CONFEROPORT 0.5 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Conferoport 0.5 mg prolonged-release hard capsules EFG

Conferoport 1 mg prolonged-release hard capsules EFG

Conferoport 2 mg prolonged-release hard capsules

Conferoport 3 mg prolonged-release hard capsules EFG

Conferoport 5 mg prolonged-release hard capsules EFG

tacrolimus

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Conferoport and what is it used for
2. What you need to know before you take Conferoport
3. How to take Conferoport
4. Possible side effects
5. Storing Conferoport
6. Contents of the pack and other information

1. What is Conferoport and what is it used for

Conferoport contains the active substance tacrolimus. It is an immunosuppressant. After your organ transplant (liver, kidney), your body's immune system will try to reject the new organ. Conferoport is used to control your body's immune response, allowing it to accept the transplanted organ.

You may also receive Conferoport to treat a rejection that is occurring in your liver, kidney, heart, or other transplanted organ, when any previous treatment you were following does not control this immune response after your transplant.

Conferoport is used in adults.

2. What you need to know before you take Conferoport

Do not take Conferoport

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

Warnings and precautions

Tacrolimus immediate-release capsules and Conferoport both contain the active substance tacrolimus. However, Conferoport is taken once a day, while tacrolimus immediate-release capsules are taken twice a day. This is because Conferoport capsules allow for prolonged release (slower release over a longer period) of tacrolimus. Conferoport and tacrolimus immediate-release capsules are not interchangeable.

Tell your doctor or pharmacist before taking Conferoport:

• if you are taking any medicine mentioned in "Other medicines and Conferoport",
• if you have or have had liver problems,
• if you have had diarrhea for more than a day,
• if you feel strong abdominal pain accompanied by other symptoms such as chills, fever, nausea, or vomiting,
• if you have a heart condition called "prolonged QT interval",
• if you have or have had damage to the small blood vessels, known as thrombotic microangiopathy/thrombocytopenic purpura/hemolytic uremic syndrome. Tell your doctor if you develop fever, bruising under the skin (which can appear as red spots), unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urine output, loss of vision, and seizures (see section 4). When taking tacrolimus with sirolimus or everolimus, the risk of these symptoms may increase.

Please avoid taking any herbal preparations, e.g., St. John's Wort (Hypericum perforatum) or any other plant-based product, as this may affect the effectiveness and dose of tacrolimus you need to receive. If you have any doubts, please consult your doctor before taking any plant-based product or preparation.

Tell your doctor immediately if you experience:

• vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced field of vision.

Your doctor may need to adjust your dose of Conferoport.

You should stay in regular contact with your doctor. From time to time, to establish the correct dose of Conferoport, your doctor may need to perform blood and urine tests, heart tests, and eye tests.

You should limit your exposure to sunlight and UV (ultraviolet) light while taking Conferoport. This is because immunosuppressants can increase the risk of skin cancer. Wear protective clothing and use a sunscreen with a high sun protection factor.

Handling precautions:

During preparation, avoid contact with any part of the body, such as skin or eyes, as well as breathing near the injection solutions, powder, or granules contained in the tacrolimus products. If such contact occurs, wash the skin and eyes.

Children and adolescents

Conferoport is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Conferoport

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription and plant-based preparations.

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

If you need to visit a different doctor than your transplant specialist, tell the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you need to use another medicine that may increase or decrease your blood level of tacrolimus.

Tacrolimus blood levels may be changed due to other medicines you are taking, and blood levels of other medicines may be changed by the administration of tacrolimus, which may require interruption, increase, or decrease of the dose of Conferoport.

Some patients have experienced increases in tacrolimus blood levels while taking other medicines. This could cause serious side effects, such as kidney problems, nervous system problems, and heart rhythm disorders (see section 4).

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

• antifungals and antibiotics, especially 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 pharmacoenhancer cobicistat, and combined or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine), used to treat HIV infection,
• HCV protease inhibitors (e.g., telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir, with or without dasabuvir), elbasvir/grazoprevir, and glecaprevir/pibrentasvir, used to treat hepatitis C infection,
• nilotinib, imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (used to treat certain types of cancer),
• mycophenolic acid, used to suppress the immune system as a prevention of transplant rejection,
• medicines for stomach ulcers and acid reflux (e.g., omeprazole, lansoprazole, or cimetidine),
• antiemetics, used to treat nausea and vomiting (e.g., metoclopramide),
• cisapride or the antacid magnesium-aluminum hydroxide, used to treat acidity,
• the contraceptive pill or other hormonal treatments with ethinylestradiol, hormonal treatments with danazol,
• medicines used to treat high blood pressure or heart problems (e.g., nifedipine, nicardipine, diltiazem, and verapamil),
• antiarrhythmic medicines (amiodarone) used to control irregular heartbeat,
• medicines known as "statins" used to treat high cholesterol and triglycerides,
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy,
• corticosteroids prednisolone or methylprednisolone, belonging to the class of corticosteroids used to treat inflammation or suppress the immune system (e.g., transplant rejection),
• nefazodone, used to treat depression,
• plant-based medicines that contain St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera,
• metamizole, a medicine used to treat pain and fever,
• cannabidiol (its use includes, among others, the treatment of epileptic seizures).

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

Tell 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., acyclovir, ganciclovir, cidofovir, foscarnet). These medicines may worsen kidney or nervous system problems when taken with Conferoport.

Tell your doctor if you are taking sirolimus or everolimus. When taking tacrolimus with sirolimus or everolimus, the risk of thrombotic microangiopathy, thrombocytopenic purpura, and hemolytic uremic syndrome may increase (see section 4).

Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, high blood pressure, and kidney disease (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim and cotrimoxazole, which may increase potassium levels in your blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used for fever, inflammation, and pain, anticoagulants (which prevent blood clotting), or oral medicines for diabetes treatment, while taking Conferoport.

If you are planning to get vaccinated, consult your doctor.

Taking Conferoport with food and drinks

Avoid grapefruit (also in juice) while being treated with Conferoport, as it may affect your blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Conferoport passes into breast milk. Therefore, you should not breastfeed while taking Conferoport.

Driving and using machines

Do not drive or use tools or machines if you feel dizzy or drowsy, or have problems seeing clearly after taking Conferoport. These effects are more frequent if you also drink alcohol.

0.5 mg and 2 mg capsules

Conferoport contains lactose and azoic colorants, which contain sodium and soy

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause allergic reactions because it contains orange-yellow S (E 110) and allura red AC (E 129) and tartrazine (E 102).

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule; this is, essentially "sodium-free".

The printing ink used on the Conferoport capsules contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.

1 mg, 3 mg, and 5 mg capsules

Conferoport contains lactose and azoic colorants, which contain sodium and soy

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause allergic reactions because it contains orange-yellow S (E 110) and allura red AC (E 129).

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule; this is, essentially "sodium-free".

The printing ink used on the Conferoport capsules contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Conferoport

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. This medicine should only be prescribed by a doctor with experience in the treatment of patients with transplants.

Make sure you receive the same tacrolimus medicine each time you collect your prescription. Unless your transplant specialist has agreed to change to a different tacrolimus medicine, this medicine should be taken once a day. If the appearance of this medicine is not the same as usual, or if the dosing instructions have changed, consult your doctor or pharmacist as soon as possible to ensure you have the correct medicine.

The initial dose to prevent rejection of your transplanted organ will be determined by your doctor based on your body weight. The daily initial doses just after transplantation will generally be within the range of 0.10-0.30 mg per kg body weight and per day, depending on the transplanted organ. For treatment of rejection, these same doses may be used.

Your dose depends on your overall condition and any other immunosuppressive medication you may be taking.

After starting treatment with Conferoport, your doctor will perform frequent blood tests to determine the correct dose. Afterward, your doctor will need to perform blood tests regularly to determine the correct dose and to adjust the dose from time to time. Your doctor will usually decrease your dose of Conferoport once your condition has stabilized. Your doctor will tell you exactly how many capsules to take.

You will need to take Conferoport every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should stay in regular contact with your doctor.

Conferoport is taken orally once a day, in the morning. Take Conferoport on an empty stomach or 2 to 3 hours after a meal. Wait at least one hour until the next meal. Take the capsules immediately after removing them from the blister pack. The capsules should be swallowed wholewith a glass of water. Do not swallow the desiccant contained in the aluminum bag.

If you take more Conferoport than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Conferoport

If you have forgotten to take your Conferoport capsules in the morning, take them as soon as possible the same day. Do not take a double dose the next morning to make up for the forgotten doses.

If you stop taking Conferoport

Stopping your treatment with Conferoport may increase the risk of rejection of your transplanted organ. Do not stop treatment unless your doctor tells you to.

If you have any further questions on 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 all people suffer from them.

Conferoport reduces the body's defense mechanisms (immune system), which will not work as well when fighting infections. Therefore, if you are taking Conferoport, you will be more prone to suffering from infections. Some infections can be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.

Inform your doctor immediately if you have symptoms of an infection, including:

• Fever, cough, sore throat, feeling of weakness or general malaise,
• Memory loss, problems thinking, difficulty walking or loss of vision,

these symptoms may be due to a rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).

Severe effects can occur, including allergic reactions and anaphylaxis. Benign and malignant tumors have been reported after treatment with Conferoport.

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

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

• Gastrointestinal perforation: severe abdominal pain accompanied or not by other symptoms such as chills, fever, nausea, or vomiting.
• Insufficient function of the transplanted organ.
• Blurred vision

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

• Thrombotic microangiopathy (lesions in small blood vessels) including hemolytic uremic 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 and signs of infection.

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

• Thrombotic thrombocytopenic purpura: includes lesions in small blood vessels and is characterized by fever and bruising under the skin that can appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute kidney failure (low or no urine output), loss of vision, and seizures.
• Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that can 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 generalized skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes, and genitals, rash, swelling of the tongue, red or purple 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 (feeling heartbeats), and difficulty breathing.

Adverse effects of unknown frequency (frequency cannot be estimated from available data):

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
• Benign and malignant tumors have been reported after treatment as a result of immunosuppression, including malignant skin cancers and a rare type of cancer that can include skin lesions known as Kaposi's sarcoma. Symptoms include skin changes such as new colors or changes in existing ones, lesions, or bumps.
• Cases of pure red cell aplasia (a significant reduction in red blood cell count), hemolytic anemia (reduction in the number of red blood cells due to abnormal rupture, accompanied by fatigue), and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever). The exact frequency of these adverse effects is unknown. You may not have symptoms or, depending on the severity of the condition, you may feel: fatigue, apathy, abnormal paleness of the skin (pallor), difficulty breathing, dizziness, headache, chest pain, and feeling of cold in hands and feet.
• Cases of agranulocytosis (a significant decrease in the number of white blood cells, accompanied by sores in the mouth, fever, and infection(s)). You may not have symptoms or you may feel sudden fever, chills, and sore throat.
• Allergic reactions and anaphylaxis with the following symptoms: sudden itchy skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), and you may feel like you are going to faint.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures, and vision changes. 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 (alteration of the optic nerve): vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced visual field.

After receiving Conferoport, the following adverse effects may also occur and may be serious:

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

• Increased blood sugar, diabetes mellitus, increased potassium in the blood.
• Difficulty sleeping.
• Tremors, headache.
• Increased blood pressure.
• Abnormal liver function tests.
• Diarrhea, nausea.
• Kidney problems.

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

• Reduction in the number of blood cells (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell counts (see blood test).
• Reduction of magnesium, phosphate, potassium, calcium, or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased blood acidity, other changes in blood salts (see blood test).
• Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders.
• Seizures, disorders of the level of consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, decreased ability to write, nervous system disorders.
• Blurred vision, increased sensitivity to light, eye disorders.
• Ringing in the ears.
• Reduced blood flow in the heart vessels, faster heart rate.
• Bleeding, partial or complete blockage of blood vessels, decreased blood pressure.
• Shortness of breath, respiratory tissue disorders in the lung, fluid accumulation around the lungs, inflammation of the pharynx, cough, flu-like symptoms.
• Stomach problems such as inflammation or ulcers that cause abdominal pain or diarrhea, stomach bleeding, inflammation or ulcers in the mouth, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence (gas), abdominal swelling, loose stools.
• Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage, and liver inflammation.
• Itching, rash, hair loss, acne, increased sweating.
• Pain in the joints, limbs, back, and feet, muscle spasms.
• Insufficient kidney function, reduced urine production, difficulty or pain when urinating.
• General weakness, fever, fluid accumulation in the body, pain, and discomfort, increased alkaline phosphatase in the blood, weight gain, altered temperature sensation.

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

• Changes in blood coagulation, reduction in the number of all types of blood cells (see blood test).
• Dehydration, inability to urinate.
• Abnormal blood test results: reduction of proteins or sugar, increased phosphate, increased lactate dehydrogenase enzyme.
• Coma, brain bleeding, stroke, paralysis, brain disorders, speech and language disorders, memory problems.
• Cataract, hearing impairment.
• Irregular heartbeat, cardiac arrest, decreased heart performance, heart muscle disorders, increased heart muscle size, stronger heartbeat, abnormal ECG, abnormal heart rate and pulse.
• Blood clot in a limb vein, shock.
• Breathing difficulties, respiratory tract disorders, asthma.
• Intestinal obstruction, increased blood level of amylase enzyme, reflux of stomach contents into the throat, delayed stomach emptying.
• Skin inflammation, sensation of burning in the sun.
• Joint disorders.
• Painful and abnormal menstrual bleeding.
• Multi-organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure in the chest, restlessness or abnormal sensation, weight loss.

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

• Small skin bleeding due to blood clots.
• Increased muscle stiffness.
• Deafness.
• Fluid accumulation around the heart.
• Acute shortness of breath.
• Pancreatic cyst formation.
• Liver blood flow problems.
• Severe illness with blistering of the skin, mouth, eyes, and genitals; increased hairiness.
• Thirst, falls, feeling of chest pressure, decreased mobility, ulcer.

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

• Muscle weakness.
• Abnormal cardiac ultrasound.
• Liver failure.
• Pain when urinating, with blood in the urine.
• Increased fatty tissue.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Conferoport

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the carton and on the blister pack after "EXP". The expiration date is the last day of the month indicated. Use all capsules within one year of opening the aluminum bag and before the expiration date.

Store in the original packaging (aluminum bag) to protect it from light and moisture.

Take the capsule immediately after removing it from the blister pack.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

.

6. Package Contents and Additional Information

• The active ingredient is tacrolimus. Each capsule contains 0.5 mg, 1 mg, 2 mg, 3 mg, or 5 mg of tacrolimus (as monohydrate).
• The other ingredients are:

Capsule content: ethylcellulose, hypromellose, lactose, magnesium stearate.

Capsule shell:

Capsules of 0.5 mg and 2 mg

Brilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), orange yellow S (E110), gelatin, tartrazine (E102).

Capsules of 1 mg and 3 mg

Brilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), orange yellow S (E110), gelatin.

Capsules of 5 mg

Brilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), orange yellow S (E110), gelatin, erythrosine (E127).

Printing ink

Shellac gum, aluminum lake of allura red AC (E129), aluminum lake of brilliant blue FCF (E133), aluminum lake of orange yellow S (E110), propylene glycol (E1520), lecithin (soy).

Capsules of 1 mg, 3 mg, and 5 mg

See section 2 "Conferoport contains lactose and azoic dyes, which contain sodium and soy".

Capsules of 0.5 mg and 2 mg

See section 2 "Conferoport 0.5 mg contains lactose and azoic dyes, which contain sodium and soy.

Product Appearance and Package Contents

Capsules of 0.5 mg

Size 5 gelatin capsule with a light brown body and a light yellow cap, printed in black with "0.5 mg", containing white to yellowish powder or compacted powder (length 10.7 - 11.5 mm).

Capsules of 1 mg

Size 4 gelatin capsule with a light brown body and a white cap, printed in black with "1 mg", containing white to yellowish powder or compacted powder (length 14.0 - 14.6 mm).

Capsules of 2 mg

Size 3 gelatin capsule with a light brown body and a dark green cap, printed in black with "2 mg", containing white to yellowish powder or compacted powder (length 15.6 - 16.2 mm).

Capsules of 3 mg

Size 2 gelatin capsule with a light brown body and a light orange cap, printed in black with "3 mg", containing white to yellowish powder or compacted powder (length 17.7 - 18.3 mm).

Capsules of 5 mg

Size 0 gelatin capsule with a light brown body and a pink cap, printed in black with "5 mg", containing white to yellowish powder or compacted powder (length 21.4 - 22.0 mm).

PVC/PVDC and aluminum blister pack with a desiccant sealed in an aluminum bag. The desiccant should not be swallowed.

Package sizes: 30 hard prolonged-release capsules in a blister pack or in single-dose perforated blisters of 30x1 and 60x1 (2x30) [only for 1 mg].

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Trimlini 2D

9220 Lendava

Slovenia

Date of the Last Revision of this Leaflet: March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/