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Aceta-gel C®
Acetaminophen codeine
Soft gelatine capsule
Acetagel-C capsules containing 300 mg acetaminophen and 10 codeine phosphate .
Drug Category: Analgesic and anti-fever
Acetaminophen's active ingredient, is a para-amino-phenol derivative with anti-pain and fever effects. It is also has a weak anti-inflammatory effect. Acetaminophen, do it's analgesic effect by raising the pain threshold and antipyretic effect by impact on body temperature regulation center in the hypothalamus impact.
Codeine phosphate's active ingredient is an analgesic agonist Opioid, that By binding to specific receptors in the CNS and the change in the release of various nerve transmitters, changes, the process of perception and response to pain.
• Indications:
It is used to treat moderate to severe pain.
• Before taking this medication, consult your physician or pharmacist in the following cases:
• In the case of sensitivity to acetaminophen or codeine
• In the case of sensitivity to protective material, colors, gelatin and other materials
• In the case of use other drugs, including products containing alcohol or depressant CNS, monoamino oxidase inhibitors, tricyclic antidepressants, zidovudine, naltrexone and rifampin
• In active alcoholism or improving State, in diarrhea caused by antibiotics or poisoning, in asthma or other respiratory diseases, in liver disease (liver inflammation and Cirrus), severe bowel inflammation
• If you are taking other products containing acetaminophen, such as cold tablets.
• If you take medications such as metoclopramide, probenecid, cholestyramine, warfarin, lamotrigine, interferon, chloramphenicol.
In Pregnancy:
• It is classified in group C and should be used during pregnancy under the supervision of a physician.
• In Lactation: Codeine is excreted in breast milk, so the benefits of the medicine must be weighed against the risks.
• Children: This medication is not recommended in children under 12 years.
• Elderly: Elderly patients are more susceptible, to complications of opioid analgesics, such as respiratory depression. Seniors that have damage kidney function, prostatic hypertrophy or obstruction of the prostate, may be likely to suffer urinary retention associated with side effects of opioids. Elderly patients may be have slower metabolism and excretion of opioid analgesics, and the it is recommended that dose for these patients be reduced.
General tips for proper use of drugs:
• Meal the drug with regular intervals and complete the course of treatment.
• Do not use more than the recommended dose, because long and high consumption of acetaminophen may cause liver damage and also there are also likely to become dependent on opioid analgesics.
• Meal the drug with a glass of water or food.
• If after some weeks, did not decrease drug effects, do not exceed consumption dose and consult with your doctor.
• The drug in the elderly, children and disabled patients with respiratory problems may cause respiratory depression then it is recommended that dosage or the frequency of consumption to be reduced.
• The frequency of consumption should be determined separately for each individual relative to effect time, pain severe, patient condition, using other drugs and patient's response.
• Concomitant use with other anti-inflammatory drugs (e.g. aspirin, other salicylates, nonsteroidal anti-inflammatory and analgesic, etc.).
• regular use may be lead to resistance to drug. The first sign of resistance to the drug is reduction in opioid analgesic effect time. Resistance to respiratory weakness increase coincides with resistance to the analgesic effect. For this reason, the dose should be carefully adjusted to create proper analgesic effect and to not increase the risk of respiratory depression.
Do not use in following cases:
• The diarrhea caused by taking cephalosporins and penicillins
• At the diarrhea caused by poisoning until time that toxic substances is not Excreted from the digestive system. (Opioid analgesics may slow excretion of toxins, so diarrhea become more severe or longer.)
• In chronic respiratory weakness (May become more severe)
Note the followings during the use:
• In case of long term use of high doses, visit your doctor regularly
• In the case of new symptoms of pain, Redness or swelling of the extremities or not relieving within 10 days and Fever intensifies or It persists for more than three days, Discontinue this medication and see your doctor.
• In case of long term use of high doses, see your doctor regularly.
• If you take other medicines that contain acetaminophen or opioid analgesics, use causin.
• During treatment, avoid the use of products containing alcohol or other CNS depressant drugs unless prescribed by a doctor.
• During the treatment, do not use aspirin and other salicylates or non-steroidal inflammatory simultaneously, unless it is prescribed by a doctor or dentist.
• In case of dizziness, confusion or drowsiness, false sense of pleasure avoid from driving or operating machinery which requires complete alertness.
• Use caution when If you get up suddenly from a lying or sitting state.
• Lie down, If nausea or vomiting, dizziness or confusion occur.
• Use caution If you need the surgery (including dental surgery) or emergency treatment.
• In case of dry mouth, use sucker or ice.
• After long-term consumption with high dose, notify your doctor before stopping consumption. It is possible to prevent withdrawal symptoms, be required to reduce the dosage gradually. (Withdrawal symptoms, include pain in the body, diarrhea, fast heart rate, fever, runny nose or sneezing, leaving the skin, increased sweating, unsteadiness in walking, loss of appetite, nausea or vomiting, convulsions, tremor, abdominal pain, difficulty in the dream, enlarged pupils, and weakness)
Use in the following cases with caution:
• In chronic abdominal disease (diagnosis or clinical course of the disease may be vague)
• In allergic reactions to opioid analgesics in patients with a history of asthma and respiratory diseases
• In arrhythmias
• The seizures or a history of it
• In patients with a history of suicide or suicidal tendencies
• In Gallbladder disease or gallstones (opioids may cause the bile contraction.)
• In gastro-intestinal Surgery (opioids may change gastro intestinal movement power.)
• A head injury or increased intracranial pressure or intracranial injury
• Liver damage (because opioids are metabolized in the liver.)
• In hypothyroidism (in this disease, the risk of respiratory inhibition and prolonged weakness in the CNS, increases severely.
• In severe inflammatory bowel disease (risk of toxic mega colon increases.)
• In prostate hypertrophy or obstruction or stenosis in the genitourinary tract (Opioids may cause urinary retention.)
• The damage kidney function
Side Effects:
Along with the favorable effects, any drug therapy may cause side effects in some people.
• Blood disorders including thrombocytopenia, leukopenia, pancytopenia, neutropenia and agranulocytosis
• Skin rashes or other allergic reactions
• Liver or kidney tissue necrosis in the case of taking too much acetaminophen
• Pancreatitis
• Weakness in the respiratory with disorder of it
• hallusination
• Confusion, seizures, high blood pressure
• Dementia or other symptoms of CNS
• kidney function Damage
• Excitation
• Constipation
• Physical dependence (which can be with or without physiological dependence. (Codeine relative to opioid agonists have less dependence and more abuse).
Drug and dosage:
Adults: 1 to 2 capsules every 4 hours as needed.
Children: Not recommended for children under 12 years.
Poisoning:
• In the case of taking something more than the amount prescribed, stop treatment and transfere the patient to medical centers, immediately. Poisoning with these drugs can cause severe side effects in the liver and kidneys.
Maintenance:
• keep drug at temperatures below 25 ° C
• Keep away from the reach of children.
• Do not use expired drug.
Dosage forms:
Acetagel soft capsules (acetaminophen codeine) are supplied in 50 numerical boxes.
