ORBENIN 125 mg/5ml ORAL SUSPENSION POWDER

Introduction

Leaflet: Information for the user

Orbenin 125 mg/5ml Powder for oral suspension

Cloxacillin (sodium)

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

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

Contents of the leaflet:

1. What is Orbenin and what is it used for
2. What you need to know before taking Orbenin
3. How to take Orbenin
4. Possible side effects
5. Storage of Orbenin
6. Package contents and additional information

1. What is Orbenin and what is it used for

This medicine contains cloxacillin, which is an antibiotic belonging to the penicillin family.

It is indicated in adults and children to treat uncomplicated skin and soft tissue infections, such as impetigo

2. What you need to know before taking Orbenin

Do not take Orbenin

• If you are allergic to cloxacillin or any other component of this medicine (listed in section 6).
• If you are allergic to penicillins.
• If you are allergic to cephalosporins. Although allergy to cephalosporins does not necessarily imply an allergy to this penicillin, it should be determined whether the patient has previously experienced immediate, moderate, or severe allergic reactions to a cephalosporin, in which case it is recommended to avoid using this penicillin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

-you are allergic to penicillins or cephalosporins. In patients allergic to cephalosporins, the possibility of cross-allergic reactions should be considered.

-during treatment, you suffer from pseudomembranous colitis (persistent and/or severe diarrhea during or after cloxacillin administration). If these symptoms appear, treatment should be discontinued.

-during a previous antibiotic treatment (even with another family of antibiotics), you have had any type of allergic reaction such as hives or other rashes, itching, sudden swelling of the face and neck.

-you have kidney or liver disease.

-you have a history of seizures and/or epilepsy, especially in patients with renal or hepatic impairment.

-if you are taking oral contraceptives, it is recommended to use an alternative, effective, and safe method during treatment and up to one week after treatment, as the use of Cloxacillin and combined oral contraceptives may reduce the effectiveness of the contraceptive.

Interference with analytical tests

If you are going to undergo any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Children

This medicine should be administered with caution in neonates due to the risk of hyperbilirubinemia due to competition at the bilirubin binding sites to serum proteins. See section 3 for the dose in this population.

Use of Orbenin with food

The oral suspension should be spaced at least 1 hour before or 2 hours after food intake.

Other medicines and Orbenin

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those purchased without a prescription. It is especially important to inform your doctor if you are taking:

• Methotrexate, which is a medicine indicated for some forms of arthritis and for the treatment of psoriasis.

• Other antibiotics (medicines used for infections caused by bacteria), such as chloramphenicol, tetracyclines, macrolides, or sulfonamides. These antibiotics may decrease the effect of Orbenin.
• Aminoglycosides, as treatment should be administered separately from Orbenin.

• Probenecid, which is a medicine for the treatment of gout, as it may increase the effect of Orbenin.
• Warfarin or other anticoagulant medicines.
• Oral contraceptives, as Orbenin suspension may decrease the contraceptive effectiveness. It is recommended to use an alternative, effective, and safe method during treatment and up to 1 week after treatment.

Pregnancy, breastfeeding, and fertility

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

This medicine passes into breast milk. Consult your doctor before breastfeeding your baby.

Treatment should be discontinued in case of diarrhea, candidiasis, or skin rashes in the baby.

Driving and using machines

There is no evidence of effects on the ability to drive or use machines.

Orbenin contains sodium:

This medicine contains less than 1 mmol of sodium (23mg) per 5ml; this is essentially "sodium-free".

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 5 mg of sodium benzoate in each 5 ml of suspension. The salt of benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Orbenin

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Use in children

With normal kidney function:

Children under 2 years: 5 ml (125mg of cloxacillin (sodium)), 1 spoonful every 6 hours.

Between 2 and 10 years: 10 ml (250mg of cloxacillin (sodium)), 2 spoonfuls every 6 hours.

The dosage in children with renal and/or hepatic insufficiency has not been sufficiently studied.

If there is an association between hepatic and renal insufficiency, the daily dose should be reduced by half.

Adults, elderly patients, and children over 10 years:

It is recommended to administer in hard capsules of 500mg.

It should be administered preferably on an empty stomach (1 hour before or 2 hours after meals).

Instructions for preparing the suspension:

Invert the position of the bottle to loosen the powder adhering to its bottom.

Add a little water and shake. Fill with water up to the line marked by the arrow. Shake before use.

If you take more Orbenin than you should

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

If you forget to take Orbenin

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

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

4. Possible side effects

Like all medicines, Orbenin can cause side effects, although not everyone gets them.

Very rare frequency (may affect up to 1 in 10,000 people): Severe skin redness, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Frequency not known (frequency cannot be estimated from the available data):

-Allergic reactions on the skin: itching, skin rash, hives.

-Diarrhea, nausea, and vomiting

-Decrease in the number of neutrophils and platelets in the blood

-Neurological symptoms: seizures (disorder of mental status accompanied by muscle contractions). This effect is more frequent in people with significantly impaired renal function.

-Jaundice (yellowing of the skin), increased liver enzyme values, and hepatitis (inflammation of the liver).

Also, in subjects sensitized to penicillins, allergic reactions such as swelling of the face, lips, mouth, tongue, or throat may occur, which can cause difficulty swallowing or breathing (angioedema).

Gastrointestinal tract disorders such as severe or persistent diarrhea, or if blood or mucus is observed in the stool.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Orbenin

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

Orbenin 125 mg/5ml Powder for oral suspension: Store in a dry place.

Once reconstituted, the validity period is 7 days in a refrigerator at 4°C to 8°C.

Do not use this medicine after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Orbenin 125mg Powder for oral suspension

The active ingredient is cloxacillin (sodium).

The other ingredients are:

Sodium benzoate, sodium citrate, disodium edetate, ammonium glycyrrhizate, sodium glutamate, tutti-fruti flavor, orange flavor, mint flavor, sodium saccharin, and sucrose.

Appearance of the product and package contents

Each box contains a bottle of powder for reconstitution and a 5ml spoon. Once reconstituted, it contains 60 ml of oral suspension. Each 5 ml spoonful contains 125mg of cloxacillin.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio Reig Jofré, S.A.

Jarama 111 - 45007

Toledo (Spain)

Date of the last revision of this leaflet: January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/