Orbenin 125 mg/5 ml powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orbenin 125 mg/5ml Powder for oral suspension

Cloxacillin (sodium)

Read this entire leaflet carefully before you start taking the medicine, because it contains important information for you.

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

Leaflet contents:

1. What Orbenin is and what it is used for
2. What you need to know before taking Orbenin
3. How to take Orbenin
4. Possible adverse effects
5. How to store Orbenin
6. Contents of the pack and other information

1. What Orbenin is and what it is used for

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

It is indicated in adults and children for the treatment of uncomplicated skin and soft tissue infections, such as impetigo.

2. What you need to know before starting to take Orbenin

Do not take Orbenin

• If you are allergic to cloxacillin or to any of the other ingredients 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 allergy to this penicillin, it is advisable to determine whether the patient has previously experienced immediate, moderate or severe allergic reactions to a cephalosporin, in which case it would be recommended to avoid using this penicillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

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

• You develop pseudomembranous colitis during treatment (persistent and/or severe diarrhoea during or after administration of cloxacillin). If these symptoms occur, treatment should be discontinued.

• You have previously experienced any type of allergic reaction during or after prior antibiotic treatment (even with another antibiotic class), such as urticaria 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.

• You are taking oral contraceptives. An alternative, effective and safe contraceptive method is recommended during treatment and for one week after, as concomitant use of cloxacillin and combined oral contraceptives may reduce contraceptive efficacy.

Interference with diagnostic tests

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

Children

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

Taking Orbenin with food

The oral suspension should be taken at least 1 hour before or 2 hours after meals.

Other medicines and Orbenin

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

• Methotrexate, a medicine used for certain forms of arthritis and treatment of psoriasis.

• Other antibiotics (medicines used to treat bacterial infections), such as chloramphenicol, tetracyclines, macrolides, or sulfonamides. These antibiotics may reduce the effect of Orbenin.

• Aminoglycosides, as treatment should be administered separately from Orbenin.

• Probenecid, a medicine used to treat gout, which may increase the effect of Orbenin.

• Warfarin or other anticoagulant medicines.

• Oral contraceptives, as Orbenin suspension may reduce contraceptive efficacy. An alternative, effective and safe contraceptive method is recommended during treatment and for one week after treatment.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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.

Treatment should be discontinued if diarrhoea, candidiasis, or skin rashes occur in the breastfed infant.

Driving and using machines

There is no evidence of effects on the ability to drive or operate machinery.

Orbenin contains sodium:

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

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

This medicine contains 5 mg of sodium benzoate in each 5 ml of suspension. Benzoic acid salts 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 exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Use in children

With normal kidney function:

Under 2 years: 5 ml (125 mg of cloxacillin (sodium)), 1 teaspoon every 6 hours.

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

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

If hepatic and renal insufficiency occur together, the daily dose should be reduced by half.

Adults, elderly patients, and children over 10 years:

Administration in 500 mg hard capsules is recommended.

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

Instructions for preparing the suspension:

Invert the bottle to loosen any powder adhering to its bottom.

Add a small amount of water and shake. Then add water up to the level marked by the arrow. Shake well 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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Orbenin

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

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

4. Possible adverse effects

Like all medicines, Orbenin can cause adverse effects, although not everyone experiences them.

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

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

• Skin allergic reactions: pruritus, cutaneous rash, urticaria.

• Diarrhea, nausea, and vomiting.

• Decreased number of neutrophils and platelets in the blood.

• Neurological symptoms: seizures (mental state disorder accompanied by muscle contractions). This effect is more frequent in individuals with markedly reduced kidney function.

• Jaundice (yellowing of the skin), increased liver enzyme levels, and hepatitis (liver inflammation).

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Orbenin

Keep this medicine out of sight and reach of children.

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

After reconstitution, the shelf life is 7 days when stored in the refrigerator at 4°C to 8°C.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orbenin 125mg Powder for oral suspension

The active substance is cloxacillin (sodium).

The other components are:

Sodium benzoate, sodium citrate, disodium edetate, ammonium glycyrrhizinate, sodium glutamate, tutti frutti flavour, orange flavour, mint flavour, sodium saccharin and sucrose.

Nature of the product and contents of the container

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio Reig Jof ré, S.A.
Jarama 111 - 45007
Toledo (Spain)

Date of the most recent review of this leaflet: January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/