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  Ceridol

10 tablets
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.
GENERAL INFORMATION

Package Leaflet: Patient Information

Ceridol 250 mg/150 mg/50 mg таблетки
Ceridol 250 mg/150 mg/50 mg tablets

paracetamol / propipenazone / caffeine
paracetamol / propyphenazone / caffeine

Read all of this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may have to read it again.
  • If you need more information or advice, ask your pharmacist.
  • Ако получите някакви нежелани реакции, уведомете Вашия лекар или фармацевт.

Това включва и всички възможни нежелани реакции, неописани в тази листовка. Вижте точка 4.

  • If after 7 days you do not feel better or your condition gets worse, you should seek medical attention.

What this leaflet contains:

  1. Какво представлява Церидол и за какво се използва
  2. Какво трябва да знаете, преди да приемете Церидол
  3. Как да приемате Церидол
  4. Possible side effects
  5. Как да съхранявате Церидол
  6. Packaging content and additional information

 

  1. Какво представлява Церидол и за какво се използва

Тseridol is an analgesic. It is designed to treat headaches, toothache, menstrual, rheumatic and post-operative pains. Ceriodol lowers the temperature and relieves cold pain.

If after 7 days you do not feel better or your condition gets worse, you should seek medical attention.

  1. Какво трябва да знаете, преди да приемете Церидол

 Do not take Tseriodol:

  • ако сте алергични към активните вещества (парацетамол, пропифеназон, кофеин) или към някоя от останалите съставки на това лекарство (изброени в точка 6);
  • ако сте алергични (свръхчувствителни) към пиразолони или сходни вещества

(свръхчувствителни към продукти, съдържащи феназон, пропифеназон, аминофеназон, метамизол), към продукти, съдържащи фенилбутазон, или към ацетилсалицилова киселина;

  • ако страдате от наследствена глюкозо-6-фосфатна дехидрогеназна недостатъчност (доказана от хемолитична анемия);
  • ако имате остра чернодробна порфирия.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Tseridol:

  • ако имате нарушена чернодробна функция (например в случаи на хронична злоупотреба с алкохол или при хепатит);
  • ако имате нарушена бъбречна функция;
  • ако страдате от синдром на Жилбер (различна по интензитет доброкачествена жълтеница, вследствие на глюкуронил-трансферазна недостатъчност);
  • ако имате хематопоетична дисфункция.

If you are treated with Ceriodol or other analgesics containing paracetamol for an extended period of time, you may experience renal impairment and even irreversible renal failure.

You should remember that if you take prolonged periods of analgesics to treat a headache, it can become chronic.

If you have a fever or pain that lasts for more than a week, consult a doctor.

If you have asthma, chronic rhinitis or skin rash, or if you have an increased sensitivity to other analgesics or anti-rheumatic drugs, you should only be treated with Ceriodol after consultation with your doctor.

There have been reports of single cases of asthma and anaphylactoid shock (severe allergic reaction) associated with the use of preparations containing propipenazone and paracetamol in susceptible patients.

Very rare cases of serious skin reactions have been reported. In the event of skin redness, rash, blistering or scaling, immediately stop taking paracetamol and seek medical attention.

Children and adolescents
Ceriodol is not used in children under 12 years of age.

Other medicines and Ceriodol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some hypnotics, antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine) and rifampicin may increase the liver toxicity of paracetamol. The same applies to alcohol abuse.

By delaying the emptying of the stomach, for example with propantheline, the rate of absorption of paracetamol may be reduced and the onset of its action delayed. Acceleration of gastric emptying, for example after metoclopramide, increases the rate of absorption.

Combination with chloramphenicol prolongs the elimination of the drug with a higher risk of toxicity.

Taking metoclopram accelerates the rate of absorption. The clinical relevance of interactions between paracetamol and derivatives of warfarin or coumarin has not been established. Therefore, regular long-term use of paracetamol in patients treated with oral anticoagulants should only be performed under medical supervision.

The incidence of neutropenia (low white blood cell counts) is higher with concomitant use of paracetamol and AZT (zidovudine). For this reason, Ceriodol can be used in combination with AZT only after consultation with a doctor.

Кофеинът е антагонист на много седативни вещества като барбитурати, антихистамини и други. Кофеинът засилва тахикардията, предизвикана от симпатомиметици, тироксин и други. При вещества с широк спектър на действие (напр. бензодиазепини), взаимодействията могат да се проявят в множество форми и не са предсказуеми. Пероралните контрацептиви, симетидин и дисулфирам понижават метаболизма на кофеин, докато барбитуратите и тютюнопушенето го ускоряват. Кофеинът понижава елиминацията на теофилин. Кофеинът повишава потенциала за пристрастяване към вещества като ефедрин. Едновременната употреба на някои инхибитори на гираза може да удължи елиминацията на кофеин и неговия метаболит параксантин.

Although theoretically possible, there is no clinical evidence that caffeine increases the potential for addiction to painkillers such as paracetamol.

Tseridol with food, beverages and alcohol
Do not take painkillers such as Ceriodol at the same time as alcohol or if you suffer from disability due to alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breast-feeding, you should not take Ceriodol unless you have the express permission of a doctor.

Driving and using machines
Some patients may experience dizziness or drowsiness with paracetamol. Patients should be careful when conducting activities requiring caution.

  1. Как да приемате Церидол

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.

The recommended dose is: Adults: 1-2 tablets 1-3 times a day. Use in children over 12 years of age:  1 tablet 1-3 times a day.
The stretch mark is only to facilitate breakage if you are difficult to swallow the entire tablet.
The tablets should be taken with a sufficient amount of liquid. Adhere to the dose indicated on the package or prescribed by the physician. If you think the effect of the medicine is too strong or too weak, talk to your doctor.
Do not take Ceriodol at doses higher than those listed in this leaflet. As with other analgesics, Ceriodole should not be used regularly for long periods of time unless you are under medical supervision.

If you take more than the required dose of Ceriodol
Please tell your doctor if you overdose Ceriodol. Depending on the degree of intoxication, it will decide what measures to take.

If you forget to take Тсeriodol
Do not take a double dose to make up for the missed dose.

If you stop taking Ceriodol
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Както всички лекарства, това лекарство  може да предизвика нежелани реакции, въпреки че не всеки ги получава.

Нежеланите реакции се класифицират по системо-органни класове и по честота по следния начин: много чести (≥1/10), чести (≥ 1/100 до < 1/10), нечести (≥ 1/1 000 до < 1/100), редки (≥1/10 000 до <1/1000), много редки (≤ 1/10 000), с неизвестна честота (от наличните данни не може да бъде направена оценка).

Respiratory, thoracic and mediastinal disorders
Very rare - shortness of breath, asthma.

Blood and lymphatic system disorders
Very rare - decrease in the number of different types of blood cells (thrombocytopenia, thrombocytopenic purpura, leucopenia, agranulocytosis, pancytopenia).

Gastrointestinal disorders
Rare - nausea, vomiting, stomach discomfort, diarrhea and abdominal pain.

Hepatobiliary disorders
Very rare - hepatic impairment, hepatitis, and dose-dependent hepatic failure, hepatic necrosis (including fatal outcome). Chronic unapproved use can lead to liver fibrosis, cirrhosis of the liver, including fatal outcome.

Nervous system disorders
Vertigo, drowsiness.

Renal and urinary disorders
Very rare - renal impairment, especially in case of overdose.

Skin and subcutaneous tissue disorders
Very rare cases of serious skin reactions have been reported.
Pruritus, skin redness, rash, allergic edema and angioedema, Stеvens-Johnson, токсична епидермална некролиза и други.

Immune system disorders
Very rare - hypersensitivity reactions, severe anaphylactoid reactions, anaphylactic shock.

If you notice any such effects, stop taking Ceriodol and tell your doctor immediately.

Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet.

Можете също да съобщите нежелани реакции директно чрез Изпълнителната агенция по лекарствата, ул. Дамян Груев № 8, 1303 София: тел. +359 2 8903417, уебсайт www.bda.bg.

As you report side effects, you can contribute to getting more information on the safety of this medicine.

  1. Как да съхранявате Церидол

Keep out of the reach and sight 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 Ceriodol if you notice visible signs of product quality impairment.
Do not dispose of medicines in the sewer or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

  1. Packaging content and additional information

 What Ceriodol contains

  • Активните вещества в една таблетка са: парацетамол (250 mg), пропифеназон (150 mg), кофеин (50 mg).
  • Други съставки (помощни вещества) са: микрокристална целулоза, магнезиев стеарат, колоиден безводен силициев диоксид, талк.

Как изглежда Церидол  и какво съдържа опаковката
Blister of white, opaque PVC / PVDC / Alu foil with 10 tablets.
Each box contains 1 blister of 10 tablets.

Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen kut street,
Sofia 1362, Bulgaria

Date of the last review of the package leaflet
November 2017

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.

 

  1. 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.

 

  1. 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.

 

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

Respiratory, thoracic and mediastinal disorders

Bronchospasm, asthma.

 

Blood and lymphatic system disorders

Reducing in the count blood cells (thrombocytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia).

 

Gastrointestinal disorders

Nausea, vomiting, stomach upset, diarrhea and abdominal pain

 

Hepatobiliary disorders

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

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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Bulgarian Drug Agency, 8 Damyan Gruev Str. Sofia 1303, Bulgaria. By reporting side effects you can help provide more information on the safety of this medicine.

 

  1. 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.

 

  1. 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

Ceridol contains 10 tablets in a 1 blister.

10 (ten) tablets in a blister pack from PVC/PVDC white/aluminium foil.

Each box contains 10 tablets in a 1 blister and the package leaflet.

 

Marketing Authorisation Holder and Manufacturer

Fortex Nutraceuticals Ltd.

10, Prohladen kat str., Suhodol distr.,

1362 Sofia, Bulgaria


This leaflet was last revised in
July 2016

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