sandoz d.d. Eesti filiaal Tel: +372 665 2 sterreich Sandoz GmbH Tel: +43 5338 2 SANDOZ HELLAS . . : +30 216 600 5Polska Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 Espa a Sandoz Farmac utica, S.A. Tel: +34 900 456 Portugal Sandoz Farmac utica Lda. Tel: +351 21 000 86 France Sandoz SAS T l: +33 1 49 64 48 Rom nia Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 Hrvatska Sandoz d.o.o. Tel: +385 1 23 53 Slovenija Sandoz farmacevtska dru ba d.d. Tel: +386 1 580 29 Ireland Rowex Ltd. Tel: + 353 27 50Slovensk republika Sandoz d.d. - organiza n zlo ka Tel: +421 2 48 200 Italia Sandoz S.p.A. Tel: +39 02 96Suomi/Finland Sandoz A/S Puh/Tel: +358 10 6133
Sandoz Pharmaceuticals d.d. : +357 22 69 0United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2Latvija Sandoz d.d. Latvia fili le Tel: +371 67 892 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: