NITROXOLIN 250 mg. 90 capsules

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

Excipients: Yellow wax, hydrated soybean oil, partially hydrated soybean, defatted soybean phospholipids, triglycerides with medium length chains, H-ethoxy-4-hydroxybenzaldehyde, 1- (4-methoxyphenyl) ethanone, gelatin, glycerol, purified water, titanium dioxide (E171), coloring agent (E 124).

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

1. WHAT IS NITROXOLIN-MIR FORTE AND WHAT IT IS USED?

Nitroxolin-MIR forte is, for treatment of urinary tract infections:
Marketing Authorisation Holder: Manufacturer:
MIP Pharma GmbH Chephasaar Chem.-pharm. Fabrik GmbH
Germany
Nitroxolin-MIR forte is used in acute and chronic urinary tract infections caused by susceptible bacteria and fungi nitroxoline and prevention of repeated infections (prevention of recurrence).

2. BEFORE YOU TAKE NITROXOLIN-MIR FORTE

2.1 Do not take Nitroxolin-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.

2.2 Take special treatment Nitroxolin-MIR forte in the following cases:

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

b) Patients with impaired renal function in renal function (serum creatinine above 2 mg / 100 ml), the release is delayed but nevertheless reach effective concentrations in the urine. In more severe renal insufficiency release nitroxoline urine is very limited and clinical efficacy is uncertain.

c) Pregnancy and lactation
According to the data obtained in animal experiments can not be completely excluded disorders in the nervous system in the newborn when treated with Nitroksolin MIR-forte during pregnancy. Therefore, you may be treated with MTR-Nitroksolin forte if your doctor has considered it imperative that, after a strict evaluation of the benefit / risk (after analyzing the antibiogram).
Due to lack of data on excretion in breast milk, you should not take Nitroksolin MIR-forte during lactation. Y infant can be obtained by reacting the physiological intestinal flora as a result of which the occurrence of diarrhea and colonization of the intestine with the fungus. The possibility of sensitization should also be borne in mind.

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

e) Other warnings
In case of prolonged use should be regularly monitored laboratory values of liver function.
Since the drug is excreted in the urine, taking it leads to harmless yellow urine. If the urine is caused staining of clothing discoloration can be achieved through a common washing program.
As a precaution during treatment with Nitroksolin-MIR forte should not be used clothing from synthetic fabrics.

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

2.3 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, no reported interactions with other drugs nitroxoline.

3. HOW TO TAKE NITROXOLIN-MIR FORTE

Always take Nitroxolin-MIR forte according to doctor's instructions. Ask your doctor or pharmacist if you are not completely sure.

3.1 Method of administration: Oral

3.2 Dosage

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

Chronic urinary tract infections and prevention of recurrent infections, administration of 1 -2 capsules Nitroxolin-MIR forte day
The capsules should be swallowed with a glass of water about 1 hour before meals.

For the prevention of re-infection, the dosage to be taken only in the evening.

3.3 Duration

About duration of intake, please follow the instructions of your doctor. Do not stop treatment if symptoms of your illness have improved.

3.4 If you take more Nitroksolin-MIR forte than you have been prescribed

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

3.5 If you forgot to take Nitroxolin-MIR forte

If you miss a dose Nitroxolin-MIR forte not compensate by taking a double dose, but continue to take your prescribed dose.

3.6 Effects of discontinuing the Nitroksolin-MIR forte

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

4. POSSIBLE SIDE EFFECTS

Like any medicine Nitroxolin-MIR forte can cause side effects.
Assessment of adverse reactions is helpful to use a fresh classification of their frequency:

Very common: More than 1 1 0 patients treated

Common: Less than 1 in 10 but more than 1 in 100 patients treated

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

Rare: Less than 1 in 1000 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

4.1 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 the blood picture (reducing the number of platelets) during treatment have been reported rarely.
Neurological side effects such as fatigue, headache, dizziness and uncertain gait may occur in rare cases.
Note: In rare cases, small amounts of the active ingredient may be excreted in sweat. This can lead to harmless and temporary coloring of the skin, hair and nails. Very rarely possible temporary yellowing of the sclera.
Soybean oil and color (E124) may rarely cause severe allergic reactions.

4.2 Countermeasures

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

4.3 What should you do if side effects occur?

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

5. HOW TO STORE NITROXOLIN-MIR FORTE

Keep at temperatures below 25 ° C.
Keep out of reach of children.
Do not use after the expiry date stated on the packaging.