Envarsus 1 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Envarsus 0.75 mg prolonged-release tablets

Envarsus 1 mg prolonged-release tablets

Envarsus 4 mg prolonged-release tablets

tacrolimus

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 or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Envarsus is and what it is used for
2. What you need to know before taking Envarsus
3. How to take Envarsus
4. Possible side effects
5. How to store Envarsus
6. 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 immunosuppressant. After undergoing a kidney or liver transplant, your immune system will attempt to reject the new organ.

Envarsus is used to control your body's immune response, allowing it to accept the transplanted organ.

Envarsus may also be prescribed to treat rejection occurring in your liver, kidney, heart, or other transplanted organ, in cases where previous treatment has failed to control this immune response after your transplant.

Envarsus is used for treatment in adults.

2. What you need to know before taking Envarsus

Do not take Envarsus

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

Warnings and precautions

Envarsus contains the active substance tacrolimus in a prolonged-release formulation. Envarsus is taken once daily and cannot be interchanged with other medicines containing tacrolimus (immediate- or prolonged-release) on an equivalent dose basis.

Consult your doctor or pharmacist before starting Envarsus if:

• you have or have had liver problems;

• you have had diarrhoea for more than one day;

• you are taking any of the medicines listed below under the section "Other medicines and Envarsus";

• you have a disturbance in the electrical activity of the heart known as "QT prolongation".

• severe abdominal pain, with or without other symptoms such as chills, fever, nausea or vomiting;

• an infection leading to kidney problems or neurological symptoms;

• headache, altered mental state, seizures, and visual disturbances;

• weakness, change in skin or eye colour, easy bruising, infection, cough, anaemia;

• you have or have had damage to 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 volume, vision loss, 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 preparations, e.g., St. John’s wort (Hypericum perforatum) or any other herbal products, as they may affect the effectiveness and required dose of Envarsus. If you have any doubts, please consult your doctor before taking any herbal product or preparation.

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 need to perform blood, urine, heart, or eye tests to determine the appropriate dose of Envarsus.

You should limit your exposure to sunlight and ultraviolet (UV) radiation while taking Envarsus. This is because immunosuppressants may increase the risk of skin cancer. Use appropriate protective clothing and a high-protection-factor sunscreen.

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 need to take any other medicines, including those available without a prescription and herbal medicines.

Concomitant use of Envarsus with cyclosporine (another medicine used to prevent organ transplant rejection) is not recommended.

If you need to see a doctor other than your transplant specialist, inform the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you are prescribed another medicine that could increase or decrease your blood levels of tacrolimus.

The blood concentrations of Envarsus may be affected by other medicines you take, and conversely, the blood concentrations of other medicines may be affected by taking Envarsus, which could require interruption, increase, or decrease in the dose of Envarsus.

Some patients have experienced increased blood levels of tacrolimus while taking other medicines. This could lead to serious adverse effects such as kidney problems, nervous system disorders, and cardiac rhythm disturbances (see section 4).

The effect on blood levels of Envarsus may occur soon after starting another medicine, so it may be necessary to monitor blood levels of Envarsus frequently and continuously during the first days of taking another medicine and regularly while continuing its use. Some other medicines may cause blood levels of tacrolimus to decrease, which could increase the risk of organ transplant rejection. In particular, inform your doctor if you are taking or have recently taken medicines such as:

• antifungal and antibiotic agents, especially those known as 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 diseases caused by CMV (human cytomegalovirus);
• HIV protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat, and combination tablets or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine) used to treat HIV infection;
• HCV protease inhibitors (e.g., telaprevir, boceprevir, the combination of 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 cancers);
• mycophenolic acid, used to suppress the immune system to 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 aluminium and magnesium hydroxide, used to treat heartburn;
• oral contraceptives or other hormonal treatments containing ethinylestradiol, hormonal treatments with danazol;
• medicines used to treat high blood pressure or heart problems (e.g., nifedipine, nicardipine, diltiazem, and verapamil);
• antiarrhythmics (e.g., amiodarone) used to control arrhythmia (irregular heartbeat);
• medicines known as "statins", used to treat high cholesterol and triglycerides;
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy;
• metamizole, used to treat pain and fever;
• the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammation or suppress the immune system (e.g., in case of transplant rejection);
• nefazodone, used to treat depression;
• herbal medicines containing St. John’s wort (hypericum) or extracts of Schisandra sphenanthera;
• cannabidiol (its use includes, among others, treatment of epileptic seizures).

Inform your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for hepatitis C may alter your liver function and may affect blood levels of tacrolimus. Blood levels of tacrolimus may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor blood levels of tacrolimus and make necessary dose adjustments after starting treatment for hepatitis C.

Inform your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation, and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections), or antivirals (used to treat 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).

While taking Envarsus, your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension, and nephropathy (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole, which may increase potassium levels in your blood, non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) used to treat fever, inflammation, and pain, anticoagulants, or oral medicines for diabetes.

Inform your doctor in advance if you need to receive any vaccine.

Taking Envarsus with food and drinks

Avoid consuming grapefruit (including grapefruit juice) while being treated with Envarsus, as it may affect the blood concentration of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. A study evaluated pregnancy outcomes in women treated with tacrolimus and other immunosuppressants. Although there was insufficient evidence in this study to draw definitive conclusions, higher rates of spontaneous abortion were reported among liver and kidney transplant patients 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 preeclampsia) among kidney transplant patients. No increased risk of major congenital malformations was found to be associated with the use of Envarsus.

Tacrolimus passes into breast milk. Therefore, you must not breastfeed while taking Envarsus.

Driving and using machines

Do not drive or operate tools or machinery if you feel dizzy or drowsy, or if you have blurred vision 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Envarsus

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine should only be prescribed by doctors experienced in the treatment of transplant patients.

Important information

Make sure you are always given the same tacrolimus-containing medicine each time you collect your prescription, unless your transplant specialist has agreed to switch you to another medicine.

This medicine should only be taken once daily. If this medicine looks different than usual, or if the dosing instructions have changed, consult your doctor or pharmacist as soon as possible to ensure you are taking the correct medicine.

How much Envarsus should I take?

Your doctor will determine your initial dose based on your body weight to prevent rejection of your transplanted organ.

The usual initial daily doses immediately after transplantation generally fall within the range of 0.11–0.17 mg daily per kg of body weight, depending on the type of transplanted organ. The same doses may be used to treat rejection.

Your dose will depend on your general condition and on other immunosuppressants you are taking. After starting treatment with this medicine, your doctor will frequently perform blood tests to determine the correct dose. Afterwards, regular blood tests will be performed so your doctor can determine and adjust the correct dose. Your doctor will usually reduce your Envarsus dose once your condition has stabilized.

How to take Envarsus tablets

Envarsus is taken orally once daily, usually on an empty stomach.

Take the tablets immediately after removing them from the blister. The tablets should be swallowed whole with a glass of water. Do not swallow the desiccant included in the aluminum packaging.

How long should I take Envarsus tablets?

You will need to take Envarsus daily 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 an excessive dose of Envarsus, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Envarsus

Do not take a double dose to make up for missed doses. Take the 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 the transplanted organ. Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tacrolimus reduces the activity of the body's defence system (the immune system), making it less able to fight infections. Therefore, you may be more prone 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 symptoms of infection, including:

• Fever, cough, sore throat, feeling weak or generally unwell
• Memory loss, difficulty thinking, trouble walking, or vision loss – these symptoms may be due to a rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy [PML])

Contact your doctor immediately if you experience any serious effects.

Serious effects, including allergic and anaphylactic reactions, may occur. Benign and malignant tumours have been reported following treatment with Envarsus.

Inform your doctor immediately if you suspect you are experiencing any of the following serious adverse effects:

Frequent serious adverse 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 your transplanted organ.
• Blurred vision.

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

• Thrombotic microangiopathy (damage to small blood vessels), including haemolytic uraemic syndrome, with the following symptoms: low or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and bruising or abnormal bleeding, along with signs of infection.

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

• Thrombotic thrombocytopenic purpura: includes damage to small blood vessels and is characterised by fever and skin bruising that may appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), symptoms of acute kidney failure (low or no urine output), vision loss, and seizures.
• Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that may peel off in large areas of the body.
• Blindness.

Very rare serious adverse 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, tongue swelling, red or purple rash that spreads, and skin peeling.
• Torsades de pointes: changes in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness, nausea, palpitations (awareness of heartbeats), and difficulty breathing.

Serious adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhoea, fever, and sore throat.
• Benign and malignant tumours have been reported after treatment as a result of immunosuppression, including malignant skin cancers and a rare type of cancer that may involve skin lesions known as Kaposi's sarcoma. Symptoms include skin changes such as new discolorations or changes in existing ones, lesions, or lumps.
• Cases of pure red cell aplasia (a marked reduction in red blood cell count), haemolytic anaemia (reduced number of red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in infection-fighting white blood cells, accompanied by fever) have been reported. The exact frequency of these adverse effects is unknown. You may have no symptoms, or depending on severity, you may experience: fatigue, apathy, abnormal paleness of the skin (pallor), difficulty breathing, dizziness, headache, chest pain, and cold sensation in hands and feet.
• Cases of agranulocytosis (a marked decrease in white blood cells accompanied by mouth ulcers, fever, and infection[s]). You may have no symptoms or may suddenly experience fever, chills, and sore throat.
• Allergic and anaphylactic reactions with the following symptoms: sudden itchy skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and feeling faint.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures, and visual disturbances. These could be signs of a disorder known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
• Optic neuropathy (damage to the optic nerve): vision problems such as blurred vision, changes in colour vision, difficulty seeing details, or reduced visual field.

The following adverse effects may also occur after receiving Envarsus and may be serious:

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

• Increased blood sugar or potassium levels, diabetes mellitus
• Difficulty falling asleep
• Tremors, headache
• Increased blood pressure
• Abnormal liver function tests
• Diarrhoea, nausea
• Kidney problems

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

• Reduced number of certain blood cells (platelets, red blood cells, or white blood cells), increased number of white blood cells, changes in red blood cell count (seen in blood tests)
• Reduced blood levels of magnesium, phosphate, potassium, calcium, or sodium, fluid overload (hypervolemia), increased blood levels of uric acid or lipids, decreased appetite, loss of appetite, increased blood acidity, other changes in blood electrolytes (seen in blood tests)
• Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
• Seizures, altered consciousness, tingling and numbness (sometimes painful) in hands and feet, dizziness, writing impairment, nervous system disorders
• Increased light sensitivity, eye disorders
• Ringing in the ears
• Reduced blood flow to the heart's blood vessels, rapid heartbeat
• Bleeding, partial or complete blockage of blood vessels, decreased blood pressure
• Shortness of breath, changes in lung tissue, fluid accumulation around the lung, sore throat inflammation, cough, flu-like symptoms
• Inflammations or ulcers causing abdominal pain or diarrhoea, stomach bleeding, mouth ulcers or inflammation, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, soft 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
• Insufficient kidney function, reduced urine output, urinary disturbances, or pain during urination
• General weakness, fever, fluid accumulation in the body, pain and discomfort, increased blood levels of alkaline phosphatase enzyme, weight gain, sensation of altered temperature

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

• Changes in blood coagulation, reduced number of all types of blood cells (seen in blood tests)
• Dehydration
• Psychotic behaviour, such as delusional ideas, hallucinations, and confusion
• Reduced protein or sugar in the blood, increased blood phosphate levels
• Coma, brain haemorrhage, stroke, paralysis, brain disorder, speech and language disturbances, memory problems
• Clouding of the lens, total or partial hearing loss
• Irregular heartbeats, cardiac arrest, reduced heart function, myocardial disorder, enlarged heart muscle, stronger heartbeats, electrocardiogram abnormalities, changes in heart rate and pulse
• Blood clot in a vein of a limb, shock
• Difficulty breathing, respiratory tract disorders, asthma
• Acute or chronic inflammation of the pancreas, inflammation of the inner abdominal wall lining, intestinal obstruction, increased blood levels of amylase enzyme, stomach contents refluxing into the throat, delayed defecation
• Skin inflammation, burning sensation upon exposure to sunlight
• Joint disorders
• Inability to urinate, painful menstruation, abnormal menstrual bleeding
• Multi-organ failure, flu-like illness, increased sensitivity to heat and cold, chest pressure, nervousness or unusual sensations, increased blood lactate dehydrogenase enzyme levels, weight loss

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

• Small skin haemorrhages due to blood clots
• Increased muscle stiffness
• Deafness
• Fluid accumulation around the heart
• Acute breathing difficulty
• Cyst formation in the pancreas, pre-obstructive intestinal condition
• Problems with liver blood flow
• Severe illness with blistering of the skin, mouth, eyes, and genitals
• Increased hair growth
• Thirst, falls, chest tightness, loss of mobility, ulcer

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

• Muscle weakness
• Hearing disorders
• Changes in cardiac examinations
• Liver failure
• Painful urination with blood in the urine
• Increased fatty tissue

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 pack, and wrapper after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Store within the original aluminium foil wrapper to protect from light.

Use all extended-release tablets within 45 days of opening the aluminium foil wrapper.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Envarsus

• 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 mg of tacrolimus (as monohydrate).

Envarsus 4 mg prolonged-release tablets

Each prolonged-release tablet contains 4 mg of tacrolimus (as monohydrate).

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

Nature of the product and pack contents

Envarsus 0.75 mg prolonged-release tablets are oval-shaped, white to bone-coloured tablets, printed with "0.75" on one side and "TCS" on the other.

Envarsus 1 mg prolonged-release tablets are oval-shaped, white to bone-coloured tablets, printed with "1" on one side and "TCS" on the other.

Envarsus 4 mg prolonged-release tablets are oval-shaped, white to bone-coloured tablets, printed with "4" on one side and "TCS" on the other.

Envarsus is supplied in PVC/Al blisters containing 10 tablets. Three blisters are packaged together in an aluminium protective wrapper with desiccant. Packs containing 30, 60 and 90 prolonged-release tablets are marketed.

Only certain pack sizes may be commercially available.

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 regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Chiesi sa/nv Tel/Tel: +32 (0)2 788 42 00	Lithuania Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919
	Luxembourg/Luxembourg Chiesi sa/nv Tél/Tel: +32 (0)2 788 42 00
Czech Republic Chiesi CZ s.r.o. Tel: +420 261221745	Hungary Chiesi Hungary Kft. Tel.: +36-1-429 1060
Denmark Chiesi Pharma AB Tlf: +46 8 753 35 20	Malta Chiesi Farmaceutici S.p.A. Tel: +39 0521 2791
Germany Chiesi GmbH Tel: +49 40 89724-0	Netherlands Chiesi Pharmaceuticals B.V. Tel: +31 0 88 5016400
Estonia Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919	Norway Chiesi Pharma AB Tlf: +46 8 753 35 20
Greece Chiesi Hellas AEBE Tel: +30 210 6179763	Austria Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919
Spain Chiesi España, S.A.U. Tel: +34 93 494 8000	Poland Chiesi Poland Sp. z.o.o. Tel.: +48 22 620 1421
France Chiesi S.A.S Tél: +33 1 47688899	Portugal Chiesi Farmaceutici S.p.A. Tel: +39 0521 2791
Croatia Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919	Romania Chiesi Romania S.R.L. Tel: +40 212023642
Ireland Chiesi Farmaceutici S.p.A. Tel: +39 0521 2791	Slovenia CHIESI SLOVENIJA, d.o.o. Tel: +386-1-43 00 901
Iceland Chiesi Pharma AB Sími: +46 8 753 35 20	Slovakia Chiesi Slovakia s.r.o. Tel: +421 259300060
Italy Chiesi Italia S.p.A. Tel: +39 0521 2791	Finland/Finland Chiesi Pharma AB Puh/Tel: +46 8 753 35 20
Cyprus Chiesi Farmaceutici S.p.A. Tel: +39 0521 2791	Sweden Chiesi Pharma AB Tel: +46 8 753 35 20
Latvia Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919	United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: +39 0521 2791

Date of the most recent review of this leaflet: February 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.