Eliquis 2.5 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Eliquis 2.5 mg film-coated tablets
apixaban
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Eliquis is and what it is used for
- What you need to know before taking Eliquis
- How to take Eliquis
- Possible side effects
- How to store Eliquis
- Contents of the pack and other information
1. What Eliquis is and what it is used for
Eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking Factor Xa, an important component in the blood clotting process.
Eliquis is used in adults:
-
to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee surgery, you may have an increased risk of developing blood clots in the veins of your legs. This can cause swelling in the legs, with or without pain. If a blood clot travels from the leg to your lungs, it can block blood flow, causing difficulty in breathing, with or without chest pain. This medical condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
-
to prevent the formation of a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose, travel to the brain and cause a stroke, or travel to other organs and block blood supply to them (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
-
to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from recurring in the blood vessels of the legs and/or lungs.
Eliquis is used in children from 28 days up to less than 18 years of age to treat blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.
2. What you need to know before taking Eliquis
Do not take Eliquis if
- you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
- you are bleeding excessively;
- you have a disease in an organ of the body that increases the risk of serious bleeding (such as an active or recent stomach or intestinal ulcer, or recent intracranial bleeding);
- you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
- you are taking medications to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching from one anticoagulant treatment to another, while you have an arterial or venous line and are being treated with heparin to keep that line open, or when a catheter is inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).
Warnings and precautions
Tell your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:
- an increased risk of bleeding, such as:
- bleeding disorders, including conditions that result in reduced platelet function;
- very high blood pressure not controlled by medical treatment;
- you are over 75 years of age;
- you weigh 60 kg or less;
- you have severe kidney disease or are undergoing dialysis;
- you have a liver problem or a history of liver problems;
- this medicine will be used with caution in patients showing signs of impaired liver function;
- you had a catheter or received an injection in your spine (for anesthesia or pain relief), your doctor will instruct you to wait at least 5 hours after removing the catheter before taking this medicine;
- you have a heart valve prosthesis;
- if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.
Take special care with Eliquis
- if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment may need to be adjusted.
If you need surgery or a procedure that may cause bleeding, your doctor will instruct you to temporarily stop taking this medicine for a period of time. If you are unsure whether a procedure may cause bleeding, consult your doctor.
Children and adolescents
The use of this medicine is not recommended in children and adolescents with a body weight below 35 kg.
Taking Eliquis with other medicines
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Some medicines can increase the effects of Eliquis, while others may reduce its effects. Your doctor will decide whether you should be treated with Eliquis if you are taking these medicines and whether you need to be more closely monitored.
The following medicines may increase the effects of Eliquis and increase the risk of unwanted bleeding:
- some medicines for fungal infections (e.g., ketoconazole, etc.);
- some antiviral medicines for HIV/AIDS (e.g., ritonavir);
- other medicines to reduce blood clotting (e.g., enoxaparin, etc.);
- anti-inflammatory drugs or pain relievers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and taking acetylsalicylic acid, your risk of bleeding is higher;
- medicines for high blood pressure or heart problems (e.g., diltiazem);
- antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).
The following medicines may reduce Eliquis' ability to prevent blood clots:
- medicines for treating epilepsy or seizures (e.g., phenytoin, etc.);
- St. John’s wort (a herbal medicine used to treat depression);
- medicines for treating tuberculosis or other infections (e.g., rifampicin).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.
The effects of Eliquis on pregnancy and the unborn baby are unknown. You must not take this medicine if you are pregnant. Inform your doctor, pharmacist, or nurse immediately if you become pregnant while taking this medicine.
It is not known whether Eliquis is excreted in human milk. Ask your doctor or pharmacist before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or whether to stop or not start taking this medicine.
Driving and using machines
Eliquis has no effect on the ability to drive or use machines.
Eliquis contains lactose (a type of sugar) and sodium
If your doctor has informed you of an intolerance to certain sugars, speak with them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Eliquis
Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse.
Dosage
Take the tablet with water. Eliquis can be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways of taking Eliquis. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing:
- Crush the tablets with a mortar.
- Carefully transfer all the powder into a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or any of the liquids mentioned above to make the mixture.
- Swallow the mixture.
- Rinse the mortar and pestle used for crushing the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and swallow this liquid.
If necessary, your doctor may also administer the crushed Eliquis tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.
Take Eliquis according to the following recommendations:
To prevent the formation of blood clots after hip or knee replacement surgery.
The recommended dose of Eliquis is one Eliquis 2.5 mg tablet twice daily. For example, take one tablet in the morning and another in the evening.
You should take the first tablet between 12 and 24 hours after surgery.
If you have undergone major hip surgery, you will generally take the tablets for a period of 32 to 38 days.
If you have undergone major knee surgery, you will generally take the tablets for a period of 10 to 14 days.
To prevent the formation of a blood clot in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor.
The recommended dose of Eliquis is one Eliquis 5 mg tablet twice daily.
The recommended dose is one Eliquis 2.5 mg tablet twice daily if:
- you have severely reduced kidney function;
- you have two or more of the following factors:
- your blood test results indicate poor kidney function (serum creatinine level is 1.5 mg/dl (133 micromoles/l) or higher);
- you are 80 years of age or older;
- your body weight is 60 kg or less.
The recommended dose is one tablet twice daily; for example, take one tablet in the morning and another in the evening. Your doctor will tell you how long you should continue treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs (deep vein thrombosis and pulmonary embolism)
The recommended dose is two tablets of Eliquis 5 mg twice daily for the first 7 days; for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Eliquis 5 mg twice daily; for example, one tablet in the morning and another in the evening.
To prevent recurrence of blood clots after 6 months of treatment
The recommended dose is one Eliquis 2.5 mg tablet twice daily; for example, one tablet in the morning and another in the evening.
Your doctor will tell you how long you should continue treatment.
Use in children and adolescents
For the treatment of blood clots and to prevent recurrence of these blood clots in the veins and blood vessels of the lungs.
Follow exactly the instructions for taking or administering this medicine given by your doctor or pharmacist, or that of the child. If in doubt, consult your doctor, pharmacist, or nurse, or that of the child.
Try to take or administer the dose at the same time each day to achieve the best effect from treatment.
The dose of Eliquis depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four tablets of Eliquis 2.5 mg twice daily for the first 7 days; for example, four tablets in the morning and four in the evening.
After 7 days, the recommended dose is two tablets of Eliquis 2.5 mg twice daily; for example, two tablets in the morning and two in the evening.
For parents and caregivers: observe the child to ensure the full dose is taken.
It is important to keep scheduled doctor visits, as the dose may need to be adjusted based on changes in body weight.
Your doctor may change your anticoagulant treatment as follows:
- Switching from Eliquis to other anticoagulant medicines
Stop taking Eliquis. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken your next dose.
- Switching from anticoagulant medicines to Eliquis
Stop taking anticoagulant medicines. Start taking Eliquis at the time you would have taken your next dose of anticoagulant medicine, and then continue as usual.
- Switching from anticoagulant treatment containing vitamin K antagonists (e.g., warfarin) to Eliquis
Stop taking the medicine containing a vitamin K antagonist. Your doctor will need to perform blood tests and advise you when to start taking Eliquis.
- Switching from Eliquis to anticoagulant treatment containing a vitamin K antagonist (e.g., warfarin)
If your doctor instructs you to start taking a medicine containing a vitamin K antagonist, continue taking Eliquis for at least 2 days after your first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop taking Eliquis.
Patients undergoing cardioversion
If your heartbeat needs to be restored through a procedure called cardioversion, take this medicine exactly as directed by your doctor to prevent blood clots in the blood vessels of the brain and other parts of the body.
If you take more Eliquis than you should
Inform your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine packaging to your doctor, even if no tablets remain.
If you take more Eliquis than recommended, your risk of bleeding may increase. If bleeding occurs, surgery, blood transfusions, or other treatments to reverse anti-factor Xa activity may be required.
If you forget to take Eliquis
- If you forget a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
- If you forget an evening dose, you may only take it during that same night. Do not take two doses the next morning; instead, continue taking the medicine the next day as usual, twice daily as recommended.
If you are unsure what to do or if you have missed more than one dose, ask your doctor, pharmacist, or nurse.
If you stop taking Eliquis
Do not stop treatment with this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Eliquis may be used for three different conditions. The known adverse effects and their frequency may differ, and are therefore listed separately below. For these conditions, the most common adverse effect with this medicine is bleeding, which may be life-threatening and requires immediate medical attention.
The following adverse effects have been reported when taking Eliquis for the prevention of blood clots following hip or knee replacement surgery.
Common adverse effects (may affect up to 1 in 10 people)
- Anaemia, which may cause tiredness or paleness;
- Bleeding including:
- bruising and swelling;
- Nausea (general discomfort).
Uncommon adverse effects (may affect up to 1 in 100 people)
- Decrease in the number of platelets in the blood (which may affect blood clotting);
- Bleeding:
- after your surgery including bruising and swelling, discharge of blood or fluid from the surgical wound/incision (suppuration), or at the injection site;
- from the stomach, intestine, or bright/red blood in the stools;
- in the urine;
- from the nose;
- vaginal bleeding;
- Low blood pressure which may cause fainting or a faster heartbeat;
- Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a substance derived from red blood cells, which may cause yellowing of the skin and eyes;
- Itching.
Rare adverse effects (may affect up to 1 in 1,000 people)
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
- Bleeding:
- into a muscle;
- in the eyes;
- from the gums and coughing up blood;
- from the rectum;
- Hair loss.
Frequency not known (cannot be estimated from available data)
- Bleeding:
- in the brain or spinal cord;
- in the lungs or throat;
- in the mouth;
- in the abdomen or the space behind the abdominal cavity;
- haemorrhoidal bleeding;
- tests showing blood in the stools or urine;
- Skin rash that may blister and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around it) (erythema multiforme);
- Inflammation of blood vessels (vasculitis), which may cause skin rash, appearance of small, round, smooth red spots under the skin surface, or bruising.
- Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).
The following adverse effects have been reported when taking Eliquis to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
Common adverse effects (may affect up to 1 in 10 people)
- Bleeding including:
- in the eyes;
- in the stomach or intestine;
- from the rectum;
- blood in the urine;
- from the nose;
- from the gums;
- bruising and swelling;
- Anaemia, which may cause tiredness or paleness;
- Low blood pressure which may cause fainting or a faster heartbeat;
- Nausea (general discomfort);
- Blood tests may show:
- increased gamma-glutamyl transferase (GGT).
Uncommon adverse effects (may affect up to 1 in 100 people)
- Bleeding:
- in the brain or spinal cord;
- in the mouth or coughing up blood;
- in the abdomen or vagina;
- bright/red blood in the stools;
- after your surgery including bruising and swelling, discharge of blood or fluid from the surgical wound/incision (suppuration), or at the injection site;
- haemorrhoidal bleeding;
- tests showing blood in the stools or urine;
- Decrease in the number of platelets in the blood (which may affect blood clotting);
- Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a substance derived from red blood cells, which may cause yellowing of the skin and eyes;
- Skin rash;
- Itching;
- Hair loss;
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Rare adverse effects (may affect up to 1 in 1,000 people)
- Bleeding:
- in the lungs or throat;
- into the space behind the abdominal cavity;
- into a muscle.
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Skin rash that may blister and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around it) (erythema multiforme).
Frequency not known (cannot be estimated from available data)
- Inflammation of blood vessels (vasculitis), which may cause skin rash, appearance of small, round, smooth red spots under the skin surface, or bruising.
- Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).
The following adverse effects have been reported when taking Eliquis to treat or prevent recurrence of blood clots in the legs and in the blood vessels of the lungs.
Common adverse effects (may affect up to 1 in 10 people)
- Bleeding including:
- from the nose;
- from the gums;
- blood in the urine;
- bruising and swelling;
- from the stomach, intestine, or rectum;
- in the mouth;
- vaginal bleeding;
- Anaemia, which may cause tiredness or paleness;
- Decrease in the number of platelets in the blood (which may affect blood clotting);
- Nausea (general discomfort);
- Skin rash;
- Blood tests may show:
- increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (GPT).
Uncommon adverse effects (may affect up to 1 in 100 people)
- Low blood pressure which may cause fainting or a faster heartbeat;
- Bleeding:
- in the eyes;
- in the mouth or coughing up blood;
- bright/red blood in the stools;
- tests showing blood in the stools or urine;
- after your surgery including bruising and swelling, discharge of blood or fluid from the surgical wound/incision (suppuration), or at the injection site;
- haemorrhoidal bleeding;
- into a muscle;
- Itching;
- Hair loss;
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
- Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a substance derived from red blood cells, which may cause yellowing of the skin and eyes.
Rare adverse effects (may affect up to 1 in 1,000 people)
- Bleeding:
- in the brain or spinal cord;
- in the lungs.
Frequency not known (cannot be estimated from available data)
- Bleeding:
- in the abdomen or the space behind the abdominal cavity.
- Skin rash that may blister and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around it) (erythema multiforme);
- Inflammation of blood vessels (vasculitis), which may cause skin rash, appearance of small, round, smooth red spots under the skin surface, or bruising.
- Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).
Additional adverse effects in children and adolescents
Contact the child's doctor immediately if you notice any of the following symptoms:
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. These adverse effects are common (may affect up to 1 in 10 people).
In general, adverse effects observed in children and adolescents treated with Eliquis were of a similar type to those seen in adults and were mainly mild to moderate in intensity. The adverse effects most frequently observed in children and adolescents were nosebleeds and abnormal vaginal bleeding.
Very common adverse effects (may affect more than 1 in 10 people)
- Bleeding including:
- vaginal bleeding;
- nosebleeds.
Common adverse effects (may affect up to 1 in 10 people)
- Bleeding including:
- from the gums;
- blood in the urine;
- bruising and swelling;
- from the intestine or rectum;
- bright/red blood in the stools;
- after surgery including bruising and swelling, discharge of blood or fluid from the surgical wound/incision (suppuration), or at the injection site;
- Hair loss;
- Anaemia, which may cause tiredness or paleness;
- Decrease in the number of platelets in the child's blood (which may affect blood clotting);
- Nausea (general discomfort);
- Skin rash;
- Itching;
- Low blood pressure which may cause the child to faint or have a faster heartbeat;
- Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased alanine aminotransferase (GPT).
Frequency not known (cannot be estimated from available data)
-
Bleeding:
- in the abdomen or the space behind the abdominal cavity;
- in the stomach;
- in the eyes;
- in the mouth;
- haemorrhoidal bleeding;
- in the mouth or coughing up blood;
- in the brain or spinal cord;
- in the lungs;
- into a muscle;
-
Skin rash that may blister and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around it) (erythema multiforme);
-
Inflammation of blood vessels (vasculitis), which may cause skin rash, appearance of small, round, smooth red spots under the skin surface, or bruising;
-
Blood tests may show:
- increased gamma-glutamyl transferase (GGT);
- tests showing blood in the stools or urine.
-
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Eliquis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister, after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Eliquis
-
The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
-
The other components are:
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Tablet core: lactose (see section 2 "Eliquis contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Eliquis contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate (E470b);
-
Film coating: monohydrate lactose, (see section 2 "Eliquis contains lactose (a type of sugar) and sodium"), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).
Appearance of the product and contents of the pack
The film-coated tablets are round (6 mm in diameter), yellow in colour, and are marked with "893" on one side and "2½" on the other.
- They are supplied in blisters within cartons containing 10, 20, 56, 60, 168, and 200 film-coated tablets.
- Single-dose blisters are also available, supplied in clinical packs containing 60 x 1 and 100 x 1 film-coated tablets.
Only some pack sizes may be marketed.
Patient Card: managing the information
Inside the Eliquis package, together with the package leaflet, you will find a Patient Card or your doctor may provide you with a similar card.
This Patient Card includes useful information for you and will alert other physicians that you are being treated with Eliquis. You must carry this card with you at all times.
- Take the card.
- Separate the language you need (this is facilitated by the perforated edges).
- Complete the following sections or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ........mg twice daily
- Physician's name:
- Physician's telephone number:
- Fold the card and carry it with you at all times.
Marketing Authorization Holder
Bristol‑Myers Squibb/Pfizer EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale Casilina, 41
03012 Anagni (FR)
Italy
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
Swords Laboratories Unlimited Company T/A Bristol‑Myers Squibb Pharmaceutical Operations,
External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Pfizer Ireland Pharmaceuticals
Little Connell Newbridge
Co. Kildare
Ireland
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
Belgium/Belgium/Belgium N.V. Bristol-Myers Squibb Belgium S.A. Tel/Tel: + 32 2 352 76 11 | Lithuania Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 5 251 4000 |
| Luxembourg/Luxembourg N.V. Bristol-Myers Squibb Belgium S.A. Tel/Tel: + 32 2 352 76 11 |
Czech Republic Pfizer, spol. s r.o. Tel.: +420 283 004 111 | Hungary Pfizer Kft. Tel.: + 36 1 488 37 00 |
Denmark Bristol-Myers Squibb Denmark Tlf: + 45 45 93 05 06 | Malta Vivian Corporation Ltd. Tel: +356 21344610 |
Germany Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 89 121 42 350) | Netherlands Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222 |
Estonia Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500 | Norway Bristol-Myers Squibb Norway AS Tlf: + 47 67 55 53 50 |
Greece Pfizer Ελλάς Α.Ε. Tel: +30 210 6785800 | Austria Bristol-Myers Squibb GesmbH Tel: + 43 1 60 14 30 |
Spain Bristol-Myers Squibb, S.A. Tel: + 34 91 456 53 00 | Poland Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00 |
France Bristol-Myers Squibb SAS Tél: + 33 (0)1 58 83 84 96 | Portugal Bristol-Myers Squibb Farmacêutica Portuguesa, S.A. Tel: + 351 21 440 70 00 |
Croatia Pfizer Croatia d.o.o. Tel: + 385 1 3908 777 | Romania Pfizer Romania S.R.L Tel: +40 (0)21 207 28 00 |
Ireland Bristol-Myers Squibb Pharmaceuticals uc Tel: 1 800 749 749 (+ 353 (0)1 483 3625) | Slovenia Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400 |
Iceland Icepharma hf. Sími: +354 540 8000 | Slovakia Pfizer Luxembourg SARL, organizacná zložka Tel: +421-2-3355 5500 |
Italy Bristol-Myers Squibb S.r.l. Tel: + 39 06 50 39 61 | Finland Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 230 |
Cyprus Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tel: +357 22817690 | Sweden Bristol-Myers Squibb Aktiebolag Tel: + 46 8 704 71 00 |
Latvia Pfizer Luxembourg SARL filiale Latvija Tel.: +371 670 35 775 |
Date of the most recent review of this leaflet: {MM/YYYY}.
Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.