RESTHROTEC

Description

RESTHROTEC is a combination therapy containing Diclofenac Sodium (75 mg), a potent NSAID with analgesic, anti-inflammatory, and antipyretic properties, and Misoprostol (200 mcg), a prostaglandin E1 analog that protects the gastrointestinal mucosa. This combination helps in the effective treatment of osteoarthritis and rheumatoid arthritis while reducing the risk of NSAID-induced gastric and duodenal ulcers.

Composition:

• Diclofenac Sodium BP: 75 mg

• Misoprostol USP: 200 mcg

• Excipients: q.s.

• Colour: Titanium Dioxide USP

Mechanism of Action:

• Diclofenac: Inhibits cyclooxygenase (COX-1 and COX-2) to reduce prostaglandin synthesis, thereby decreasing pain and inflammation.

• Misoprostol: Provides gastric mucosal protection by replacing the prostaglandins inhibited by NSAIDs, reducing acid secretion and enhancing mucus production in the stomach.

Indications:

✅ Treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk of NSAID-induced gastric and duodenal ulcers and their complications.

Contraindications:

❌ Known hypersensitivity to diclofenac, misoprostol, or other NSAIDs.
❌ History of asthma or allergic reactions to NSAIDs.
❌ Active gastrointestinal bleeding or ulcers.
❌ During pregnancy (can cause fetal harm).
❌ After coronary artery bypass graft (CABG) surgery.

Warnings & Precautions:

• Talk to your doctor or pharmacist before taking Diclofenac sodium and Misoprostol 75 mg/200 mcg if:

  • You smoke.

  • You have diabetes.

  • You have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

  • You have any heart problems, previous stroke, or think you may be at risk (due to high BP, poor circulation, diabetes, high cholesterol, or smoking).

  • You have liver or kidney disease.

  Do NOT take this medicine if:

  • You have severe kidney or liver failure.

  • You currently have or previously had an ulcer or bleeding in your stomach or intestines.

  • You bleed or bruise easily.

  • You have ulcerative colitis or Crohn’s disease.

  • You have or ever had asthma or an allergic disease.

  • You have an infection (as this medicine may mask fever or infection signs).

  • You are dehydrated.

  • You are over 65 years (your doctor may need to monitor you regularly).

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  Important Warnings:

  • NSAIDs like Diclofenac + Misoprostol may cause bleeding or ulcers. If this happens, stop treatment.

  • May increase the risk of heart attack or stroke, especially at high doses or prolonged treatment.

  • Do not exceed the recommended dose or treatment duration.

  • To reduce side effects, use the lowest effective dose for the shortest duration necessary.

  • May increase blood pressure; your doctor may monitor your BP regularly.

  • If you have heart, liver, or kidney problems, regular monitoring will be required.

  Other Precautions:

  • This medicine may cause dizziness or drowsiness.

  • Do not drive or operate machinery if you feel dizzy or drowsy after taking it.

Side Effects:

Common side effects:

• Diarrhea

• Headache

• Nausea or vomiting

• Stomach pain or cramps

• Heartburn or gas

• Dizziness

• Menstrual irregularities

• Increased liver enzymes

Serious side effects:

• Allergic reactions (rash, swelling, hives)

• Abnormal bleeding (black stools, blood in urine/vomit)

• Heart attack (chest pain, breathing difficulty)

• Stroke (slurred speech, weakness)

• Kidney issues (swelling, weight gain)

• Jaundice (yellowing of skin/eyes)

Discontinue use and seek medical attention immediately if serious side effects occur.

Interactions:

RESTHROTEC may interact with:

• Aspirin: May reduce diclofenac protein binding.

• Voriconazole: May increase diclofenac blood levels.

• Other NSAIDs, anticoagulants, and certain antihypertensives may interact; consult your doctor before use.

Dosage:

• Use strictly as directed by your doctor.

• Do not exceed the prescribed dose or duration.

Storage:

• Store below 30°C in the original packaging.

• Protect from light and moisture.

• Keep out of reach of children.

Presentation:

RESTHROTEC is available in a pack of 10 film-coated tablets in one alu-alu strip, with 10 strips in one carton with an insert.

Key Benefits:

✅ Effective pain relief in arthritis
✅ Provides gastric protection during NSAID therapy
✅ Reduces the risk of NSAID-induced ulcers
✅ Dual-action for symptom control and GI safety

How to Use:

1️⃣ Take the tablet as prescribed, preferably with food to minimize gastrointestinal discomfort.
2️⃣ Swallow whole with water; do not crush or chew.
3️⃣ Follow your doctor’s guidance on duration and monitoring while on this medication.