ITRACONAZOLE VIATRIS 100 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Itraconazol Viatris 100 mg Hard Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

? Keep this package leaflet, as you may need to read it again.

? If you have any questions, consult your doctor or pharmacist.

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

? If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Itraconazol Viatris and what is it used for
2. What you need to know before taking Itraconazol Viatris
3. How to take Itraconazol Viatris
4. Possible side effects
5. Storage of Itraconazol Viatris
6. Package Contents and Additional Information

1. What is Itraconazol Viatris and what is it used for

Itraconazol belongs to the group of medications called “antifungals”.

It is indicated for the treatment of infections caused by fungi of the vagina, skin, mouth, eyes, nails, or internal organs.

2. What you need to know before taking Itraconazol Viatris

Do not take Itraconazol Viatris

• If you are allergicto itraconazole or to any of the other components of this medicine, listed in section 6 "Package contents and additional information").

• If you have a disease called heart failure (also called congestive heart failure or CHF). This medicine could worsen it. If your doctor considers that you should take this medicine, contact him immediately if you notice that you are short of breath, gain weight unexpectedly, have swollen legs, feel unusually tired, or start waking up at night.
• If you are pregnant, think you may be pregnant, or may become pregnant(see pregnancy section), your doctor will assess whether you should take this medicine.
• If you are of childbearing age, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine can stay in your body for a long time, you should extend contraceptive measures until the next menstrual period after finishing treatment with this medicine.
• Itraconazole cannot be used with some medicines. There are many medicines that interact with itraconazole; see the section "Other medicines and Itraconazol Viatris" and the list below.

Before taking itraconazole, inform your doctor if you are taking any medicine.

Do not use Itraconazol Viatris ifyou are taking any of the following medicines, or within 2 weeks after finishing itraconazole:

Medicines used to treat heart, blood, or circulation problems

? aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)

? bepridil, ivabradine, or ranolazine (for angina)

? dabigatran or ticagrelor (for blood clots)

? disopyramide, dofetilide, dronedarone, or quinidine (for irregular heart rhythm)

• finerenone (for kidney problems in patients with type 2 diabetes)

? lomitapide, lovastatin, or simvastatin (to lower cholesterol)

? sildenafil (for pulmonary arterial hypertension)

Medicines for stomach or constipation problems

? cisapride (for stomach disorders)

? domperidone (for nausea and vomiting)

? naloxegol (for constipation caused by taking opioid pain relievers)

Medicines for headaches, sleep, or mental health problems

? dihydroergotamine or ergotamine (ergot alkaloids used for migraines)

? midazolam (oral) or triazolam (for sedation or sleep induction)

? lurasidone, pimozide, quetiapine, or sertindol (for schizophrenia, bipolar disorder, or other mental health disorders)

Medicines for urinary problems

? darifenacin (for urinary incontinence)

? fesoterodine or solifenacin (for an irritated urinary bladder) when used in patients with certain kidney or liver problems

Medicines for allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines for erection and ejaculation problems

? avanafil (for erectile dysfunction)

? dapoxetine (for premature ejaculation)

? vardenafil (for erectile dysfunction) when used in men over 75 years old

Other medicines containing:

? colchicine (for gout) when used in patients with kidney or liver problems

? ergometrine (ergonovine) or methylergometrine (methylergonovine), ergot alkaloids used after childbirth

? eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body

? halofantrine (for malaria)

? irinotecan (for cancer)

? isavuconazole (for fungal infections)

? ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for hepatitis C)

• venetoclax (for chronic lymphocytic leukemia) when you first start taking venetoclax or when you take increasing doses at the beginning of treatment
• voclosporin (for kidney problems related to lupus)

Remember: do not take any of the above medicines during 2 weeks after your last treatment with itraconazole.

This is not a complete list; inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take itraconazole:

? If you have heart problems, consult your doctor. Inform your doctor immediately if you experience difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these may be symptoms of heart failure.

? If you have any liver problems. It may be necessary to adjust the dose of this medicine. If any of the following symptoms appear during treatment with this medicine, stop taking it and consult your doctor immediately: loss of appetite, nausea, vomiting, fatigue, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), dark urine, or pale stools. If you are taking itraconazole capsules, it is likely that your doctor will order regular blood tests, as liver disorders have occurred in very rare cases.

? If you have any kidney problems, consult your doctor. It may be necessary to adjust the dose of this medicine.

? Consult your doctor or seek immediate medical attention if, while taking itraconazole, you have a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or swelling of the face).

? Stop taking this medicine and consult your doctor immediately if you become too sensitive to sunlight.

? Stop taking itraconazole and consult your doctor immediately if you experience a severe skin disorder, such as a widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or a rash with small blisters or bumps.

? Contact your doctor if you have neutropenia, AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.

? If you have had an allergic reaction due to itraconazole or another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction can be recognized, for example, by the appearance of a skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or swelling of the face. If you experience a severe allergic reaction, consult your doctor immediately.

? If you have cystic fibrosis, consult your doctor before taking itraconazole.

? Stop taking itraconazole and consult your doctor immediately if you experience any sensation of tingling, numbness, decreased sensitivity, or weakness in the extremities or other nerve problems in the arms and legs (neuropathy).

? Stop taking this medicine and contact your doctor immediately if you experience any hearing loss. In rare cases, temporary or permanent hearing loss has occurred.

? Inform your doctor if your vision becomes blurred or double, if you hear a ringing in your ears, if you lose control of your urine or urinate more than usual.

? This medicine is not recommended for elderly patients. Only in exceptional cases may it be prescribed by the doctor.

Other medicines and itraconazole Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or are going to take any other medicine, including those obtained without a prescription.

There are medicines that you must not takewhile taking itraconazole. These medicines are listed above under the heading "Do not take Itraconazol Viatris"

It is not recommended to use certain medicines with itraconazole.

Your doctor may decide that you must not take some medicines at the same time as itraconazole or in the 2 weeks following its completion.

Examples of these medicines are:

Medicines for heart, blood, or circulation problems

• apixaban, edoxaban, rivaroxaban, or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)

? felodipine (for hypertension)

? riociguat or tadalafil (for pulmonary hypertension)

Medicines for epilepsy, headaches, or mental health problems

? phenytoin, carbamazepine, or phenobarbital (antiepileptics)

? eletriptan (for migraines)

? St. John's Wort (Hypericum perforatum) (a plant-based medicine used for mental health problems)

Medicines for urinary problems

? tamsulosin (for male urinary incontinence)

? tolterodine (for an irritated urinary bladder)

Medicines for cancer

? axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedina, trastuzumab emtansine, venetoclax (when you are on a stable dose of venetoclax for chronic lymphocytic leukemia, or at any time during treatment for acute myeloid leukemia) or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines for tuberculosis

? bedaquiline, isoniazid, rifabutin, or rifampicin (for tuberculosis)

Medicines for human immunodeficiency virus (HIV) or hepatitis

? efavirenz or nevirapine (for HIV/AIDS)

? elbasvir/grazoprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis)

Medicines used after organ transplantation

? everolimus, rapamycin (also known as sirolimus), temsirolimus

Medicines for benign prostatic hyperplasia

? alfuzosin, silodosin

Medicines for lung problems, allergies, or inflammatory conditions

? ciclesonide (for inflammation, asthma, and allergies)

? ebastine (for allergies)

? salmeterol (for asthma or chronic obstructive pulmonary disease, COPD)

Medicines for erection and ejaculation problems

? tadalafil or vardenafil (when used in men 75 years old or less) (for erectile dysfunction)

Other medicines containing:

? colchicine (for gout)

? fentanyl (for pain)

? lumacaftor/ivacaftor (for cystic fibrosis)

Remember: do not take any of the above medicines during 2 weeks after your last treatment with itraconazole capsules.

This list is not complete, so you should inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Caution is required when using itraconazole with certain medicines.

You may be more likely to experience side effects or it may be necessary to modify the dose of itraconazole or the other medicine. Examples of these medicines are:

Medicines for heart, blood, or circulation problems

? bosentan (for pulmonary hypertension)

? calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)

• verapamil (for hypertension)

? cilostazol (for circulatory problems)

? "coumarins" such as warfarin (for blood clots)

? digoxin (for atrial fibrillation)

? nadolol (for pulmonary hypertension or angina)

Medicines for stomach or diarrhea problems

? aprepitant or netupitant (for nausea and vomiting during cancer treatment)

? loperamide (for diarrhea)

? antacids such as aluminum, calcium, magnesium, or sodium bicarbonate; H2 receptor antagonists such as cimetidine, ranitidine; or proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems)

Medicines for sleep disorders or mental health problems

? alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or sleep induction)

? zopiclone (for sleep induction)

? reboxetine or venlafaxine (for depression and anxiety)

? aripiprazole, cariprazine, haloperidol, or risperidone (for schizophrenia, bipolar disorder, or other mental health problems)

? galantamine (for Alzheimer's disease)

? guanfacine (for attention deficit hyperactivity disorder)

Medicines for urinary problems

? imidafenacin, fesoterodine, oxybutynin, solifenacin (for an irritated urinary bladder)

Medicines for cancer

? bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib, or tretinoin (oral)

Medicines for infections

? ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)

? delamanid (for tuberculosis)

? artemether-lumefantrine or quinine (for malaria)

? praziquantel (for worms and tapeworms)

Medicines for human immunodeficiency virus (HIV) or hepatitis

? cobicistat, elvitegravir boosted, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir, or saquinavir (for HIV)

? glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplantation

? cyclosporine or tacrolimus

Medicines for benign prostatic hyperplasia

? dutasteride

Medicines for lung problems, allergies, or inflammatory conditions

? bilastine or rupatadine (for allergies)

? methylprednisolone or dexamethasone (oral or injectable medicines for asthma, allergies, or inflammatory conditions)

? budesonide or fluticasone (for asthma, allergies)

Medicines for erection and ejaculation problems

? sildenafil (for erectile dysfunction)

Medicines for pain

? alfentanil, buprenorphine, oxycodone, or sufentanil (for pain)

? meloxicam (for inflammation and joint pain)

Other medicines containing:

? alitretinoin (oral) (for eczema)

• cabergoline (for Parkinson's disease)

? cannabis-based products, including medicines (for nausea and vomiting or muscle spasms in patients with multiple sclerosis)

? cinacalcet (for excess parathyroid activity)

? dienogest or ulipristal (contraceptives)

? eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body

? ivacaftor (for cystic fibrosis)

? methadone (for drug addiction)

? repaglinide or saxagliptin (for diabetes)

This list is not complete, so you should inform your doctor if you are taking or plan to take any of these medicines or any other medicine, so that the necessary measures can be taken.

There must be sufficient acidity in the stomach to ensure the absorption of itraconazole capsules. Therefore, medicines that neutralize stomach acid should be used at least 2 hours before taking itraconazole or after 2 hours of taking this medicine. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole capsules with a cola drink (see section 3 "How to take Itraconazol Viatris").

In case of doubt, consult your doctor or pharmacist.

Taking Itraconazol Viatris with food and drinks

Take this medicine immediately after finishing one of the main meals.

If you are taking any medicine that regulates stomach acid production, it is recommended to take this medicine with a cola drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Itraconazole will not be used in case of pregnancy.

If you are of childbearing age and may become pregnant, consult your doctor. You should use effective contraceptives to ensure you do not become pregnant while taking the medicine.

Because itraconazole can stay in your body for some time, you should extend contraceptive measures until the next menstrual period after finishing treatment with this medicine. (See section 2 "Do not take Itraconazol Viatris").

Breastfeeding

If you are breastfeeding, consult your doctor before taking itraconazole, as small amounts of the medicine may appear in breast milk.

Driving and using machines

Itraconazole can sometimes cause dizziness, blurred or double vision, or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

This medicine contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to Take Itraconazol Viatris

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not suspend treatment beforehand. If you think the effect of the medication is too strong or too weak, inform your doctor or pharmacist.

You should take itraconazol immediately after meals, as it is better absorbed this way. Swallow the capsules whole with a little water. The number of capsules you should take and for how long depends on the type of fungus and the location of the infection. Your doctor will tell you exactly how much itraconazol you should take.

There must be sufficient acidity in the stomach to ensure the absorption of this medication. Therefore, medications that neutralize stomach acidity should be used after two hours of taking this medication or taken two hours before taking itraconazol. For the same reason, if you are taking medications that regulate stomach acid production, take itraconazol with a cola drink.

The following doses are the most frequent:

? Nail infections: depending on your personal needs, your doctor will opt for continuous or intermittent treatment.

• Continuous treatment for foot nail infections:

• Intermittent treatment for nails:

It consists of two capsules twice a day for 1 week; then stop taking itraconazol for 3 weeks. Then, the cycle is repeated, once for hand nails and twice for foot nails (with or without nail infection) (see the following table).

In skin infections, the lesions will disappear a few weeks after finishing treatment. This is characteristic of fungal spots: the medication eliminates the fungus itself, but the lesion does not disappear until new skin grows.

Nail lesions will disappear 6 to 9 months after finishing treatment, since the medication only eliminates the fungus itself. The nail has to grow, and this takes several months. Therefore, do not worry if you do not notice improvement during treatment: the medication remains in your nails for several months and fulfills its mission. Therefore, you should interrupt treatment at the time your doctor indicates, even if you do not see any improvement.

Internal organ infections:higher doses and longer treatment periods may be necessary.

Always follow your doctor's instructions; they will adapt the treatment to your personal needs.

Use in Children

Itraconazol capsules should not be used in children. Only in exceptional cases can it be prescribed by a doctor.

If you take more Itraconazol Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Toxicology Information Service immediately. Phone 91 562 04 20, indicating the medication and the amount used.

In case of accidental overdose, your doctor will apply supportive measures. Itraconazol is not eliminated by hemodialysis. No specific antidotes are known.

If you forget to take Itraconazol Viatris:

If you forget to take the medication, take the next dose that corresponds to you and continue the treatment as indicated by your doctor. Do not take a double dose to make up for forgotten doses. Resume taking the medication as soon as possible.

If you interrupt treatment with Itraconazol Viatris

Do not interrupt treatment with itraconazol without consulting your doctor, as the symptoms of your disease may reappear or worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The following adverse effects are mentioned, which were seen during the marketing of the medication and clinical trials.

Adverse reactions were classified according to frequency using the following convention:

Very frequent: affects more than 1 in 10 patients

Frequent: affects between 1 and 10 in 100 patients

Uncommon: affects between 1 and 10 in 1,000 patients

Rare: affects between 1 and 10 in 10,000 patients

Very rare: affects less than 1 in 10,000 patients. Frequency not known: cannot be estimated with available data

? Infections and infestations

Uncommon: sinusitis (irritation and swelling of the nasal sinuses), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa that runs with watery discharge and frequent sneezing)

? Blood and lymphatic system disorders

Rare: leukopenia

? Immune system disorders

Uncommon: hypersensitivity and allergic reactions

Rare: anaphylactic reactions (allergic), serum sickness (allergy that appears after injection of some sera and is characterized by the appearance of hives, fluid accumulation, joint pain, fever, and extreme exhaustion), angioedema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract)

? Metabolism and nutrition disorders

Rare: increased triglycerides

? Nervous system disorders

Frequent: headache

Rare: tremor, tingling sensation in the limbs (paresthesia), decreased sensitivity (hypoesthesia), unpleasant taste (bad taste in the mouth)

? Eye disorders

Rare: visual disturbances (including blurred vision and double vision)

? Ear and labyrinth disorders

Rare: permanent or transient hearing loss, subjective sensation of noises in the ear

? Cardiac disorders

Rare: congestive heart failure

? Respiratory, thoracic, and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea)

? Gastrointestinal disorders

Frequent: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with eating, diarrhea and constipation, gas accumulation in the intestine (flatulence)

Rare: pancreatitis

? Hepatobiliary disorders

Uncommon: abnormal liver function

Rare: elevated bilirubin levels in blood (hyperbilirubinemia), severe hepatotoxicity (including cases of severe acute liver failure)

? Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching

Rare: toxic epidermal necrolysis (severe skin disease characterized by skin rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe skin, mucous membrane, and eye erythema), a severe skin disorder (widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (skin disease characterized by skin peeling), leukocytoclastic vasculitis (inflammation of the blood vessel wall), alopecia (hair loss), photosensitivity (exaggerated skin response to sunlight)

? Renal and urinary disorders

Rare: increased urination frequency

? Reproductive system and breast disorders

Uncommon: menstrual disorders

Rare: erectile dysfunction

? General disorders and administration site conditions

Rare: edema (fluid accumulation)

? Investigational procedures

Rare: increased creatine phosphokinase in blood (parameter that measures liver function)

Description of certain adverse effects

The following adverse effects associated with itraconazol were reported in clinical trials of itraconazol oral and/or intravenous solution, excluding the adverse effect "inflammation at the injection site" since this effect is specific to the injection route.

Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decrease in some blood cells)

Immune system disorders: anaphylactoid reaction

Metabolism and nutrition disorders: hyperglycemia (increased sugar in blood), hyperkalemia (increased potassium in blood), hypokalemia (decreased potassium in blood), hypomagnesemia (decreased magnesium in blood)

Psychiatric disorders: feeling of confusion or disorientation

Nervous system disorders: peripheral neuropathy (peripheral nerve damage with tingling, numbness, or weakness in the limbs), dizziness, somnolence

Cardiac disorders: heart failure, left ventricular failure, tachycardia (rapid heart rate)

Vascular disorders: high blood pressure (hypertension), low blood pressure (hypotension)

Respiratory, thoracic, and mediastinal disorders: pulmonary edema, hoarseness, cough

Gastrointestinal disorders: gastrointestinal disorder

Hepatobiliary disorders: liver failure, hepatitis, jaundice (yellowish coloration of the skin, eyes, mucous membranes, and secretions)

Skin and subcutaneous tissue disorders: erythematous rash (red skin rash), excessive sweating

Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia)

Renal and urinary disorders: renal failure, urinary incontinence (loss of urine)

General disorders and administration site conditions: excessive fluid accumulation in body tissues (generalized edema), fluid accumulation in the face (facial edema), chest pain, fever, pain, fatigue, chills

Investigational procedures: increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased lactate dehydrogenase in blood, increased urea in blood, increased gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis

Adverse effects in the pediatric population

Based on data from clinical trials in pediatric patients, the most frequently reported adverse effects were: headache, vomiting, abdominal pain, diarrhea, abnormal liver function, low blood pressure, nausea, and urticaria

In general, the nature of the adverse effects is similar to that observed in adult patients, although the incidence is higher in pediatric patients

If you experience any of these adverse effects, consult your doctor

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist

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 not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

5. Conservation of Itraconazol Viatris

Keep this medication out of sight and reach of children

Do not use Itraconazol Viatris after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated

Do not store at a temperature above 30°C

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment

6. Packaging Content and Additional Information

Composition of Itraconazol Viatris

• The active ingredient is itraconazol. Each capsule contains 100 mg of itraconazol
• The other components (excipients) are: sugar spheres (consisting of cornstarch and sucrose), poloxamer 188, and hypromellose. The capsule is composed of indigo carmine (E-132), quinoline yellow (E-104), titanium dioxide (E-171), and gelatin

Appearance of the Product and Packaging Content

Itraconazol Viatris are hard capsules that have a green opaque cap and body

Itraconazol Viatris is available in blisters of 7, 14, or 100 (clinical packaging) hard capsules and in perforated unit-dose blisters of 7 and 14 hard capsules

Only some package sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Liconsa, S.A.

Avda. Miralcampo, nº 7

Pol. Ind. Miralcampo

19200 – Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this prospectus: January 2025

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