Lopenca

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Anti-inflammatory analgesics
Barcode: 8935206008432
Description

LOPENCA

COMPOSITION:

Paracetamol .............................................................................. 325 mg

Ibuprofen .................................................................................. 200 mg

Excipients q.s .............................................................................1 tablet

(Lactose, wheat starch, talc, magnesium stearate, aerosil, sodium starch glycolate, PVP K30, orange color E110).

DOSAGE FORM: Tablet.

PRESENTATION: Box of 5 blisters x 20 tablets.

ACTIONS:

Lopenca is an analgesic, anti-inflammatory combination of two active ingredients:

Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. The drug produces analgesia by elevation of the pain threshold. Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized in the liver and excreted via the kidney.

Ibuprofen is a nonsteroidal anti-inflammatory agent and has shown anti-inflammatory, analgesic, and antipyretic activities. Ibuprofen may involve inhibition of prostaglandin synthetase and thereafter prevent the production of prostaglandin, an agent of inflammation, pain, and fever. Ibuprofen is well absorbed. Maximum plasma concentrations are reached 1 - 2 hours after ingestion. The half-life of ibuprofen is around 2 hours. Ibuprofen is mainly excreted in the urine. 

With a combined formula of pain relief, Lopenca is indicated in musculoskeletal pains and traumatic pains.

INDICATIONS:

For analgesia and anti-inflammation associated with traumatic arthralgia, rheumatoid arthritis, neuritis such as backache, torticollis, sprain, excessive muscle strain, fracture, dislocation, postoperative pains, etc.

For the treatment of feverish cold, headache, toothache, period pain, aches and pains from motor organs, etc.

CONTRAINDICATIONS:

Patients with a known hypersensitivity to one of the ingredients of the drug. Patients with progressive gastro-duodenal ulcers. Patients with asthma or bronchospasm, bleeding disorder, cardiovascular disease, collagenose. Patients with hypersensitivity to aspirin or other NSAIDs. Patients with congestive heart failure, reduced circulatory volume caused by diuretics or kidney failure. Women during the last trimester of pregnancy.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

The drug should be used with caution in patients with hepatic, renal failure and alcoholism. Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol. Ibuprofen should be used with caution in the elderly. Ibuprofen should be used with caution in patients who may be adversely affected by a prolongation of bleeding time, since the drug may inhibit platelet aggregation.

The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).

Cardiovascular thrombotic events: Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the first weeks of treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

Physicians should remain alter for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk of adverse cardiovascular event in NSAID-treated patients, use the lowest effective daily dose with the shortest duration possible.

PREGNANCY AND LACTATION:

Use of the drug is not recommended during pregnancy, particularly the last trimester of pregnancy. The drug appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug should be used with caution in drivers, machinery operators because of possibility of headache, dizziness.

INTERACTIONS:

Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandion-derivative anticoagulants. The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy. Anticonvulsants (including phenytoin, barbiturates, carbamazepine) that induce hepatic microsomal enzymes may increase paracetamol-induced liver toxicity because of increasing the drug metabolism into toxic substances to the liver. The concurrent use of isoniazid and paracetamol may lead to the risk of paracetamol-induced liver toxicity.

Ibuprofen can increase the ADR on CNS associated with quinolone antibiotics and the toxicity of methotrexate and digoxin. Concomitant use with other NSAIDs causes an increased risk of gastrointestinal bleeding and ulcer.

ADVERSE EFFECTS: Gastrointestinal disturbances such as nausea, vomiting, dyspepsia, stomach pain, epigastralgia, gastrointestinal bleeding, headache, dizziness.

Cardiovascular thrombotic events (see Warnings and precautions).

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Overdose and treatment of paracetamol:

Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 - 10 g daily for 1 - 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.

Symptoms of paracetamol overdose include nausea, vomiting, abdominal pain, and cyanosis on skin, mucosa and nail.

In case of severe paracetamol overdose, full supportive treatment is required. In any cases, gastric lavage should be carried out especially within 4 hours after administration. 

The main detoxification therapy is use of sulfhydryl compounds. N-acetylcysteine gives with its effects followed by oral route or an intravenous infusion. N – acetylcysteine should be administered immediately, preferably within 36 hours of overdose. N – acetylcysteine is more effective if administered within 10 hours of overdose. It can be diluted with water or alcohol-free drinks to a 5% solution and orally taken within 1 hour. Oral N – acetylcysteine is given as a 140 mg/kg body-weight initial dose followed by 70 mg/kg body-weight every four hours for 17 more doses.

Methionin, activated charcoal and/or salt cathartics are also advised to treat overdose.

Overdose and treatment of ibuprofen:

The treatment of ibuprofen overdose is primarily symptomatic and supportive. In case of acute overdose, the following measures should be taken to enhance elimination and inactivate the drug’s action: gastric lavage, induced emesis and diuresis, orally administered activated charcoal or saline cathatics. In case of severe overdose, hemodialysis or blood transfusion should be given. Because ibuprofen causes acidification and is excreted in the urine, it is theoretically beneficial from an infusion for alkaline and diuresis

DOSAGE & ADMINISTRATION:

Lopenca should be orally given after meals.

Adults: 1 - 2 tablets x 2 - 3 times a day.

Or as directed by the physician.                       

Read the directions carefully before use.         

Consult the physician for more information.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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