Conferoport 3 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

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 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 other people, even if they have the same symptoms as you, because it could 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.

Package leaflet contents

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

1. What Conferoport is and what it is used for

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

You may also receive Conferoport to treat ongoing rejection of your transplanted liver, kidney, heart, or other organ, when any previous treatment you were receiving has failed to control this immune response following your transplant.

Conferoport is used in adults.

2. What you need to know before starting Conferoport

Do not take Conferoport

• if you are allergic (hypersensitive) 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 (e.g., erythromycin, clarithromycin, josamycin),
• if you are allergic to peanuts or to soybeans.

Warnings and precautions

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

Inform your doctor or pharmacist before taking Conferoport:

• if you are taking any of the medicines listed in “Other medicines and Conferoport”,
• if you have or have had liver problems,
• if you have had diarrhoea for more than one day,
• if you experience severe abdominal pain with or without other symptoms such as chills, fever, nausea, or vomiting,
• if you have an abnormality in the electrical activity of your heart called “QT interval prolongation”,
• if you have or have had damage to your 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 tiredness, 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 these may affect the effectiveness and required dose of tacrolimus. If you have any doubts, please consult your doctor before taking any herbal product or preparation.

Inform your doctor immediately if, during treatment, you experience:

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

Your doctor may need to adjust your dose of Conferoport.

You should maintain regular contact with your doctor. From time to time, to establish the appropriate dose of Conferoport, your doctor may need to carry out blood and urine tests, cardiac tests, and eye examinations.

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

Handling precautions:

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

Children and adolescents

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

Other medicines and Conferoport

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal preparations.

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

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

Blood levels of tacrolimus may be altered by other medicines you are taking, and the blood levels of other medicines may be altered by taking tacrolimus, which may require interruption, increase, or decrease in the dose of Conferoport.

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 heart rhythm disturbances (see section 4).

The effect on blood levels of Conferoport may occur soon after starting another medicine, so it may be necessary to monitor Conferoport blood levels frequently and continuously during the first few days of starting 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 medicines, 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 booster cobicistat, and combined tablets 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 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 magnesium-aluminum hydroxide, used to treat heartburn,
• oral contraceptives or other hormonal treatments containing ethinylestradiol, or 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 arrhythmia (irregular heartbeat),
• medicines known as "statins" used to treat high cholesterol and triglycerides,
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy,
• metamizole, a medicine used to treat pain and fever,
• 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,
• herbal medicines containing St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera,
• cannabidiol (used, among others, for the 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 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 tacrolimus blood levels and make necessary dose adjustments of Conferoport after starting hepatitis C treatment.

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 Conferoport.

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 you are taking potassium supplements or certain diuretics used for heart failure, high blood pressure, and nephropathy (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 the treatment of diabetes, while taking Conferoport.

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

Taking Conferoport with food and drinks

Avoid grapefruit (including grapefruit juice) while being treated with Conferoport, as it may affect its blood levels.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using Conferoport. One study evaluated pregnancy outcomes in women treated with tacrolimus and other immunosuppressants. Although this study did not provide sufficient evidence 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 occurring 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 tacrolimus.

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

Driving and operating machinery

Do not drive or operate tools or machines if you feel dizzy or drowsy, or if you have difficulty seeing clearly after taking Conferoport. These effects are more common if you also consume alcohol.

Capsules of 0.5 mg and 2 mg

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

This medicinal product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

This medicine may cause allergic reactions because it contains sunset yellow FCF (E 110), 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; hence, it is essentially "sodium-free".

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

Capsules of 1 mg, 3 mg and 5 mg

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

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110) and allura red AC (E129).

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 Conferoport capsules contains soy lecithin. If you are allergic to peanuts or soy, you must not take this medicine.

3. How to take Conferoport

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. This medicine should only be prescribed by a physician experienced in the treatment of transplant patients.

Ensure that you receive the same tacrolimus medicine each time you collect your prescription, unless your transplant specialist has agreed to switch to a different tacrolimus medicine. This medicine should 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 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. Initial daily doses immediately after transplantation are generally within the range of 0.10 – 0.30 mg per kg of body weight per day, depending on the transplanted organ. These same doses may be used to treat rejection.

Your dose depends on your general condition and on other immunosuppressive medications you may be taking.

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

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

Conferoport is taken orally once daily in the morning. Take Conferoport on an empty stomach or 2 to 3 hours after a meal. Wait at least one hour before the next meal. Take the capsules immediately after removing them from the blister pack. The capsules must be swallowed whole with a glass of water. Do not swallow the desiccant contained in the aluminum pouch.

If you take more Conferoport than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Conferoport

If you forget to take your Conferoport capsules in the morning, take them as soon as possible on the same day. Do not take a double dose the next morning to make up for missed 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 do so.

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 everybody will experience them.

Conferoport reduces the defence mechanisms of your body (immune system), which will therefore not work as effectively in fighting infections. As a result, if you are taking Conferoport, you will be more prone to infections. 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, problems thinking, difficulty walking, or loss of vision,

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

Serious adverse effects, including allergic and anaphylactic reactions, may occur. Benign and malignant tumours have been reported after treatment with Conferoport.

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.
• Insufficient function of your transplanted organ.
• Blurred vision.

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

• Thrombotic microangiopathy (damage to the smallest 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, and signs of infection.

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

• Thrombotic thrombocytopenic purpura: includes damage to the smallest blood vessels and is characterised by fever and bruising under the skin appearing 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), 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 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, a serious illness with blistering of the skin, mouth, eyes, and genitals, rashes, tongue swelling, red or purple rash that spreads, and 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 your heartbeat), 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 include skin lesions known as Kaposi's sarcoma. Symptoms include skin changes such as new discolourations or changes in existing ones, lesions, or lumps.
• Cases of pure red cell aplasia (a marked reduction in red blood cell count), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever) have been reported. The exact frequency of these adverse effects is unknown. You may have no symptoms, or depending on the 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.

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

Very frequent 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.
• Abnormalities in liver function tests.
• Diarrhoea, nausea.
• Kidney problems.

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

• Decreased 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 tests).
• Reduced 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 tests).
• Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders.
• Seizures, disorders of consciousness level, tingling and numbness (sometimes painful) in hands and feet, dizziness, reduced writing ability, nervous system disorders.
• Blurred vision, increased light sensitivity, eye disorders.
• Ringing in the ears.
• Reduced blood flow in heart vessels, faster heartbeat.
• 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.
• Stomach problems such as inflammation or ulcers causing abdominal pain or diarrhoea, stomach bleeding, mouth inflammation or ulcers, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence (gas), abdominal bloating, loose stools.
• Biliary tract disorders, yellowing of the skin due to liver problems, liver tissue damage, and liver inflammation.
• Itching, rash, hair loss, acne, increased sweating.
• Joint, limb, back, and foot pain, 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 blood alkaline phosphatase enzyme, weight gain, sensation of altered temperature.

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

• Changes in blood clotting, reduced number of all types of blood cells (see blood tests).
• Dehydration.
• Abnormal blood test results: reduced protein or sugar levels, increased phosphate.
• Coma, brain haemorrhage, stroke, paralysis, brain disorders, speech and language abnormalities, memory problems.
• Clouding of the lens, hearing deterioration.
• Irregular heartbeat, cardiac arrest, reduced heart performance, disorders of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, abnormal heart rate and pulse.
• Blood clot in a vein of a limb, 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, burning sensation in 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 sensation, restlessness or abnormal sensation, increased blood lactate dehydrogenase enzyme, weight loss.

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

• Small skin bleedings due to blood clots.
• Increased muscle rigidity.
• Deafness.
• Fluid accumulation around the heart.
• Acute shortness of breath.
• Cyst formation in the pancreas.
• Problems with blood flow in the liver.
• Serious illness with blister formation on the skin, mouth, eyes, and genitals; increased hairiness.
• Thirst, falls, chest tightness, 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, blood in the urine.
• Increase in fatty tissue.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the carton and on the blister pack after “CAD/EXP”. The expiry date refers to the last day of the month indicated. Use all capsules within one year after opening the aluminium pouch and before the expiry date.

Store in the original packaging (aluminium pouch) to protect from light and moisture.

Take the capsule immediately after removing it from the blister.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the Sigre Point at your pharmacy. 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

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

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

Capsule shell:

0.5 mg and 2 mg capsules

Brilliant Blue FCF (E133), Allura Red AC (E129), titanium dioxide (E171), Sunset Yellow FCF (E110), gelatin, Tartrazine (E102).

1 mg and 3 mg capsules

Brilliant Blue FCF (E133), Allura Red AC (E129), titanium dioxide (E171), Sunset Yellow FCF (E110), gelatin.

5 mg capsules

Brilliant Blue FCF (E133), Allura Red AC (E129), titanium dioxide (E171), Sunset Yellow FCF (E110), gelatin, Erythrosine (E127).

Printing ink

Shellac, Allura Red AC aluminium lake (E129), Brilliant Blue FCF aluminium lake (E133), Sunset Yellow FCF aluminium lake (E110), propylene glycol (E1520), lecithin (from soy), simethicone.

1 mg, 3 mg and 5 mg capsules

See section 2 “Conferoport contains lactose and azo dyes, which contain sodium and soy”.

0.5 mg and 2 mg capsules

See section 2 “Conferoport contains lactose and azo dyes, which contain sodium and soy”.

Nature and contents of the container

0.5 mg capsules

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).

1 mg capsules

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).

2 mg capsules

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).

3 mg capsules

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).

5 mg capsules

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 aluminium blister packs with a desiccant sealed in an aluminium pouch. The desiccant must not be swallowed.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Trimlini 2D

9220 Lendava

Slovenia

Date of the most recent revision of this leaflet: December 2025.

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