Empaped ® 125 mg Suppository

EMPAPED ® is a medicine relieving mild to moderate pain and reducing fever (analgesic and antipyretic), when oral treatment is not possible.

Do not use EMPAPED ® suppositories:

• If you are or your child is hypersensitive (allergic) to paracetamol or to any of the other ingredients of the suppositories (listed in section 6).

Warnings and precautions

Take special care with EMPAPED ®:

• if you or your child suffers from chronic alcoholism,
• if you have or your child has an impaired liver function (inflammation of the liver, Gilbert’s syndrome),
• in case of pre-existing damage to the kidneys,
• with concomitant use of medicines impairing the liver function,
• in case of hereditary deficiency of the enzyme glucose-6-phosphate dehydrogenase, which can lead to severe anemia, also called favism,
• in case of hemolytic anemia (anemia due to red blood cell disintegration),
• in case of deficiency of the protein involved in liver metabolism, glutathione (for example malnutrition, alcohol abuse),
• in case of a lack of fluid in the body (dehydration) e.g. due to drinking low volume of fluids, diarrhoea or vomiting,
• in case of chronic malnutrition,
• with a body weight of less than 50 kg,
• at a higher age,
• in the presence of diseases associated with reduced glutathione levels (dose adjustment e.g. in diabetes mellitus, HIV, Down’s syndrome, tumours (cancers), if applicable)

Under these circumstances, you should ask for your doctor’s advice before you or your child uses EMPAPED ®. You must contact a doctor if your symptoms or the symptoms of your child worsen or do not improve after 3 days or in case of high fever. To avoid the risk of overdose, make sure that concurrently used medicines do not contain paracetamol. The prolonged improper use of large doses of pain killers may cause headache which must not be treated with increased doses of the product concerned. In general, the habitual use of painkillers, above all of those containing more than one active ingredient, may lead to permanent damage to the kidney, which might result in renal failure (analgesic nephropathy). Headache, tiredness, muscular pain, nervousness and vegetative symptoms may result from the abrupt removal of pain killers taken in large amounts for extended periods of time or not used properly. Such withdrawal symptoms subside after a few days. No pain killer should be taken within this period. A medical practitioner should be consulted before resuming treatment. EMPAPED ® should not be used for long periods of time or in large doses without a medical practitioner’s or a dentist’s advice.

Do not share medicines prescribed for you with any other person. Always use EMPAPED ® exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are unsure. The dose of paracetamol depends on the patient’s age and body weight. The usual single dose is 10 to 15 mg/kg, the maximum daily dose 60 mg/kg body weight. The dosage interval depends on the symptoms and the maximum daily dose. It should be at least six hours. The usual dose is:

• Infants (6 months to 2 years): One 125 mg suppository up to 4 times daily.
• Children (2 to 8 years): One 250 mg suppository up to 4 times daily.

How to insert a suppository:

• Ensure that the suppository feels hard in its foil wrapper. If it feels soft, hold the sealed wrapper in cold water until it hardens. (The suppositories may be warmed up in the hands or dipped briefly in warm water to improve their sliding properties).
• Remove the outer foil wrapper.
• Lay your child on his / her left side and raise the right knee to his / her chest.
• Insert the suppository; tip first, into the rectum for 1 – 2 cm. Hold in place for a few seconds.

Duration of treatment

EMPAPED ® should not be used for more than three days without consulting a doctor.

Special patient groups

Disorders of liver function and slightly impaired kidney function: In patients with disorders of liver or kidney function or Gilbert’s syndrome, the dose of EMPAPED ® should be reduced and the dosage interval should be increased. A total daily dose of 2 g must not be exceeded without medical advice. Severe kidney failure: In the presence of severe kidney failure (GFR < 30 ml/min), the dosage interval should be at least eight hours. Elderly patients: Experience has shown that no special dose adjustment is required. However, in weakened, immobilised elderly patients with impaired hepatic or renal function, a dose reduction or prolongation of the dosing interval may be required. Without medical advice, the maximum daily dose of 60 mg/kg body weight (up to a maximum of 2 g/day) should not be exceeded with:

• Body weight less than 50 kg
• Chronic alcoholism
• Dehydration
• Chronic malnutrition

Children and adolescents with low body weight: The use of EMPAPED ® 125 mg suppositories in children below the age of six months or weighing less than 7 kg, or EMPAPED ® 250 mg in children under two years or weighing less than 13 kg, is not recommended. Please tell your doctor or pharmacist if you feel that the effect of Empaped ® is too strong or too weak.

If you use more EMPAPED ® than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. To avoid the risk of overdosage, make sure that no other product containing paracetamol is being used concurrently. In children, the total daily dose must not exceed 60 mg paracetamol/kg body weight (see Special patient groups above). In general, overdosage leads to nausea, vomiting, lack of appetite, paleness and abdominal pain within 24 hours. Immediately seek medical assistance, if an amount exceeding the maximum dose of EMPAPED ® has been used.

If you forget to use EMPAPED ® Give the next dosage as soon as you remember, and the following dosage more or less 6 hours thereafter. Do not give a double dose to make up for forgotten individual doses.

EMPAPED ® can have side effects. If any of the following happens, stop using EMPAPED ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting or shock

Side effects are reported with the following incidence rates:

Less frequent:

• mild increase in certain liver enzymes (serum transaminases)
• Changes to the blood count manifested as a decrease in the number of blood platelets (thrombocytopenia) or an intense decrease in white blood cells (agranulocytosis)
• Constriction of the airways in sensitive persons

Not all side effects reported for EMPAPED ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EMPAPED ®, please consult your health care provider for advice.

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

Reporting of side effects

If you or your child get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of EMPAPED ®.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Do not use this medicine after the expiry date printed on the container.
• Keep the foil strips in the outer container.
• Do not store in a bathroom.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).