CEFOXITINE LDP LABORATORIOS TORLAN 1 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

1. What is Cefoxitin LDP-Laboratorios TORLAN and what is it used for

Cefoxitin is a beta-lactam antibiotic of the second-generation cephalosporin group.

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

Cefoxitin is indicated for:

• Complicated urinary tract infections.
• Pyelonephritis.

Cefoxitin may be particularly useful in intra-abdominal infections and in some gynecological infections.

2. What you need to know before you use Cefoxitin LDP-Laboratorios TORLAN

Do not use Cefoxitin LDP-Laboratorios TORLAN

• If you are allergic to cefoxitin or to any other antibiotic of the cephalosporin group or to any of the ingredients of this medicinal product (listed 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, monobactams and carbapenems).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with Cefoxitin.

Allergic reactions

You should immediately inform your doctor if you experience any symptoms of an allergic reaction (rash, itching...) during treatment. If a severe allergic reaction occurs, administration of Cefoxitin should be discontinued. Before starting this treatment, inform your doctor if you have ever had urticaria or any other type of rash, itching, edema (sudden swelling of the face and neck caused by an allergic reaction) during any previous treatment with antibiotics.

Diarrhea

The onset of diarrhea during antibiotic treatment should not be treated without medical supervision. Diarrhea can occur while you are taking antibiotics, including cefoxitin, or after you have stopped taking them. If it becomes severe or persistent, or you notice 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 bowel movements.

In case of doubt, consult your doctor or pharmacist.

Neurological disorders

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

Kidney 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 kidney function.

Laboratory tests

Some laboratory test results may be altered during treatment with this medicinal product.

Other medications and Cefoxitin

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

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

Breastfeeding

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

Driving and using machines

Cefoxitin has a major influence on the ability to drive and use machines, especially due to the possible onset of encephalopathy (see sections 3 and 4).

Cefoxitin LDP-Laboratorios TORLAN contains sodium

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

3. How to use Cefoxitin LDP-Laboratorios TORLAN

Follow exactly the instructions for administration of this medicinal product as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Your doctor or another healthcare professional will administer this medicinal product to you by intravenous route.

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 kidney problems, your doctor may change your dose.

Use in children

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

How to use Cefoxitin LDP-Laboratorios TORLAN

Cefoxitin 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 medicinal product.

For instructions on reconstitution and dilution of the medicinal product before administration, see the information intended for healthcare professionals.

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

As with all antibiotics belonging to this therapeutic group, administration of this medicinal product may carry the risk of encephalopathy (which can lead to confusion, altered consciousness, convulsions, abnormal movements) and, particularly, in case of overdose or renal failure. 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, telephone: 91 562 04 20, indicating the medicinal product and the amount ingested.

If you forget to use Cefoxitin LDP-Laboratorios TORLAN

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

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

4. Possible side effects

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

Frequency not known:

• Local reactions.
• Local inflammation of the vein with clot formation that can 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 looks like it is caused by nettle sting (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, bone marrow hypoplasia), characterized by an increase in certain blood components (eosinophils) or a decrease in certain blood components that can result in unexplained fever, nosebleeds or bleeding gums, pallor or extreme fatigue. Contact your doctor as soon as possible.
• Increased levels of certain liver enzymes - transient elevation of transaminases (AST, ALT), lactate dehydrogenase, alkaline phosphatase.
• Kidney failure, especially when certain medications are used at the same time (aminoglycosides, diuretics), which can lead to abnormal blood test results (elevated creatinine and/or urea levels).
• Exacerbation of myasthenia gravis (muscle disease).
• Serious neurological disorders known as encephalopathy (which can lead to confusion, altered consciousness, convulsions, abnormal movements) and, particularly, in case of high doses or renal failure (see sections 2 and 3).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Cefoxitin LDP-Laboratorios TORLAN

Keep the medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicinal product does not require any special storage conditions.

After reconstitution:

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

After dilution of the reconstituted solution with the solvents:

Do not refrigerate

Chemical and physical stability has been demonstrated for 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 in-use storage times and conditions are the responsibility of the user.

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

Composition of Cefoxitin LDP-Laboratorios TORLAN

-The active substance 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 Cefoxitin LDP-Laboratorios TORLAN and contents of the pack

Cefoxitin LDP-Laboratorios TORLAN is a white or almost white powder.

Cefoxitin 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.

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

Cefoxitin LDP-Laboratorios TORLAN 2g powder for solution for injection and infusion EFG is available in packs of 1, 5, 10, 20, 25, 50 and 100 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

LDP LABORATORIOS TORLAN, S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Vallés

Barcelona

Spain

Local Representative Laphysan, SAUC/ Anabel Segura 11. Edificio A., Planta 4,.Puerta D28108 AlcobendasMadridSpain

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

France:

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

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

United Kingdom:

RENOXITIN 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION

RENOXITIN 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION

Date of last revision of this leaflet:April 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es

Medical advice:

What should you know about antibiotics?

Antibiotics are effective against infections caused by bacteria and do not work against infections caused by viruses.

Your doctor has also chosen to prescribe this antibiotic for you as it is suitable for 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 can render certain antibiotic treatments ineffective.

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

You can promote the development of bacterial resistance and thus delay your recovery or even render the medicinal product ineffective if you do not:

-Take the prescribed dose.

-Take it exactly as prescribed,

-Complete the entire course of treatment.

Therefore, to preserve the efficacy of this medicinal product:

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 disease that seems similar.
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 open packaging to your pharmacist so that they can dispose of the medicinal product in a correct and appropriate manner.

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 injections. 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 0.9%,

-Glucose 5% buffered with sodium bicarbonate 0.02%,

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

-Ringer's lactate solution.

-Combined solution of glucose 5% and Ringer's lactate,

-Combined solution of fructose 5% or 10% in water for injections,

-Fructose 10% solution in saline solution,

-Sodium lactate solution M/6.

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

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

Reconstitution

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

Cefoxitin LDP-Laboratorios TORLAN is a very soluble medicinal product, for intravenous use, it is preferable to dissolve it in 10 ml of water for injections, for both 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 withdrawn using a syringe.

Dilution

The reconstituted solution should be diluted with the solvents mentioned in section 6.6: add approximately 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.

Disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.