CERIDOL 250mg/150mg/50mg x 20 tabl
What is CERIDOL and what is it used for?
CERIDOL is a medicinal product with analgesic effect. It is intended for the treatment of headache (including migraine, tension headache, neuralgia and sinus pain), toothache, menstrual, rheumatic, postoperative and muscle pain.
CERIDOL lowers fever and relieves pain from flu and colds.
If you do not feel better after 7 days or your condition worsens, you should seek medical attention.
2. What you need to know before you take CERIDOL
Do not take CERIDOL if:
you are allergic to the active substances (paracetamol, propyphenazone, caffeine) or to any of the other ingredients of this medicine (listed in section 6);
you are allergic (hypersensitive) to pyrazolones or similar substances
(hypersensitive to products containing phenazone, propyphenazone, aminophenazone, metamizole), to products containing phenylbutazone, or to acetylsalicylic acid;
you suffer from hereditary glucose-6-phosphate dehydrogenase deficiency (proven by hemolytic anemia);
if you have acute hepatic porphyria.
Warnings and precautions:
Talk to your doctor or pharmacist before taking CERIDOL:
if you have impaired liver function (for example, in cases of chronic alcohol abuse or hepatitis);
if you have impaired kidney function;
if you suffer from Gilbert's syndrome (benign jaundice of varying intensity due to glucuronyl transferase deficiency);
if you have hematopoietic dysfunction.
If you are treated with CERIDOL or other analgesics containing paracetamol for a long period of time, you may experience kidney damage and even irreversible kidney failure.
You should remember that if you take analgesics for a long time to treat a headache, it can become chronic.
If you have a fever or pain that lasts more than a week, consult a doctor.
If you have asthma, chronic rhinitis or skin rash, or are hypersensitive to other analgesics or antirheumatic drugs, you should only be treated with CERIDOL after consulting your doctor.
There have been reports of isolated cases of asthma attacks and anaphylactic shock (severe allergic reaction) associated with the use of preparations containing propyphenazone and paracetamol in sensitive patients.
Very rare cases of serious skin reactions have been reported. In case of skin redness, rash, blistering or peeling, stop taking paracetamol immediately and seek medical advice.
Children and adolescents
CERIDOL is not used in children under 12 years of age.
Other medicines and CERIDOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some hypnotics, antiepileptic drugs (e.g. phenobarbital, phenytoin and carbamazepine) and rifampicin may increase the liver toxicity of paracetamol. The same applies to alcohol abuse.
By delaying gastric emptying, for example with propantheline, the rate of absorption of paracetamol can be reduced and its onset of action delayed. Acceleration of gastric emptying, for example after administration of metoclopramide, enhances the rate of absorption.
Combining with chloramphenicol prolongs the elimination of the drug with a greater risk of toxicity.
Metoclopramide administration accelerates the rate of absorption. The clinical significance of interactions between paracetamol and warfarin or coumarin derivatives has not been established. For this reason, regular long-term use of paracetamol by patients treated with oral anticoagulants should only be carried out under medical supervision.
The incidence of neutropenia (low white blood cell count) is higher with concomitant use of paracetamol and AZT (zidovudine). For this reason, CERIDOL should only be used in combination with AZT after consulting a doctor.
Caffeine is an antagonist of many sedative substances such as barbiturates, antihistamines, etc. Caffeine enhances tachycardia induced by sympathomimetics, thyroxine, etc. With substances with a broad spectrum of action (e.g. benzodiazepines), interactions can occur in many forms and are unpredictable. Oral contraceptives, cimetidine and disulfiram reduce the metabolism of caffeine, while barbiturates and smoking accelerate it. Caffeine reduces the elimination of theophylline. Caffeine increases the potential for addiction to substances such as ephedrine. Concomitant use of some gyrase inhibitors may prolong the elimination of caffeine and its metabolite paraxanthine.
Although theoretically possible, there is no clinical evidence that caffeine increases the potential for addiction to painkillers such as paracetamol.
CERIDOL with food, drink and alcohol
Do not take painkillers such as CERIDOL at the same time as alcohol or if you suffer from alcohol-related impairment.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, you should not take CERIDOL unless you have the express permission of a doctor.
Driving and using machines
Some patients may experience dizziness or drowsiness when using paracetamol. Patients should be careful when performing activities requiring increased attention.
3. How to take CERIDOL
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dosage:
Adults: 1-2 tablets 1-3 times daily.
Use in children over 12 years of age: 1 tablet 1-3 times daily.
The score line is only to make breaking easier if you have difficulty swallowing the tablet whole.
The tablets should be taken with sufficient liquid. Stick to the dose indicated on the package or prescribed by the doctor. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Do not take CERIDOL in doses higher than those indicated in this leaflet. As with other analgesics, CERIDOL should not be used regularly for a long period of time unless you are under medical supervision.
Liver damage
Paracetamol is contraindicated in patients with severe hepatic insufficiency. Paracetamol should be used with caution in patients with mild to moderate hepatic insufficiency.
Kidney damage
Paracetamol should be used with particular caution in patients with severe renal insufficiency. Dosage adjustment may be necessary in patients with impaired renal function.
If you take more CERIDOL than you should
Please inform your doctor if you overdose on CERIDOL. Depending on the degree of intoxication, he will decide what measures to take.
If you forget to take CERIDOL
Do not take a double dose to make up for a missed dose.
If you stop taking CERIDOL
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.
Adverse reactions are classified by system organ class and frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (≤1/10,000), not known (frequency cannot be estimated from the available data).
Respiratory, thoracic and mediastinal disorders
Very rare - shortness of breath, asthma.
Blood and lymphatic system disorders
Very rare - decrease in the number of various types of blood cells (thrombocytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia).
Gastrointestinal disorders
Rare - nausea, vomiting, stomach discomfort, diarrhea and abdominal pain.
Hepatobiliary disorders
Very rare - liver damage, hepatitis, as well as dose-dependent liver failure, liver necrosis (including fatal outcome). Chronic use can lead to liver fibrosis, cirrhosis of the liver, including fatal outcome.
Nervous system disorders
Dizziness, drowsiness.
Kidney and urinary tract disorders
Very rare - kidney damage, especially in case of overdose.
Skin and subcutaneous tissue disorders
Very rare cases of serious skin reactions have been reported.
Itching, skin redness, rash, allergic edema and angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis and others.
Immune system disorders
Very rare - hypersensitivity reactions, severe anaphylactoid reactions, anaphylactic shock.
If you notice such effects, stop taking CERIDOL and tell your doctor immediately.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
The Executive Agency for Medicines
Damyan Gruev Str. No. 8
1303 Sofia
tel. +359 2 8903417
website: www.bda.bg
By reporting side effects, you can contribute to obtaining more information about the safety of this medicine.
4. How to store CERIDOL
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not use CERIDOL if you notice any visible signs of product deterioration.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What CERIDOL contains
The active ingredients in one tablet are: paracetamol 250 mg, propyphenazone 150 mg, caffeine 50 mg.
Excipients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, talc.