Prospecto: Information for the user

Cefoxitina LDP-Laboratorios TORLAN 1 g powder for injectable solution and for infusion EFG.

Cefoxitina LDP-Laboratorios TORLAN 2 g powder for injectable solution and for infusion EFG.

Cefoxitina Sodium

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may have. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to use the medicine, because it contains important information for you

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Content of the prospectus :

1. What is Cefoxitina LDP-Laboratorios TORLAN and what it is used for
2. What you need to know before starting to use Cefoxitina LDP-Laboratorios TORLAN
3. How to use Cefoxitina LDP-Laboratorios TORLAN
4. Possible adverse effects
5. Storage of Cefoxitina LDP-Laboratorios TORLAN
6. Contents of the package and additional information

Cefoxitina is a beta-lactam antibiotic belonging to the second-generation cephalosporins group.

This medication is indicated in adults and adolescents for the treatment of infections, when they are known or suspected to be caused by pathogens sensitive to cefoxitina.

Cefoxitina is indicated for:

• Complicated urinary tract infections.
• Pelonephritis.

Cefoxitina may have notable utility in intra-abdominal infections and some gynecological infections.

Do not use Cefoxitina LDP-Laboratorios TORLAN.

• If you are allergic to cefoxitina, or to any other antibiotic in the cephalosporin group or to some of the ingredients of this medication (mentioned in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) (e.g. severe skin peeling; swelling of the face, hands, feet, lips, tongue, or throat; or difficulty swallowing or breathing) to any other type of beta-lactam antibiotic (penicillins, monobactam, and carbapenems).

Warnings and Precautions

Consult with your doctor, pharmacist, or nurse before starting to use Cefoxitina.

Allergic Reactions

You must inform your doctor immediately if you experience any symptoms of an allergic reaction (hives, itching...) during treatment. If a severe allergic reaction occurs suddenly, the administration of Cefoxitina will need to be interrupted. Before starting this treatment, inform your doctor if you have ever had urticaria or any other type of rash, itching, Quincke's edema (sudden swelling of the face and neck caused by an allergic reaction) during any previous treatment with antibiotics.

Dysentery

The appearance of diarrhea during antibiotic treatment should not be treated without medical follow-up. Diarrhea can manifest while taking antibiotics, including cefoxitina, or after stopping them. If it becomes severe or persistent, or if you observe that your stools contain blood or mucus, contact your doctor immediately, as this can be life-threatening. Do not take medications that stop or slow down intestinal movements.

In case of doubt, consult with your doctor or pharmacist.

Neurological Alterations

As with all antibiotics in this therapeutic group, the administration of this medication may lead to a risk of encephalopathy (which can result in confusion, altered consciousness, seizures, abnormal movements) and, particularly, in the case of overdose or renal insufficiency. If any of these symptoms appear, inform your doctor or pharmacist immediately (see sections 3 and 4).

Renal Function

Inform your doctor if you have kidney disease, as your dose may need to be adjusted.

If you are taking other medications that are harmful to your kidneys or if you use diuretics, your doctor will monitor your renal function.

Laboratory Tests

Some laboratory test results may be altered during the taking of this medication.

Other Medications and Cefoxitina

Inform your doctor if you are using, have recently used, or may use other medications.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before taking this medication.

Pregnancy

Cefoxitina may be used during pregnancy only under the supervision of a doctor.

If you discover that you are pregnant while taking Cefoxitina, consult your doctor, as only they can decide whether you should continue treatment.

Breastfeeding

Stop breastfeeding while using this medication to avoid any allergic reaction in your baby.

Driving and Operating Machines

Cefoxitina has a significant influence on the ability to drive and operate machines, especially due to the possible appearance of encephalopathy (see sections 3 and 4).

Cefoxitina LDP-Laboratorios TORLAN contains Sodium.

This medication contains 50 mg of sodium (main component of table salt/for cooking) in each gram. This is equivalent to 2.5% of the maximum daily sodium intake recommended for an adult. This should be taken into account if you are following a controlled low-sodium diet.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor or another healthcare professional will administer this medication intravenously.

Recommended dose

Your doctor will decide the dose you need each day and how often the injections/infusions should be administered per day.

The usual dose is:

Adults and adolescents: 2 g every 4-6 hours up to a maximum of 12 g/day

Patients with kidney disease

If you have a kidney problem, your doctor may change your dose.

Use in children

There are not enough data to recommend a dosage in children under 11 years old.

How to use Cefoxitina LDP-Laboratorios TORLAN

Cefoxitina can be administered by slow intravenous injection over a period of 3 to 5 minutes.

It can also be administered by continuous intravenous infusion of a solution of this medication.

For instructions on reconstitution and dilution of the medication before administration, consult the information directed to healthcare professionals.

If you use more Cefoxitina LDP-Laboratorios TORLAN than you should

As with all antibiotics in this group, the administration of the medication may carry the risk of encephalopathy (which may lead to confusion, altered consciousness, convulsion, abnormal movements) and, particularly, in case of overdose or renal dysfunction. If any of these symptoms appear, consult your doctor or pharmacist immediately (see sections 2 and 4).

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

If you forgot to use Cefoxitina LDP-Laboratorios TORLAN

Do not take a double dose to make up for a missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Unknown frequency:

• Local reactions.
• Local vein inflammation with clot formation that may obstruct/impede intravenous administration.
• Fever, allergic reactions, Quincke's edema (sudden swelling of the face and neck caused by allergies), interstitial nephritis (kidney disease).
• Rash that appears to be caused by nettle stings (urticaria), itching, and rarely severe skin lesions.
• Nausea, vomiting, diarrhea, rare cases of pseudomembranous colitis (intestinal disease with diarrhea and abdominal pain) (see warnings and precautions).
• Blood abnormalities (eosinophilia, leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia, medullary hypoplasia), characterized by elevated levels of certain blood components (eosinophils) or a decrease in certain blood components, which may result in fever without apparent cause, nosebleeds, or gum bleeding, extreme paleness, or extreme fatigue. Contact your doctor as soon as possible.
• Increased levels of certain liver enzymes-elevated transaminases (AST, ALT), lactate dehydrogenase, alkaline phosphatase.
• Renal insufficiency, especially when certain medications are used at the same time (aminoglycosides, diuretics), which may result in abnormal blood test results (elevated creatinine and/or urea nitrate levels).
• Exacerbation of myasthenia gravis (muscular disease).
• Severe neurological disorders known as encephalopathy (which may result in confusion, altered consciousness, seizures, abnormal movements) and, particularly, in cases of high doses or renal dysfunction (see sections 2 and 3).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear 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 adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special conditions for conservation.

After reconstitution:

Chemical or physical stability has been demonstrated for use during 8 hours at 25°C and 2-8°C with injectable water. From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of conservation during use are the responsibility of the user.

After diluting the reconstituted solution with solvents:

Do not refrigerate

Chemical and physical stability has been demonstrated for use during 4 hours at 25°C.

From a microbiological point of view, if the dilution method does not rule out the risk of microbial contamination, the product should be used immediately.

If not used immediately, the times and conditions of conservation during use are the responsibility of the user.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. This will help protect the environment.

Composition of Cefoxitina LDP-Laboratorios TORLAN

-The active ingredient is cefoxitin sodium.

Each vial contains 1.0515 g of cefoxitin sodium equivalent to 1000 mg of cefoxitin.

Each vial contains 2.103 g of cefoxitin sodium equivalent to 2000 mg of cefoxitin.

Appearance of Cefoxitina LDP-Laboratorios TORLAN and packaging contents

Cefoxitina LDP-Laboratorios TORLANis a white or almost white powder.

Cefoxitina LDP-Laboratorios TORLAN is supplied in vials containing 1000 mg or 2000 mg of cefoxitin in the form of sodium salt, closed with a chlorobutyl rubber stopper and sealed with an aluminum cap with a polypropylene flip-off.

Cefoxitina LDP-Laboratorios TORLAN1 g powder for injectable solution and for infusion EFG is available in packs of 1, 5, 10, 20, 25, 50, and 100 vials.

Cefoxitina LDP-Laboratorios TORLAN2g powder for injectable solution and for infusion EFG is available in packs of 1, 5, 10, 20, 25, 50, and 100 vials.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer:

LDP LABORATORIOS TORLAN, S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Vallés

Barcelona

Spain

Local Representative
Laphysan, SAU
C/ Anabel Segura 11. Edificio A., Planta 4,.Puerta D
28108 Alcobendas
Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:

CEFOXITINE LDP-LABORATORIOS TORLAN 1g, powder for injectable solution/for infusion

CEFOXITINE LDP-LABORATORIOS TORLAN 2g, powder for injectable solution/for infusion

United Kingdom:

RENOXITIN 1 G POWDER FOR SOLUTION FOR INJECTION/ INFUSION

RENOXITIN 2 G POWDER FOR SOLUTION FOR INJECTION/ INFUSION

Last review date of this leaflet:April 2019

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

Medical Advice:

What should I know about antibiotics?

Antibiotics are effective against bacterial infections that are not caused by viruses.

Your doctor also chose to prescribe this antibiotic for you because it suits your particular case and current illness.

Some bacteria have the ability to survive and reproduce despite the action of the antibiotic. This phenomenon is known as resistance: which inactivates certain antibiotic treatments.

Resistance is the result of excessive or improper use of antibiotics.

You can promote the development of bacterial resistance and therefore, delay your recovery or even inactivate the medication, if you do not:

-Take the prescribed dose.

-Do not take it exactly as prescribed,

-Complete the entire treatment course.

Therefore, to preserve the effectiveness of this medication:

1. Do not use an antibiotic unless it has been prescribed by your doctor.
2. Take it exactly as prescribed.
3. Do not reuse an antibiotic without a prescription, even if you think you are treating a similar illness.
4. Never give your antibiotic to another person as it may not be suitable for their illness.
5. Once your treatment is complete, return any opened box to your pharmacist so they can dispose of the medication properly and appropriately.

The following information is intended only for healthcare professionals:

Preparation and administration of the reconstituted solution:

Cefoxitin can be reconstituted with 10 ml of water for injectable preparations. Immediately after reconstitution, this cefoxitin solution can be added to 40 ml of the following solutions, frequently used in infusions (1 g or 2 g in 50 ml of solution, corresponding to 20-40 mg/ml):

-Sodium Chloride 0.9%,

-Glucose 5% or 10%,

-Combined solution of glucose 5% and sodium chloride 9%,

-Glucose 5% buffered with sodium bicarbonate 0.02%

-Glucose 5% supplemented with saline solution 0.2% or 0.45%

-Lactate Ringer solution.

-Combined solutionof glucose at 5% and Ringer lactate,

-Combined solutionof fructose at 5% or 10% in water for injectable preparations,

-Fructose solution at 10% in saline solution,

-Sodium lactate solution at M/6.

This medicinal product can be administered together with other antibiotics (intravenously with separate syringes or in infusions).

When this medicinal product is administered at the same time as other antibiotics, these should not be mixed in the same syringe or infusion.

Reconstitution

Cefoxitin LDP-Laboratorios TORLAN should be reconstituted with water for injectable preparations: 1 g is soluble in 2 ml.

Cefoxitin LDP-Laboratorios TORLANis a very soluble medicine, for intravenous use, it is preferable to dissolve it in 10 ml of water for injectable preparations, both for the 1 g and 2 g doses in the vial. The solution should be shaken to dissolve the powder and once shaken, the contents of the vial should be extracted using a syringe.

Dilution

The reconstituted solution should be diluted with the solvents mentioned in section 6.6: add around 40 ml of the solvent to the reconstituted solution to reach a total volume of 50 ml.

The product should be used immediately after reconstitution/dilution.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.