00 mg hard capsules
Itraconazole

What Itrakonazole STADA is and what it is used for

Itraconazole Stada contains the active substance itraconazole, which belongs to a group of antifungal medicines.

Itraconazole Stada is used to treat infections caused by fungus or yeast. It is used for:

– Infection is in the mouth or vagina that causes cod (a specific type of inflammation of the mucous membrane)

– Skin infections

– Infection is in nails

Itraconazole contained in Itraconazole STADA may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Itraconazole STADA

Do not use Itraconazole STADA

– if you are allergic (hypersensitive) to itraconazole or any of the other ingredients of Itraconazole Stada (see section 6 Further information, at the end of this leaflet).

– if you are pregnant or may become pregnant unless your doctor has explicitly stated that you can (see section “Pregnancy and breastfeeding”).

– if you have or have had heart failure.

– if you are being treated at the same time with any of the following medicines:

  • terfenadine, astemizole or mizolastine ( antihistamines used to treat allergies )
  • cisapride (for certain digestive disorders)
  • quinidine or dofetilide (for arrhythmias of the heart) or bepridil for the treatment of certain heart diseases.
  • pimozide or sertindole (for mental disorders)
  • levacetylmethadol (for the treatment of drug abuse [opioid dependence])
  • simvastatin , atorvastatin or lovastatin (cholesterol lowering agents)
  • triazolam (sleeping pill)
  • midazolam taken by mouth (for anxiety)
  • powdery mildew alkaloids such as dihydroergotamine and ergotamine (for migraine ), ergometry (ergonovine) and methylergonovine (methylergonovine) are used after childbirth
  • eletriptan (for migraines )
  • nisoldipine (for high blood pressure )

Warnings and cautions

Antifungal drugs

Talk to your doctor if you have previously had a hypersensitivity / allergic reaction to any medicine containing an azole substance (eg fluconazole ). It is possible that you are then also allergic to Itraconazole Stada.

Liver disease

If you have impaired liver function due to excessive alcohol intake ( cirrhosis ), your doctor may need to adjust your dosage.

Kidney disease

If you have impaired kidney function, your doctor may need to adjust your dosage.

Heart disease

Tell your doctor if you suffer from heart failure (when your heart can no longer pump enough blood with symptoms such as shortness of breath, swollen ankles, and problems with cardio). If you develop any of these symptoms during treatment, stop taking Itraconazole Stada and see a doctor.

If you have or have had heart failure, you should not take Itrakonazole Stada unless your doctor considers the benefits to outweigh the risks. In order for the doctor to be able to determine this, it is important that you tell them if you have any other diseases.

Gastric acid

Your medicine is better absorbed if your stomach contains stomach acid. If you are taking antacids (eg aluminum hydroxide), take the antacid at least two hours after Itraconazole Stada.

It is possible that your stomach does not contain enough stomach acid so that you do not produce normal levels. This can happen if you have HIV ( AIDS ) or if you are taking medicines for stomach ulcers such as:

– H 2 – antagonist is

– Proton pump inhibitors

If this is the case, take Itraconazole Stada with something sour to drink, such as a carbonated soft drink or fruit juice, which are usually acidic. Itraconazole Stada will be properly absorbed.

Liver disease

If you are taking Itrakonazole Stada, your doctor may need to check your liver function during treatment. If you have any symptoms of inflammation of the liver ( hepatitis ), you must stop taking Itraconazole Stada immediately and contact your doctor. Symptoms include:

– Loss of appetite ( anorexia )

– Nausea

Vomiting

Fatigue

– Stomach pain

– Dark-colored urine

You should not take Itraconazole Stada if:

– you have a liver disease

– your blood tests show elevated levels of liver enzymes

– you have had liver problems in connection with taking medicine before

Neuropathy

If you develop signs of nerve damage ( neuropathy ), you should stop taking Itraconazole Stada. Signs of nerve damage include:

loss of sensation

shaking

tingling and tingling

– the feeling of weakness

Hearing loss

Tell your doctor if you notice any hearing loss. The hearing loss usually disappears when treatment is stopped but may persist in some patients.

High blood pressure

Tell your doctor if you have high blood pressure and are being treated with a medicine that belongs to the group of calcium channel blockers (eg dihydropyridines, verapamil). The dosage one with your blood pressure medication may need to be changed.

Resistant infection you

Some infections may be resistant to medicines of the same type as Itraconazole Stada. For example, cod may be resistant to treatment with fluconazole.

Tell your doctor if you have previously been treated with fluconazole for cod without effect. Your doctor may consider prescribing a medicine other than Itrakonazole Stada. Your doctor may also perform a test to find out if Itraconazole Stada will be effective.

Patients with immediate life-threatening systemic fungal infections

Itraconazole Stada capsules are not recommended for initiating treatment of patients with direct life-threatening systemic fungal infections.

Other diseases

Tell your doctor if you have AIDS or your immune system is not working as well as it should.

Children and the elderly

Itraconazole Stada capsules are not normally given to children or the elderly. DO NOT TAKE Itraconazole Stada capsules unless your doctor tells you to. Your doctor can determine if the benefits outweigh the risks.

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

Children and young people

Itraconazole Stada capsules are not normally given to children. DO NOT TAKE Itraconazole Stada capsules unless your doctor tells you to. Your doctor can determine if the benefits outweigh the risks.

Other medicines and Itraconazole STADA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Effect of other drugs on Itraconazole Stada

The breakdown of Itraconazole Stada in the liver is affected by drugs such as:

  • rifabutin, rifampicin and isoniazid ( antibiotics used to treat tuberculosis )
  • phenytoin and phenobarbital (to treat epilepsy )
  • carbamazepine (to treat epilepsy and mood disorders associated with mental diagnoses)
  • St. John’s wort (a natural remedy for depression)

These medicines may make itraconazole Stada treatment less effective. After stopping any of the above medicines, you should wait two weeks before starting treatment with Itrakonazole Stada.

If you are taking any of the following medicines, your concentration of Itraconazole Stada in your blood may be elevated:

  • ritonavir, indinavir and saquinavir (medicines for HIV )
  • sildenafil and tadalafil (for the treatment of impotence )
  • certain cancer drugs (antineoplastic substances)
  • sirolimus (used to prevent organ rejection after transplants)
  • clarithromycin and erythromycin ( antibiotics )

Tell your doctor if you are taking other medicines. Your doctor knows if the medicines you are taking will affect the effect of Itraconazole Stada.

Medicines for stomach ulcers can affect the stomach’s production of acid.

Tell your doctor if you are taking other medicines. Itraconazole Stada may reduce their effect.

You should not take any of the following medicines with Itrakonazole Stada:

  • terfenadine, astemizole or mizolastine ( antihistamines used to treat allergies )
  • cisapride (for certain digestive disorders)
  • quinidine or dofetilide (to treat arrhythmias) or bepridil (to treat certain heart conditions)
  • levacetylmethadol (levomethadyl) (for the treatment of drug abuse [opioid dependence])
  • pimozide and sertindole (for mental illness)
  • triazolam (sleeping pill)
  • midazolam taken by mouth (for anxiety)
  • simvastatin , atorvastatin or lovastatin (cholesterol lowering agents)
  • powdery mildew alkaloids such as ergotamine and dihydroergotamine (for migraine ), Ergometrine (ergonovine) and methylergometry (methylergonovine) (used after childbirth)
  • eletriptan (for migraines )
  • nisoldipine (for high blood pressure )

If you are taking any of the following medicines, your doctor may need to adjust your dose:

  • calcium channel blockers (blood pressure lowering drugs eg dihydropyridines and verapamil)
  • warfarin (a blood thinner)
  • ritonavir, indinavir or saquinavir (medicines for HIV )
  • sildenafil or tadalafil (medicines for impotence )
  • certain anticancer medicines (eg vinca alkaloids, busulfan, docetaxel and trimetrexate)
  • ciclosporin, tacrolimus or rapamycin (also known as sirolimus) (medicines that prevent rejection after organ transplantation). Your doctor will monitor your levels of these medicines.
  • digoxin (a heart medicine). Your doctor will monitor your digoxin levels to prevent them from becoming too high.
  • intravenous dexamethasone (a steroid preparation given through a blood vessel)
  • methylprednisolone, fluticasone and budesonide (a steroid preparation)
  • alprazolam (sleeping pill)
  • buspirone (anti-anxiety drug)

The following medicines may also need to be dosed:

  • carbamazepine, alfentanil, brotizolam, intravenous midazolam, rifabutin, ebastine, reboxetine, cilostazol, disopyramide , fentanyl , halofantrine, repaglinide.

Itraconazole STADA with food, drink and alcohol

You should take Itrakonazole Stada immediately after a meal. Swallow the capsules whole. If you are taking medicines that reduce your stomach acid, you should drink something acidic, such as a carbonated drink. The uptake of the drug into the body is thus optimized.

Pregnancy, breastfeeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

This medicine can harm the unborn baby. Do not take Itraconazole Stada again

  • you are planning to get pregnant
  • if you are pregnant

other than on a specific prescription from a doctor.

Your doctor will decide if you should take itraconazole capsules after carefully examining:

  • the possible benefits of treatment
  • the possible risks of treatment

You must use an effective contraceptive

  • during treatment and
  • until your next period (menstruation).

Breast-feeding

Itraconazole Stada is excreted in the breast milk of your baby. You should not breastfeed if you are taking itraconazole. Your doctor may advise you to take Itraconazole Stada after careful consideration of the positive effects of the treatment and the possible risk to your baby if breastfed.

Driving and using machines

In very rare cases, Itraconazole Stada may cause dizziness, blurred/double, visual or hearing impairment. If you experience this symptom, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Itraconazole STADA contains sucrose

Itraconazole Stada contains sucrose, a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Itraconazole STADA

Always take Itraconazole Stada exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Swallow the capsules whole. You should take Itrakonazole Stada immediately after a meal.

Adults

The recommended dose is:

Vaginal cod ( vulvovaginal candidiasis )

The daily dose is 2 capsules (200 mg) in the morning and 2 capsules (200 mg) in the evening.

Cod in the mouth ( oral candidiasis )

1 capsule (100 mg) daily for 2 weeks.

Skin infections caused by yeast ( pityriasis Versicolor )

2 capsules (200 mg) daily for 1 week.

Fungal infections of the body or groin ( tinea corporis, tinea cruris )

1 capsule (100 mg) twice daily for 4 weeks.

Infection in the nails caused by fungus or yeast ( onychomycosis )

Pulse therapy: A dosing system called pulse therapy can be used to treat nail infections. One pulse is 2 capsules twice daily for 1 week (400 mg per day), followed by 3 weeks without medication. The following number of pulses should be followed:

  • Infection of toenails: 3 pulse scars
  • Fingernail infection : 2 pulse scars

Continuous treatment: continuous treatment can also be used for nail infections. For continuous treatment, you should take 2 capsules once daily for 3 months (200 mg per day).

Processing time

In case of skin infections, the treatment will show the best effect 1 to 4 weeks after the end of treatment. For the treatment of nail infections, your treatment will show the best effect 6 to 9 months after the end of treatment. This is because Itraconazole Stada is stored in the skin and nails for a long time.

Children and the elderly

You should not take Itraconazole Stada unless your doctor tells you to. Your doctor may prescribe Itraconazole Stada to you after considering that the benefits outweigh the risks.

If you have liver or kidney problems

Your doctor will measure your liver and kidney function. If you have any liver or kidney disease, your doctor will monitor your blood levels of Itraconazole Stada. Your dose may need to be adjusted (see section 2 Take special care with Itraconazole Stada)

If you have reduced stomach acid

If you use:

  • drugs to treat stomach ulcers
  • drugs that neutralize stomach acid

Your doctor will monitor your blood levels of Itraconazole Stada. Your dose may need to be adjusted (see section 2 Take special care with Itraconazole Stada)

If you have

  • HIV ( AIDS )
  • low levels of a special type of white blood cell ( neutropenia )

Your doctor will monitor your blood levels of Itraconazole Stada. Your dose may need to be adjusted (see section 2 Take special care with Itraconazole Stada)

Use for children and adolescents

You should not take Itraconazole Stada unless your doctor tells you to. Your doctor may prescribe Itraconazole Stada to you after considering that the benefits outweigh the risks.

If you use more Itraconazole STADA than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Bring the medicine pack and the remaining capsules. Symptoms of overdose may include:

  • nausea
  • abdominal pain
  • dizziness
  • headache

Your doctor will treat the symptoms of Itraconazole Stada overdose.

If you forget to use Itraconazole STADA

Take the next dose as soon as you remember if it is not almost time for your next dose . Do not take a double dose to make up for a forgotten capsule.

If you stop using Itrakonazole STADA

You should continue to take your capsules for as long as your doctor tells you to. It is important that you continue to take them even if you feel better. If you stop too fast, an infection can start again. Sometimes your doctor may want you to continue taking your capsules to prevent infection, a comeback

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

4. Possible side effects

Like all medicines, Itraconazole Stada can cause side effects, although not everybody gets them.

You should STOP taking Itraconazole Stada and contact your doctor immediately if you:

  • may have swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing ( angioedema , allergic (hypersensitivity) reaction including shock )
  • gets severe and life-threatening allergic reaction in the skin, mouth, eyes and other mucous membranes (Steven-Johnson syndrome) including more symptoms such as fever, chills, headache and fatigue.

The most commonly reported side effects are:

  • those that affect the gastrointestinal tract ( gastrointestinal )
  • those that affect the liver ( hepatic )
  • those that affect the skin (dermatological)

Tell your doctor or pharmacist if you experience any of the following side effects:

Common (affects less than 1 user in 10):

  • feeling sick (nausea)
  • abdominal pain (abdominal pain)
  • rash

Uncommon (affects less than 1 user in 100):

  • Problems with menstruation (menstrual disorders)
  • Headache
  • Dizziness
  • nausea (vomiting)
  • indigestion ( dyspepsia )
  • runny stools (diarrhea)
  • constipation
  • taste changes ( dysgeusia )
  • air in the stomach
  • hair loss ( alopecia )
  • itching ( pruritus )
  • hives ( urticaria )
  • feeling of numbness and tingling ( paresthesia )
  • general swelling ( edema )
  • hypersensitivity (see section “Take special care with Itraconazole Stada”)

Rare (affects less than 1 user in 1,000)

  • decreased white blood cell count ( leukopenia )
  • ringing in the ears ( tinnitus )
  • vision problems (visual disturbances)
  • frequent daytime urination (pollakiuria)
  • fever or high temperature (fever)
  • increase in blood test results for liver enzymes. These return to normal when you stop treatment.
  • inflammation of the pancreas ( pancreatitis )
  • loss of sensitivity to pain or touch ( hypesthesia )

No known frequency (cannot be calculated from the available data):

  • decreased white blood cell count ( neutropenia ) and platelets ( thrombocytopenia )
  • severe allergic reactions ( Stevens-Johnson syndrome, toxic epidermal necrolysis , erythema multiforme, exfoliative dermatitis , leukocytoclastic vasculitis )
  • serum sickness
  • Angioedema (severe allergic reaction that causes face, tongue or throat, difficulty swallowing or hives and difficulty breathing)
  • Allergic reaction ( hypersensitivity reaction ) including shock and shock- like reactions
  • Low levels of potassium in the blood ( hypokalaemia )
  • Elevated blood lipid levels ( hypertriglyceridemia )
  • Nerve disorders that can cause weakness, tingling or numbness ( peripheral neuropathy )
  • Heart problems ( heart failure ) which can lead to shortness of breath and swollen ankles
  • Swelling of the lungs ( pulmonary edema )
  • Sudden, severe liver failure
  • Serious liver damage
  • increased sensitivity to sunlight
  • urinary incontinence
  • erection difficulties
  • hearing loss (may be permanent)
  • visual disturbances including blurred vision or double vision
  • muscle aches, joint pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Itraconazole STADA

Keep out of sight and reach of children.
Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Content declaration

The active substance is itraconazole.

One capsule of 100 mg Itraconazole Stada contains 100 mg of itraconazole.

The other ingredients in the capsule core are:

– Sugar spheres (sucrose/corn starch)

– Hypromellos

– Sorbitan stearate

– Colloidal, aqueous silicon

The other ingredients in the capsule shell are:

– Gelatin

– Red iron oxide (E172)

– Titanium dioxide (E171)

What the medicine looks like and contents of the pack

Itraconazole Stada 100 mg capsules are hard, red, opaque, elongated gelatin capsules (size 0).

Itraconazole Stada capsules are packaged in PVC / PVdC / Aluminum blisters.

The 100 mg capsules pack contains 4, 6, 8, 14, 15, 18, 28, 30, 50, 60 and 84 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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