Envvarsus: detailed information

Package leaflet: Information for the patient

Envarsus 0.75 mg prolonged-release tablets, 1 mg prolonged-release tablets, 4 mg prolonged-release tablets

tacrolimus
Please read this leaflet carefully before taking 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Envarsus is and what it is used for
What you need to know before taking Envarsus
How to take Envarsus
Possible side effects
How to store Envarsus
Contents of the pack and other information

1. What Envarsus is and what it is used for

Envarsus contains the active substance tacrolimus. It is an immunosuppressive medicine. After a kidney or liver transplant, the body's immune system will try to reject the new organ. Envarsus is used to control the body's immune response, enabling it to accept the transplanted organ.

You may also be given Envarsus if there is ongoing rejection of a transplanted liver, kidney, heart, or other organ, when one of the treatments you previously received has not proven effective in controlling this immune response after transplantation.
Envarsus is used in adults.

2. What you should know before taking Envarsus

Do not take Envarsus

if you are allergic to tacrolimus or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to sirolimus or to any macrolide antibiotic (for example erythromycin, clarithromycin, josamycin).

Warnings and precautions
Envarsus contains the active substance tacrolimus in a prolonged-release formulation.
Envarsus is taken once daily and is not interchangeable with other existing medicines containing
tacrolimus (immediate-release or prolonged-release) at the same dose.
Talk to your doctor or pharmacist before taking Envarsus:

if you have or have had liver problems.
if you have had diarrhoea for more than one day.
if you are taking any of the medicines listed under the section “Other medicines and Envarsus”.
if you have an abnormality in the electrical activity of the heart known as “QT prolongation”.
if you have severe abdominal pain, with or without other symptoms such as chills, fever, nausea or vomiting.
if you have an infection causing kidney problems or neurological symptoms.
if you have headache, altered mental status, seizures, or vision disturbances.
if you have weakness, changes in skin or eye colour, easy bruising, infection, cough, or anaemia.
if you have or have had damage to the small blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Inform your doctor if you develop fever, bruising under the skin (which may appear as red spots), unexplained fatigue, confusion, yellowing of the skin or eyes, reduced urine output, loss of vision, or seizures (see section 4). The risk of developing these symptoms may increase when tacrolimus is taken together with sirolimus or everolimus.

Please avoid taking any herbal remedy, such as St. John’s wort (Hypericum perforatum) or any other herbal product, as it may alter the effectiveness and required dose of Envarsus. If you are unsure, please consult your doctor before taking any herbal product or remedy.
Your doctor may need to adjust your dose of Envarsus or decide to discontinue treatment with tacrolimus.
You should maintain regular contact with your doctor. Periodically, your doctor may consider it necessary to perform blood and urine tests, or heart and eye examinations, to determine the correct dose of Envarsus.
You must limit your exposure to sunlight and ultraviolet (UV) light while taking Envarsus.
This is necessary because immunosuppressants may increase the risk of skin cancer.
Wear suitable protective clothing and apply sunscreen with a high protection factor.

Children and adolescents
The use of Envarsus is not recommended in children and adolescents under 18 years of age.

Other medicines and Envarsus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal preparations.
The concomitant use of Envarsus with ciclosporin (another medicine used to prevent organ transplant rejection) is not recommended.
If you consult a doctor other than your transplant specialist, inform them that you are taking
tacrolimus. Your doctor may need to consult with the transplant specialist if you need to take another
medicine that may increase or decrease tacrolimus blood levels.
The blood levels of Envarsus may be affected by other medicines you are taking, and conversely, the blood levels of other medicines may be affected by taking Envarsus, which may require interruption, or an increase or decrease in the dose of Envarsus.
Some patients have experienced increased blood concentrations of tacrolimus while taking other medicines. This may cause serious side effects such as kidney problems, nervous system disorders, and heart rhythm disturbances (see section 4).
An effect on Envarsus blood levels may occur very soon after starting another medicine; therefore, frequent and ongoing monitoring of Envarsus blood levels may be necessary in the first days after starting the other medicine and throughout its treatment. Some other medicines may cause a decrease in tacrolimus blood concentrations, which could increase the risk of organ transplant rejection. In particular, inform your doctor if you are taking or have recently taken:

antifungal and antibiotic medicines, particularly so-called macrolide antibiotics used to treat infections (e.g. ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid, and flucloxacillin)
letermovir, used to prevent a disease caused by CMV (human cytomegalovirus)
HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat, and fixed-dose combinations or non-nucleoside reverse transcriptase inhibitors of HIV (efavirenz, etravirine, nevirapine) used to treat HIV infection
HCV protease inhibitors (e.g. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir) used to treat hepatitis C
nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (used to treat certain types of cancer)
mycophenolic acid, used to suppress the immune system and prevent transplant rejection
medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole, or cimetidine)
antiemetics, used to treat nausea and vomiting (e.g. metoclopramide)
cisapride or the antacid magnesium-aluminium hydroxide, used to treat stomach acidity (heartburn)
oral contraceptives or other hormonal treatments containing ethinylestradiol, or danazol hormone therapy
medicines used to treat high blood pressure (hypertension) or heart problems (e.g. nifedipine, nicardipine, diltiazem, and verapamil)
antiarrhythmic medicines (amiodarone) used to control arrhythmias (irregular heartbeats)
medicines called "statins", used to treat high cholesterol and triglyceride levels
carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
metamizole, used to treat pain and fever
corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammation or suppress the immune system (e.g. in organ transplant rejection)
nefazodone, used to treat depression
herbal preparations containing St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera
cannabidiol (used, among others, for the treatment of seizures)

Inform your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for
hepatitis C may alter liver function and affect tacrolimus blood concentrations. Tacrolimus blood levels may either decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make necessary dose adjustments after starting hepatitis C treatment.
Inform your doctor if you are taking or need to take ibuprofen (for treatment of fever, inflammation, and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (for treatment of fungal infections), or antiviral medicines (for treatment of viral infections, e.g. aciclovir, ganciclovir, cidofovir, foscarnet). These medicines may worsen kidney or nervous system problems when taken together with Envarsus.
Inform your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of developing thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and hemolytic uremic syndrome may increase (see section 4).
Your doctor also needs to know if, while taking Envarsus, you are taking potassium supplements or certain diuretics used for heart failure, hypertension, and kidney disease (e.g. amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole which may increase potassium levels in the blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation, and pain, anticoagulants (blood thinners), or oral diabetes medicines.
If you need to receive vaccinations, discuss this with your doctor first.

Envarsus with food and drink
Avoid grapefruit (including juice) during treatment with Envarsus, as it may affect medicine levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. In a study, pregnancy outcomes were evaluated in women treated with tacrolimus and in women treated with other immunosuppressants. Although the evidence from this study is insufficient to draw definitive conclusions, higher rates of spontaneous abortion were reported among liver and kidney transplant recipients treated with tacrolimus, as well as higher rates of persistent hypertension associated with protein loss in the urine developing during pregnancy or the postpartum period (a condition called pre-eclampsia) among kidney transplant recipients. No increased risk of major birth defects has been observed with the use of Envarsus.
Tacrolimus is excreted in breast milk. Therefore, you must not breastfeed while taking Envarsus.

Driving and using machines
Do not drive or operate tools or machines if you experience dizziness or drowsiness, or if your vision is blurred after taking Envarsus. These effects are more likely if you also consume alcohol.

Envarsus contains lactose
Envarsus contains lactose (milk sugar).

Envarsus 0.75 mg tablets: 41.7 mg
Envarsus 1 mg tablets: 41.7 mg
Envarsus 4 mg tablets: 104 mg

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Envarsus

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
This medicine must be prescribed only by a doctor experienced in managing transplant patients.

Important information
Make sure you always receive the same tacrolimus-containing medicine each time you collect your prescription, unless your transplant specialist has specifically agreed to switch you to a different tacrolimus-containing medicine.
This medicine must be taken once daily. If this medicine looks different than usual or if the dosing instructions have changed, contact your doctor or pharmacist as soon as possible to ensure you have received the correct medicine.

What dose of Envarsus should I take?
The initial dose to prevent rejection of your transplanted organ will be determined by your doctor and calculated according to your body weight.
The usual daily starting doses immediately after transplantation generally range between:
0.11 and 0.17 mg per kg of body weight per day, depending on the transplanted organ. These same doses may also be used to treat rejection episodes.
Your dose depends on your general condition and on any other immunosuppressive medicines you are taking. After starting treatment with this medicine, your doctor will perform frequent blood tests to determine the correct dose. Later, periodic blood tests will be required to monitor and adjust the dose as needed.
Usually, your doctor will reduce your dose of Envarsus once your condition has stabilized.

How to take Envarsus tablets
Envarsus is taken orally once daily, generally on an empty stomach.
Take the tablets immediately after removing them from the blister pack. The tablets must be swallowed whole with a glass of water. Do not swallow the desiccant contained in the aluminum foil packaging.

How long should I take Envarsus tablets?
You will need to take Envarsus every day for as long as you require immunosuppression to prevent rejection of your transplanted organ. You should maintain regular contact with your doctor.

If you take more Envarsus than you should
If you accidentally take too much Envarsus, contact your doctor or go to the nearest hospital emergency department immediately.

If you forget to take Envarsus
Do not take a double dose to make up for the missed tablet. Take the missed tablet as soon as possible on the same day.

If you stop taking Envarsus
Stopping treatment with Envarsus may increase the risk of rejection of your transplanted organ. Do not stop treatment unless your doctor tells you to do so.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tacrolimus reduces your body’s defence mechanism (the immune system), which will therefore be less effective than before in fighting infections. As a result, you may be more susceptible to infections while taking Envarsus. Some infections may be serious or fatal and may include those caused by bacteria, viruses, fungi, parasites or other infections.
Inform your doctor immediately if you experience signs of infection, including:

Fever, cough, sore throat, feeling weak or generally unwell
Memory loss, difficulty thinking, difficulty walking or loss of vision – these may be due to a very rare and serious brain infection, which can be fatal (Progressive Multifocal Leukoencephalopathy or PML). If you experience serious side effects, contact your doctor immediately. Serious side effects may occur, including allergic and anaphylactic reactions. The occurrence of benign and malignant tumours has been reported after treatment with Envarsus.

Inform your doctor immediately if you have or suspect you may have any of the following
serious side effects:
Serious common side effects (may affect up to 1 in 10 people):
Gastrointestinal perforation: severe abdominal pain with or without other symptoms such as chills, fever, nausea or vomiting.
Inadequate function of the transplanted organ.
Blurred vision.
Serious uncommon side effects (may affect up to 1 in 100 people):
Thrombotic microangiopathy (damage to the smallest blood vessels), including haemolytic uraemic syndrome, a condition with the following symptoms: reduced or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and appearance of bruises (ecchymoses) or abnormal bleeding, and signs of infection.
Serious rare side effects (may affect up to 1 in 1,000 people):
Thrombotic thrombocytopenic purpura: a condition involving damage to the smallest blood vessels and characterised by fever and subcutaneous ecchymoses, which may appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), symptoms of acute kidney failure (reduced or absent urine output), loss of vision and seizures.
Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that may peel off large areas of the body.
Blindness.
Serious very rare side effects (may affect up to 1 in 10,000 people):
Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes and genitals, hives, swelling of the tongue, red or purplish skin rash that spreads, skin peeling.
Torsades de pointes: change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness or nausea, palpitations (strong awareness of your own heartbeat) and difficulty breathing.
Serious side effects – frequency not known (frequency cannot be estimated from the available data):
Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhoea, fever and sore throat.
The development of benign and malignant tumours has been reported following treatment, as a consequence of immunosuppression, including malignant skin cancers and a rare type of cancer that may include skin lesions, called Kaposi's sarcoma. Symptoms include skin changes such as new or changing discoloration, lesions or nodules.
Cases of pure red cell aplasia (a very severe reduction in red blood cell count), haemolytic anaemia (reduced number of red blood cells due to their abnormal destruction, accompanied by fatigue) and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever) have been reported. It is not exactly known how often these side effects occur. You may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, unusual paleness of the skin, shortness of breath, dizziness, headache, chest pain and cold hands and feet.
Cases of agranulocytosis (a severely reduced number of white blood cells accompanied by mouth ulcers, fever and infection(s)) have been reported. You may have no symptoms or may experience sudden fever, febrile chills and sore throat.
Allergic and anaphylactic reactions with the following symptoms: sudden skin rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel weak.
Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood swings, seizures and visual disturbances. These may be signs of a disorder called posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
Optic neuropathy (abnormality of the optic nerve): vision problems such as blurred vision, changes in colour vision, difficulty seeing details or restricted visual field.
The following side effects may also occur after taking Envarsus and could be serious:
Very common side effects (may affect more than 1 in 10 people):

Increased blood sugar (glucose), diabetes mellitus, increased potassium in the blood
Difficulty sleeping
Tremor, headache
Increased blood pressure
Abnormal liver function test results
Diarrhoea, nausea
Kidney problems

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

Reduced number of blood cells (platelets, red blood cells or white blood cells), increased white blood cell count, changes in red blood cell levels (detected in blood tests)
Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, loss of appetite, reduced appetite, increased blood acidity, other changes in blood electrolyte balance (detected in blood tests)
Anxiety symptoms, confusion and disorientation, depression, mood swings, nightmares, hallucinations, mental disorders
Seizures, altered state of consciousness, tingling and numbness (sometimes with pain) in hands and feet, dizziness, impaired writing ability, nervous system disorders
Increased sensitivity to light, eye disorders
Ringing in the ears
Reduced blood flow in heart vessels, increased heart rate
Bleeding, partial or complete blockage of blood vessels, reduced blood pressure
Shortness of breath, changes in lung tissue, fluid accumulation around the lungs, pharyngitis, cough, flu-like symptoms
Inflammation or ulcers causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcers in the mouth, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools, stomach problems
Biliary disorders, yellowing of the skin due to liver problems, liver tissue damage and liver inflammation
Itching, skin rash, hair loss, acne, increased sweating
Joint, limb or back pain, muscle cramps
Impaired kidney function, reduced urine production, impaired or painful urination
Generalised weakness, fever, fluid accumulation in the body, pain and discomfort, increased alkaline phosphatase enzyme in the blood, weight gain, sensation of temperature alteration

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

Blood clotting disorders, decrease in all types of blood cells (detected in blood tests)
Dehydration
Psychotic behaviour such as delusions, hallucinations and confusion
Decreased protein or sugar in the blood, increased phosphate in the blood
Coma, cerebral haemorrhage, stroke, paralysis, brain disorders, speech and language abnormalities, memory problems
Lens opacity of the eye, partial or total hearing loss
Irregular heartbeat, cardiac arrest, reduced heart performance, heart muscle disorders, enlargement of the heart muscle, stronger heartbeat, electrocardiogram (ECG) abnormalities, heart rate and pulse abnormalities
Blood clot in a vein of a limb, shock
Breathing difficulties, respiratory disorders, asthma
Acute or chronic inflammation of the pancreas, inflammation of the lining of the inner abdominal wall, intestinal obstruction, increased levels of amylase enzyme in the blood, reflux of stomach contents into the throat, delayed gastric emptying
Skin inflammation, burning sensation upon sun exposure
Joint disorders
Inability to urinate, painful menstruation and abnormal menstrual bleeding
Multi-organ failure, flu-like syndrome, increased sensitivity to heat and cold, chest tightness, restlessness or discomfort, increased lactate dehydrogenase enzyme in the blood, weight loss

Rare side effects (may affect up to 1 in 1,000 people):

Minor skin bleeding caused by blood clots
Increased muscle stiffness
Deafness
Fluid accumulation around the heart
Acute respiratory failure
Cyst formation in the pancreas, early-stage intestinal obstruction
Blood circulation problems in the liver
Severe illness with blistering of the skin, mouth, eyes and genitals
Increased hair growth
Thirst, falls, chest tightness, decreased mobility, ulcer

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

Muscle weakness
Impaired hearing
Echocardiogram abnormalities
Liver failure
Painful urination with blood in the urine
Increased fatty tissue

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Envarsus

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, blister, and
aluminium foil after 'Exp' or 'EXP'. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original aluminium foil to protect the medicine from light.
Use all extended-release tablets within 45 days of opening the aluminium foil.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Envarsus contains

The active substance is tacrolimus.

Envarsus 0.75 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg of tacrolimus (as monohydrate).
Envarsus 1 mg prolonged-release tablets
Each prolonged-release tablet contains 1.0 mg of tacrolimus (as monohydrate).
Envarsus 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4.0 mg of tacrolimus (as monohydrate).

The other excipients are hypromellose, lactose monohydrate, macrogol 6000, poloxamer 188, magnesium stearate, tartaric acid (E334), butylated hydroxytoluene (E321), dimethicone 350.

Description of the appearance of Envarsus and contents of the pack
Envarsus 0.75 mg prolonged-release tablets are oval, uncoated tablets, white to off-white in colour, marked with “0.75” on one side and “TCS” on the other side.
Envarsus 1 mg prolonged-release tablets are oval, uncoated tablets, white to off-white in colour, marked with “1” on one side and “TCS” on the other side.
Envarsus 4 mg prolonged-release tablets are oval, uncoated tablets, white to off-white in colour, marked with “4” on one side and “TCS” on the other side.
Envarsus is supplied in PVC/alu blister packs containing 10 tablets. Three blisters are packaged together in an aluminium protective pouch, which includes a desiccant.
Pack sizes of 30, 60 and 90 prolonged-release tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo, 26/A
43122 Parma
Italy

Manufacturer
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany
or
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma
Italy
or
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Wien
Austria

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

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: +32 (0)2 788 42 00 Tel: +43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Tel.: +359 29201205 Tél/Tel: +32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: +420 261221745 Tel.: +36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: +46 8 753 35 20 Tel: +39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: +49 40 89724-0 Tel: +31 0 88 5016400

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: +43 1 4073919 Tlf: +46 8 753 35 20

Ελλάδα Österreich
Chiesi Hellas AEBE Chiesi Pharmaceuticals GmbH
Tel: +30 210 6179763 Tel: +43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: +34 93 494 8000 Tel.: +48 22 620 1421

France Portugal
Chiesi S.A.S Chiesi Farmaceutici S.p.A.
Tél: +33 1 47688899 Tel: +39 0521 2791

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: +43 1 4073919 Tel: +40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. CHIESI SLOVENIJA, d.o.o.
Tel: +39 0521 2791 Tel: +386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: +421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: +39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Chiesi Farmaceutici S.p.A. Chiesi Pharma AB
Tel: +39 0521 2791 Tel: +46 8 753 35 20

Latvija United Kingdom (Northern Ireland)
Chiesi Pharmaceuticals GmbH Chiesi Farmaceutici S.p.A.
Tel: +43 1 4073919 Tel: +39 0521 2791

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.