Nitroxolin forte

Package Leaflet: Information for the Patient

Nitroxolin Forte, 250 mg, Soft Capsules

Nitroxolinum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you, do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Nitroxolin Forte and What is it 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. Package Contents and Other Information

1. What is Nitroxolin Forte and What is it Used For

Nitroxolin Forte contains the active substance nitroxoline. The medication is used to treat urinary tract infections caused by bacteria susceptible 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 Taking Nitroxolin Forte

When Not to Take Nitroxolin Forte:

Warnings and Precautions

Before taking Nitroxolin Forte, consult your doctor or pharmacist.
Nitroxoline may cause urine to turn yellow. This effect is harmless and disappears after the medication is discontinued.
During long-term use of Nitroxolin Forte, your doctor will regularly monitor your liver function.

Children

This medication is not intended for use in children.

Other Medications and Nitroxolin Forte

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Be cautious when taking medications or dietary supplements containing high doses of mineral substances. They may weaken the effect of Nitroxolin Forte. If you are unsure whether you are taking mineral substances, consult your doctor or pharmacist.

Nitroxolin Forte with Food and Drink

If possible, take the medication before main meals, with a glass of water.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
There is no data on the use of nitroxoline in pregnant women.
The medication should only be used during pregnancy if absolutely necessary and after your doctor has assessed 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 infants who are breastfed, nitroxoline may cause disturbances in the physiological bacterial flora of the gut, leading to diarrhea and fungal infections in the gut. Allergy may also occur.

Driving and Operating Machinery

Nitroxolin Forte has no influence or negligible influence on the ability to drive and operate machinery.
The medication contains soybean oil. Do not use if you have a known hypersensitivity to peanuts or soy.
The medication contains cochineal red, which may cause allergic reactions.

3. How to Take Nitroxolin Forte

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Recommended Dosage

Adults
1 capsule (250 mg) 3 times a day.
Capsules should be taken orally, if possible, before main meals, with a glass of water.
In patients with stomach hypersensitivity, the medication can be taken 1 to 2 hours after a meal.
Children
Do not use in children.

Taking More Than the Recommended Dose of Nitroxolin Forte

If you have taken more than the recommended dose, contact your doctor or pharmacist.

Missing a Dose of Nitroxolin Forte

If you miss a dose, take it 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 the missed dose.

Stopping Nitroxolin Forte

Stopping the medication too early or taking a break in treatment may cause the infection to recur.
If you have stopped treatment for more than one day and symptoms of the disease have returned, consult your doctor.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Nitroxolin Forte can cause side effects, although not everybody gets them.
Common Side Effects(may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea.

Uncommon Side Effects(may affect up to 1 in 100 people):

• skin redness, itching.

Rare Side Effects(may affect up to 1 in 1,000 people):

• decreased platelet count (thrombocytopenia) - increased risk of bleeding and bruising,
• hypersensitivity reactions (rash, severe swelling of the face, lips, tongue, or throat, difficulty breathing, swallowing, or speaking, low blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, respiratory or cardiac arrest) - if such symptoms occur, consult your doctor,
• yellowing of the skin, hair, and nails due to the intense yellow color of the active substance - this effect is harmless and disappears after treatment is discontinued.

Very Rare Side Effects(may affect up to 1 in 10,000 people):

• yellowing of the sclera due to the intense yellow color of the active substance - this effect is harmless and disappears after treatment is discontinued,
• fatigue,
• headache and dizziness,
• unsteady gait.

Reporting Side Effects
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Nitroxolin Forte

Store the medication out of sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the blister and carton after: "Expiry Date". The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Package Contents 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, soybean lecithin, liquid, ethyl vanillin, 4-methoxyacetophenone, gelatin, glycerol 85%, titanium dioxide (E 171), cochineal red A (E 124), purified water.

What Nitroxolin Forte Looks Like and Contents of the Package

The medication is in the form of soft red capsules.
Capsules are packaged in PVC/Aluminum blisters.
The package contains 10, 20, 30, or 90 soft capsules, along with the package leaflet, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
tel. 58 303 93 62
fax. 58 322 16 13
e-mail: info@mip-pharma.pl

Manufacturer

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

Date of Last Revision of the Package Leaflet:

• 15.03.2023