PARACO-DENK 500/30 Tablet

ហាមប្រើចំពោះ៖
- អ្នកធ្លាប់មានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ។
- កុមារអាយុក្រោម12ឆ្នាំ។
- អ្នកមានជំងឺខ្សោយមុខងារថ្លើមធ្ងន់ធ្ងរ។

- if you or your child are allergic to paracetamol, codeine phosphate or any of the other ingredients of this medicine

- if you or your child have impaired lung function (respiratory insufficiency) or depressed breathing (respiratory depression)

- in the event of deep unconsciousness (coma)

- in the event of an inflammation of the lungs (pneumonia)

- if you or your child suffer an acute attack of asthma

- if you or your child have a chronic cough, which may for example be a warning sign of the onset of bronchial asthma (particular attention to this is required in children)

- if you are due to give birth shortly

- if you have been found to be at imminent risk of giving birth shortly

- in children under 12 years of age

- for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome

- if you know that you or your child metabolize very rapidly codeine into morphine

- if you are breastfeeding

ផលរំខាន រួមមាន៖ ស្ងួតមាត់ ចង្អោរ ក្អួត ទល់លាមក អស់កម្លាំង ឈឺក្បាល ពិបាកដកដង្ហើម (ពិសេស អ្នកឡើងសម្ពាធឈាមខួរក្បាល និងប៉ះទង្គិចខួរក្បាល) ប្រតិកម្មអាល្លែហ្ស៊ីស្បែក ក្រហមដុំៗ រមាស់...។ ក្នុងករណីកម្រ អាចមានវិបត្តិដេកមិនលក់ ស្រមើស្រម័យ ខ្សោយគំហើញ ញៀនថ្នាំ ហើមសួត សម្ពាធឈាមចុះ បាត់បង់ស្មារីតបណ្ដោះអាសន្ន ហ៊ឹងត្រចៀក គ្រាប់ឈាមសចុះ...

Gastrointestinal disorders

- very common: nausea, vomiting, constipation,

- uncommon: dry mouth.

Hepatobiliary disorders

- rare: rise in certain liver enzymes (serum transaminase).

Nervous system disorders

- very common: fatigue, mild headache,

- common: mild drowsiness,

- uncommon: sleep disturbances.

If higher doses are taken or in the case of particularly sensitive patients, the capacity for visual fixation of objects (visuomotor or co-ordination) and visual performance can be impaired dose-dependently. Similarly, disorders of respiratory drive (respiratory depression) and an abnormally elated mood (euphoria) can occur,

It is possible for dependence to develop after the prolonged intake of higher doses!

(See the package insert about the details.)

ឱសថនេះអាចមានអន្តរកម្មជាមួយឱសថ Tranquilizers, hypnotics, psychotropics, Analgesiques, Antihistaminiques, Psycotropes, Antiepileptiques, Carbamazepine, Phenobarbital, Phenytoine, Rifampicine, Chloramphenicol...។

(See the package insert about the details.)

Tranquilizers, hypnotics, psychotropics (phenothiazine, chlorpromazin, thioridazine, perphenazine), drugs depressing the central nervous system, drugs for the treatment of allergies (antihistaminics as for example promethazine, meclozin), antihypertensive drugs, certain analgesics as well as by alcohol.

Certain sleeping tablets and antiepileptic drugs (including phenobarbital, phenytoin, carbamazepine) as well as rifampicin.

Products delaying stomach emptying.

Drugs accelerating gastric emptying like metoclopramide.

zidovudine (AZT or Retrovir)

probenecid

Cholestyramine

Alcohol

Certain medicines for depression (tricyclic antidepressants) such as imipramine, amitriptyline and opipramole

MAO inhibitors such as tranylcypromine

Analgesics such as buprenorphine or pentazocine

Cimetidine and other medicines that affect liver metabolism

Morphine

ឱសថនេះអាចប្រើបានចំពោះស្ត្រីមានផ្ទៃពោះនិងស្ត្រីបំបៅកូន តែត្រូវស្ថិតនៅក្រោមការត្រួតពិនិត្យរបស់គ្រូពេទ្យ។

Pregnancy

You may only take this medicine on the express instructions of your doctor, since unwanted effects on the development of the unborn child cannot be excluded.

You may not take this medicine if you are about to give birth or if there is an imminent risk of giving birth prematurely, since the active substance codeine contained in this medicine crosses the placental barrier and can cause breathing disorders in newborns.

If this medicine is taken for a prolonged period, codeine dependence can develop in the foetus. There are reports of withdrawal symptoms in newborns after repeated use of codeine in the last third of pregnancy. Therefore, please contact your doctor immediately if you are planning a pregnancy or are already pregnant in order to decide jointly on whether to continue with or stop the treatment.

Breastfeeding

Do not take this medicine while you are breastfeeding. Paracetamol and codeine as well as its degradation product morphine pass into breast milk.

・ត្រូវប្រើដោយប្រុងប្រយ័ត្ន និងត្រូវមានការឯកភាពពីគ្រូពេទ្យព្យាបាល ចំពោះ
- អ្នកញៀនគ្រឿងញៀន
- អ្នកមានវិបត្តិខាងស្មារតី
- អ្នកមានវិបត្តិប្រព័ន្ធដកដង្ហើម និងមុខងារដកដង្ហើម
- អ្នកមានសម្ពាធឈាមខួរក្បាលឡើងខ្លាំង។
・ត្រូវបន្ថយកម្រិតប្រើ ឬពន្យាររយៈពេលនៃចន្លោះពេលប្រើម្ដងៗ ចំពោះ
- អ្នកមានជំងឺខ្សោយថ្លើម រលាកថ្លើម អ្នកប្រមឹកស្រា
- អ្នកមានអត្រា Bilirubine ឡើងពីកំណើត
- អ្នកមានជំងឺខ្សោយតម្រងនោមដែលត្រូវលាងឈាម។
・ការប្រើឱសថនេះក្នុងរយៈពេលយូរ ឬក្នុងកម្រិតខ្ពស់ ឬប្រើប្រាស់មិនត្រឹមត្រូវ អាចបណ្ដាលអោយឈឺក្បាល និងប៉ះពាល់ដល់មុខងារតម្រងនោមនិងថ្លើម។
・ហាមពិសាសុរា ក្នុងអំឡុងពេលព្យាបាល។

This medicine should be used only with physician’s consent in case of:

- opioid dependence (including strong analgesics and sedatives)

- impaired consciousness

- conditions associated with increased intra-cranial pressure

- disorders of the respiratory centre and the respiratory function

- simultaneous use of monoamine oxidase (MAO) inhibitors (group of medicines for the treatment of depression)

- ventilation disorder of the lung due to chronic bronchitis or (bronchial) asthma

- previously removed gallbladder (status post cholecystectomy)

- higher doses if you or your child have low blood pressure due to a lack of fluid

You or your child may only take this medicine in smaller doses or less often than stated in the dosage instructions (dose reduction or prolongation of the dosage interval) if you have:

- liver function disorders (for example due to long-term alcohol abuse or inflammation of the liver)

- impairment of liver function (inflammation of the liver, Gillbert-Meulengracht disease)

- kidney function disorders (including if dialysis is required)

- diseases that may be associated with reduced glutathione levels (dose adjustment where necessary, e.g. in diabetes mellitus, HIV, Down’s syndrome, tumors)

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. In these people, symptoms of overdosage are possible, even when treated with doses this medicine prescribed by a doctor. If you notice any of the following side effects, you or your child must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, vision disorders, circulatory problems, nausea or vomiting, constipation, lack of appetite.

In order to avoid the risk of an overdose, one should make sure that concurrent medication does not contain paracetamol or codeine phosphate.

If large amounts of analgesics are taken for extended periods of time and at high dosage, they may cause headache which should not be treated with increased doses.

In general, the habitual use of analgesics, especially the combination of different analgesic drugs, may lead to permanent kidney damage, which might result in renal failure (analgesic nephropathy).

Headache, fatigue, muscular pain, nervousness and vegetative symptoms may occur after abrupt discontinuation of analgesics not used as directed or taken in large doses over long periods of time. No analgesic should be used before subsidence of such symptoms, which usually disappear within a few days. A physician should be consulted before resuming treatment.

At the beginning of treatment your doctor will monitor your individual response to this medicine. This applies in particular to elderly patients and patients with impaired kidney function or disorders of respiratory function. Severe acute hypersensitivity reactions (for example anaphylactic shock) are very rarely observed.

Treatment must be discontinued on the first signs of a hypersensitivity reaction after taking this medicine. Any medically necessary measures commensurate with the symptoms must be instigated by professional staff.

Special patient groups

(See the package insert.)

Impaired liver function and slight renal impairment

Severe renal insufficiency

Elderly patients

Children and adolescents