Afastural

Package Leaflet: Information for the User

Afastural, 3 g, Granules for Oral Solution

Fosfomycin

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine Has Been Prescribed for You. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack::

• 1. What Afastural Is and What It Is Used For
• 2. Before You Take Afastural
• 3. How to Take Afastural
• 4. Possible Side Effects
• 5. How to Store Afastural
• 6. Contents of the Pack and Other Information

1. What Afastural Is and What It Is Used For

Afastural Contains the Active Substance Fosfomycin (as Fosfomycin Trometamol).
This Is an Antibiotic That Works by Killing Bacteria That Can Cause Infections.
Afastural Is Used to Treat Uncomplicated Urinary Tract Infections in Women and Adolescent Girls.
Afastural Is Used as Part of Prophylactic Antibiotic Therapy in the Case of Transrectal Prostate Biopsy in Adult Men.

2. Before You Take Afastural

Do Not Take Afastural:

If You Are Allergic to Fosfomycin or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Warnings and Precautions

Before Taking Afastural, Talk to Your Doctor, Pharmacist, or Nurse If You:

• Have Chronic Urinary Tract Infections,
• Have Had Diarrhea After Taking Other Antibiotics in the Past.

Things to Consider
Afastural Can Cause Serious Side Effects. These Include Allergic Reactions and Inflammation of the Colon. While Taking This Medicine, Pay Attention to Specific Symptoms to Reduce the Risk of Problems. See "Serious Side Effects" in Section 4.

Children and Adolescents

Do Not Give This Medicine to Children Under 12 Years of Age, as the Safety and Efficacy in This Age Group Have Not Been Established.

Afastural with Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking, or Have Recently Taken, and Any You Plan to Take, Including Those Obtained Without a Prescription.
This Is Especially Important If You Are Taking:

• Metoclopramideor Other Medicines That Increase Gastric and Intestinal Motility, as They May Reduce the Absorption of Fosfomycin by the Body,
• Anticoagulant Medicines, as Fosfomycin and Other Antibiotics May Affect Their Ability to Prevent Blood Clots.

Afastural with Food

Food May Delay the Absorption of Fosfomycin. This Medicine Should Be Taken on an Empty Stomach (2-3 Hours Before a Meal or 2-3 Hours After a Meal).

Pregnancy, Breast-Feeding, and Fertility

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.
Your Doctor Will Only Prescribe This Medicine During Pregnancy if It Is Clearly Necessary.
Breast-Feeding Mothers Can Take a Single Dose of This Medicine.

Driving and Using Machines

It Is Possible to Experience Side Effects Such as Dizziness, Which May Affect Your Ability to Drive or Use Machines.

Afastural Contains Sucrose

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 Take Afastural

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Check with Your Doctor or Pharmacist.
For the Treatment of Uncomplicated Urinary Tract Infections in Women and Adolescent Girls, the Recommended Dose Is One Sachet of Afastural (3 g Fosfomycin).
For Prophylactic Antibiotic Therapy in the Case of Transrectal Prostate Biopsy, the Recommended Dose Is One Sachet of Afastural (3 g Fosfomycin) 3 Hours Before the Procedure and One Sachet of Afastural (3 g Fosfomycin) 24 Hours After the Procedure.
Use in Patients with Renal Impairment
Do Not Use This Medicine in Patients with Severe Renal Impairment (Creatinine Clearance Less Than 10 ml/min).
Use in Children and Adolescents
Do Not Use This Medicine in Children Under 12 Years of Age.

Method of Administration

Oral Use.
This Medicine Should Be Taken 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

If You Accidentally Take More Than the Prescribed Dose, Contact Your Doctor or Pharmacist.
If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Serious Side Effects

Stop Taking the Medicine and Contact Your Doctor Immediately if You Experience Any of the Following Symptoms:

While Taking Afastural, the Following Symptoms May Occur:

• 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 - Pseudomembranous Colitis (Frequency Not Known). Do Not Take Anti-Diarrheal Medicines That Reduce Intestinal Motility (Antiperistaltic Medicines).

Other Side Effects

Common (May Affect Up to 1 in 10 People):

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

Uncommon (May Affect Up to 1 in 100 People):

• Vomiting
• Rash
• Hives
• Itching.

Unknown (Cannot Be Estimated from the Available Data):

• Allergic Reactions.

Reporting of Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Afastural

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton After "Expiry Date:" or "EXP". The Expiry Date Refers to the Last Day of That Month.
This Medicine Does Not Require Any Special Storage Conditions.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Afastural Contains

The Active Substance Is Fosfomycin. Each Sachet Contains 5631 mg Fosfomycin Trometamol, Equivalent to 3 g Fosfomycin.
The Other Ingredients Are:
Orange Flavor Consisting of Maltodextrin, Dextrose Monohydrate, Gum Arabic (E 414), Anhydrous Citric Acid (E 330), Butylhydroxyanisole (E 320);
Sodium Saccharin, Sucrose, Calcium Hydroxide.

What Afastural Looks Like and Contents of the Pack

White or Grayish Granules in a Single-Dose Sachet.
Afastural Is Available in the Following Packs:
Sachet Made of Paper/LDPE/Aluminum/LDPE in a Cardboard Box.
1 Sachet of 8 g (3 g Fosfomycin)
2 Sachets of 8 g (Each Containing 3 g Fosfomycin)
Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw

Manufacturer

SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:

United Kingdom: Fosfomycin 3g Granules for Oral Solution
Czech Republic:
Urifos 3g
Estonia:
Fosfomycin LadeePharma 3g
Hungary:
Fosfomycin Exeltis 3g Granulátum Belsőleges Oldható
Lithuania:
Fosfomycin LadeePharma 3g Granulės Geriamajam Tirpalui
Latvia:
Fosfomycin LadeePharma 3g Granulas Iekšķīgi Lietojama Šķīduma Pagatavošanai
Poland:
Afastural
Slovakia:
Afastural 3g

Date of Last Revision of the Leaflet:

• 06.09.2020