Metpen Oral Solution

The name of your medicine is METPEN 125 mg/5 mL and 250 mg/5 mL Powder for oral solution. It is available in two strengths as powder for reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding water to the powder to give 100 ml of oral solution. The strength you are given will be decided by your doctor.

METPEN contains the active substance called Phenoxymethylpenicillin potassium which belongs to the group of medicines called penicillins, which are used to kill bacteria that cause infections in your body.

METPEN is used to:

• treat bacterial infections of the ear, throat, respiratory tract, skin and soft tissues
• prevent infections such as rheumatic fever or chorea (an abnormal involuntary movement disorder) recurring

Do not take METPEN:

• if you are hypersensitive (allergic) to phenoxymethylpenicillin potassium, cephalosporin or any of the other ingredients of METPEN (listed in section 6).
• if you have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic.

Warnings and precautions

Take special care with METPEN:

• If you suffer from any stomach problems e.g. vomiting
• If you suffer from any kidney problems
• If you suffer from allergies and/or asthma

Other medicines and METPEN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

• Anticoagulants (medicines that prevent clotting of blood),
• Methotrexate (medicine used to treat cancer and psoriasis)
• Sulfinpyrazone or Probenecid (medicines used to treat gout)
• Oral Typhoid vaccine (penicillin can stop this working)
• Chloramphenicol and Tetracyclines (broad spectrum antibiotics).
• Neomycin which can result in decreased absorption of METPEN.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking METPEN.

Driving and using machines

It is not always possible to predict to what extent METPEN may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which METPEN affects them.

Do not share medicines prescribed for you with any other person. Always take METPEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

1. Streptococcal infections:
   • Adults: 125 to 250 mg every 4 hours
   • Children: upto 1 year 60 mg every 6 hours
   • 1 to 5 years: 125 mg every 6 hours
   • 6 to 12 years: 250 mg every 6 hours
2. Rheumatic fever prophylaxis: 125 mg every 12 hours.

Direction for reconstituting; 100 mL syrup. Add 65 mL water and shake well to dissolve. Shake the bottle well before use.

Duration of administration: Your doctor will tell you how long your treatment with METPEN.

Method of administration: Shake the bottle well before use.

If you take more METPEN than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take METPEN: Do not take a double dose to make up for forgotten individual doses.

If you stop taking METPEN: Do not stop treatment early because if you feel better. If you have the impression that the effect of METPEN is too strong or too weak, tell your doctor or pharmacist.

METPEN can have side effects. Not all side effects reported for METPEN are included in this leaflet. If your general state of health worsens while taking this medicine, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking METPEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction - symptoms may include: shortness of breath, skin rash or itching, hives, swelling of the skin (especially of the lips, face or tongue), chills or fever, painful joints,
• severe peeling/blistering of the skin,
• serum sickness - like reactions (characterised by fever, chills, joint pains and oedema),
• seizures,
• profuse watery diarrhoea usually with blood and mucus, stomach pain and fever.

These are very serious side effects. If you have them, you may have had a serious reaction to METPEN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• pins and needles or numbness
• nausea, vomiting

Less frequent side effects:

• infections or fever (may be caused by low white blood cells)
• anaemia (may cause lack of energy or tiredness)
• jaundice (yellowing of skin or whites of the eyes)
• kidney problems, which might cause blood in the urine or reduced amounts of urine

Side effects with frequency unknown:

• problems with blood clotting (unusual bleeding or bruising)
• sore mouth
• sore throat
• black hairy tongue
• rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered heart disease (Kounis syndrome)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of METPEN.

Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected].

Store all medicines out of reach of children.

Unconstituted powder: Store in a dry place at or below 25 °C.

Reconstituted oral solution: Store for 7 days in a refrigerator.

Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).