100 mg hard capsules
itraconazole

What Itraconazole Actavis is and what it is used for

Itraconazole Actavis contains itraconazole which is an antifungal medicine. It prevents the fungus from building a normal cell wall. Without a well-functioning cell wall, the fungus dies.

Itraconazole Actavis is used to treat fungal infections of the vagina, mouth, skin, and nails.

Itraconazole contained in Itraconazole Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Actavis

Do not use Itraconazole Actavis

  • if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant. See also under Pregnancy, breast-feeding and fertility .
  • if you have ever had heart problems, including heart failure (also called congestive heart failure )
  • if you are also taking a medicine that contains any of the following substances:
    • terfenadine, astemizole or mizolastine (for allergies )
    • cisapride (for certain digestive disorders)
    • pimozide and sertindole (for mental disorders)
    • quinidine or dofetilide (for arrhythmias in the heart).
    • levacetylmethadole (for the treatment of drug abuse (opioid dependence))
    • bepidril and nisoldipine (calcium antagonists for angina (oppressive chest pain) and high blood pressure )
    • lovastatin, simvastatin and atorvastatin (cholesterol lowering agents)
    • midazolam or triazolam orally (sleeping pills)
    • ergotamine , dihydroergotamine or eletriptan (for migraine )
    • ergometry or methylergometry (used after delivery)
    • ranolazine (for chest pain)
    • dabigatran etexilate (prevents blood clots in vessels one after knee or hip surgery)

Warnings and cautions

Talk to your doctor before taking Itraconazole Actavis

  • if you have previously been allergic to any other antifungal agent.
  • if you have heart problems because then you may be at greater risk of getting certain side effects . Contact your doctor immediately if you experience shortness of breath, unexpected weight gain, leg or abdominal swelling, feeling abnormal fatigue or if you start waking up at night.
  • if you have impaired liver or kidney function as dose one may need to be changed.
  • if you have Acquired Immunodeficiency Syndrome ( AIDS ) or if your immune system is not working as well as it should.

Children

Itraconazole capsules are not normally given to children. However, your doctor may prescribe them in special cases.

Older

Itraconazole capsules are not normally given to the elderly. However, your doctor may prescribe them in special cases.

Discontinue treatment and contact a doctor immediately if you experience symptoms of liver problems such as loss of appetite, nausea, vomiting, fatigue, abdominal pain, or heavy dark urine. Your doctor may prescribe blood tests regularly to check your liver function. It is important that you go to these checks (see section 4).

If you feel tingling, numbness, or weakness in your hands or feet, talk to your doctor as soon as possible (see section 4).

Other medicines and Itraconazole Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Itraconazole Actavis may affect or be affected by other medicines. This may increase or decrease the effect of any of the medicines.

Some medicines must not be taken with Itraconazole Actavis. These medicines are listed under the heading “Do not take Itraconazole Actavis”.

If you are taking any of the following medicines, your doctor may need to change the dose of one Itraconazole Actavis or the other medicine :

  • certain antibiotics e.g. clarithromycin and erythromycin
  • certain drugs that affect the heart and blood vessels (eg digoxin , disopyramide and calcium channel blockers such as verapamil and cilostazol)
  • drugs that reduce the blood’s ability to coagulate (eg warfarin )
  • certain medicines for HIV ( protease inhibitors such as ritonavir, indinavir, saquinavir)
  • certain anticancer medicines (eg vinca alkaloids, busulfan, docetaxel and trimetrexate)
  • ciclosporin, tacrolimus and sirolimus commonly given after organ transplantation (immunosuppressive agents)
  • dexamethasone, budesonide, fluticasone and methylprednisolone (for inflammation )
  • certain anti-anxiety drugs such as buspirone, alprazolam, brotizolam and intravenous midazolam
  • phenytoin , phenobarbital and carbamazepine (for epilepsy )
  • rifabutin and rifampicin and isoniazid (for tuberculosis )
  • ebastine (for allergies )
  • reboxetine (for depression)
  • alfentanil and fentanyl (for pain during surgery)
  • herbal medicine with St. John’s wort (Hypericum Perforatum)
  • omeprazole and esomeprazole (for stomach ulcers and acid reflux)
  • halofantrine (against malaria )
  • repaglinide (for diabetes )

Itraconazole is only absorbed by the body if there is enough acid in the stomach. If you are taking antacids (eg for digestive problems), take them at the earliest 2 hours after taking Itraconazole Actavis and always take Itraconazole Actavis with an acidic beverage, such as orange juice or a cola drink.

Itraconazole Actavis with food and drink

Take Itraconazole Actavis capsules immediately after a meal as this increases the absorption into the body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Itraconazole Actavis during pregnancy except on certain prescribed by a doctor. If you are pregnant, you should use contraception during the period you are taking itraconazole.

Continue to use contraception until the menstrual period that occurs after stopping treatment, as itraconazole remains in the body for some time after you take it.

Itraconazole is excreted in human milk but is unlikely to affect breastfed infants. Talk to your doctor or pharmacist before taking Itraconazole Actavis while breastfeeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. Side effects such as dizziness, visual disturbances, and hearing loss may occur (see section 4). Avoid driving or using machines if you experience any of these side effects. Read all information in this leaflet for guidance.

If you are not sure, talk to your doctor or pharmacist.

Itraconazole Actavis contains sucrose

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 Actavis

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

Take Itraconazole Actavis capsules immediately after a meal to make it easier to absorb. Swallow the capsules whole.

Dose one is determined by the doctor who adjusts it individually for you. The usual dose for adults varies between 1 and 4 capsules daily.

The length of treatment is determined by the type of infection and varies between 1 day and 3 months. In fungal infections of the nails, either continuous treatment or so-called pulse treatment is given. Continuous treatment usually lasts for 3 months. In pulse treatment, two or three pulse scars are given. Each pulse is given for one week and is separated by 3 weeks of freedom of treatment.

If you use more Itraconazole Actavis than you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, pharmacy staff, or the Poison Information Center for risk assessment and advice. Symptoms of overdose include nausea, abdominal pain, dizziness, headache, and other side effects described in section 4.

If you forget to use Itraconazole Actavis

If you miss a dose, take dose one as soon as you remember. If it is almost time to take the next dose, do not take the missed dose but take the next dose as usual instead. Do not take a double dose to compensate for the dose you forgot.

If you stop using Itraconazole Actavis

Your doctor will tell you how long the treatment should last. Do not stop taking the capsules before the end of the prescribed treatment period, as it is then not certain that the infection is completely cured. It may take several weeks after you stop treatment until all symptoms have stopped.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking your capsules and tell your doctor immediately or go to the nearest emergency room.

Has been reported (occurs in an unknown number of users):

  • Symptoms of angioedema , such as swelling of the face, tongue and throat, hives and difficulty swallowing and breathing.
  • Severe allergic reactions with fever, rash, swelling and sometimes a drop in blood pressure
  • Serum disease (rash, fever, joint pain, enlarged lymph nodes ).
  • A tingling and / or burning sensation, numbness and / or weakness in your arms and legs ( peripheral neuropathy ).
  • Heart failure , with symptoms such as difficulty breathing, unexpected weight gain, swollen legs or stomach, abnormal fatigue or starting to wake up at night.
  • Shortness of breath due to abnormal accumulation of fluid in the lungs ( pulmonary edema )
  • Liver disease with symptoms such as: loss of appetite, malaise, vomiting, feeling weak, stomach pain, hepatitis (yellow hue of the skin and whites of the eyes), markedly darker urine or pale stools.
  • Severe skin diseases with rash, blisters, blistering or flaking on the skin, mouth, eyes and genitals together with fever,
  • Hearing loss. There is a small risk that this will become permanent.

Other possible side effects of Itraconazole Actavis :

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

Nausea. Stomach pain.

Rash.

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

Hypersensitivity.

Headache or dizziness. Numbness or tingling (parastesis)

Vomiting, constipation, diarrhea. If diarrhea lasts for several days, you should contact your doctor as you may need to change treatment. Indigestion. Altered taste ( dysgeusia ). Gases.

The increased amount of liver enzymes (detected by a blood test)

Itchy skin rash ( urticaria ). Skin itching ( pruritus ). Unusual hair loss or thinning hair ( alopecia )

Menstrual problems.

Swelling due to fluid under the skin ( edema ).

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

Low white blood cell count ( leukopenia ).

Lost feeling of pain or touch (hypoaesthesia).

Visual disturbances.

Ringing or rumbling sound in the ears ( tinnitus ).

Severe pain in the upper abdomen, often with nausea and vomiting due to inflammation of the pancreas.

Increased need to urinate ( pollakiuria )

Fever.

Has been reported (occurs in an unknown number of users):

Decreased white blood cell count ( neutropenia ). Reduced platelet count ( thrombocytopenia ).

Reduced amount of potassium in the blood. The increased amount of triglyceride is in the blood.

Blurred vision or double vision ( diplopia ).

Photosensitive skin.

Blood vessel inflammation.

Muscle pain ( myalgia ). Joint pain ( arthralgia ).

Difficulty controlling urine.

Erection difficulties.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

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 Actavis

Do not store above 25 ° C.

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

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.

Medicines 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. 1 capsule contains 100 mg itraconazole.
  • The other ingredients are sugar spheres (sucrose and corn starch), poloxamer and hypromellose. The capsule shell contains: Gelatin and dyes (indigo carmine (E 132), quinoline yellow (E 104) and titanium dioxide (E 171)).

What the medicine looks like and contents of the pack

Appearance: Opaque green gelatin capsules with yellowish powder.

Itraconazole Actavis is available in the following pack sizes: 4, 6, 15, 18, 28, 30, and 100 pcs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

LABORATORIOS LICONSA SA

Avda. Miralcampo, No 7,

Poligono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Muhammad Nadeem

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