Bostaflam

Bostaflam

201912-0096 • 13073 Views • Box of 01 blister x 10 sugar-coated tablets.
COMPOSITION

Each sugar-coated tablet contains

Active ingredients:

Diclofenac potassium 25 mg

Short-term treatment of the following acute conditions:

- Post-traumatic pain, inflammation and swelling, e.g. due to sprains.

- Post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery

- Primary dysmenorrhea or adnexitis

- Migraine attacks

- Painful syndromes of the vertebral column

- Non-articular rheumatism

- As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.

METHOD OF ADMINISTRATION AND POSOLOGY

Method of administration

- Bostaflam should be swallowed whole with liquid, preferably with meals, and must not be divided or chewed.

- Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Posology

Adults 

- The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient.

- The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.

- In primary dysmenorrhea, the daily dose should be individualized and is usually between 50-150 mg. A starting dose of 50 mg is usually sufficient. If necessary, a starting dose of 100 mg may be prescribed with a maximum dose of 200 mg/day achieved over a course of several menstrual cycles. Treatment should be started at the first symptom and, depending on the symptoms, continued for several days.

- In migraine, an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200mg per day.

Special populations 

Pediatric population

- Bostaflam is not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops or suppositories of diclofenac 12.5 mg and 25 mg could be used. For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient

- The maximum dose of 150 mg per day should not be exceeded. The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.

- The use of Bostaflam in migraine attacks has not been established in children and adolescents.

Elderly (patients 65 years and older)

- No adjustment of the starting dose is generally required for elderly patients.

Established cardiovascular disease or significant cardiovascular risk factors 

- In general, treatment with Bostaflam is not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant cardiovascular risk factors should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for more than 4 weeks. 

- As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment is continuous for more than 4 weeks.

- Patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a physician immediately in case of such an event.

Renal impairment

- Bostaflam is contraindicated in patients with severe renal failure.

- No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Diclofenac Potassium Tablets to patients with mild to moderate renal impairment

Hepatic impairment

- Bostaflam is contraindicated in patients with severe hepatic failure

- No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Bostaflam to patients with mild to moderate hepatic impairment.

CONTRAINDICATIONS

- Hypersensitivity to the active substance or any of the excipients.

- Children under 14 years old

- Active gastric or intestinal ulcer.

- History of gastrointestinal bleeding or perforation.

- Patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs.

- Pregnancy (especially the last trimester of pregnancy).

- Severe cardiac failure, established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Gastrointestinal effects:

- Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving Bostaflam, the treatment should be discontinued.

- As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing Bostaflam in patients with symptoms indicative of gastrointestinal disorders, or with a history suggestive of gastric or intestinal ulceration, bleeding, or perforation. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses including diclofenac, and in patients with a history of ulcers, particularly if complicated with hemorrhage or perforation and in the elderly. 

- To reduce the risk of GI toxicity in patients with a history of ulcers, particularly if complicated with hemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.

- Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal products likely to increase gastrointestinal risk.

- Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications that could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, and selective serotonin reuptake inhibitors.

- Close medical surveillance and caution should be exercised in patients with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated.

Respiratory effects (Pre-existing asthma):

- In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases, or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms),
reactions to NSAIDs like asthma exacerbations (so called intolerance to analgesics/analgesics asthma), Quincke's edema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such
patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus, or urticaria.

Hepatic effects:

- Close medical surveillance is required when prescribing Bostaflam to patients with impairment of hepatic function as their condition may be exacerbated.

- As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Bostaflam, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur  (eosinophilia, rash), Bostaflam should be discontinued. Hepatitis may occur with Bostaflam without prodromal symptoms.

- Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack

Skin effects:

- Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Bostaflam. Patients appear to be at the highest risk of these reactions early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Bostaflam should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

- As with other nonsteroidal anti-inflammatory drugs including diclofenac, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

Renal effects:

- As fluid retention and edema have been reported in association with NSAIDs therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery. Monitoring of renal function is recommended as a precautionary measure when using Bostaflam in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.

Elderly patients

- Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dosage be used in frail elderly
patients or those with low body weight.

Interactions with NSAIDs

- The concomitant use of Bostaflam with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Mask the signs and symptoms of the infection

- Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.

Cardiovascular Thrombotic Risk

- Systemic nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with the duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

- Physicians should periodically evaluate the occurrence of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and see a doctor immediately when these symptoms appear.

- Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms

- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration

Precaution with excipients:

- Bostaflam contains lactose and therefore is not recommended for patients with rare hereditary problems of fructose intolerance, severe sucrase-isomaltase deficiency or glucose-galactose malabsorption

SHELF LIFE

36 months. Do not use the products over the expiry date.

Box of 01 blister x 10 sugar-coated tablets.

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