ITRACONAZOLE SANDOZ 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Itraconazol Sandoz 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 Itraconazol Sandoz is and what it is used for
2. What you need to know before taking Itraconazol Sandoz
3. How to take Itraconazol Sandoz
4. Possible side effects

5 Storage of Itraconazol Sandoz

1. Package contents and additional information

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

Itraconazol Sandoz 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 Sandoz

Do not take Itraconazol Sandoz:

• if you are allergic to itraconazole or any of the other components of this medicine (listed in section 6),
• 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 the 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 section "Other medicines and Itraconazol Sandoz" and the list below.

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

Do not use itraconazole if you 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 heartbeat),
• lomitapide, lovastatin, or simvastatin (to lower cholesterol),
• sildenafil (for pulmonary arterial hypertension).

Medicines for the treatment of stomach or constipation problems

• cisapride (for stomach disorders),
• domperidone (for nausea and vomiting),
• naloxegol (for constipation caused by taking opioid painkillers)

Medicines for the treatment of 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 the treatment of urinary problems

• darifenacin (for urinary incontinence),
• fesoterodine or solifenacin (for irritated urinary bladder) when used in patients with certain kidney or liver problems.

Medicines for the treatment of allergies

• astemizole, mizolastine, or terfenadine (for allergies).

Medicines for the treatment of 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 that contain:

• 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 treatment).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take itraconazole. Be especially careful with 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, 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 to itraconazole or any other 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 limbs or other nerve problems in the arms and legs (neuropathy).
• Stop taking this medicine and contact your doctor immediately if you do not hear correctly. In very rare cases, temporary or permanent hearing loss has occurred.
• Inform your doctor if your vision becomes blurred or you see 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 Itraconazol Sandoz

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

There are medicines that you should not take while taking itraconazole. These medicines are listed above under the heading "Do not take Itraconazol Sandoz"

It is not recommended to use certain medicines with itraconazole. Your doctor may decide that you should not take some medicines at the same time as itraconazole or in the 2 weeks following.

Examples of these medicines are:

Medicines for the treatment of heart, blood, or circulation problems

• apixaban, rivaroxaban, or vorapaxar (for blood clots),
• atorvastatin (to lower cholesterol),
• felodipine (for hypertension),
• riociguat or tadalafil (for pulmonary hypertension).

Medicines for the treatment of 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 the treatment of urinary problems

• tamsulosin (for male urinary incontinence),
• tolterodine (for irritated urinary bladder).

Medicines for the treatment of cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine, or vinca alkaloids (e.g., vinflunine, vinorelbine).

Medicines for the treatment of tuberculosis

• bedaquiline, isoniazid, rifabutin, or rifampicin (for tuberculosis).

Medicines for the treatment of the human immunodeficiency virus (HIV) or hepatitis

• efavirenz or nevirapine (for HIV/AIDS),
• elbasvir/grazoprevir, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis).

Medicines used after an organ transplant

• everolimus, rapamycin (also known as sirolimus), temsirolimus.

Medicines for the treatment of benign prostatic hyperplasia

• alfuzosin, silodosin.

Medicines for the treatment of 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 the treatment of erection and ejaculation problems

• tadalafil or vardenafil (when used in men 75 years or younger) (for erectile dysfunction).

Other medicines that contain:

• 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.

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:

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

Medicines for the treatment of 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) or 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 the treatment of 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, and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for stomach acid problems).

Medicines for the treatment of 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 the treatment of urinary problems

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for irritated urinary bladder).

Medicines for the treatment of cancer

• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, ponatinib, ruxolitinib, or sonidegib.

Medicines for the treatment of infections

• ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections),
• delamanid (for tuberculosis),
• artemether-lumefantrine or quinine (for malaria),
• praziquantel (for worms and tapeworms).

Medicines for the treatment of the 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 an organ transplant

• cyclosporine or tacrolimus.

Medicines for the treatment of benign prostatic hyperplasia

• dutasteride.

Medicines for the treatment of 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 the treatment of erection and ejaculation problems

• sildenafil (for erectile dysfunction),

Medicines for the treatment of pain

• alfentanil, buprenorphine, oxycodone, or sufentanil (for pain),
• meloxicam (for inflammation and joint pain),

Other medicines that contain:

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

In case of doubt, consult your doctor or pharmacist.

Taking Itraconazol Sandoz 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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

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 the body for a long time, you should extend contraceptive measures until the next menstrual period after finishing treatment with this medicine. (See section 2 "Do not take Itraconazol Sandoz").

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Itraconazol Sandoz contains sucrose and sodium

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

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

3. How to take Itraconazol Sandoz

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. 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 before.

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. Swallow the capsules whole with a little water. The amount 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 should be enough 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 pulsatile treatment.

• Continuous treatment for foot nail infections:

• Pulsatile treatment for nails:

It consists of two capsules twice a day for 1 week; then stop taking itraconazol 100 mg capsules 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 may be needed.

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

Use in Children and Adolescents

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

If you take more Itraconazol Sandoz than you should

If you have taken more itraconazol than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the prospectus to the healthcare professional.

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 Sandoz

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

If you interrupt treatment with Itraconazol Sandoz

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone suffers from them.

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

The following side effects are mentioned, which have been seen during the commercialization of the medication and clinical trials.

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

Very frequent side effects (may affect more than 1 in 10 people)

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

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

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

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

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 mucus production and frequent sneezing).

Blood and lymphatic system disorders

Rare: leukopenia.

Immune system disorders

Uncommon: hypersensitivity and allergic reaction.

Rare: anaphylactic reactions (allergic), serum sickness (allergy that appears after injection of some sera and is characterized by the appearance of urticaria, 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 meals, diarrhea and constipation, gas accumulation in the intestine (flatulence).

Rare: pancreatitis.

Hepatobiliary disorders:

Uncommon: abnormal liver function

Rare: elevated bilirubin levels in the 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 frequency of urination.

Reproductive system and breast disorders

Uncommon: menstrual disorders.

Rare: erectile dysfunction.

General disorders and administration site conditions

Rare: edema (fluid accumulation).

Investigations

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

Description of certain side effects

The following side effects associated with itraconazol were reported in clinical trials of itraconazol oral and/or intravenous solution, except for the side 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 the blood), hyperkalemia (increased potassium in the blood), hypokalemia (decreased potassium in the blood), hypomagnesemia (decreased magnesium in the blood).

Psychiatric disorders: feeling of confusion or disorientation.

Nervous system disorders: peripheral neuropathy (peripheral nerve damage with a tingling sensation, 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.

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

Side effects in the pediatric population

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

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

If you experience any of these side effects, consult your doctor.

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

Reporting side effects

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

5. Conservation of Itraconazol Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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

6. Package contents and additional information

Composition of Itraconazol Sandoz

• The active ingredient is itraconazol. Each capsule contains 100 mg of itraconazol.
• The other components are:

Sugar spheres (consisting of cornstarch and sucrose), poloxamer 188, micronized poloxamer 188, hypromellose.

Hard gelatin capsule: gelatin, indigo carmine (E132), quinoline yellow (E104) (contains sodium), and titanium dioxide (E171).

Appearance of the product and package contents

Size 0 green opaque capsules containing yellowish-beige spherical microgranules, packaged in Alu/Alu blisters, 7, 14, or 100 (clinical package) capsules.

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:

Liconsa, S.A.

Gran Vía Carlos III, 98, 7ª planta

08028 Barcelona

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the last revision of this prospectus:January 2022

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