Itraconazole Cinfa 100 mg capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

itraconazol cinfa 100 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

What itraconazol cinfa is and what it is used for
What you need to know before taking itraconazol cinfa
How to take itraconazol cinfa
Possible side effects
How to store itraconazol cinfa
Contents of the pack and other information

1. What itraconazol cinfa is and what it is used for

Itraconazole belongs to a group of medicines 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 starting to take itraconazole cinfa

Do not take itraconazole cinfa:

If you are allergic to itraconazole or to any of the other components of this medicine (listed in section 6).
If you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine could worsen it.

If your doctor decides you should take this medicine, contact them immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or begin waking up at night.

If you are pregnant, think you might be pregnant, or could become pregnant (see section "Pregnancy and breastfeeding"), your doctor will assess whether you should take this medicine.
If you are of childbearing age, you must use adequate contraceptive measures to prevent pregnancy during treatment. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine.
Itraconazole cannot be used together with certain medicines. Many medicines interact with itraconazole; see section “Other medicines and itraconazole cinfa” and the list below.

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

Do not use itraconazole if you are taking any of the following medicines, or within 2 weeks after stopping 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 to treat stomach problems or constipation:

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

Medicines to treat headaches, sleep disorders, 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 sertindole (for schizophrenia, bipolar disorder, or other mental health disorders)

Medicines to treat urinary problems:

darifenacin (for urinary incontinence)
fesoterodine or solifenacin (for overactive bladder) when used in patients with certain kidney or liver problems

Medicines to treat allergies:

astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erectile dysfunction and premature ejaculation:

avanafil (for erectile dysfunction)
dapoxetine (for premature ejaculation)
vardenafil (for erectile dysfunction) when used in men over 75 years of age

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 disease) when used in patients who cannot metabolize certain medicines
halofantrine (for malaria)
irinotecan (for cancer)
isavuconazole (for fungal infections)
ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for treating hepatitis C)

Remember: do not take any of the above medicines within 2 weeks after your last dose of itraconazole.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take itraconazole cinfa:

If you have heart problems, consult your doctor. Inform your doctor immediately if you develop difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these may be symptoms of heart failure.
If you have liver problems. Your dose may need to be adjusted. If any of the following symptoms occur during treatment, stop taking the medicine and contact 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 on long-term treatment with this medicine, your doctor may request regular blood tests, as very rare cases of liver disorders have been reported.
If you have kidney problems, consult your doctor. Your dose may need to be adjusted.
Contact your doctor or seek immediate medical attention if you experience a severe allergic reaction while taking itraconazole (characterized by severe skin rash, itching, hives, difficulty breathing, and/or facial swelling).
Stop taking this medicine and contact your doctor immediately if you become overly sensitive to sunlight.
Stop taking itraconazole and contact your doctor immediately if you develop a serious skin disorder, such as widespread rash with skin peeling and blisters in the mouth, eyes, or genitals, or a rash with small pustules or blisters.
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 to another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction may present as skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, contact your doctor immediately.
If you have cystic fibrosis, consult your doctor before taking itraconazole.
Stop taking this medicine and contact your doctor immediately if you experience tingling, numbness, reduced sensation, or weakness in your limbs or other nerve problems in the arms and legs (neuropathy).
Stop taking this medicine and contact your doctor immediately if you experience hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.
Inform your doctor if your vision becomes blurred or double, if you hear ringing in your ears, if you lose control of urination, or if you urinate more than usual.
This medicine is not recommended for elderly patients. It may only be prescribed by a doctor in exceptional cases.

Other medicines and itraconazole cinfa

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

There are medicines that you must not take while you are taking itraconazole. These medicines are listed above under the heading “Do not take itraconazole cinfa”.

The use of certain medicines with itraconazole is not recommended.

Your doctor may decide that you should not take certain medicines at the same time as itraconazole or within 2 weeks after stopping itraconazole.

Examples of these medicines are:

Medicines to treat 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 to treat epilepsy, headaches, or mental health problems:

phenytoin, carbamazepine, or phenobarbital (antiepileptics)
eletriptan (for migraines)
St. John’s wort (Hypericum perforatum) (a herbal medicine used for mental health problems)

Medicines to treat urinary problems:

tamsulosin (for male urinary incontinence)
tolterodine (for overactive bladder)

Medicines to treat 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 to treat tuberculosis:

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

Medicines to treat 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 organ transplantation:

everolimus, sirolimus (also known as rapamycin), temsirolimus

Medicines to treat benign prostatic hyperplasia:

alfuzosin, silodosin

Medicines to treat lung problems or allergies:

ciclesonide (for inflammation, asthma, and allergies)
ebastine (for allergies)
salmeterol (for asthma or chronic obstructive pulmonary disease, COPD)

Medicines to treat erectile dysfunction and premature ejaculation:

tadalafil or vardenafil (when used in men aged 75 years or younger) (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 within 2 weeks after your last dose of itraconazole.

This list is not exhaustive, so you must 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 adverse effects, or the dose of itraconazole or the other medicine may need to be adjusted. Examples of such medicines are:

Medicines to treat heart, blood, or circulation problems:

bosentan (for pulmonary hypertension)
calcium channel blockers such as dihydropyridines, including 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 to treat stomach problems or diarrhea:

aprepitant or netupitant (for nausea and vomiting during cancer treatment)
loperamide (for diarrhea)
antacids such as aluminium, calcium, magnesium, or sodium bicarbonate; H2-receptor antagonists such as cimetidine, ranitidine; proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat acid-related stomach problems)

Medicines to treat sleep or mental health disorders:

alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (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 to treat urinary problems:

imidafenacina, fesoterodine, oxybutynin, solifenacin (for overactive bladder)

Medicines to treat cancer:

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

Medicines to treat infections:

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

Medicines to treat human immunodeficiency virus (HIV) or hepatitis:

cobicistat, boosted elvitegravir, maraviroc, ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir, or saquinavir (for HIV)
glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplantation:

ciclosporin or tacrolimus

Medicines to treat benign prostatic hyperplasia:

dutasteride

Medicines to treat lung problems, allergies, or inflammatory conditions:

bilastine or rupatadine (for allergies)
methylprednisolone or dexamethasone (orally administered or injectable medicines for asthma, allergies, or inflammatory conditions)
budesonide or fluticasone (for asthma, allergies)

Medicines to treat erectile dysfunction and premature ejaculation:

sildenafil (for erectile dysfunction)

Medicines to treat pain:

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

Other medicines containing:

alitretinoin (administered orally) (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 overactive parathyroid function)
dienogest or ulipristal (contraceptives)
eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain medicines
ivacaftor (for cystic fibrosis)
methadone (for drug addiction)
repaglinide or saxagliptin (for diabetes)

This list is not exhaustive, so you must inform your doctor if you are taking or plan to take any of these medicines or any other medicine, so appropriate measures can be taken.

Sufficient stomach acidity is required to ensure absorption of this medicine. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before or at least 2 hours after taking itraconazole. For the same reason, if you are taking medicines that reduce stomach acid production, take itraconazole with a cola drink (see section 3 “How to take itraconazole cinfa”).

If in doubt, consult your doctor or pharmacist.

Taking itraconazole cinfa with food and drinks

Take this medicine immediately after finishing one of your main meals. If you are taking a 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

This medicine will not be used during pregnancy.

If you are of childbearing age and could become pregnant, consult your doctor. You must use effective contraception to ensure you do not become pregnant while taking this medicine. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine (see section 2 “Do not take itraconazole cinfa”).

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 pass into breast milk.

Driving and using machines

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

itraconazole cinfa contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take itraconazole cinfa

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

Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment early. If you think the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

You should take this medicine immediately after meals, as it is better absorbed this way. Swallow the capsules whole with some water. The number of capsules you need to 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 itraconazole you should take.

There must be sufficient stomach acidity to ensure proper absorption of this medicine. Therefore, medicines that neutralize stomach acidity should be taken either two hours after taking this medicine or two hours before taking itraconazole. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole with a cola drink.

The following doses are the most common:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Vaginal infection	2 capsules twice a day or 2 capsules once a day	1 day 3 days
Skin infection	2 capsules once a day or 1 capsule once a day	7 days 2 weeks
If palms of the hands or soles of the feet are affected, 2 capsules twice a day for 7 days or 1 capsule once a day for 1 month may be required.
Mouth infections	1 capsule once a day	2 weeks
Eye infections	2 capsules once a day	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

Nail infections: depending on your individual needs, your doctor will choose a continuous or pulsed treatment.
Continuous treatment for toenail infections:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Continuous treatment for nails	2 capsules once daily	3 months

Pulsed therapy for nails:

Consists of two capsules twice a day for 1 week; then stop taking itraconazole for 3 weeks. The cycle is then repeated—once for fingernails and twice for toenails (with or without fingernail infection). (See the following table)

Week

Toenails with or without fingernail involvement

Take 2 capsules twice a day

No itraconazole treatment

Take 2 capsules twice a day

No itraconazole treatment

Take 2 capsules twice a day

Interrupt treatment

Fingernails only

Take 2 capsules twice a day

No itraconazole treatment

Take 2 capsules twice a day

Interrupt treatment

In skin infections, lesions will disappear a few weeks after treatment ends. This is characteristic of spots caused by fungi: the medicine eliminates the fungus itself, but the lesion does not disappear until new skin has grown.

Nail lesions will disappear 6 to 9 months after treatment ends, as the medicine only eliminates the fungus itself. The nail must regrow, which takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medicine remains in your nails for several months and fulfills its purpose. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections: Higher doses and prolonged treatment may be required.

Always follow your doctor's instructions; he or she will adapt the treatment to your needs.

Use in children

This medicine must not be used in children. It may be prescribed by a doctor only in exceptional cases.

If you take more itraconazol cinfa than you should

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

In case of accidental overdose, your doctor will implement supportive measures. Itraconazole is not removed by hemodialysis. Specific antidotes are not known.

If you forget to take itraconazol cinfa

If you forget to take the medicine, take the next scheduled dose and continue treatment as directed by your doctor. Do not take a double dose to make up for missed doses.

If you interrupt treatment with itraconazol cinfa

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

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

4. Possible adverse effects

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

The adverse reactions listed below have been observed during the marketing of the medicine and in clinical trials.

Adverse reactions are classified according to frequency using the following convention: Very common (may affect more than 1 in 10 people);
Common (may affect up to 1 in 10 people);
Uncommon (may affect up to 1 in 100 people);
Rare (may affect up to 1 in 1,000 people);
Very rare (may affect up to 1 in 10,000 people);
Frequency not known (cannot be estimated from the available data).

Infections and infestations

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

Blood and lymphatic system disorders

Rare: leucopenia.

Immune system disorders

Uncommon: hypersensitivity and allergic reactions.
- Rare: anaphylactic (allergic) reactions, serum sickness (an allergic reaction occurring after injection of certain sera, characterized by urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that may affect the mouth and upper airways).

Metabolism and nutrition disorders

Rare: increased triglycerides.

Nervous system disorders

Common: headache.
Rare: tremor, tingling sensation in the limbs (paresthesia), reduced sensation (hypoesthesia), unpleasant taste (dysgeusia).

Eye disorders

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

Ear and labyrinth disorders

Rare: permanent or transient hearing loss, subjective sensation of ringing in the ears (tinnitus).

Cardiac disorders

Rare: congestive heart failure.

Respiratory, thoracic and mediastinal disorders

Rare: irregular breathing, difficulty breathing (dyspnea).

Gastrointestinal disorders

Common: abdominal pain, nausea.
Uncommon: vomiting, discomfort associated with meals, diarrhea and constipation, accumulation of gas in the intestine (flatulence).
Rare: inflammation of the pancreas.

Hepatobiliary disorders

Uncommon: abnormal liver function.
Rare: elevated levels of bilirubin in blood (hyperbilirubinemia), severe hepatotoxicity (including cases of very severe acute liver failure).

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching.
Rare: toxic epidermal necrolysis (a serious skin disease characterized by skin rash, blisters, and peeling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes, and eyes), a serious skin disorder (generalized rash with skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (a skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (a skin disease characterized by skin peeling), leukocytoclastic vasculitis (inflammation of the walls of blood vessels), 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 blood creatine phosphokinase (a parameter measuring liver function).

Description of specific adverse effects

Listed below are adverse effects associated with itraconazole reported in clinical trials of oral and/or intravenous itraconazole solution, excluding the adverse effect "injection site inflammation," as this effect is specific to the injectable route of administration.

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

Immune system disorders: anaphylactoid reaction.

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

Psychiatric disorders: feeling confused or disoriented.

Nervous system disorders: peripheral neuropathy (peripheral nerve damage causing 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 (yellowing of the skin, eyes, mucous membranes, and secretions).

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

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

Renal and urinary disorders: renal failure, urinary incontinence (urine leakage).

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 blood, increased lactate dehydrogenase in blood, increased blood urea, increased gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis.

Other adverse effects in children

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.

Reporting of adverse effects

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

5. Storage of itraconazole cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of itraconazole cinfa

The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
The other components (excipients) are:

Capsule contents: sugar spheres (containing sucrose, corn starch and purified water), poloxamer 188 and hypromellose.

Capsule shell: gelatin, purified water, FD&C Blue No. 2, indigotine, indigo carmine (E-132), quinoline yellow (E-104) and titanium dioxide (E-171).

Appearance of the product and contents of the container

Hard gelatin capsules with an opaque green cap and body, containing yellowish-beige spherical microgranules.

Presented in aluminum/aluminum blisters. Each pack contains 7, 14 or 100 capsules (clinical pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

LICONSA, S.A.

Avda. Miralcampo, Nº 7 Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: July 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65773/P_65773.html

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