5 mg and 50 mg nitrofurantoin tablets

1. What Furadantin is and what it is used for

Furadantin contains nitrofurantoin , which has a bactericidal effect. It is effective against most bacterial species that cause urinary tract infections.

Furadantin is used to treat urinary tract infections.

The nitrofurantoin contained in Furadantin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Furadantin

Do not use Furadantin

Do not give to newborns or children under 1 month of age.

Do not use when breastfeeding children under 1 month of age.

Should not be used by persons with a known lack of enzyme et glucose -6-phosphate dehydrogenase.

Do not use it in case of severe renal impairment or if you are allergic to nitrofurantoin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before taking Furadantin if you have any of the following conditions: diabetesanemia, B-vitamin deficiency, or renal impairment.

Sometimes the urine can turn brown, but it is completely harmless.

Stop taking Furadantin and contact a doctor immediately if you get any of the following symptoms ( angioedema )

Talk to your doctor if you experience fatigue, yellowed skin or eyes, itching, rash, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or gray stools. This may be a symptom of liver disease.

Other medicines and Furadantin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Immediately following delivery, Furadantin should be given only after special consideration.

Furadantin passes into breast milk. Do not use Furadantin when breastfeeding children under 1 month of age.

Driving and using machines

Furadantin has no known effects on the ability to drive and use machines.

Furadantin contains lactose

Furadantin contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Furadantin

Always take Furadantin exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

The usual dose for adults: 50 mg 3 times daily for 5 days.

The usual dose for children (not less than 1 month of age): 3 mg/kg body weight and day divided into at least two doses during a week.

Furadantin should be taken with food, partly to reduce nausea and partly to improve the effect. The tablets can be crushed and mixed in a little liquid or mixed in the food.

In recurrent urinary tract infections, long-term treatment for several months and even years is often necessary. It is important to complete the medication according to the doctor’s prescription to prevent infection from recurring.

If you take more Furadantin then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Furadantin

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Furadantin can cause side effects, although not everybody gets them.

Uncommon (affects less than 1 in 100 people): Nausea and vomiting, especially at higher doses and when taken on an empty stomach.

Hypersensitivity reactions may occur. Symptoms include shortness of breath, fever, fatigue, rash, itching, headache, dizziness, diarrhea, asthmatic symptoms, dry mouth, muscle aches.

External nerve damage with symptoms such as tingling and numbness in the feet and hands can be caused by overdosing on kidney function, especially in people with diabetes, anemia, B- vitamin deficiency, or acid-base balance disorders. Liver effects and changes in blood counts may occur.

Rare (affects less than 1 in 1,000 people): difficulty concentrating, hair loss. Benign pressure increase inside the skull. Pancreatitis. Morbid increase in tissue in the lungs during long-term treatment. Swelling of the face, lips, tongue, or throat, sometimes with shortness of breath or difficulty swallowing so-called angioedema (see Warnings and precautions).

Has been reported (occurs in an unknown number of patients): Very severe hypersensitivity reaction with fever, rash, swelling and sometimes drop in blood pressure (anaphylactic shock ), abdominal painInflammation of small blood vessel walls causes skin diseases, liver inflammation as a result of the immune system’s effect on liver cells, kidney tissue inflammation with surrounding tubules which causes impaired kidney function.

If any of these side effects occur, stop treatment and consult a doctor.

5. How to store Furadantin

Keep this medicine out of the sight and reach of children.

Tablet 5 mg: Do not store above 25 ° C.

Tablet 50 mg: No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is nitrofurantoin 5 mg and 50 mg per tablet respectively.
  • The other ingredients are lactose monohydrate 177.5 mg and 132.5 mg respectively, potato starch, methylcellulose, anhydrous colloidal silica, magnesium stearate.

What the medicine looks like and the contents of the pack

Furadantin 5 mg tablets are yellow, round, cupped, with a cross-section and the imprint FV within arches and a diameter of 9 mm.

Pack size:

50 tablets in a plastic jar.

Furadantin 50 mg tablets are yellow, round, cupped, with a cross notch and the FZ imprint within arches and a diameter of 9 mm.

Pack sizes:

15 tablets and 25 tablets in a pressure pack, 100 tablets in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB, Box 906, 170 09 Solna. Phone 08-630 19 00.

Muhammad Nadeem

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