BGNac Gel

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component.
• Of the container. For a complete listing, see the Dosage Forms, Composition and Packaging.
• Section of the product monograph.
• Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are.
• precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents.
• Concomitant use of other products containing diclofenac.
• Concomitant use of oral non-steroidal anti-inflammatory drugs (NSAIDs).
• During the last trimester of pregnancy

A: Diclofenac Diethylamine: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting the production of substances in the body that cause inflammation and pain, such as prostaglandins. Pain relief: By reducing inflammation, diclofenac helps relieve pain associated with conditions like arthritis, sprains, and strains.

B: Oleum lini (Linseed oil): Anti-inflammatory: Linseed oil contains omega-3 fatty acids, which have anti-inflammatory properties. It can help reduce inflammation and soothe pain. Moisturizing: Linseed oil has moisturizing properties, which can help keep the skin hydrated and may contribute to the overall soothing effect of the gel.

C: Menthol: Cooling effect: Menthol produces a cooling sensation on the skin, which can help distract from pain and provide a soothing feeling. Local anesthetic: Menthol has mild local anesthetic properties, which may contribute to a numbing effect on the skin, helping to reduce the perception of pain.

D: Methyl Salicylate: Analgesic (pain-relieving) and anti-inflammatory: Methyl Salicylate is related to salicylic acid, which is a compound with analgesic and anti-inflammatory properties. It can help alleviate pain and reduce inflammation. Vasodilation: Methyl Salicylate can cause blood vessels to widen (vasodilation), promoting increased blood flow to the affected area. Improved blood circulation can aid in the healing process. When these ingredients are combined in a gel formulation, they work synergistically to provide both immediate and prolonged relief from pain and inflammation.

• Diclofenac diethylamine gel is for topical use only and should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth.
• Discontinue the treatment if a skin rash develops after applying the product.
• Systemic availability of diclofenac diethylamine through percutaneous absorption is low compared with plasma levels obtained following ingestion of oral forms of diclofenac. Nevertheless, the possibility of systemic side effects cannot be completely excluded. Chances of this may be increased where Diclofenac diethylamine gel is applied to a relatively large area of skin and/or over an extended period of time (e.g., especially if this goes beyond the maximum duration recommended for use).
• Some possibility of gastro-intestinal bleeding in patients with a significant history of peptic ulceration has been reported in isolated cases in users of diclofenac diethylamine gel. Diclofenac diethylamine gel should therefore be used with caution by patients under medication for active peptic ulcers in the stomach or duodenum (e.g., proton pump inhibitors or histamine H2 receptor antagonists). If the patient is uncertain, they should be advised to consult their doctor or pharmacist.
• Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of bronchial asthma.
• Asthma has been rarely reported in patients using topical NSAID preparations.
• Local irritation, erythema, pruritus or dermatitis may occasionally occur with topical diclofenac diethylamine. Skin photosensitivity, desquamation, discoloration and bullous or vesicular eruptions have been reported in isolated cases. Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.

• Pregnant Women:

  Since no experience has been acquired with diclofenac diethylamine gel in pregnancy, it is not recommended for use in these circumstances. It is contraindicated during the last trimester of pregnancy, owing to the possibility of uterine inertia, fetal renal impairment with subsequent oligohydramnios and/or premature closure of the ductus arteriosus. Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy.

• Nursing Women:

  Since no experience has been acquired with diclofenac diethylamine gel in lactation, it is not recommended for use in these circumstances. Following oral doses of 50 mg diclofenac administered every 8 hours, diclofenac passes into breast milk in quantities so small that no undesirable effects on the infant are to be expected.

• The adverse event incidence in the clinical studies was very low. The adverse events occurring in studies were usually either moderate or mild. Serious adverse events observed in all the studies, conducted over more than a decade, were very few in number and all unrelated to study treatment. In post-marketing surveillance, approximately 90% of case reports are non-serious. Cutaneous adverse events, occurring mostly at the application site, constitute the most common symptoms reported.
• Drug Interactions - No drug-drug interactions were noted in the clinical studies presented.
• Effects on laboratory test

NA

The safety evaluation of calcium citrate malate was based on specific toxicity studies and extensive information on calcium supplementation trials in humans, as well as existing safety evaluations of its individual component substances, citric acid, and malic acid. On this basis, the Panel concluded that the use of calcium citrate malate as a source for calcium intended for use in foods for Particular Nutritional Uses (PARNUTS) and foods for the general population (including food supplements) is of no safety concern at the maximum levels estimated in this opinion.

• Pregnancy: If you are pregnant or planning to become pregnant, it's important to consult your doctor before taking Bgcal Gold Tablet. They will assess the benefits and risks for you and your baby.
• Breastfeeding: Before using Bgcal Gold Tablet while breastfeeding, consult your doctor. They will guide you on whether it is safe for you and your baby.
• Alcohol: It is recommended to consult your doctor regarding alcohol consumption while taking Bgcal Gold Tablet to ensure its safe use.
• Liver: If you have liver disease or any liver-related concerns, seek advice from your doctor before starting Bgcal Gold Tablet.
• Kidney: If you have kidney disease or any kidney-related issues, it is advisable to consult your doctor before using Bgcal Gold Tablet.
• Using Machines & Driving: The Bgcal Gold Tablet does not usually affect your ability to drive or operate machinery. However, if you experience dizziness or any other side effects, it's best to avoid these activities and consult your doctor.
• Allergy: Inform your doctor if you have any known allergies to the ingredients in Bgcal Gold Tablet or similar medications.
• Children: Bgcal Gold Tablet is not recommended for use in children without proper medical advice.
• Older patients may require special precautions when using the Bgcal Gold Tablet. Consult your doctor for personalised guidance based on your specific health conditions.