Prospecto: information for the user

CANADIOL 100 mg capsules

itraconazol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is CANADIOL 100 mg capsules and for what it is used

1. What you need to know before starting to take CANADIOL 100 mg capsules
2. How to take CANADIOL 100 mg capsules
3. Possible adverse effects
4. Storage of CANADIOL 100 mg capsules

6.Contents of the package andadditional information

CANADIOL 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.

Do not use CANADIOL 100 mg capsules

• if you are allergic (hypersensitive) to itraconazole or to any of the other ingredients 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 may make it worse. If your doctor thinks 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 section “Pregnancy”).
• if you are fertile, you should take appropriate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine may stay in the body for a long time, you should prolong the contraceptive measures until the next menstrual period after finishing treatment with this medicine.

• you cannot use CANADIOL capsules with some medicines. There are many medicines that interact with CANADIOL capsules, see section “Use of other medicines and CANADIOL capsules” and the list below.

Inform your doctor if you are taking any medicine before taking CANADIOL capsules.

Do not useCANADIOLcapsulesifyou are taking certain medicines, or within 2 weeks of the end of CANADIOL capsules treatment. The following list includes examples of medicines that you should not take with CANADIOL capsules or within 2 weeks of the end of CANADIOL capsules treatment:

Medicines used to treat heart, blood or circulation problems

Medicines to treat stomach or constipation problems

Medicines to treat headache, sleep or mental health problems

Medicines to treat urinary problems

Medicines to treat allergies

• astemizole, mizolastine or terfenadine (for allergies)

Medicines to treat erection and ejaculation problems

Other medicines that contain:

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

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

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

There are medicines thatyou should not takewhile takingCANADIOLcapsules. These medicines are listed above under the heading “Do not takeCANADIOL100 mg capsules”

Be especially careful with CANADIOL 100 mg capsules

• if you have heart problems, consult your doctor. Inform your doctor immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or insomnia, as these may be symptoms of heart failure.

• if you have any liver problems. You may need 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 continue treatment with CANADIOL capsules, your doctor may regularly send you blood tests, as rare cases of liver disorders have occurred.
• if you have any kidney problems, consult your doctor. You may need to adjust the dose of this medicine.
• consult your doctor or seek immediate medical attention if you experience a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or facial swelling).
• stop taking this medicine and consult your doctor immediately if you become too sensitive to sunlight.
• stop taking CANADIOL capsules and consult your doctor immediately if you experience a severe skin disorder, such as a generalized rash with skin peeling and blisters on the mouth, eyes, and genitals, or a rash with small pustules or blisters.

• contact your doctor if you have neutropenia, HIV/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 CANADIOL capsules or another antifungal medicine (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 facial swelling. If you experience a severe allergic reaction, consult your doctor immediately.
• if you have cystic fibrosis, consult your doctor before taking CANADIOL capsules.
• stop taking CANADIOL capsules and consult your doctor immediately if you experience any numbness, tingling, decreased sensitivity, or weakness in your arms and legs (neuropathy).
• stop taking this medicine and contact your doctor immediately if you do not hear correctly. In rare cases, temporary or permanent hearing loss has occurred.
• inform your doctor if your vision becomes blurry or double, if you hear a buzzing in your ears, if you lose control of your urine or urinate more than usual.
• do not recommend taking this medicine in elderly patients. It is only prescribed by a doctor in exceptional cases.

Other medicines and CANADIOL capsules

Do not use certain medicines withCANADIOL.

Your doctor may decide thatyou should not take some medicines at the same time asCANADIOLcapsules or within 2 weeks after its end.

Examples of these medicines are:

Medicines to treat heart, blood or circulation problems

Medicines to treat epilepsy, headache or mental health problems

Medicines to treat urinary problems

Medicines to treat cancer

Medicines to treat tuberculosis

Medicines to treat HIV or hepatitis

Medicines used after organ transplantation

Medicines to treat benign prostatic hyperplasia

Medicines to treat respiratory, allergy or inflammatory problems

Medicines to treat erection and ejaculation problems

Medicines to treat pain

Other medicines that contain:

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 appropriate measures can be taken.

You should have enough acidity in the stomach to ensure the absorption of CANADIOL capsules. Therefore, medicines that neutralize stomach acidity should be taken at least 2 hours before taking CANADIOL capsules or 2 hours after taking this medicine. For the same reason, if you are taking medicines that regulate the production of acid in the stomach, take CANADIOL capsules with a cola drink (see section 3 “How to take CANADIOL 100 mg capsules”).

If in doubt, consult your doctor or pharmacist.

Taking CANADIOL 100 mg capsules with food and drinks

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

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

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

CANADIOL will not be used during pregnancy.

If you are fertile and may become pregnant, consult your doctor. You should use effective contraceptive measures to ensure that you do not become pregnant while taking the medicine. Because CANADIOL capsules may stay in the body for a long time, you should prolong the contraceptive measures until the next menstrual period after finishing treatment with this medicine (see section 2 “Do not take CANADIOL 100 mg capsules”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and operating machines

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

Important information about some of the excipients of CANADIOL 100 mg capsules

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

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

Follow exactly the administration instructions of CANADIOL capsules indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication.Do not discontinue treatment before.

If you estimate that the medication's action is too strong or weak, inform your doctor or pharmacist.

You must take CANADIOL capsules immediately after meals, as this is when they are best absorbed. 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 many CANADIOL capsules you should take.

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

The following doses are the most common:

?Fingernail infections: Depending on your personal needs, your doctor will choose a continuous or pulsatile treatment.

• Continuous treatment for foot nail infections:

-Pulsatile treatment for nails:

This consists of 2 capsules twice a day for 1 week; then stop taking CANADIOL 100 mg capsules for 3 weeks. The cycle is then repeated, once for the hands and twice for the feet (with or without nail infection on the hands). (See the following table)

Lesions on the skin will disappear a few weeks after completing 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 from 6 to 9 months after completing treatment, as the medication only eliminates the fungus itself. The nail must grow, which 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 must interrupt treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections:Higher doses may be needed and for a long time.

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

Use in Children

CANADIOL capsules should not be used in children. They can only be prescribed by a doctor in exceptional cases.

If you take more CANADIOL 100 mg capsules than you should

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

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

If you forgot to take CANADIOL 100 mg capsules

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 compensate for the missed doses.

If you interrupt treatment with CANADIOL 100 mg capsules

Do not discontinue treatment with CANADIOL 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 product, ask your doctor or pharmacist.

Like all medicines, CANADIOL 100 mg capsules may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The following side effects have been seen during the marketing of the medicine and clinical trials.

Adverse reactions were classified by frequency using the following convention:

Very common: affects more than 1 in 10 patients

Common: 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 unknown: 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 is accompanied by frequent sneezing)

?Haematological and lymphatic system disorders

Rare: leucopenia

• Immune system disorders

Uncommon: hypersensitivity and allergic reactions

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

• Metabolic and nutritional disorders

Rare: increased triglycerides

• Nervous system disorders

Common: headache

Rare: tremor, sensation of numbness in the extremities (paresthesia), decreased sensitivity (hypoesthesia), unpleasant taste (bad taste)

?Eye disorders

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

?Ear and labyrinth disorders

Rare: permanent or temporary hearing loss, subjective sensation of noise in the ear

• Cardiac disorders

Rare: congestive heart failure

• Respiratory, thoracic and mediastinal disorders

Rare: dyspnoea, shortness of breath

• Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with meals, diarrhoea and constipation, accumulation of gas in the intestine (flatulence)

Rare: pancreatitis

• Hepatobiliary disorders:

Uncommon: abnormal liver function

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

• Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, pruritus

Rare: toxic epidermal necrolysis (a severe skin disease characterized by skin rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe skin, mucous membrane, and eye inflammation), a severe skin disorder (generalised rash with peeling of the skin 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 peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), alopecia (hair loss), photosensitivity (exaggered skin response to sunlight)

?Renal and urinary disorders

Rare: increased frequency of urination

• Reproductive and breast disorders

Uncommon: menstrual disorders

Rare: erectile dysfunction

• General disorders and administration site conditions

Rare: oedema (fluid accumulation)

• Laboratory investigations

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

Description of certain side effects

The following side effects are associated with itraconazole reported in clinical trials of CANADIOL oral and/or intravenous solution, excluding the side effect "inflammation at the injection site" as this side effect is specific to the injection route.

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

Immune system disorders:anaphylactoid reaction

Metabolic and nutritional disorders:hyperglycaemia (increased blood sugar), hyperkalaemia (increased potassium in blood), hypokalaemia (decreased potassium in blood), hypomagnesaemia (decreased magnesium in blood)

Mental and behavioural disorders:sensation of confusion or disorientation

Nervous system disorders:peripheral neuropathy (affecting peripheral nerves with sensation of numbness, tingling, or weakness in the extremities), dizziness, somnolence

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

Vascular disorders:hypertension, hypotension

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

Gastrointestinal disorders:gastrointestinal disorder

Hepatobiliary disorders::liver insufficiency, hepatitis, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions)

Skin and subcutaneous tissue disorders:erythematous rash, excessive sweating

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

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

General disorders and administration site conditions:generalised oedema, facial oedema, chest pain, fever, pain, fatigue, chills

Laboratory investigations: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

Side effects in the paediatric population

Based on clinical trial data in paediatric patients, the most frequently reported side effects were: headache, vomiting, abdominal pain, diarrhoea, abnormal liver function, hypotension, 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 paediatric patients.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use CANADIOL after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of CANADIOL 100 mg capsules

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole
• The other components are: sugar spheres (sucrose, cornstarch), hypromellose, and macrogol. The capsule components are: titanium dioxide (E171), indigotindisulfonate sodium (E132), erythrosine sodium, and gelatin.

Appearance of the product and contents of the packaging

CANADIOL 100 mg capsules are presented in pink and blue capsules containing 100 milligrams of itraconazole in packs of 7 and 14 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

This leaflet was approved in August 2023

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