NITROXOLIN FORTE

Package leaflet: Information for the patient

Nitroxolin forte, 250 mg, soft capsules
Nitroxolinum
Read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Nitroxolin forte is and what it is used for
2. Important information before taking Nitroxolin forte
3. How to take Nitroxolin forte
4. Possible side effects
5. How to store Nitroxolin forte
6. Contents of the pack and other information

1. What Nitroxolin forte is and what it is used for

Nitroxolin forte contains the active substance nitroxoline. The medicine is used in the treatment of urinary tract infections caused by bacteria sensitive to nitroxoline.
Indications for use:

• short-term treatment of acute infections and exacerbations of chronic, recurrent lower urinary tract infections (cystitis, urethritis) in adult patients.

2. Important information before using Nitroxolin forte

When not to use Nitroxolin forte:

• if the patient is allergic to nitroxoline or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney function disorders,
• if the patient has severe liver function disorders,
• in case of known hypersensitivity to peanuts or soy.

Warnings and precautions
Before starting treatment with Nitroxolin forte, consult a doctor or pharmacist.
Nitroxoline may cause yellow discoloration of urine. This effect is harmless and disappears after discontinuation of the medication.
During long-term use of Nitroxolin forte, the doctor will regularly monitor liver function.

Children
This medicine is not intended for use in children.

Other medicines and Nitroxolin forte
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Exercise caution when taking medications or dietary supplements containing high doses of minerals. Concomitant use may reduce the effectiveness of Nitroxolin forte. If the patient is unsure whether they are taking mineral supplements, they should contact a doctor or pharmacist.

Nitroxolin forte with food and drink
If possible, the medicine should be taken before main meals, with a glass of water.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data available on the use of nitroxoline in pregnant women.
The medicine may be used during pregnancy only if strictly necessary and after the doctor has evaluated the risk to the fetus.
There is insufficient data on the passage of nitroxoline into breast milk. Therefore, Nitroxolin forte should not be used during breastfeeding.
In breastfed infants, nitroxoline may cause disturbances in the physiological intestinal bacterial flora, which may lead to diarrhea and fungal infections in the gut. Hypersensitivity reactions may also occur.

Driving and operating machinery
Nitroxolin forte has no effect or has negligible effect on the ability to drive or operate machinery.

The medicine contains soybean oil. Do not use if known hypersensitivity to peanuts or soy exists.
The medicine contains cochineal red (carmine), which may cause allergic reactions.

3. How to use Nitroxolin forte

This medicine should always be used as directed by a physician. In case of doubt, consult a
doctor or pharmacist.
Recommended dosage
Adults
1 capsule (250 mg) three times daily.
The capsules should be taken orally, preferably before main meals, with a glass of water.
In patients with gastric hypersensitivity, the medicine may be taken 1 to 2 hours after a meal.
Children
Do not use in children.
Taking more Nitroxolin forte than recommended
If more than the recommended dose is taken, contact a doctor or pharmacist immediately.
Missing a dose of Nitroxolin forte
If a dose is missed, take the medicine as soon as possible. If it is almost time for the next dose,
skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Nitroxolin forte treatment
Premature discontinuation of treatment or interruption of therapy may result in recurrence of
infection.
If treatment is interrupted for more than one day and symptoms reappear, consult a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients):

• nausea, vomiting, diarrhoea.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• skin redness, itching.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• decreased platelet count (thrombocytopenia) – increased risk of bleeding and bruising,
• hypersensitivity reactions (rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing, decreased blood pressure, slow or rapid pulse, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest and cardiac arrest) – if such symptoms occur, contact a doctor immediately,
• yellowing of the skin, hair and nails due to the intense yellow colour of the active substance in this medicine – this effect is harmless and resolves after completion of treatment.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• yellowing of the sclera of the eye due to the intense yellow colour of the active substance – this effect is harmless and resolves after completion of treatment,
• fatigue,
• pains and dizziness,
• unsteady gait.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nitroxolin forte

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the blister and carton after:
"Expiry date". The expiry date refers to 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. This will help protect
the environment.

6. Contents of the package and other information

What Nitroxolin forte contains

• The active substance is nitroxoline. Each capsule contains 250 mg of nitroxoline.
• Other ingredients are: medium-chain triglycerides, hydrogenated soybean oil, partially hydrogenated soybean oil, yellow wax, liquid soybean lecithin, ethylaniline, 4-methoxyacetophenone, gelatin, glycerol 85%, titanium dioxide (E 171), carmine red A (E 124), purified water.

What Nitroxolin forte looks like and contents of the pack
Nitroxolin forte is in the form of red soft capsules.
The capsules are packed in PVC/Aluminium blisters.
The pack contains 10, 20, 30 or 90 soft capsules, together with the package leaflet, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MIP Pharma Polska Sp. z o.o.
Orzechowa 5
80-175 Gdańsk
Poland
Tel. 58 303 93 62
Fax 58 322 16 13
e-mail: [email protected]

Manufacturer
Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany
15.03.2023