KISQALI 200 mg Film-Coated Tablets

Зміст інструкції

1. Kisqali 200 mg film-coated tablets
   1. What is Kisqali and what is it used for
   2. What you need to know before taking Kisqali
   3. How to take Kisqali
   4. Possible side effects
   5. How to store Kisqali
   6. Package contents and other information

Kisqali 200 mg film-coated tablets

ribociclib

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• 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 Kisqali is and what it is used for
• 2. What you need to know before you take Kisqali
• 3. How to take Kisqali
• 4. Possible side effects
• 5. How to store Kisqali
• 6. Contents of the pack and other information

1. What is Kisqali and what is it used for

What is Kisqali
Kisqali contains the active substance ribociclib, which belongs to the group of medicines called selective cyclin-dependent kinase (CDK) 4 and 6 inhibitors.

What is Kisqali used for
Kisqali is used in patients with a type of breast cancer called hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that is:

• located in the breast or that may have spread to lymph nodes in the breast area, without detectable spread to other parts of the body, has been surgically removed and has certain characteristics that increase the risk of cancer recurrence. It is used in combination with an aromatase inhibitor, used as hormonal anticancer therapy (early-stage breast cancer). Women who have not yet reached menopause and men will also be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist that blocks the production of certain hormones.
• or is advanced or metastatic. This means that the cancer has grown outside the breast and has spread to the lymph nodes in the breast (locally advanced) or has spread to other parts of the body (metastatic). Kisqali is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies. Women who have not yet reached menopause will also be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist that blocks the production of certain hormones.

How does Kisqali work
Kisqali works by stopping the growth signals transmitted by the CDK 4 and 6 proteins and therefore stopping
the growth and spread of cancer cells. In early-stage breast cancer, it can
prevent the cancer from recurring after surgery (treatment after surgery is
called adjuvant therapy). In advanced or metastatic breast cancer, it can slow down
cancer progression.
If you have any questions about how Kisqali works or why you have been prescribed the
medicine, ask your doctor, pharmacist or nurse.

2. What you need to know before taking Kisqali

Follow all of your doctor's instructions carefully. They may differ from general information

Do not take Kisqali

• if you are allergic to ribociclib, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Kisqali.

If any of these apply to you before taking Kisqali, tell your doctor or pharmacist:

• If you have a fever, sore throat, or mouth sores due to infections (signs of a low level of white blood cells).
• If you have liver problems or have had any liver disease in the past.
• If you have or have had heart problems or changes in your heart rhythm, such as an irregular heartbeat, including a condition called prolonged QT interval (QT prolongation) or low levels of potassium, magnesium, calcium, or phosphorus in your blood.

If any of these apply to you during treatment with Kisqali, tell your doctor or pharmacist:

• If you have a combination of any of the following symptoms: skin rash, skin redness, blistering on lips, eyes or mouth, peeling skin, high fever, flu-like symptoms and swollen lymph nodes (these may be signs of a serious skin reaction). If you have a serious skin reaction, your doctor will ask you to stop taking Kisqali immediately.
• Difficulty breathing, cough, and shortness of breath (these may be signs of lung or breathing problems). If necessary, your doctor may stop or reduce the dose of Kisqali or decide to stop treatment with Kisqali permanently.

Monitoring during treatment with Kisqali
You will need to have regular blood tests before and during treatment with Kisqali to check your liver function and the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (salts in the blood such as potassium, calcium, magnesium and phosphate) in your body. Your heart activity will also be monitored before and during treatment with Kisqali with a test called an electrocardiogram (ECG). If necessary, further tests will be performed during treatment with Kisqali to assess kidney function. If necessary, your doctor may reduce the dose of Kisqali or temporarily stop treatment to allow the liver, kidneys, blood cell count, electrolyte levels or heart activity to recover. Your doctor may also decide to stop treatment with Kisqali permanently.

Children and adolescents
Kisqali must not be used in children and adolescents under 18 years of age.

Other medicines and Kisqali
Before taking Kisqali, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines with or without a prescription, herbal medicines, or supplements, because these can affect the effect of Kisqali. Always tell your doctor if you have been prescribed a new medicine after starting treatment with Kisqali. This includes in particular:

• Tamoxifen, another medicine for the treatment of breast cancer.
• Some medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole or posaconazole.
• Some medicines used to treat HIV/AIDS such as ritonavir, saquinavir, indinavir, lopinavir, nelfinavir, telaprevir and efavirenz.
• Some medicines used to treat epilepsy or convulsions (anti-epileptics) such as carbamazepine and phenytoin.
• St John's Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
• Some medicines used to treat heart rhythm problems or high blood pressure such as amiodarone, disopyramide, procainamide, quinidine, sotalol and verapamil.
• Antimalarials such as chloroquine.
• Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin, levofloxacin and azithromycin.
• Some medicines used for sedation or anesthesia such as midazolam.
• Some medicines used as antipsychotics such as haloperidol.
• Medicines used for the treatment of angina such as bepridil.
• Methadone, used to treat pain or opioid dependence.
• Medicines such as ondansetron given by vein, used to prevent nausea and vomiting induced by chemotherapy (cancer treatment medicines).

Kisqali can increase or decrease the levels of some medicines in the blood. This includes in particular:

• Medicines used for the treatment of symptoms of benign prostatic hyperplasia, such as alfuzosin.
• Tamoxifen, another medicine for the treatment of breast cancer.
• Antiarrhythmics such as amiodarone or quinidine.
• Antipsychotics such as pimozide or quetiapine.
• Medicines used to improve fat levels in the blood such as simvastatin or lovastatin, pitavastatin, pravastatin or rosuvastatin.
• Medicines used to treat high blood sugar levels (for example diabetes), such as metformin.
• Medicines used to treat heart problems, such as digoxin.
• Medicines used to treat pulmonary arterial hypertension and erectile dysfunction, such as sildenafil.
• Medicines used to treat low blood pressure or migraine, such as dihydroergotamine.
• Some medicines used to treat seizures or used for sedation or anesthesia, such as midazolam.
• Medicines used to treat sleep disorders, such as triazolam.
• Pain relievers such as alfentanil and fentanyl.
• Medicines used to treat gastrointestinal disorders, such as cisapride.
• Medicines used to prevent rejection of an organ transplant, such as tacrolimus, sirolimus and cyclosporine (also used to treat inflammation in rheumatoid arthritis and psoriasis).
• Everolimus, used for various types of cancer and tuberous sclerosis (also used to prevent organ transplant rejection).

Ask your doctor or pharmacist if you are not sure whether your medicine is among those listed above.

Kisqali with food and drink
Do not eat grapefruit or foods that contain grapefruit or drink juices that contain grapefruit
during treatment with Kisqali. These can change the way Kisqali is broken down in the body and can increase the amount of Kisqali in the blood.

Pregnancy and breastfeeding
If you are pregnant, or if you are breastfeeding, if you suspect or are planning a pregnancy ask your doctor for advice before taking this medicine.
Your doctor will need to discuss with you the potential risks associated with taking Kisqali during pregnancy.
Pregnancy and women of childbearing potential
Kisqali must not be taken during pregnancy as it may harm the unborn baby.
If you are a woman of childbearing potential, you must have evidence of a negative pregnancy test before starting treatment with Kisqali. You must use effective contraception (for example, double barrier contraception such as a condom and diaphragm) during treatment with Kisqali and for at least 21 days after the last dose. Ask your doctor about the methods available for effective contraception.
Breastfeeding
You must not breastfeed during treatment with Kisqali and for at least 21 days after the last dose.

Driving and using machines
Treatment with Kisqali may cause fatigue, dizziness or feeling lightheaded. You are advised to be careful when driving or using machines during treatment with Kisqali.

Kisqali contains soy lecithin
Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Kisqali

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. Your doctor, pharmacist or nurse will tell you exactly how many tablets to take and
on which days. If you have any doubts, ask your doctor, pharmacist or nurse. Do not change the dose or
time of taking Kisqali without consulting your doctor.
Do not exceed the recommended dose prescribed by your doctor.

The amount of Kisqali to take

• On the outer packaging of Kisqali there is a “calendar” that allows you to keep track of taking the daily dose of Kisqali by blacking out a circle for each tablet taken in the 28-day treatment cycle.
• Your doctor will tell you exactly how many tablets of Kisqali you need to take. In some cases (for example in case of liver or kidney problems) your doctor may instruct you on how to take a lower dose of Kisqali.

It is very important to follow your doctor’s instructions. If side effects occur, your doctor
may ask you to take a lower dose, to interrupt the treatment with Kisqali or to
interrupt it permanently.

When to take Kisqali
Take Kisqali once a day at the same time each day, preferably in the morning. This will
help you remember to take the medicine and to notice any side effects that may
occur so you can contact your doctor immediately.

How to take Kisqali
Kisqali tablets must be swallowed whole (tablets must not be chewed,
crushed or opened before swallowing). Do not take the tablet if it is broken, chipped or otherwise
damaged.

Kisqali with food and drinks
Take Kisqali once a day every day at the same time, preferably in the morning. You can
take it with or without food.

For how long to take Kisqali
Take Kisqali once a day from day 1 to day 21 in a 28-day cycle. Continue the
treatment with Kisqali for as long as established by your doctor.
In early stage breast cancer, a maximum treatment duration of
3 years is recommended. In advanced or metastatic breast cancer, this is a long-term treatment. Your
doctor will regularly check your condition to verify that the treatment is having
the desired effect.

If you take more Kisqali than you should
If you take too many tablets, or if someone else takes your medicine, contact your
doctor or a hospital immediately for advice. Show the Kisqali packaging. Medical
treatment may be necessary.

If you forget to take a dose of Kisqali
If you vomit after taking the dose or if you forget to take a dose, skip the missed dose
of that day. Take the next dose the next day at the usual time.
Do not take a double dose to make up for the missed dose. Instead, wait for the time to
take the next scheduled dose and take the usual dose.

If you stop taking Kisqali
If you think the dose is too high or too low, contact your doctor. Do not stop taking Kisqali
unless your doctor tells you to do so. Stopping the treatment with Kisqali may cause a
worsening of the cancer.
If you have any doubts about 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.
Read this section carefully. Side effects that may be serious are presented first (“ Some side effects may be serious”), followed by all other side effects (“ Other possible side effects”) in decreasing order of frequency.

Early-stage breast cancer
Some side effects may be serious.
Your doctor may ask you to take a lower dose, stop treatment with
Kisqali, or discontinue it permanently. Immediately inform your doctor if you experience
any of the following symptoms during treatment with Kisqali:

• Fever, sweating or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in sputum, sores on the body, warm or painful areas of the body, diarrhea or stomach pain, or feeling very tired (signs or symptoms of infections). Very common(may affect more than 1 in 10 people).
• Fever, chills, weakness and frequent infections with symptoms such as sore throat or mouth ulcers. These may be signs of a low level of white blood cells in the blood ( verycommon, may affect more than 1 in 10 people) or a low level of lymphocytes ,which are a specific type of white blood cell (common, may affect up to 1 in 10 people).
• Abnormal blood test results that provide information about liver health (altered liver function tests). Very common (may affect more than 1 in 10 people).
• Spontaneous bleeding or bruising (signs of a low level of platelets). Common (mayaffect up to 1 in 10 people).
• Reduced potassium levels in the blood, which may lead to heart rhythm disturbances. Common (may affect up to 1 in 10 people).
• Chest pain or discomfort, changes in heartbeat (fast or slow), palpitations, mild confusion, fainting, dizziness, lips turning blue, shortness of breath, swelling (edema) of the lower limbs or skin (these may be signs of heart problems). Common (may affect up to 1 in 10 people).
• Fatigue, yellowing and itching of the skin, or yellowing of the whites of the eyes, nausea or vomiting, loss of appetite, pain in the upper right side of the abdomen, dark or brown urine, bleeding or bruising more than usual (these may be signs of a liver problem). Common (may affect up to 1 in 10 people).
• Inflammation of the lungs, which can cause a dry cough, chest pain, fever, shortness of breath and difficulty breathing (these may be signs of interstitial lung disease/pneumonitis, which, if severe, can be life-threatening). Common (may affect up to 1 in 10 people).
• Sore throat or mouth ulcers with a single episode of fever of at least 38.3°C or fever above 38°C for more than an hour and/or with infection (febrile neutropenia). Uncommon(may affect up to 1 in 100).

Other possible side effects
Other side effects include those listed below. If these side effects become
serious, talk to your doctor, pharmacist or nurse.

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

• Sore throat, runny nose, fever (signs of a respiratory tract infection)
• Painful and frequent urination (signs of a urinary tract infection)
• Nausea (feeling sick)
• Headache
• Fatigue (tiredness)
• Asthenia (weakness)
• Alopecia (hair loss or thinning hair)
• Diarrhea
• Constipation
• Cough
• Abdominal pain (stomach ache)
• Pyrexia (fever)

Common(may affect up to 1 in 10 people)

• Skin rash
• Dizziness or mild confusion
• Fatigue, pale skin (potential sign of a low level of red blood cells, anemia)
• Vomiting
• Pruritus (itching)
• Peripheral edema (swelling of hands, ankles or feet)
• Dyspnea (shortness of breath, difficulty breathing)
• Stomatitis (mouth ulcers with inflammation of the gums)
• Oropharyngeal pain (sore throat)
• Reduced calcium levels in the blood, which may sometimes cause cramps
• Reduced appetite
• Altered renal function tests (high creatinine levels in the blood)

Advanced or metastatic breast cancer
Some side effects may be serious
Your doctor may ask you to take a lower dose, stop treatment with
Kisqali, or discontinue it permanently. Immediately inform your doctor if you experience
any of the following symptoms during treatment with Kisqali:

• Fever, sweating or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in sputum, sores on the body, warm or painful areas of the body, diarrhea or stomach pain, or feeling very tired (signs or symptoms of infections). Very common(may affect more than 1 in 10 people).
• Fever, chills, weakness and frequent infections with symptoms such as sore throat or mouth ulcers (signs of a low level of leukocytes or lymphocytes, which are types of white blood cells in the blood). Very common (may affect more than 1 in 10 people).
• Abnormal blood test results that provide information about liver health (altered liver function tests). Very common (may affect more than 1 in 10 people).
• Spontaneous bleeding or bruising (signs of a low level of platelets). Common (mayaffect up to 1 in 10 people).
• Sore throat or mouth ulcers with a single episode of fever of at least 38.3°C or fever above 38°C for more than an hour and/or with infection (febrile neutropenia). Common (mayaffect up to 1 in 10 people).
• Fatigue, yellowing and itching of the skin, or yellowing of the whites of the eyes, nausea or vomiting, loss of appetite, pain in the upper right side of the abdomen, dark or brown urine, bleeding or bruising more than usual (these may be signs of a liver problem). Common (may affect up to 1 in 10 people).
• Reduced potassium levels in the blood, which may lead to heart rhythm disturbances. Common (may affect up to 1 in 10 people).
• Chest pain or discomfort, changes in heartbeat (fast or slow), palpitations, mild confusion, fainting, dizziness, lips turning blue, shortness of breath, swelling (edema) of the lower limbs or skin (these may be signs of heart problems). Common (may affect up to 1 in 10 people).
• Inflammation of the lungs, which can cause a dry cough, chest pain, fever, shortness of breath and difficulty breathing (these may be signs of interstitial lung disease/pneumonitis, which, if severe, can be life-threatening). Common (may affect up to 1 in 10 people).
• Serious infection with increased heart rate, rapid breathing, fever and chills (these may be signs of sepsis, which is a blood infection that can be life-threatening). Uncommon (may affect up to 1 in 100).
• Severe skin reaction that may include a combination of any of the following symptoms: rash, red skin, blisters on lips, eyes or mouth, peeling skin, high fever, flu-like symptoms, swollen lymph nodes (toxic epidermal necrolysis [TEN]). Frequency not known (frequency cannot be estimated from available data).

Other possible side effects
Other side effects include those listed below. If these side effects become
serious, talk to your doctor, pharmacist or nurse.

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

• Fatigue, pale skin (potential sign of a low level of red blood cells, anemia)
• Sore throat, runny nose, fever (signs of a respiratory tract infection)
• Painful and frequent urination (signs of a urinary tract infection)
• Reduced appetite
• Headache
• Dizziness or mild confusion
• Dyspnea (shortness of breath, difficulty breathing)
• Cough
• Nausea (feeling sick)
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain (stomach ache)
• Stomatitis (mouth ulcers with inflammation of the gums)
• Dyspepsia (stomach discomfort, indigestion, heartburn)
• Alopecia (hair loss or thinning hair)
• Skin rash
• Pruritus (itching)
• Back pain
• Fatigue (tiredness)
• Peripheral edema (swelling of hands, ankles or feet)
• Pyrexia (fever)
• Asthenia (weakness)

Common( may affect up to 1 in 10 people)

• Abdominal pain, nausea, vomiting and diarrhea (signs of gastroenteritis, which is an infection of the gastrointestinal tract)
• Reduced calcium levels in the blood, which may sometimes cause cramps
• Reduced phosphate levels in the blood
• Vertigo (feeling dizzy)
• Watery eyes
• Dry eyes
• Reduced potassium levels in the blood, which may lead to heart rhythm disturbances
• Dysgeusia (strange taste in the mouth)
• Dry skin
• Erythema (redness of the skin)
• Vitiligo (skin with patches due to loss of color)
• Oropharyngeal pain (sore throat)
• Dry mouth
• Altered renal function tests (high creatinine levels in the blood)

Rare(may affect up to 1 in 1,000)

• Skin reaction that causes red spots or patches to appear on the skin, which may look like a “target” or be “iris”, with a dark red core surrounded by light red rings (erythema multiforme).

Reporting of side 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 Kisqali

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 pack after Scad. and on the
blister after EXP. The expiry date refers to the last day of that month.
Pharmacy: Store in a refrigerator (2°C – 8°C) for up to 10 months.
Patient: Store at a temperature below 25°C for up to 2 months. Store in the original
packaging.
Do not take this medicine if you notice any damage to the packaging or if there are signs of
tampering.
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 Kisqali contains

• The active ingredient is ribociclib. Each film-coated tablet contains ribociclib succinate equivalent to 200 mg of ribociclib.
• The other excipients are: Tablet core: microcrystalline cellulose; crospovidone type A; low-substituted hydroxypropylcellulose; magnesium stearate; anhydrous colloidal silicon dioxide. Coating material: black iron oxide (E172); red iron oxide (E172); talc; soybean lecithin (E322) (see “Kisqali contains soybean lecithin” in section 2); polyvinyl alcohol (partially hydrolysed); titanium dioxide (E171); xanthan gum.

Description of the appearance of Kisqali and package contents
Kisqali is supplied in film-coated tablets in blisters.
The film-coated tablets are light greyish-purple in colour, non-divisible, round, with
“RIC” engraved on one side and “NVR” on the other side.
The following pack sizes are available: packs containing 21, 42 or 63 film-coated tablets
and multiple packs containing 63 (3 packs of 21), 126 (3 packs of 42) or 189 (3 packs
of 63) film-coated tablets.
Kisqali packs contain 63 tablets which are intended for use by patients
who need to take a daily dose of 600 mg of ribociclib (3 tablets once a day).
Kisqali packs contain 42 tablets which are intended for use by patients
who need to take a daily dose of 400 mg of ribociclib (2 tablets once a day).
Kisqali packs contain 21 tablets which are intended for use by patients
who need to take the lowest daily dose of 200 mg of ribociclib (1 tablet once a
day).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana
Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovškova Ulica 57
1000 Ljubljana
Slovenia
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

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

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu