Prospecto: Information for the Patient

Solufos Fosfomicina Calcium 500 mg Hard Capsules

Fosfomicina Calcium

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the package and additional information

Calcium Phosphomycin Solufos contains the active ingredient phosphomycin (as calcium phosphomycin). It is an antibiotic that acts by eliminating bacteria that can cause infections.

Calcium Phosphomycin Solufos is used for the treatment of uncomplicated urinary tract infections in women.

Do not take Fosfomicina cálcica Solufos

• if you are allergic (hypersensitive) to fosfomicina or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Fosfomicina cálcica solufos if you are in any of the following situations:

• you have persistent urinary tract infections,
• you have ever had diarrhea after taking any other antibiotic.

Symptoms to which you should pay attention

Fosfomicina cálcica Solufos may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while you are being treated with this medication, in order to reduce the risk of problems. See "severe side effects" in section 4.

Children and adolescents

This medication should not be administered to children under 12 years of age, as its safety and efficacy have not been established in this age group.

Other medications and Fosfomicina cálcica Solufos

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication, including medications purchased without a prescription.

This is especially important if you are taking:

• metoclopramidaor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomicina in your body,
• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomicina cálcica Solufos with food and drinks

Food may delay the absorption of fosfomicina. Therefore, this medication should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, your doctor will only prescribe this medication when it is strictly necessary.

Driving and operating machinery

You may experience side effects, such as dizziness, that may affect your ability to drive or operate machinery.

S ee exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For the treatment of uncomplicated urinary tract infections in women, the recommended dose is 500 mg–1 g (1 or 2 capsules) every 8 hours.

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10

Use in children and adolescents

This medication should not be used in children under 12 years of age.

Administration form

For oral use.

This medication should be taken orally, with an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), the last dose preferably before going to bed and after urination.

If you take more Fosfomicina Calcium Solufos than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Fosfomicina Calcium Solufos

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, take the next one as soon as possible and continue as before.

If you interrupt treatment with Fosfomicina Calcium Solufos

Remember to take your medication. Your doctor will indicate the duration of your treatment with Fosfomicina Calcium Solufos. Do not interrupt treatment, even if you feel better, unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

If during treatment with Fosfocina calcium Solufos you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:

• anaphylactic shock, a potentially fatal allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing or difficulty breathing,
• swelling of the face, lips, tongue or throat with difficulty breathing (angioedema) (unknown frequency),
• moderate to severe diarrhea, abdominal cramps, bloody stools and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take anti-diarrheal medications that prevent intestinal movement (antiperistaltics).

Other side effects

Frequent (may affect up to 1 in 10 people):

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

Infrequent (may affect up to 1 in 100 people):

• vomiting
• hives
• urticaria
• itching

Rare (may affect up to 1 in 1,000 people):

• anemia
• superinfections with bacteria resistant to the antibiotic

Unknown frequency (cannot be estimated from available data):

• allergic reactions
• visual disturbances
• loss of appetite
• venous inflammation
• increased white blood cell and platelet count
• appearance of petechiae (small skin vessel hemorrhages)
• liver enzyme alterations

If any of these reactions or other discomforts appear during treatment, you should inform your doctor as soon as possible.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Phosphomycin calcium Solufos after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Fosfomicina Calcica Solufos

• The active ingredient is fosfomicin.

Each capsule contains 500 mg of fosfomicin in the form of calcium salt.

• The other components are: polyethylene glycol 6000, sodium docusate, gelatin, iron oxide red (E-172), erythrosine (E-127), and titanium dioxide (E-171).

Appearance of the product and contents of the package

Fosfomicina Calcica Solufos 500 mg hard capsules are presented in the form of oral administration capsules in packages with 12 and/or 24 units.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Q pharma S.L.

C/ Portugal Entlo. C.

03003 Alicante. Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid). Spain.

Last review date of this leaflet: October 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/