INTRODUCTION

FOSIROL SACHET contains Fosfomycin, which belongs to the group of medicines called Antibiotics. It is used to treat or prevent uncomplicated infections of the bladder in women and female adolescents. It is also used as an antibiotic prophylaxis for transrectal prostate biopsy in men.

FOSIROL SACHET should not be used in patients who have severe kidney problems or are on haemodialysis. It should be used cautiously in patients who have persistent infections of the bladder and who have experienced symptoms of diarrhoea after taking any other antibiotics.

FOSIROL SACHET is not recommended for use in pregnant women unless considered necessary and is not recommended for use in breastfeeding women as it may pass through the breast milk. FOSIROL SACHET is generally not recommended for use in children (under 12 years of age) and should be used with caution in elderly patients. The most common side effects are headaches, dizziness, diarrhoea, nausea and indigestion. If any of these symptoms worsen, contact your doctor.

USES OF FOSIROL SACHET

• Treats or prevents uncomplicated infection of the bladder in women and female adolescents
• Prophylactic management of transrectal prostate biopsy in adult man

HOW FOSIROL SACHET WORKS

FOSIROL SACHET works by killing bacteria through the inactivation of an enzyme involved in bacterial cell wall synthesis and reduces adherence of the bacteria to the cells lining the urinary tract. This kind of action helps to treat uncomplicated urinary tract infections and prevent infections after prostate biopsy.

DIRECTIONS FOR USE

Take FOSIROL SACHET as advised by your physician. Check the label for directions before use. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF FOSIROL SACHET

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Sit down or lie down slowly when you are feeling dizzy. Take some time to rest and drink plenty of water. Avoid coffee and other carbonated drinks. If there is no improvement in the symptom, contact your doctor.

Headache:

Try to rest and relax. Apply pain balm to the head to ease the pain. Sip on some hot water or ginger tea. If your symptoms do not improve, contact your doctor immediately.

Nausea:

Take FOSIROL SACHET with or just after, meals. Stick to simple meals and avoid eating foods rich in oil or spicy foods. If your symptoms do not improve, contact your doctor immediately.

Indigestion:

Take your meal at the right time, drink lots of water and go for a walk after each meal. If the symptom does not improve, contact your doctor immediately.

Diarrhoea:

Increase your intake of fluids, such as water or fruit juice, to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor immediately.

Stomach pain:

Take a rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Place a heating pad on your stomach. If the symptom does not improve, contact your doctor immediately.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking FOSIROL SACHET, inform your doctor if you are taking any of the following medicine:

• metoclopramide (medicine that increases the movement of food through the stomach and intestines)
• anticoagulants (used to prevent blood clots)
• cimetidine (used to treat ulcers)

Overdosage:

If you or anyone else accidentally take too much of FOSIROL SACHET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are vestibular loss, impaired hearing, metallic taste and a general decline in taste perception.

SYNOPSIS

MORE INFORMATION

• Keep FOSIROL SACHET out of reach of children
• Store at room temperature

FAQs ABOUT FOSIROL SACHET

Can FOSIROL SACHET cause diarrhoea?

Yes, FOSIROL SACHET may cause diarrhoea in some individuals. Increase your intake of fluids, such as water or fruit juice, to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor.

How long does FOSIROL SACHET take to act?

After taking FOSIROL SACHET exactly as instructed by your doctor, your symptoms should improve in 2–3 days. If the symptoms do not improve, contact your doctor immediately.

Can we use FOSIROL SACHET for people with kidney problems?

FOSIROL SACHET is not recommended for use in patients with severe kidney problems, those undergoing haemodialysis treatment (a procedure used to clean the blood by removing waste and extra fluids when the kidneys are not functioning), etc. It should be used with caution in patients with other kidney problems. Consult your doctor before taking it.

What should I do if I forget to take FOSIROL SACHET?

Take the missed dose of FOSIROL SACHET as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Can I take FOSIROL SACHET during pregnancy?

No, FOSIROL SACHET should not be used in pregnant women unless prescribed by a doctor. Consult your doctor before taking it.

REFERENCES

1. KD Tripathi. Antimicrobial Drugs. Essentials of medical pharmacology. 8th editions. 2019. Page – 731.

2. George G. Zhanel, Andrew J. Walkty, and James A. Karlowsky. Fosfomycin: A First-Line Oral Therapy for Acute Uncomplicated Cystitis, NIH National Library of Medicine, National Center for Biotechnology Information. PMC, PubMed Central. May 2016. [Accessed on 13th June 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4904571/

3. Lynn L. Silver. Fosfomycin: Mechanism and Resistance. NIH National Library of Medicine, National Center for Biotechnology Information. PMC, PubMed Central. February 2017. [Accessed on 13th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5287057/

4. Zambon. Fosfomycin. [Accessed on 13th June 2022] https://biosupply.fffenterprises.com/fosfomycin-tromethamine-3gm.html

5. Special Product’s Line S.p.A. Electronic Medicines Compendium (EMC). [Revised in November 2017] [Accessed on 13th June 2022] https://www.medicines.org.uk/emc/files/pil.7219.pdf

6. Zambon S.p.A. Health Products Regulatory Authority (HPRA). [Revised in June 2020] [Accessed on 13th June 2022] http://www.hpra.ie/img/uploaded/swedocuments/075c78a7-31e0-4d29-8dcb-901d014d64b1.pdf

7. Ciplamed. Fosirol. [Revised in May 2016] [Accessed on 13th June 2022] https://www.ciplamed.com/content/fosirol-powder

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count
• Urine Routine & Microscopy