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Fosfoseptic 3 g. 1 sache

Product Code: Fosfoseptic 3 g. 1 sache
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What Fosfoseptic is and what it is used for

Your medicine contains the active substance fosfomycin trometamol. Phosphoseptic is an antibiotic that is used to treat acute, uncomplicated lower urinary tract (UTI) infections caused by phosphomycin-sensitive pathogens in women and girls over 12 years of age.
Phosphomycin is used for the prevention of urinary tract infections in diagnostic and surgical procedures involving the lower urinary tract in adult men and women.

2. What you need to know before taking Fosfoseptic

Do not take Fosfoseptic

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 <10 ml / min);
if you are on hemodialysis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Phosphoseptic.
Diarrhea associated with the administered antibiotic has been reported with the use of almost all broad-spectrum antibiotics, including fosfomycin trometamol. This is important to consider in patients who experience severe diarrhea during or after the use of fosfomycin trometamol. In this situation, appropriate treatment should be started immediately. In these cases, the use of drugs that suppress peristalsis are contraindicated.

Children and adolescents
The safety and efficacy of Phosphoseptic 3 g in children under 12 years has not been established.

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

It is important to know that co-administration with metoclopramide decreases serum and urine phosphomycin concentrations and should be avoided. It is especially important to tell your doctor if you are taking other medicines that increase the gastrointestinal motility and can cause similar effects.

Phosphoseptic with food and drink
Food may delay the absorption of the drug, causing a slight decrease in peak blood and urine levels.
Therefore, the medicinal product should be taken on an empty stomach (2-3 hours after meals), preferably before bedtime, immediately after bladder emptying.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will decide if you can use this medicine if you are pregnant or breast-feeding.

Observations in pregnant women (between 300 and 1000 pregnant) showed no harm to the fetus and newborn (neither malformations nor feto / neonatal toxicity of fosfomycin trometamol).
It is unknown whether phosphomycin / fosfomycin metabolites are excreted in human milk. Phosphomycin is excreted in human breast milk at a low level after a single injection. A single oral dose of fosfomycin may be used during lactation.

Driving and using machines
There is no evidence that the medicinal product affects concentration or reaction time. Dizziness has been reported, which may affect the ability of some patients to drive and use machines.

Phosphoseptic contains sucrose
This medicine contains sucrose. If you have fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency, ask your doctor before taking this product.

3. How to take Fosfoseptic

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

The dose to be taken during your treatment will be determined by your doctor.

The recommended dose for the treatment of uncomplicated infections of the lower urinary tract in women and girls over 12 years is a single dose of Phosphoseptic 3 g of sachet.

The recommended dose for the prevention of urinary tract infections in surgical diagnostic procedures involving the lower urinary tract in adult men and women is two doses of Phosphoseptic 3 g of sachet, the first dose of 3 g of Phosphoseptic to be taken 3 hours before surgery and one dose Phosphoseptic 3 g sachet - 24 hours after surgery.

Application method
Phosphoseptic is for oral use and should be taken on an empty stomach, preferably at bedtime, immediately after bladder emptying. The contents of one sachet are dissolved in a glass of water and drunk immediately.

If you have used more than the required dose of Fosfoseptic
When Phosphoseptic is in packs containing only one sachet, there is almost no risk of overdose.
The following reactions have been observed with Phosphoseptic overdose: vestibular disorders, impaired hearing, metallic taste, and general reduction of taste.
If you take more than the required dose, it is sufficient to stimulate the elimination of the drug with urine by taking enough fluids.
Possible side effects

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

The most common side effects after administration of single doses of fosfomycin trometamol affect the gastrointestinal tract and are mainly expressed by diarrhea. These reactions are usually short-lived and disappear spontaneously.
The following side effects are possible when treated with this medicine:

Very common (occurs in at least 1 in every 10 people and less than 1 in every 100 people who take the medicine);
Common (occurs in at least 1 in 100 people and in less than 1 in 10 people who take the medicine);
Uncommon (occurring in at least 1 in every 1,000 people and less than 1 in every 100 people taking the medicine);
Rare (occurring in at least 1 in every 10,000 people and in less than 1 in every 1000 people taking the medicine);
Very rare (occurs in at least 1 in every 10,000 people who take the medicine);
Not known (no data can be estimated from the available data).
Infections and infestations:

Common: vulvovaginitis (inflammation of the genitals in women).
Immune system disorders:

Unknown frequency: anaphylactic reactions including anaphylactic shock (a severe allergic reaction that causes difficulty breathing or dizziness), hypersensitivity.
Nervous system disorders:

Common: headache, dizziness;
Uncommon: paraesthesia (tingling, tingling and other sensations on the skin).
Cardiac disorders:

Rare: tachycardia (fast heart rate).
Respiratory, thoracic and mediastinal disorders:

Not known: asthma.
Gastrointestinal disorders:

Common: diarrhea, nausea, dyspepsia (indigestion);
Uncommon: vomiting, abdominal pain;
Not known: colitis (inflammation of the colon that causes abdominal pain and diarrhea / constipation) associated with antibiotic intake.
Skin and subcutaneous tissue disorders:

Uncommon: rash, hives, itching;
Not known: Angioedema (a severe allergic reaction that causes swelling of the face or throat).
Common site disorders and effects:

Uncommon: Fatigue.
Vascular disorders:

Not known: Hypotension (decrease in blood pressure).

How to store Phosphoseptic

Keep out of the reach and sight of children.

Store in the original package at below 25 ° C.

Do not use this medicine after the expiry date which is stated on the sachet after the abbreviation "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

Active substance: Phosphomycin trometamol (Fosfomycin trometamol) 5.631 g (equivalent to 3 g of fosfomycin).
The other ingredients are sucrose, saccharin, orange flavor, tangerine flavor
What Phosphoseptic looks like and contents of the pack
Granules for oral solution 8.0 g in sachets of paper / aluminum / polyethylene.
One pack contains 1 or 2 sachets.


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