Fenaflam

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Barcode: 8935206008753
Description

FENAFLAM

COMPOSITION:

Diclofenac potassium ............................................. 25 mg

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

(Wheat starch, lactose monohydrate, avicel, aerosil, sodium starch glycolate, magnesium stearate, PVP K30, HPMC, PEG 6000, titanium dioxide, red ferric oxide, orange E110, talc).

DOSAGE FORM: Film coated tablets.

PRESENTATION: Box of 2 blisters x 10 tablets.

PHARMACODYNAMICS: Fenaflam contains Diclofenac potassium which is a nonsteroidal anti-inflammatory drug (NSAID) used for anti-inflammatory, analgesic, antipyretic conditions. Diclofenac promptly inhibits the activity of cyclooxygenase to reduce remarkably the formation of prostaglandin, prostacyclin, and thromboxane that cause inflammations, pains, and fever.

PHARMACOKINETICS: Diclofenac is well dissolved in the intestinal juice, easily absorbed by the gastrointestinal tract after oral administration and obtains a maximum concentration in plasma, high bioavailability. The drug is bound to a great deal of plasma-protein (over 99%), mainly to albumin. Diclofenac easily penetrates into synovial fluid where the drug concentration is still maintained while plasma concentration decreased. The plasma half-life is about 1 to 2 hrs. Elimination half-life from synovial fluid is 3-6 hrs. Approximately 60% of the administered dose is excreted in the bile as metabolites (conjugated glucuronide and sulphate). Less than 1% is excreted as unchanged substances; the rest of the dose is eliminated via the bile and faeces. The process of absorption, metabolism, and excretion does not depend on age.

INDICATIONS: Short-term treatment of acute inflammatory and painful conditions in dysmenorrhea and acute painful and inflammatory states in gynaecology, odonto-stomatology, ear-nose-throat, migraine attacks, extra-articular rheumatism, post-traumatic or postoperative pains.

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with a history of allergy (asthma, rashes, acute rhinitis,...) to prostaglandin inhibitors or acetyl salicylic acid groups. Patients with progressive gastro-intestinal ulcer or a history of gastrointestinal bleeding. Patients with bleeding, stasis heart failure, severe renal and hepatic impairment, a decrease in circulatory volume, collagenosis.

Pregnant women should not take NSAIDs in the last trimester of pregnancy.

Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, cerebrovascular disease.

WARNINGS AND PRECAUTIONS: Patients with a history of gastrointestinal bleeding, ulceration and perforation. Patients with renal and hepatic failure, systemic lupus erythematosus. Renal, hepatic function should be monitored during long-term therapy with NSAIDs. Patients with hypertension or cardiopathy associated with fluid retention or oedema. Patients with infections. Patients with a history of hemophilia, bleeding.

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 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 alert 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 for an adverse cardiovascular event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.

PREGNANCY AND LACTATION: The drug should only be used in these subjects if clearly needed. The drug is advised not to be taken during the last trimester of pregnancy. Diclofenac should not be given to the subjects who have planned to become pregnant.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

Cautions should be taken when driving vehicles and operating machinery.

INTERACTIONS: Diclofenac should not be used concomitantly with the following substances:

NSAIDs, salicylate derivatives, and glucocorticoids: Increased risk of gastrointestinal ulcer, bleeding.

Anticoagulants e.g., heparin, coumarin, ticlopidine: Increased risk of hemorrhage.

Quinolone antibiotics: Increased risk of adverse effects on CNS (e.g., seizures).

IUD: Decreased effect of contraception.

Lithium, digoxin: A rise in plasma concentrations of lithium, dixogin, leading to toxicity may be seen. Doses of lithium and diogxin should be adjusted in case of obligate concomitant administration with diclofenac; moreover, plasma lithium and digoxin concentrations should be carefully monitored.

Methotrexate: Toxicity has occurred following concomitant administration of diclofenac and methotrexate.

Diclofenac may be used concomitantly with the following substances but the patient should be monitored:

Ciclosporin: Renal function should be monitored.

Diuretics: Patients receiving diuretics may have an increased risk of developing renal failure secondary to decreased renal blood flow.

Anti-hypertensives (angiotensin converting enzyme inhibitors, beta-blockers, etc.).

Antacids: Antacids may reduce intestinal irritations by diclofenac, but decreasing plasma diclofenac concentrations.

Caution should be taken if diclofenac is concomitantly used the following substances:

Cimetidine mildly decreases plasma diclofenac concentration, but does not reduce diclofenac’s effect and helps to protect the duodenum, stomach from the adverse effects of diclofenac.

Probenecid makes a double diclofenac concentrations. This is a good clinical effect on patients with arthropathy but poisoning of diclofenac may occur, particularly in patients with impaired renal function. The effect of uricaciduria excretion is not affected. The dose of diclofenac should be reduced if necessary.

ADVERSE EFFECTS:

Commonly: nausea, vomiting, diarrahoea, constipation, epigastralgia.

Rarely: ulceration, gastrointestinal bleeding (in case of long-term treatment), hematological disturbances (hypoleukocytosis, thrombocytopenia, anemia), headache, insomnia, irritability, urticaria, Quincke's oedema, asthma, bronchiospasm, blurred vision, optical pains and aches, diplopia, acute renal impairment, interstitial nephritis, urina cruenta, increased hepatic transaminase, hepatitis.

Cardiovascular thrombotic events: Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see more Warnings and precautions).

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

OVERDOSAGE: Acute diclofenac overdosage produces manifestations that are mainly extensions of adverse effects of the drug. General measures should include immediately emptying the stomach by inducing emesis or by gastric lavage, followed by initiation of symptomatic and supportive treatment. Administration of activated charcoal after emesis or gastric lavage may be useful in minimizing absorption of diclofenac from the gastrointestinal tract and enterohepatic cycle. Forced diuresis may not be beneficial because the drug is highly protein bound. If forced diuresis is used an attempt, fluid and electrolyte balance should be monitored carefully, since potentially serious electrolyte disturbances and fluid retention may occur.

DOSAGE & ADMINISTRATION:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Warnings and precautions).

Adults: oral dose of 1 - 2 tablets x 2 - 3 times daily.

Fenaflam should be taken before meals in case of primary dysmenorrhea.

Or as directed by the physician.

Read the directions carefully before use.                    

Consult the physician for more information.               

The drug is for prescriptions only.

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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