Fosfomicin Us Pharmacia

Package Leaflet: Information for the Patient

Fosfomycin US Pharmacia

3 g, Granules for Oral Solution

Fosfomycin

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

• Keep this Package Leaflet, as you may Need to Read it Again.
• In Case of any Doubts, Consult your Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for you. Do not Pass it on to Others. The Medication 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, Inform your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Fosfomycin US Pharmacia and what is it Used for
• 2. Important Information Before Taking Fosfomycin US Pharmacia
• 3. How to Take Fosfomycin US Pharmacia
• 4. Possible Side Effects
• 5. How to Store Fosfomycin US Pharmacia
• 6. Package Contents and other Information

1. What is Fosfomycin US Pharmacia and what is it Used for

Fosfomycin US Pharmacia Contains the Active Substance Fosfomycin (in the Form of Fosfomycin Tromethamine). It is an Antibiotic that Works by Killing Bacteria that can Cause Infections.
Fosfomycin US Pharmacia is Used to Treat Uncomplicated Urinary Tract Infections in Women and Adolescent Girls.
Fosfomycin US Pharmacia is Used as Part of Prophylactic Antibiotic Therapy in the Case of Transrectal Prostate Biopsy in Adult Men.

2. Important Information Before Taking Fosfomycin US Pharmacia

When not to Take Fosfomycin US Pharmacia

• If you are Allergic to Fosfomycin or any of the other Ingredients of this Medication (Listed in Section 6);

Warnings and Precautions

Before Starting Fosfomycin US Pharmacia, Discuss with your Doctor, Pharmacist, or Nurse if you have:

• Chronic Urinary Tract Infections,
• Diarrhea that has Occurred in the Past after Taking other Antibiotics.

Things to Consider
Fosfomycin US Pharmacia may Cause Severe Side Effects, including Allergic Reactions and Inflammation of the Colon. While Taking the Medication, Pay Attention to Specific Symptoms to Minimize the Risk of Problems. See "Severe Side Effects" in Section 4.

Children and Adolescents

Do not Give this Medication to Children under 12 Years of Age, as the Safety and Efficacy have not been Established in this Age Group.

Fosfomycin US Pharmacia and other Medications

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, including those Available without a Prescription.
This is Especially Important when Taking:

• Metoclopramideor other Medications that Increase Gastric and Intestinal Motility, as they may Decrease the Absorption of Fosfomycin by the Body,
• Anticoagulant Medications, as Fosfomycin and other Antibiotics may Affect their Ability to Prevent Blood Clots.

Taking Fosfomycin US Pharmacia with Food

Food may Delay the Absorption of Fosfomycin. Therefore, Take this Medication on an Empty Stomach (2-3 Hours before a Meal or 2-3 Hours after a Meal).

Pregnancy, Breastfeeding, and Fertility

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.
Your Doctor will Only Prescribe this Medication during Pregnancy if it is Clearly Necessary.
Breastfeeding Mothers may Take a Single Dose of this Medication.

Driving and Operating Machines

Side Effects such as Dizziness may Occur, which may Affect your Ability to Drive or Operate Machines.

Fosfomycin US Pharmacia Contains Sucrose, Orange Yellow, and Sodium

Fosfomycin US Pharmacia Contains 1.923 g of Sucrose. If you have been Diagnosed with Intolerance to some Sugars, Consult your Doctor before Taking this Medication.
Fosfomycin US Pharmacia Contains Orange Yellow, which may Cause Allergic Reactions.
The Medication Contains less than 1 mmol (23 mg) of Sodium per Sachet, which means it is Considered "Sodium-Free".

3. How to Take Fosfomycin US Pharmacia

Always Take this Medication Exactly as your Doctor or Pharmacist has Told you. If you are not Sure, Consult your Doctor or Pharmacist.
For the Treatment of Uncomplicated Urinary Tract Infections in Women and Adolescent Girls, the Recommended Dose is one Sachet of Fosfomycin US Pharmacia (3 g of Fosfomycin).
For Prophylactic Antibiotic Therapy in the Case of Transrectal Prostate Biopsy, the Recommended Dose is one Sachet of Fosfomycin US Pharmacia (3 g of Fosfomycin) 3 Hours before the Procedure and one Sachet of Fosfomycin US Pharmacia (3 g of Fosfomycin) 24 Hours after the Procedure.
Use in Patients with Renal Impairment
Do not Use this Medication in Patients with Severe Renal Impairment (Creatinine Clearance <10 ml min).
Use in Children and Adolescents
Do not Use this Medication in Children under 12 Years of Age.

Method of Administration

Oral Administration.
Take this Medication Orally, on an Empty Stomach (2-3 Hours before a Meal or 2-3 Hours after a Meal), Preferably before Going to Bed and after Emptying the Bladder.
Dissolve the Contents of one Sachet in a Glass of Water and Drink Immediately.

Overdose of Fosfomycin US Pharmacia

If you have Accidentally Taken a Higher Dose than Prescribed, Consult your Doctor or Pharmacist.
If you have any Further Questions on the Use of this Medication, Consult your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Fosfomycin US Pharmacia can Cause Side Effects, although not Everybody gets them.

Severe Side Effects

Stop Taking the Medication and Consult your Doctor Immediately if you Experience any of the Following Symptoms while Taking Fosfomycin US Pharmacia:

• Anaphylactic Shock, a Life-Threatening Allergic Reaction (Frequency not Known). Symptoms include Sudden Onset of Rash, Itching, or Hives on the Skin, or Difficulty Breathing, Wheezing, or Shortness of Breath,
• Swelling of the Face, Lips, and Tongue, or Throat and Difficulty Breathing - Angioedema (Frequency not Known),
• Diarrhea of Moderate to Severe Intensity, Abdominal Cramps, Bloody Stools, and (or) Fever may Indicate Infection of the Colon - Antibiotic-Associated Colitis (Frequency not Known). Do not Take Anti-Diarrheal Medications that Reduce Intestinal Motility.

Other Side Effects

Common(may Affect up to 1 in 10 People):

• Headache,
• Dizziness,
• Diarrhea,
• Nausea,
• Indigestion,
• Abdominal Pain,
• Vaginal Infection Characterized by Inflammation, Irritation, Itching (Vaginitis).

Uncommon(may Affect up to 1 in 100 People):

• Vomiting,
• Rash,
• Hives,
• Itching.

Unknown(Frequency cannot be Estimated from Available Data):

• Allergic Reactions.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Package Leaflet, Inform your Doctor, Pharmacist, or Nurse.
Side Effects can be Reported Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Fosfomycin US Pharmacia

Store the Medication out of Sight and Reach of Children.
There are no Special Storage Instructions for this Medication.
Do not Use this Medication after the Expiration Date Stated on the Carton and Blister Pack (Month/Year). The Expiration Date is Indicated as EXP - Expiration Date, Lot - Batch Number.
Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and other Information

What Fosfomycin US Pharmacia Contains

• The Active Substance of the Medication is Fosfomycin (in the Form of Fosfomycin Tromethamine). 1 Sachet Contains 8 g of Granules, including 3 g of Fosfomycin in the Form of Fosfomycin Tromethamine (5.631 g).
• Other Ingredients are: Sucrose, Calcium Hydroxide, Orange Flavor (Maltodextrin, Dextrose Monohydrate, Arabic Gum [E414], Citric Acid Anhydrous [E330], Orange Yellow [E110], Butylhydroxyanisole [E320], Flavor Enhancers and Aromas), Sodium Saccharin [E954].

What Fosfomycin US Pharmacia Looks like and what the Package Contains

Fosfomycin US Pharmacia is a White or Almost White Granule for Oral Solution. The Immediate Packaging is a Sachet made of Paper/LDPE/Aluminum/LDPE.
Packaging: 1 Sachet in a Carton.

Marketing Authorization Holder:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław

Manufacturer:

SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy
To Obtain more Detailed Information about this Medication, Contact the Representative of the Marketing Authorization Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of Last Revision of the Package Leaflet: