Furaginum hasco forte

Patient Information Leaflet

Furaginum Hasco Forte, 100 mg/5 ml, oral suspension
Furazidinum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Table of contents

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

1. What Furaginum Hasco Forte is and what it is used for

Furaginum Hasco Forte contains furazidinum (also known as furagin) as the active substance.
Furazidinum is a nitrofuran derivative that inhibits the growth of bacteria causing urinary tract infections.
Furaginum Hasco Forte is used in the treatment of acute and recurrent uncomplicated lower urinary tract infections in children, adolescents, and adults.

2. Important information before using Furaginum Hasco Forte

When not to use Furaginum Hasco Forte:

• if the patient is allergic to nitrofurantoin, other nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6),
• during the first three months of pregnancy,
• in late-term pregnancy (from week 38) and during childbirth, due to the risk of haemolytic anaemia (anaemia caused by destruction of red blood cells) in the newborn,
• in children under 3 months of age,
• if the patient has renal failure (as shown by laboratory tests: creatinine clearance below 60 ml/min or elevated serum creatinine levels),
• if the patient has peripheral neuropathy (a nervous system disorder involving damage to peripheral nerves, which may manifest as motor or sensory disturbances), e.g. in the course of diabetes,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in red blood cell metabolism).

Warnings and precautions
Before starting treatment with Furaginum Hasco Forte, discuss this with your doctor,
pharmacist, or nurse, particularly if the patient has:

• impaired kidney function,
• impaired liver function,
• neurological disorders,
• anaemia,
• electrolyte imbalances,
• deficiency of B-complex vitamins and folic acid,
• lung diseases,
• diabetes. In the above cases, the use of nitrofurantoin increases the risk of nerve damage.

Immediately discontinue taking Furaginum Hasco Forte and consult a doctor:

• if symptoms of neurological dysfunction occur (tingling, numbness, sensation of electric shocks). Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. In severe cases, this disorder may be irreversible and life-threatening;
• if fever, chills, cough, chest pain, or shortness of breath occur during treatment. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives. These symptoms usually resolve quickly or very quickly after discontinuation of the drug. If the drug has been used long-term, the severity and resolution of symptoms after stopping depend on how long treatment was continued after the first adverse effects appeared. Early recognition of adverse effects and prompt discontinuation of the drug are crucial. Lung dysfunction may become irreversible. Chronic reactions have occurred in patients taking nitrofurantoin for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may particularly affect elderly patients;
• if symptoms of liver dysfunction occur (jaundice of the eyes, skin, and mucous membranes, dark urine, itching, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, and weight loss). Jaundice may occur during short-term use of nitrofurans (within two weeks). Chronic hepatitis may occur during prolonged use of nitrofurans (usually longer than 6 months);
• if the patient develops severe and persistent diarrhoea during or after treatment. This may be a sign of pseudomembranous colitis—a complication that may occasionally occur after antibacterial treatment. Contact a doctor immediately and do not take antidiarrhoeal medicines that inhibit intestinal peristalsis.

If the patient is receiving long-term treatment, the doctor will order blood tests and assessments of kidney and liver function.
Effect on laboratory tests
The medicine may cause false-positive results in urine glucose tests using Benedict's or Fehling's solutions. Before submitting a urine sample for such testing, inform the medical staff that the patient is taking Furaginum Hasco Forte.
Results of urine glucose tests performed by enzymatic methods are usually accurate.
Children
Furaginum Hasco Forte oral suspension may be used in children over 3 months of age.
Furaginum Hasco Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Exercise caution when using the following medicines concurrently:

• quinolone antibiotics (e.g. nalidixic acid, norfloxacin, oxolinic acid) – nitrofurantoin inhibits their bacteriostatic effect,
• aminoglycoside and tetracycline antibiotics – enhance the antibacterial effect of nitrofurantoin,
• chloramphenicol and ristomycin (antibiotics) – increase the toxic effect of nitrofurantoin on blood cells,
• drugs that increase uric acid excretion, such as probenecid (in high doses) or sulfinpyrazone – reduce urinary concentration of nitrofurantoin and may cause its accumulation in the body, reducing treatment efficacy and increasing toxicity,
• antacids containing magnesium trisilicate – reduce absorption of nitrofurantoin,
• atropine – delays absorption of nitrofurantoin, but the total amount absorbed remains unchanged,
• B-complex vitamins – increase absorption of nitrofurantoin.

Furaginum Hasco Forte, food, drink, and alcohol
Furaginum Hasco Forte should be taken orally with meals containing protein, which enhances drug absorption.
Avoid alcohol consumption during treatment with Furaginum Hasco Forte.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Furaginum Hasco Forte must not be used during the first three months of pregnancy (first trimester) due to lack of clinical data on safety during this period.
Exercise particular caution when using the medicine during the last three months of pregnancy (third trimester). The medicine may be used in the third trimester only after prior consultation with a doctor.
The medicine must not be used from week 38 of pregnancy and during childbirth, as nitrofurantoin may cause haemolytic anaemia in the newborn.
Breastfeeding
Furaginum Hasco Forte should not be used during breastfeeding. Nitrofurantoin passes into breast milk and may harm the breastfed infant.
Fertility
Nitrofurantoin may adversely affect testicular function, leading to reduced sperm motility and unfavourable changes in sperm morphology, as well as reduced total ejaculate volume.
Driving and operating machinery
There is no data on the effect of nitrofurantoin on the ability to drive or operate machinery.
However, some patients may experience adverse effects that could affect driving ability (dizziness, drowsiness, visual disturbances) – see section 4 "Possible side effects".
Furaginum Hasco Forte contains non-crystallizing liquid sorbitol and sodium benzoate
The medicine contains 2250.09 mg of sorbitol and 29.5 mg of sodium benzoate in 5 ml of suspension.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of suspension, meaning the medicine is considered "sodium-free".
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

3. How to use Furaginum Hasco Forte

This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor.
The medicine should be taken orally during protein-containing meals, as protein enhances the absorption of furazidin.
Before each use, shake the bottle vigorously.
The dose prescribed by the physician should be measured using the oral syringe provided in the package, with a capacity of 5 millilitres. The syringe scale allows measuring the dose volume with accuracy up to 0.1 millilitre (i.e. 2 mg of furazidin).

Adults and adolescents
First day of treatment: 400 mg per day in 4 divided doses (5 ml of suspension every 6 hours).
Subsequent days: 300 mg per day in 3 divided doses (5 ml of suspension every 8 hours).
The medicine should be used for 7–10 days. If necessary, the physician may repeat the treatment after 10–15 days.

Children over 3 months of age
The recommended dose is 5–7 mg/kg body weight per day, in 2 or 3 divided doses.
The medicine should be used for 7–10 days. If necessary, the physician may repeat the treatment after 10–15 days.
Furaginum Hasco Forte may be used in children over 3 months of age.

Use of a higher than recommended dose of Furaginum Hasco Forte
If a higher than recommended dose of Furaginum Hasco Forte is taken, symptoms such as nausea, vomiting, headache, dizziness, allergic reactions, or anaemia may occur.
If such symptoms occur, seek immediate medical attention at the nearest hospital emergency department, as specialist treatment may be required (including gastric lavage and intravenous fluid administration, and in severe cases, haemodialysis). Due to renal excretion of the drug, the risk of overdose is increased in patients with impaired kidney function.

Missed dose of Furaginum Hasco Forte
If a dose of Furaginum Hasco Forte is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.

Discontinuation of Furaginum Hasco Forte
If you have any further questions regarding 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.
You should stop taking this medicine immediately and contact your doctor or go to the
nearest hospital if any of the following adverse reactions occur
[which occurred rarely, i.e. in 1 to 10 out of 10,000 patients, or with unknown frequency (frequency cannot
be estimated from the available data)]:

• allergic reactions: itching, urticaria, rash (frequency not known), anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by the development of localized swelling) (rare),
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - bullous erythema multiforme) (rare),
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), liver necrosis (usually during long-term use) (rare),
• asthmatic reaction (shortness of breath) in patients with asthma; respiratory hypersensitivity reactions, including (frequency not known):
• acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath - which usually resolve quickly after discontinuation of the medicine,
• chronic reactions - including lung changes (e.g. pulmonary fibrosis, pneumonia) - the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first adverse symptoms appear; once an adverse reaction is detected, the medicine must be discontinued immediately; lung function impairment may be irreversible,
• tingling, numbness, sensation of electric shocks due to peripheral nerve damage (including acute or irreversible forms, especially in patients with impaired renal function, anaemia, diabetes, electrolyte disturbances, or vitamin B deficiency) (frequency not known),
• pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhoea, headache, and fever) (frequency not known),
• cyanosis due to methaemoglobinaemia; in patients with glucose-6-phosphate dehydrogenase deficiency, the use of nitrofurantoin may lead to the development of megaloblastic or haemolytic anaemia (frequency not known).

In addition, the following adverse reactions have been observed in patients taking nitrofurantoin:
Common (in 1 to 10 out of 100 patients):

• nausea, excessive flatulence,
• headache.

Frequency not known (frequency cannot be estimated from the available data):

• dizziness, drowsiness, visual disturbances,
• constipation, diarrhoea, dyspeptic symptoms,
• vomiting, abdominal pain, loss of appetite,
• sialadenitis, pancreatitis,
• alopecia (transient),
• infections with microorganisms resistant to nitrofurantoin,
• fever, chills, malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should 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,
Tel.: + 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 allows the collection of additional information on the safety of the medicine.

5. How to store Furaginum Hasco Forte

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 6 months.
Medicines must not be disposed of via sewage 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 Furaginum Hasco Forte contains

• The active substance is furazidinum (furazidinum), also known as furagin. 5 ml of suspension contains 100 mg of furazidinum.
• Other ingredients (excipients) are: liquid, non-crystallizing sorbitol (E 420), citric acid, sodium citrate, glycerol, xanthan gum, banana flavour, sodium benzoate (E 211), polysorbate 80, purified water.

What Furaginum Hasco Forte looks like and contents of the pack
Furaginum Hasco Forte is a yellow suspension.
One package contains 100 ml or 140 ml of suspension in an amber glass bottle with a polyethylene closure and a polyethylene cap with a tamper-evident ring, together with an oral syringe made of PE with a plunger made of PS, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Product Information
tel.: 22 742 00 22
e-mail: [email protected]