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Fosfomycin 3g. 1 sachet

Product Code: Fosfomycin 3g. 1 sachet
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What Fosfomycin is and what it is used for
Fosfomycin contains the active substance phosphomycin. Fosfomycin is an antibacterial agent for systemic use.
Fosfomycin is used to treat acute, uncomplicated cystitis in women over 12 years of age.
Fosfomycin is indicated for peri-procedural prophylaxis in the diagnosis and transurethral surgical procedures in adults.

2. What you need to know before taking Fosfomycin
Do not take Fosfomycin

if you are allergic to fosfomycin trometamol or any of the other ingredients of this medicine (listed in section 6);
if you have severe kidney failure (creatinine clearance
if you are on hemodialysis;
for children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Phosphomycin

Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during treatment with fosfomycin, which can be life-threatening. If such a reaction occurs, fosfomycin should not be re-administered and appropriate treatment required.

Pseudomembranous colitis
If severe, persistent diarrhea occurs during or in the first weeks after treatment end, severe bowel inflammation (pseudomembranous colitis) should be considered (see section 4. Possible side effects). Contact your doctor immediately.

Children and adolescents
Acute uncomplicated cystitis: Phosphomycin should not be used in children under 12 years of age (see section 3. How to take Phosphomycin ). This medicine is contraindicated in children under 6 years. There is another dosage for children between 6 and 11 years of age.
Prevention procedures: This medicine is not recommended in this population.

Other medicines and Fosfomycin
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
When co-administered with metoclopramide, a decrease in the required high concentration of fosfomycin trometamol in the urine is observed. Therefore, it should be taken after at least 2 to 3 hours.
Keep in mind that this information applies to other recently taken medicines.
If you are taking an anticoagulant (the so-called vitamin K antagonist) while taking some antibiotics, blood clotting may change temporarily. Therefore, your doctor may decide to closely monitor your blood clotting while you are taking Phosphomycin 

Fosfomycin with food and drink
This medicine should be taken on an empty stomach 1 hour before and at least 2-3 hours after a meal.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine.
Like all medicines, Phosphomycin  should be taken during pregnancy and breast-feeding only after your doctor has carefully evaluated the risks and benefits.
The use of fosfomycin trometamol in pregnant women has not been shown to have an adverse effect on the health of the fetus or newborn.
Even animal tests show no adverse effects on the fetus caused by the active substance.
The active substance passes into the bloodstream of the fetus and also into small amounts in the breast milk.

Driving and using machines
Phosphomycin  can cause dizziness and thus affect your ability to drive or use machines. Do not drive or operate machinery until it is known whether this medicine affects your ability to perform these activities.

Fosfomycin contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Fosfomycin
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:
Adults and adolescents (12 to 18 years):
For the treatment of acute uncomplicated cystitis, 1 sachet (3 g) as a single dose.

Adults:
For pre-treatment prophylaxis, 1 sachet (3 g) 3 hours before and 1 sachet (3 g) 24 hours after the procedure.

Patients with renal insufficiency
No dose adjustments are necessary in patients with mild to moderate renal insufficiency.
This medicine is contraindicated in patients with severely impaired renal function (creatinine clearance

Usage
For oral use.
Fosfomycin should be taken approximately 1 hour before or 2 hours after a meal. It should be taken on an empty stomach, preferably at bedtime, immediately after bladder emptying.
Dissolve the contents of the sachet in a glass of water (approximately 150-200 ml) and drink immediately. The reconstituted solution is slightly whitish and cloudy with a fruity aroma (orange mandarin).

If you take more  Fosfomycin than you should
After overdose, patients complain of an imbalance
Uncommon side effects: May affect up to 1 in 100 people:

vomiting;
stomach ache;
rash (skin damage);
hives (a type of skin rash);
itching;
paresthesia (skin tingling).
Rare side effects: May affect up to 1 in 1,000 people:

bacterial superinfection;
aplastic anemia (small number of blood cells).
Frequency unknown: frequency cannot be determined from available data):

an increase in the number of eosinophils;
petechiae;
allergic reaction, anaphylactic shock;
hypersensitivity;
decreased appetite;
impaired vision;
dyspnoea (shortness of breath);
bronchospasm;
colitis caused by Clostridium difficile;
decreased alkaline phosphatase in the blood;
angioedema (swelling of the skin);
phlebitis at the site of application.

How to store Fosfomycin
Keep out of the reach and sight of children.
Store below 30 ° C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fosfomycin  contains
The active substance is fosfomycin trometamol (Fosfomycin trometamol). Each single dose sachet contains 3 g of fosfomycin (such as fosfomycin trometamol).
The other ingredients are: sucrose, saccharin sodium (E954), mandarin flavor (maltodextrin (corn), gum arabic, ascorbic acid (E300), butylhydroxyanisole (E320) and flavoring agents), orange flavor (maltodextrin, aromatics, gum preparations).

What  Fosfomycin  looks like and contents of the pack
Granules for oral solution in sachets. White or almost white granules without lumps or particles in a single dose sachet.
The sachets are delivered in cartons containing 1 or 2 sachets.
Not all pack sizes may be marketed.

 

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