Tibrolin D Tab

TIBROLIN D TAB

Name: Tibrolin D Tablet (Brand: Tibrolin D, Manufacturer: Zuventus Healthcare Ltd.)

Composition: Each tablet contains a combination of four active ingredients:

• Trypsin: 48 mg
• Bromelain: 90 mg
• Rutoside Trihydrate: 100 mg (also referred to as Rutoside)
• Diclofenac Sodium: 50 mg (also referred to as Diclofenac)

Uses: Tibrolin D Tablet is an anti-inflammatory drug used in adults primarily for pain relief and to reduce swelling and inflammation. It is prescribed as a supportive treatment for a range of conditions, including:

• Swelling, inflammation, or pain resulting from injury.
• Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
• Post-surgical pain and inflammation, including dental procedures and tooth extraction.
• Muscle pain, backache, headache, ear pain, and throat pain.
• Superficial vein inflammation (thrombophlebitis).
• Inflammation of the urinary and genital tract (urogenital tract).
• Soft tissue rheumatism.
• Treatment of edema and inflammation of traumatic origin (e.g., contusions, lacerations, cuts) and post-surgery.

Dosage and Administration: The typical dosage for adults is one tablet 2-3 times daily. Tablets should be swallowed whole on an empty stomach, at least 30 minutes before meals or 2 hours after meals, to ensure proper absorption and effectiveness. Tibrolin D is not recommended for use in children.

Side Effects: Common side effects may include:

• Stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, wind, loss of appetite.
• Headache, dizziness, vertigo, drowsiness, tiredness.
• Skin rash or spots, itching.
• Raised levels of liver enzymes in the blood.

Serious side effects, though less common, can include gastrointestinal bleeding, ulceration, and perforation, which can be fatal. Cardiovascular thrombotic events, chest pain, and heart disorders have also been reported.

Precautions:

• Allergies: Do not take if hypersensitive to the active substances, any excipients, or to pineapples or papain.
• Cardiovascular Risks: Increased risk of serious cardiovascular thrombotic events (myocardial infarction, stroke). Contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Use with caution in patients with a history of hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
• Gastrointestinal Risks: Increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation. Avoid in patients with active gastric or intestinal ulcers, or a history of GI bleeding related to NSAID therapy.
• Coagulation Disorders: Use with caution in patients with hereditary coagulation disorders (e.g., hemophilia) or those on other medications that affect blood clotting; discontinue 4 days before any surgical intervention.
• Renal/Hepatic Impairment: Contraindicated in patients with severe liver damage, dialyzed patients, or hepatic/renal failure.
• Pregnancy and Breastfeeding: Must not be used during the last trimester of pregnancy and breastfeeding due to potential risks.
• Driving and Machinery: Patients experiencing visual disturbances, dizziness, vertigo, drowsiness, or fatigue should avoid driving or operating machinery.
• Drug Interactions: Exercise caution with concomitant use of other NSAIDs, corticosteroids, anticoagulants, lithium, digoxin, diuretics, antihypertensive agents, ciclosporin, tacrolimus, or trimethoprim.

Storage: Store Tibrolin D Tablets in a cool, dry place, below 30°C, and protected from light. Keep the medicine in its original packaging and out of the reach of children and pets.

What is Tibrolin D Tablet used for?

Tibrolin D Tablet is primarily used to relieve pain and reduce inflammation. It is prescribed for conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, post-surgical pain, tooth extractions, muscle aches, backaches, menstrual pain, and pain and swelling resulting from injuries like sprains and strains. It also aids in wound and tissue healing.

How does Tibrolin D Tablet work?

Tibrolin D Tablet is a combination of four active ingredients: Trypsin, Bromelain, Rutoside, and Diclofenac. Trypsin and Bromelain are enzymes that help reduce inflammation and pain by increasing blood supply to the affected area and aiding in the breakdown of proteins involved in swelling. Rutoside is an antioxidant that protects the body from cell damage and further reduces swelling. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that works by blocking the production of chemical messengers called prostaglandins, which are responsible for causing pain and inflammation.

What is the usual dosage for Tibrolin D Tablet?

For adults, the usual dosage is one tablet 2 to 3 times daily. It is generally recommended to swallow the tablets on an empty stomach, at least 30 minutes before meals or 2 hours after meals, to ensure optimal absorption. Some sources also suggest taking it with food or milk to minimize stomach upset. It is crucial to follow your doctor's specific instructions regarding dosage and duration.

What are the possible side effects of Tibrolin D Tablet?

Common side effects may include nausea, vomiting, heartburn, indigestion, stomach upset, loss of appetite, diarrhea, headache, and dizziness. Less common but more serious side effects can include skin rashes, blurred vision, and an increased risk of gastrointestinal adverse events such as bleeding, ulceration, and perforation of the stomach or intestines. If you experience persistent or severe side effects, or any signs of bleeding (like dark stools or vomiting blood), contact your doctor immediately.

Is Tibrolin D Tablet safe during pregnancy or breastfeeding?

Tibrolin D Tablet is generally not recommended during pregnancy, especially in the last trimester, and during breastfeeding, due to potential risks to the developing baby. There are no adequate studies on its use during these periods. If you are pregnant, planning to become pregnant, or breastfeeding, you should consult your doctor before taking this medicine.

Can Tibrolin D Tablet be taken with other medications?

Caution is advised when taking Tibrolin D Tablet with other medications. It can interact with:

• Anticoagulants and anti-platelet agents: May increase the risk of bleeding.
• Other NSAIDs or corticosteroids: Increased risk of gastrointestinal bleeding or ulceration.
• Lithium and Digoxin: May increase plasma concentrations of these drugs.
• ACE inhibitors: May enhance their hypotensive effect.
• Potassium-sparing diuretics, ciclosporin, tacrolimus, or trimethoprim: May increase serum potassium levels.
• Certain antibiotics (e.g., ciprofloxacin, amoxicillin): May alter their effect or cause fits.
• Benzodiazepines, barbiturates, narcotics, and antidepressants: Bromelain may increase drowsiness. Always inform your doctor about all other medicines, supplements, and herbal products you are currently taking.

What precautions should be taken while using Tibrolin D Tablet?

Tibrolin D Tablet should be used with caution and is contraindicated in certain conditions. Avoid it if you have hypersensitivity to its components, a history of gastric or intestinal ulcers, bleeding or perforation, severe liver or renal damage, hereditary coagulation disorders (like hemophilia), established congestive heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or have recently undergone coronary artery bypass graft (CABG) surgery. It is also not recommended for children under 18. If you experience dizziness, blurred vision, or drowsiness, refrain from driving or operating machinery. Alcohol consumption should be avoided as it can increase the risk of stomach irritation and bleeding.

What happens if a dose of Tibrolin D Tablet is missed?

If you miss a dose of Tibrolin D Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should Tibrolin D Tablet be stored?

Tibrolin D Tablet should be stored in a cool, dry place, away from direct sunlight and moisture. The temperature should ideally be below 30°C. Keep this medicine out of the reach and sight of children and pets.