Blockium B12 tablets N15

This medication is contraindicated if the patient is allergic to diclofenac potassium or any of its ingredients, or if taking other nonsteroidal drugs (e.g., ibuprofen) causes asthma attacks, urticaria, or acute rhinitis.

This medication should also not be taken if the patient has:
— gastric and/or duodenal ulcers,
— renal failure,
— gastrointestinal or other bleeding,
— hemorrhagic diathesis,
— the patient is taking anticoagulants,
— ischemia with angina,
— osteoporosis,
— diabetes mellitus,
— peripheral arterial disease,
— cerebral disorders after stroke.
This medication is not recommended for patients with established cardiovascular disease or arterial hypertension.
Not for use in pediatrics (under 14 years of age).

Dosage form: Film-coated tablets.
15 tablets per blister, 1 blister per cardboard box.

Composition: 1 film-coated tablet contains 50 mg diclofenac potassium, 0.3 mg betamethasone, 5 mg cyanocobalamin. Excipients: corn starch, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, povidone, hydroxypropyl methylcellulose, polyethylene glycol, propylene glycol, talc ponceau 4 R (E 124), sodium saccharin, titanium dioxide (E 171).

15 tablets in a blister, 1 blister in a cardboard box.

Diclofenac is an NSAID. It inhibits the activity of the COX enzyme and, consequently, prostaglandin synthesis. By blocking prostaglandin synthesis, diclofenac eliminates and significantly reduces the severity of inflammatory symptoms, such as pain at rest and with movement, morning stiffness, and joint swelling.

Betamethasone is a glucocorticoid drug that suppresses inflammation through several mechanisms of action. It inhibits the production of various inflammatory mediators, including vasoactive and chemotactic factors, suppresses the secretion of lipolytic and proteolytic enzymes, inhibits leukocyte transudation to damaged areas, and reduces fibrosis.

Vitamin B12 is vital for cell growth and replication. It has two coenzyme forms: methylcobalamin and deoxyadenosylcobalamin. Its main function is the transfer of methyl groups (transmethylation). It is involved in protein and nucleic acid metabolism (methionine and deoxyribonucleotide synthesis) and plays a key role in folic acid metabolism.

Vitamin B12 deficiency can cause irreversible changes in the nervous system, including progressive neuronal edema, demyelination, and neuronal death.

Food slows the absorption of diclofenac, reducing its peak plasma concentrations. It is 99% rebound to plasma proteins. Diclofenac is metabolized in the liver; its sulfate- and glucuronide-conjugated metabolites are excreted in the urine (65%) and bile (35%). No changes in pharmacokinetics were observed in elderly patients or those with hepatic or renal impairment.
Betamethasone is well absorbed from the gastrointestinal tract. It undergoes a first-pass effect in the liver, with a bioavailability of 72%. It is 64% bound to plasma proteins, and its half-life is 5.6 hours.

Vitamin B12 binds to intrinsic factor, which is essential for its absorption. The vitamin B12-intrinsic factor complex is transported to the ileum, where it interacts with specific receptors in the mucosa, ensuring its absorption. Vitamin B12 then binds to transcobalamin II, transporting it to tissues and undergoing rapid plasma elimination. Vitamin B12 is distributed primarily in the liver parenchyma, which is its primary storage site.

Taking this medication may cause side effects such as:
— epigastric pain,
— nausea, vomiting, diarrhea, abdominal cramps,
— dyspepsia, gastrointestinal bleeding,
— gastric and intestinal ulcers,
— glossitis, stomatitis, esophageal mucosal lesions,
— intestinal adhesions, vertigo,
— constipation, pancreatitis, elevated transaminase levels,
— headaches, drowsiness, anxiety, nightmares, hair loss,
— skin rashes, urticaria, eczema, erythema multiforme,
— edema, renal failure, hematuria, nephrotic syndrome, papillary necrosis,
— hepatitis, agranulocytosis, thrombocytopenia, leukopenia, anemia,
— tachycardia, chest pain, decreased blood pressure.

Betamethasone may mask signs of infection. Patients should not receive immunizations during treatment due to the potential for altered immune responses. It should also be used with caution in patients with suspected Strongyloides infections, as it may provoke dissemination of the infection and lead to a life-threatening condition. Patients with latent tuberculosis or increased reactivity to tuberculin should be monitored closely, as the disease may reactivate.

Corticosteroid therapy for more than 2 weeks may cause corticoadrenal insufficiency due to inhibition of ACTH release, which causes adrenal atrophy. In these cases, adrenal insufficiency may be triggered by stressful situations (surgery, severe trauma, severe infections) or as a result of abrupt discontinuation of corticosteroids.

Blokium B12 contains diclofenac and should be used with caution in patients with cardiovascular, renal, or hepatic disorders, in patients who have undergone surgery, or in patients with reduced intravascular volume. Diclofenac may cause exacerbations of the disease in patients with hepatic porphyria and bronchial asthma.

Blokium B12, which contains diclofenac, should be prescribed to patients with significant cardiovascular risk factors (such as hypertension, hyperlipidemia, diabetes mellitus, and smoking) only after careful clinical evaluation. Since the cardiovascular risks of diclofenac may increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the most effective dose. The patient's need for diclofenac for symptom relief and response to therapy should be periodically assessed. Blokium B12 should be administered with caution to patients with hemostatic disorders, diverticulitis, recent intestinal anastomoses, gastric ulcers, ulcerative colitis, abscesses or other purulent infections, hypertension, osteoporosis, and myasthenia gravis. Caution should be exercised when prescribing the drug to patients with herpes simplex virus infection, emotional instability, psychotic tendencies, and hypothyroidism.

With long-term therapy with Blokium B12, hematological parameters, renal and hepatic function should be monitored.
Use with caution in patients over 65 years of age.
May affect reaction time when driving or operating machinery.

If side effects involving the central nervous system (dizziness, drowsiness), or visual impairment occur, patients should refrain from driving or operating machinery during treatment.

When Blokium B12 is co-administered with other systemic NSAIDs, the incidence of side effects increases. Strict monitoring of coagulation is recommended in patients treated with oral anticoagulants, as corticosteroids and diclofenac increase the risk of hemorrhage.
Blokium B12 may inhibit the pharmacological action of diuretics. It may also lead to increased serum potassium levels when administered with potassium-sparing diuretics.

Prescribing Blokium B12 24 hours before and after methotrexate may increase methotrexate blood levels and its toxicity.

Concomitant administration of Blokium B12 and lithium preparations may increase lithium levels without visible signs of overdose.

Since Blokium B12 contains a steroid hormone (betamethasone), the following should be considered. When co-administered with erythromycin, astemizole, bepridil, halofantrine, pentamidine, terfenadine, sultopride, vicamine, amiodarone, bretylium, dispopyramide, guinidin, and solatolol, there is a risk of developing torsades de pointes (hypokalemia, bradycardia, and prolongation of the QT interval increase the risk of arrhythmia).

Combinations requiring caution when used
Insulin, metformin, hypoglycemic sulfonamides: The patient is advised to strengthen glycemic control and adjust the dose of antidiabetic agents during and after treatment with corticosteroids.

Isoniazid: When co-administered with corticosteroids, plasma isoniazid levels decrease, so clinical and microbiological monitoring is necessary. Phenobarbital, phenytoin, primidone, carbamazepine, ribafurin, and rifampin are enzyme inducers that reduce the effectiveness of corticosteroids. Therefore, it is recommended to adjust the drug dosage during and after treatment with these drugs.

Aspirin and corticosteroids accelerate the elimination of salicylates, so after a break in corticosteroid treatment, there is a risk of salicylate overdose. Dose adjustment of salicylates is recommended when discontinuing corticosteroid treatment.

Interactions to Consider
Antihypertensive Drugs: Corticosteroids reduce the therapeutic effects of antihypertensive drugs.

Alpha-Interferon: Corticosteroids may inhibit its therapeutic effect.
Vaccines containing attenuated microorganisms carry a risk of developing systemic diseases, which can be fatal. This risk is especially increased in patients with immunosuppressive conditions. It is better to use vaccines with inactivated microorganisms.

The shelf life of the drug is up to 3 years, storage temperature is not higher than 30°C.

Blokium B12 should be taken after meals with plenty of liquid.

Take 1 tablet every 8-12 hours. A maximum of 3 tablets per day can be taken.
Take this medication at the first sign of symptoms and continue for several days, taking into account the symptomatic progression. However, it is advisable to take the lowest dose for the shortest possible period. The exact dosage and duration of treatment are determined individually by the attending physician.

Elderly patients and those with mild to moderate liver and/or kidney impairment do not require dosage adjustment. Caution is advised in patients over 65 years of age.

There are no descriptions of the effects of diclofenac potassium. In cases of acute poisoning with other nonsteroidal drugs, symptomatic therapy is used to treat possible increases or decreases in blood pressure, respiratory depression, seizures, and gastrointestinal complications (nausea, epigastric pain, bleeding).
Hemodialysis or forced diuresis are ineffective. Gastric lavage and enterosorbents are recommended.

Use with extreme caution during pregnancy. This medication is contraindicated during the third trimester.
Breastfeeding should be discontinued while taking this medication.