Nifuroxazide hasco
Poland
Table of Contents
Package leaflet: information for the patient
NIFUROKSAZID HASCO
100 mg, coated tablets
Nifuroxazidum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
a physician, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 3 days, or if your condition worsens, contact your doctor.
Table of contents
- What Nifuroksazid Hasco is and what it is used for
- Important information before taking Nifuroksazid Hasco
- How to take Nifuroksazid Hasco
- Possible side effects
- How to store Nifuroksazid Hasco
- Contents of the pack and other information
1. What Nifuroksazid Hasco is and what it is used for
Nifuroxazide exhibits antibacterial activity against most bacteria causing intestinal infections. The drug acts on Gram-positive cocci of the genera Staphylococcus and Streptococcus, as well as on Gram-negative microorganisms (Salmonella, Shigella, Klebsiella, Escherichia). It is ineffective against bacteria of the genera Proteus, Pseudomonas, Providentia. It does not disturb the normal microbiological balance of the gastrointestinal tract.
Nifuroxazide acts rapidly, achieving high concentrations in the intestinal lumen, which ensures its antibacterial effect. It does not exert systemic effects and is rapidly eliminated from the body.
Indications
Nifuroksazid Hasco is indicated in acute or chronic diarrhoea due to bacterial infections of the gastrointestinal tract.
2. Information before using Nifuroksazyd Hasco
When not to use Nifuroksazyd Hasco:
- if the patient is allergic to nifuroxazide, derivatives of 5-nitrofuran, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Nifuroksazyd Hasco, discuss this with your doctor, pharmacist,
or nurse.
As a precautionary measure, Nifuroksazyd Hasco should not be administered during
pregnancy and breastfeeding.
During treatment, it is essential to replenish fluids and electrolytes.
If diarrhoea persists after 2–3 days of treatment or worsens during therapy, contact your doctor immediately.
Children
This medicine should not be used in children under 6 years of age.
Nifuroksazyd Hasco with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Nifuroksazyd Hasco with food, drink, and alcohol
The medicine should be taken together with strict dietary compliance, excluding juices, raw vegetables and fruits, spicy and hard-to-digest dishes.
Consuming alcohol during treatment may cause a reaction characterised by severe diarrhoea, vomiting, and abdominal pain.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, Nifuroksazyd Hasco should not be administered during
pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Hasco may be used only if effective contraception is used.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
The medicine contains aluminium lake of quinoline yellow (E 104), aluminium lake of sunset yellow (E 110), and sodium
The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
3. How to use Nifuroksazyd Hasco
This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The medicine is taken orally.
Recommended dose:
Adults: 800 mg per day in 2–4 divided doses.
Children over 6 years of age: 600 to 800 mg per day in 2–4 divided doses.
Do not use for longer than 3 days without consulting a doctor.
Taking more Nifuroksazyd Hasco than recommended
If large quantities of the medicine are taken intentionally or accidentally, induce vomiting and seek medical advice immediately.
Missing a dose of Nifuroksazyd Hasco
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Nifuroksazyd Hasco is generally well tolerated. Hypersensitivity reactions may occur, manifesting as allergic skin reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 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 Nifuroksazyd Hasco
Keep this medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Nifuroksazyd Hasco contains
- The active substance is nifuroxazid (Nifuroxazidum). Each coated tablet contains 100 mg of nifuroxazid.
- The other ingredients (excipients) are: potato starch, povidone, magnesium stearate and the coating (Opadry II HP 85F22064 Yellow) containing: polyvinyl alcohol, polyethylene glycol 3350, quinoline yellow aluminium lake (E 104), talc, titanium dioxide (E 171), sunset yellow aluminium lake (E 110), indigo carmine aluminium lake (E 132).
What Nifuroksazyd Hasco looks like and contents of the pack
The medicine is in the form of yellow, biconvex, round tablets with a smooth and uniform surface.
One pack contains 24 coated tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]