Denk Pharma
Suppository – rectal use
Analgesic and antipyretic medicine
Active substance: paracetamol
For use in children aged between 2 and 8 years
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you or your child do not feel better or if you feel worse after 3 days.
WHAT IS IN THIS LEAFLET
What Para-Denk Suppos is and what it is used for
What you need to know before you use Para-Denk Suppos
How to use Para-Denk Suppos
Possible side effects
How to store Para-Denk Suppos
Contents of the pack and other information
1. WHAT PARA-DENK SUPPOS IS AND WHAT IT IS USED FOR
Para-Denk Suppos is a painkiller (analgesic) and a medicine to reduce fever (antipyretic).
Para-Denk Suppos is used in the symptomatic treatment of mild to moderate pain and/or fever.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARA-DENK SUPPOS
Do not use Para-Denk Suppos
if you or your child are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Para-Denk Suppos.
Only use Para-Denk Suppos after consulting your doctor:
if you or your child suffer from chronic alcoholism
if you or your child suffer from impaired liver function (such as inflammation of the liver, Gilbert's syndrome)
if you or your child have pre-existing kidney damage
if you or your child are currently taking medicines that impair liver function
if you or your child have a hereditary condition called glucose-6-phosphate dehydrogenase deficiency, which can lead to severe anaemia (also known as favism)
if you or your child have haemolytic anaemia (caused by a breakdown of red blood cells)
if you or your child have a deficiency of glutathione, a protein involved in liver metabolism (e.g. due to malnutrition, alcohol abuse, or conditions associated with a reduced level of glutathione; if appropriate adjust the dosage e.g. in diabetes, HIV, Down's syndrome, cancer)
if you or your child are lacking in body fluids (dehydration), e.g. caused by not drinking enough, diarrhoea or vomiting
if you or your child have chronic malnutrition
if you or your child weigh less than 50 kg
if you are elderly.
If your symptoms worsen or if you do not notice an improvement after 3 days or if you develop a high temperature, then you must consult your doctor.
In order to avoid the risk of an overdose, you should make sure that any other medication being taken concurrently does not contain paracetamol.
Prolonged, incorrect use of high doses of painkillers may cause headache, which must not be treated with increased doses.
In general, the habitual intake of painkillers, particularly in combination with other painkillers, may lead to permanent kidney damage associated with the risk of renal failure (analgesic nephropathy).
If high doses of painkillers that have been incorrectly used for prolonged periods of time are discontinued abruptly, headache, fatigue, muscle pain, nervousness or vegetative symptoms may occur. These withdrawal symptoms abate within a few days. Until then, painkillers should not be used and should not be taken again without consulting your doctor beforehand.
Para-Denk Suppos should not be used over long periods or at high doses without consulting your doctor or dentist.
Single administration of the total daily dose can lead to severe liver damage; in such cases, medical help should be sought immediately.
Other medicines and Para-Denk Suppos
Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other medicines.
Interactions are possible with:
drugs to treat gout, such as probenecide: the dosage of Para-Denk Suppos should be reduced when co-administered with probenecide, as concomitant use may slow down the breakdown of Para-Denk Suppos.
sleeping pills, such as phenobarbital, drugs to treat epilepsy, such as phenytoin, carbamazepine, drugs to treat tuberculosis (rifampicin), other drugs that may cause damage to the liver. Concomitant use with Para-Denk Suppos may cause liver damage.
drugs to reduce elevated serum lipids (cholestyramine) may reduce the absorption and thus the effect of Para-Denk Suppos.
drugs given for HIV infections (zidovudine): there is an increased risk of reduction in the number of white blood cells (neutropenia). Para-Denk Suppos should therefore only be used concomitantly with zidovudine upon medical advice.
flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis, malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
repeated use of paracetamol over a period longer than one week increases the effect of anticoagulants, especially warfarin. Long-term use of paracetamol in patients treated with anticoagulants should only be undertaken under medical supervision. Occasional use of paracetamol has no significant effect on one's tendency to bleed.
How using Para-Denk Suppos affects laboratory tests
Uric acid and blood sugar determination may be affected.
Para-Denk Suppos with alcohol
Para-Denk Suppos should not be used or administered with alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If necessary, Para-Denk Suppos can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.
You should therefore not take Para-Denk Suppos during pregnancy for a prolonged period, at high doses or in combination with other medicines, as its safety in such cases has not been established.
Contact your doctor, pharmacist or midwife before taking any medicine. This also applies if your pain and/or fever have not been relieved or if you are needing to use Para-Denk Suppos more frequently.
Breast-feeding
Paracetamol passes into human milk. As it is not known to be harmful to the infant, discontinuation of breast-feeding is generally not necessary.
Driving and using machines
Para-Denk Suppos does not affect the ability to drive and operate machinery. However, caution should always be exercised after taking painkillers.
Para-Denk Suppos contains soya lecithin
If you are allergic to peanut or soya, do not use this medicinal product.
3. HOW TO USE PARA-DENK SUPPOS
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The dosage complies with the specifications in the following table. The dosage of paracetamol administered depends upon body weight and age.
The usual dose is 10–15 mg per kg body weight as a single dose and up to a maximum of 60 mg/kg body weight as total daily dose.
The interval between doses depends on the symptoms and the maximum total daily dose and should be at least 6 hours.
A doctor should be consulted if symptoms persist for longer than 3 days.
Children with low body weight
Use of Para-Denk 250 Suppos is not recommended in children under the age of 2 years and/or in those with a body weight of less than 13 kg, as this dosage strength is not suitable for this age group. However, there are suitable dosage strengths and/or pharmaceutical forms available for this age group.
If you use more Para-Denk Suppos than you should
The total daily dose of paracetamol should not exceed 4,000 mg in adults and adolescents over 12 years of age (body weight of at least 43 kg) and 60 mg/kg/day in children.
In the case of an overdose, complaints such as nausea, vomiting, loss of appetite, pallor and tummy-ache usually occur within 24 hours.
If more Para-Denk Suppos than recommended has been used, ask the doctor nearest to you to come to your assistance.
If you forget to use Para-Denk Suppos
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare: may affect up to 1 in 1,000 people
Slight increase in certain liver enzymes (serum transaminases).
Very rare: may affect up to 1 in 10,000 people
Changes in blood counts, such as a reduced number of blood platelets (thrombocytopenia) or a significant reduction in white blood cells (agranulocytosis).
Constriction of the respiratory tract (analgesic-induced asthma) in predisposed people.
Allergic reactions ranging from a simple rash or urticaria to shock. If you experience an allergic shock reaction call the nearest doctor for help.
Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised pustular exanthema).
Cases of blood and fluid abnormality (high anion gap metabolic acidosis), which occur when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).
Reporting of side effects
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARA-DENK SUPPOS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister strip after "Exp.". The expiry date refers to the last day of that month.
Shelf life: 3 years
Store below 30°C.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Para-Denk 250 Suppos contains
The active substance is paracetamol.
Each suppository contains 250 mg paracetamol.
The other ingredients are hard fat and soya lecithin.
General classification for supply
OTC product
What Para-Denk 250 Suppos looks like and contents of the pack
Para-Denk 250 Suppos are ivory-coloured, torpedo-shaped suppositories.
Available in PVC/PE blisters.
Pack size: 10 suppositories.
Marketing Authorisation Holder
DENK PHARMA GmbH & Co. KG
Prinzregentenstr. 79
81675 München
Germany
Manufacturer of bulk, packaging and batch release
RubiePharm Arzneimittel GmbH
Brüder-Grimm-Straße 62
36396 Steinau an der Straße
Germany
This leaflet was last revised in 05/2022.