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Ceridol
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- quick relief from pain
- reducing fever associated to common cold and flu
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CONTENT
What Ceridol looks like and contents of the pack Blister of white, opaque PVC/PVDC/Alu foil with 10 tablets. 10 (ten) tablets in a blister pack from PVC/PVDC white/aluminium foil. Each box contains a 1 or 2 blisters with and the package leaflet
Method of use
The recommended dose is: Adults: 1-2 tablets 1-3 times a day. Use in children over 12 years: 1 tablet 1-3 times a day.
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Package leaflet: Information for the patient
Ceridol
250 mg/150 mg/50 mg tablets
paracetamol/propyphenazone/caffeine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take 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 do not feel better or if you feel worse after 7 days.
What is in this leaflet
1. What Ceridol is and what it is used for
2. What you need to know before you take Ceridol
3. How to take Ceridol
4. Possible side effects
5. How to store Ceridol
6. Contents of the pack and other information
1. What Ceridol is and what it is used for
Ceridol is an analgesic medication. It is used to treat headache, toothache, menstrual pain, rheumatic and post-operative pains. Ceridol is administered for quick relief from pain and reducing fever associated to common cold and flu.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before you take Ceridol
Do not take Ceridol:
if you are allergic to active substances (paracetamol,propyphenazone, caffeine) or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to pyrazolones or derivatives of these compounds (hypersensitivity to phenazone, aminophenazone, metamizole);
if you are allergic to aspirin (acetylsalicylic acid) or phenylbutazone;
if you suffer from congenital glucose-6-phosphate dehydrogenase deficiency;
if you suffer from acute hepatic porphyria.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ceridol:
- if you have impaired liver function (for example in case of chronic alcohol abuse or of hepatitis);
- if you have kidney function;
- if you have Gilbert's syndrome (varying in intensity benign jaundice due to glucuronyl-transferase deficiency);
- if you have hematopoietic dysfunction.
If you take large amounts of Ceridol or any other analgesic containing paracetamol (acetaminophen) over a long period you may suffer kidney damage or even kidney failure.
You should keep in mind that if you continually take analgesics to treat headaches the headaches may become chronic.
If you have fever or pain lasting more than one week you should consult your doctor.
If you suffer from asthma, chronic colds or chronic hives, or if you are hypersensitive to other analgesic or antirheumatic medications you should take Ceridol only after consulting your doctor.
Respiratory problems and circulatory system reactions have been reported in persons taking medicines containing paracetamol (acetaminophen) or propyphenazone, particularly in susceptible individuals.
Children and adolescents
Ceridol do not use 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 acetaminophen. The same goes for alcohol abuse.
During the use of drugs that slow gastric emptying, such as. Propantheline, the rate of absorption of paracetamol may slow down, which analgesic effect may be delayed. The accelerated gastric emptying, for example. Metoclopramide after taking leads to faster absorption of paracetamol.
Combining with chloramphenicol extended elimination of the drug product with greater risk of toxicity.
Taking metoclopramide accelerates the rate of absorption. The clinical relevance of interactions between paracetamol and derivatives of warfarin or coumarin not been established. For this reason, regular long-term use of paracetamol to patients treated with oral antikoagulangi should be done only under medical supervision.
Concurrent use of Paracetamol and AZT (zidovudine) increases the disposition to neutropenia. Ceridol should therefore only be used concomitantly with AZT when supervised by a doctor.
Caffeine is an antagonist of many sedatives such as barbiturates, antihistamines and others. Caffeine enhances the tachycardia induced by sympathomimetics, thyroxine and the like. When substances with a wide range of operation (eg. Benzodiazepines) interactions may occur in many forms and are not predictable. Oral contraceptives, cimetidine and disulfiram decrease the metabolism of caffeine, while barbiturates and smoking it accelerated. 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 metabolites paraxanthine.
Although theoretically possible, no clinical evidence that caffeine increases the potential for addiction to painkillers drugs such as paracetamol.
Ceridol with food, drink and alcohol
Do not take analgesics such as Ceridol together with alcohol, or if you suffer from an alcohol related disorder.
Pregnancy, breast-feeding and fertility
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.
Do not take Ceridol during pregnancy and lactation without consulting a doctor.
Driving and using machines
Do not drive or operate hazardous machinery, as this medicine may cause drowsiness or decreased responsiveness to the recommended doses.
3. How to take Ceridol
Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults: 1 to 2 tablets 1-3 times daily.
Use in children over 12 years: 1 tablet 1-3 times daily.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Take the tablets with ample water or other fluid. Keep to the dosage specified by your doctor. If you think the effect of the medicine is too weak or too strong, talk to your doctor or pharmacist.
If you take more Ceridol than you should
In case of overdose, immediately consult your doctor. Depending on the degree of intoxication, he will decide what measures should be taken.
If you forget to take Ceridol
Do not take a double dose to make up for a forgotten 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.
The adverse events are presented according to MedDRA system organ classification within each frequency area and after decreasing degree of severity: Very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Respiratory, thoracic and mediastinal disorders
Very rare - Bronchospasm, asthma.
Blood and lymphatic system disorders
Very rare - Reducing in the count blood cells (thrombocytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia).
Gastrointestinal disorders
Rare - Nausea, vomiting, stomach upset, diarrhea and abdominal pain
Hepatobiliary disorders
Very rare - Changes in the liver and liver failure, hepatitis, dose-dependent liver failure, liver necrosis (including fatal outcomes). Chronic unapproved use can lead to liver fibrosis, cirrhosis of the liver, including fatal outcome.
Nervous system disorders
Dizziness, somnolence.
Renal and urinary disorders
Kidney damage especially in overdose.
Skin and subcutaneous tissue disorders
Serious skin reactions have been reported very rarely.
Itching, skin redness, rash, allergic edema (swelling) and angioedema, Stevens-Johnson Syndrome and toxic epidermal necrolysis and other.
Immune system disorders
Very rare - Hypersensitivity reactions, severe anaphylactoid reactions, anaphylactic shock.
If you notice similar effects, you should stop taking Ceridol and tell contact your doctor.
Reporting of side effects
If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects, not listed in this leaflet. You can also report adverse events directly through the national system for reporting directly to the Bulgarian Drug Agency, Damyan Gruev Str., No 8, 1303 Sofia, tel. +359 2 8903417, website www.bda.bg. Reporting adverse reactions, you can do your bit to obtain more information on the safety of this medicine.
5. How to store Ceridol
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 blistera and carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice of the visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. 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 Ceridol contains
- The active substances are: paracetamol (250 mg), propyphenazone (150 mg), caffeine (50 mg).
- The other ingredients (excipients) are: microcrystalline cellulose, magnesium stearate, silica colloidal anhydrous, talc.
What Ceridol looks like and contents of the pack
Blister of white, opaque PVC/PVDC/Alu foil with 10 tablets.
10 (ten) tablets in a blister pack from PVC/PVDC white/aluminium foil.
Each box contains a 1 or 2 blisters with and the package leaflet.
Marketing Authorisation Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10, Prohladen kat strеet,
1362 Sofia, Bulgaria
Date of last revision of the leaflet
August 2022
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What Ceridol contains
- The active substances are: paracetamol (250 mg), propyphenazone (150 mg), caffeine (50 mg).
- The other ingredients (excipients) are: microcrystalline cellulose, magnesium stearate, silica colloidal anhydrous, talc.
