NITROKSOLIN MIP-caps. 250 mg. 90 caps

Pharmaceutical form: Soft capsules

Ingredients: 1 soft capsule contains: Active substance: 250 mg nitroxoline

Excipients: Yellow wax, hydrated soybean oil, partially hydrated soybean oil, defatted soy phospholipids, triglycerides of medium chain, H-ethoxy-4-hidroksibenzaldehid, 1 - (4-methoxyphenyl) ethanol, gelatin, glycerol, purified water titanium dioxide (E171), coloring (E 124).

Packaging: 10 (only a sample). 30 or 90 soft capsules

 WHAT IS NITROKSOLIN MIR-FORTE AND WHAT IT IS USED FOR?

Nitroksolin-MIR forte is for treatment of urinary tract infections:

Nitroksolin-MIR forte is used for acute and chronic urinary tract infections caused by susceptible bacteria and fungi nitroxoline and prevention of repeated infections (prevention of recurrences).

 BEFORE YOU TAKE NITROKSOLIN MIR-FORTE

 Do not take Nitroksolin-MIP forte

 If you are hypersensitive to nitroxoline, soybean oil, color (E124) or any of the other ingredients of the medicine.

 If you have severe kidney or liver disorders.

 Take special care with Nitroksolin MIR-forte in the following cases:

 Children and the elderly because of dose-MIR Nitroksolin forte is not suitable for children. For this age group provides products with a lower dose.

 Patients with impaired renal function, renal dysfunction (serum creatinine more than 2 mg/100 ml), the release has been delayed, but is reaching effective concentrations in urine. In more severe renal excretion of urinary nitroxoline is very limited and clinical efficacy is uncertain.

 Pregnancy

According to data obtained from animal experiments can not be fully excluded disorders of the nervous system in neonates during treatment with MIR-Nitroksolin forte, during pregnancy. Therefore, you can be treated with MTP-Nitroksolin forte if your doctor has considered it necessary, after rigorous assessment of the benefit / risk ratio (after antibiogram analysis).

Due to lack of data on excretion in breast milk should not take Nitroksolin MIR-forte during lactation. At the infant can get interaction with physiological intestinal flora as a result of which occur diarrhea and intestinal colonization by fungi. The possibility of sensitization should also be taken into account.

 Driving and operating machinery

According to this experience nitroxoline not affect your ability to concentrate and react. However, side effects such as dizziness and uncertain gait can occur in rare cases leading to risk in the pursuit of these activities.

 Other warnings

In case of prolonged use should be regularly monitored laboratory parameters of liver function.

Because the drug is excreted in the urine, its intake leads to harmless yellow urine. If the urine is caused staining of clothing discoloration can be achieved by common washing program.

As a precaution during treatment with MIR-Nitroksolin forte must not use clothing made of synthetic materials.

 Important information about some of the ingredients of Nitroksolin MIR-forte. In rare cases, soybean oil and dye (E124) can cause severe allergic reactions.

 Interactions with other drugs

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you have not been prescribed. So far there is no reported interactions with other drugs nitroxoline.

 HOW TO TAKE NITROKSOLIN MIR-FORTE

Always Nitroksolin MIR-forte according to the instructions of the physician. Ask your doctor or pharmacist if you are not completely sure.

 Method of administration: Oral

 Dosage

Adults take 3 times daily 1 capsule Nitroksolin MIR-forte, unless your doctor advises otherwise.

Chronic urinary tract infections and prevention of repeated infections, administration of 1 -2 capsules Nitroksolin MIR-day forte

The capsules should be swallowed with a glass of water 1 hour before meal.

To prevent re-infection is possible dose be taken only in the evening.

 Duration

Regarding duration of intake, please follow your doctor's instructions. Do not discontinue treatment if the symptoms of your condition has improved.

 If you take more Nitroksolin MIR-forte than you were prescribed

So far, side effects caused by high doses are not known. If you received a slight overdose no special measures. In case of severe overdose, immediately seek medical attention.

 If you forget to take Nitroksolin MIR-forte

If you miss a dose Nitroksolin MIR-forte does not compensate for this by taking a double dose but continue to take your prescribed dose.

 Effects of discontinuing the Nitroksolin MIR-forte

Discontinuation of treatment may lead to re-infection. In case of interruption of more than one day and resume symptoms should consult a doctor.

 SIDE EFFECTS

Like any medicine Nitroksolin MIR-forte can cause side effects.

Assessment of adverse effects is useful to use fresh classification of Frequencies:

Very common: More than 1 in 1 0 patients treated

Common: More than 1 in 10 but more than 1 in 100 patients

Uncommon: Less than 1 1 00 but more than 1 in 1000 patients treated

Rare: Fewer than 1 in 1,000 but more than 1 in 10,000 patients treated

Extremely rare: 1 or less than 1 in 10,000 patients treated, including isolated reports of adverse drug reactions

 Undesirable effects

Gastrointestinal disorders (eg nausea, vomiting, diarrhea) may occur frequently. These symptoms usually disappear during therapy and do not require termination.

Allergic skin reactions (redness, rash) occur rarely, are also transient and disappear spontaneously after discontinuation of the drug.

Allergic changes in blood counts (low platelets) during treatment have been reported rarely.

Neurological side effects such as fatigue, headache, dizziness and uncertain gait can occur in rare cases.

Note: In rare cases, small amounts of the active ingredient can be excreted in sweat. This can cause harmless and temporary discoloration of the skin, hair and nails. Very rarely, we may temporarily yellow whites.

Soybean oil colorant (E124) may rarely cause severe allergic reactions.

 Countermeasures

If you have gastrointestinal discomfort at the beginning of treatment may take Nitroksolin MIR-forte just before eating. In case of allergic skin reactions should consult a doctor.

 What to do if side effects occur?

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

 STORAGE NITROKSOLIN MIR-FORTE

Do not store above 25 ° C.

Keep out of reach of children.

Do not use after the expiry date stated on the packaging.