ANGINAC-SP Tablets – Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg

ANGINAC-SP Tablets by Amcare Pharmaceuticals contain a three-component combination of Aceclofenac IP 100 mg, Paracetamol IP 325 mg and Serratiopeptidase IP 15 mg. The formulation combines an NSAID for pain and inflammation, paracetamol for additional analgesic/antipyretic activity, and serratiopeptidase, a proteolytic enzyme that has been studied for postoperative swelling and inflammatory symptoms.

The product artwork specifies that the 15 mg serratiopeptidase is supplied as enteric-coated granules equivalent to 30,000 units of enzyme activity.

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Composition of ANGINAC-SP Tablets

Brand: ANGINAC-SP
Dosage form: Film-coated tablet
Route: Oral
Pack size: 10 × 10 Tablets
Company: Amcare Pharmaceuticals
Category: Prescription analgesic / anti-inflammatory combination

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What are ANGINAC-SP Tablets Used For?

ANGINAC-SP is intended for symptomatic management of pain and inflammation, particularly when swelling or inflammatory symptoms accompany a painful condition.

Aceclofenac is indicated for symptomatic relief of pain and inflammation in conditions including osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The specific aceclofenac 100 mg + paracetamol 325 mg combination has also been studied in acute painful conditions including low-back pain, acute musculoskeletal disorders, sprains, strains, dental pain, painful dental procedures and postoperative pain.

The three-drug combination of aceclofenac, paracetamol and serratiopeptidase is also commonly used in clinical/dental postoperative settings; however, evidence for serratiopeptidase itself is more limited and condition-specific.

Possible physician-directed applications include:

• Musculoskeletal pain
• Painful inflammatory joint conditions
• Osteoarthritis-related pain
• Rheumatoid arthritis-related pain
• Acute soft-tissue injury and inflammation
• Sprains and strains
• Dental/postoperative pain
• Conditions accompanied by localized swelling, when the physician considers serratiopeptidase appropriate

ANGINAC-SP should not be presented as a treatment for every type of pain or swelling.

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How Does ANGINAC-SP Work?

1. Aceclofenac 100 mg

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID).

It inhibits cyclooxygenase-related prostaglandin synthesis. Prostaglandins contribute to pain and inflammation, so reducing their production provides analgesic and anti-inflammatory effects.

Role of aceclofenac

• Helps reduce inflammatory pain
• Helps reduce inflammation
• Helps improve pain associated with inflammatory joint conditions

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2. Paracetamol 325 mg

Paracetamol provides analgesic and antipyretic activity and complements the pain-relieving action of aceclofenac.

Because ANGINAC-SP already contains paracetamol, patients should avoid accidentally taking additional paracetamol-containing medicines without medical advice. Excessive paracetamol can cause serious liver injury.

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3. Serratiopeptidase 15 mg

Serratiopeptidase is a proteolytic enzyme that has been investigated for its potential effects on postoperative swelling and inflammatory symptoms.

Clinical studies in dental surgery have reported improvements in postoperative swelling and trismus in some settings. However, systematic reviews have also noted that the overall evidence base has limitations, including small studies and inconsistent methodology.

Therefore, it is more appropriate to describe serratiopeptidase as providing supportive management of inflammatory swelling, rather than claiming that it definitively treats or eliminates swelling.

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Combined Action

The three components provide complementary pharmacological roles:

Aceclofenac → analgesic + anti-inflammatory action

Paracetamol → additional analgesic + antipyretic action

Serratiopeptidase → enzyme-based supportive role in inflammatory swelling

This combination has been used in clinical and dental postoperative settings.

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Benefits / Therapeutic Role

1. Pain Relief

Aceclofenac and paracetamol provide complementary analgesic activity.

2. Anti-inflammatory Action

Aceclofenac helps reduce inflammatory activity associated with painful musculoskeletal conditions.

3. Supportive Management of Swelling

Serratiopeptidase has been studied particularly in postoperative dental settings for swelling and restricted mouth opening.

4. Fixed-Dose Combination

Three active components are incorporated into a single oral dosage form, providing a convenient combination when all three components are considered appropriate by the prescriber.

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Dosage & Administration

ANGINAC-SP should be taken strictly according to the physician’s prescription.

The appropriate dose and duration depend on:

• The underlying diagnosis
• Severity of pain and inflammation
• Patient age
• Kidney function
• Liver function
• Cardiovascular risk
• Gastrointestinal history
• Other medicines being used

Aceclofenac product information lists 100 mg twice daily as the usual adult dose for aceclofenac alone, but this should not automatically be used as the dosing instruction for ANGINAC-SP. The complete formulation contains paracetamol and serratiopeptidase, so the treating physician should determine the appropriate regimen.

Administration

• Swallow the tablet with sufficient water.
• Follow the prescribed schedule.
• Do not crush or chew the tablet unless specifically instructed.
• Do not exceed the prescribed dose.
• Avoid taking another NSAID simultaneously unless specifically prescribed.

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Important Paracetamol Precaution

Each ANGINAC-SP tablet contains 325 mg of paracetamol.

Patients should check other medicines for ingredients such as:

• Paracetamol
• Acetaminophen
• APAP

Taking more than the recommended total amount can cause serious liver injury.

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Possible Side Effects

Possible adverse effects may include:

Aceclofenac-related

• Indigestion
• Stomach discomfort
• Nausea
• Vomiting
• Diarrhea
• Dizziness
• Headache
• Fluid retention
• Increased blood pressure

NSAIDs including aceclofenac can also cause serious gastrointestinal, renal, hepatic and cardiovascular adverse effects.

Paracetamol-related

Paracetamol is generally well tolerated at recommended doses, but excessive intake can cause serious liver injury. Rare serious allergic and blood-related reactions can also occur.

Serratiopeptidase-related

The safety evidence for serratiopeptidase is less extensive than for established analgesics. Published systematic reviews have noted limitations in the available safety and efficacy data.

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Serious Symptoms Requiring Medical Attention

Seek urgent medical attention if the patient develops:

• Vomiting blood
• Black or tarry stools
• Severe abdominal pain
• Difficulty breathing
• Swelling of the face, lips or throat
• Severe skin rash or blistering
• Yellowing of the skin or eyes
• Significant reduction in urine
• Chest pain
• Sudden weakness or other serious neurological symptoms

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Precautions & Warnings

1. Gastrointestinal Risk

Aceclofenac can cause gastrointestinal ulceration, bleeding and perforation, sometimes without warning symptoms. Risk is increased in older patients and those with previous ulcer disease or concomitant medicines that increase GI bleeding risk.

2. Kidney Function

NSAIDs can affect renal function, particularly in patients with kidney disease, dehydration, heart failure or other risk factors.

Patients receiving long-term NSAID treatment may require monitoring of kidney function.

3. Liver Function

Because ANGINAC-SP contains paracetamol and aceclofenac, caution is required in patients with liver disease.

Excessive paracetamol exposure can cause severe liver damage.

4. Cardiovascular Risk

Aceclofenac may increase cardiovascular risk, particularly with higher doses and longer treatment durations. The lowest effective dose for the shortest necessary duration is recommended.

5. Allergic Reactions

Patients who have previously experienced asthma, rhinitis, urticaria or other hypersensitivity reactions after aspirin or NSAIDs require particular caution and may be contraindicated.

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Who Should Avoid or Use ANGINAC-SP With Caution?

Medical assessment is particularly important for patients with:

• Active or recurrent peptic ulcer disease
• Previous gastrointestinal bleeding
• Kidney disease
• Liver disease
• Heart failure
• Ischemic heart disease
• High blood pressure
• Peripheral arterial disease
• Cerebrovascular disease
• Bleeding disorders
• NSAID-induced asthma or allergy
• Significant alcohol consumption
• Dehydration
• Concomitant anticoagulant treatment

Aceclofenac is contraindicated in several cardiovascular, gastrointestinal, renal, hepatic and hypersensitivity conditions.

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Drug Interactions

Inform the physician about all prescription medicines, OTC medicines and supplements.

Particular attention is required with:

• Other NSAIDs
• Aspirin
• Warfarin and other anticoagulants
• Antiplatelet medicines
• Corticosteroids
• ACE inhibitors
• ARBs
• Diuretics
• Lithium
• Methotrexate
• Digoxin
• Certain medicines affecting kidney function

Aceclofenac product information specifically warns about interactions with other NSAIDs, anticoagulants, antihypertensives, diuretics, lithium, methotrexate and cardiac glycosides.

Avoid duplicate paracetamol

Do not take ANGINAC-SP together with another paracetamol-containing medicine unless your doctor has specifically advised it.

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Pregnancy & Breastfeeding

ANGINAC-SP should be used during pregnancy only when specifically determined appropriate by a healthcare professional.

Aceclofenac should generally be avoided during pregnancy, with the cited prescribing information contraindicating use during the third trimester and describing additional fetal risks with later-pregnancy exposure.

Patients who are pregnant, planning pregnancy or breastfeeding should discuss the medicine with their physician before use.

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Driving & Operating Machinery

Some patients may experience:

• Dizziness
• Drowsiness
• Headache
• Visual disturbances

If these effects occur, avoid driving or operating machinery until the effects have resolved.

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Alcohol & ANGINAC-SP

Patients should exercise caution with alcohol while taking ANGINAC-SP.

Alcohol can increase gastrointestinal irritation associated with NSAIDs, while excessive alcohol consumption can increase concern regarding paracetamol-associated liver injury.

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Storage

Store ANGINAC-SP Tablets:

• In a cool, dry place
• Away from direct sunlight
• Protected from moisture
• In the original packaging
• Out of reach of children

Always follow the storage conditions specified on the approved product packaging.

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Key Product Features

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Why Choose ANGINAC-SP by Amcare Pharmaceuticals?

ANGINAC-SP combines:

• Aceclofenac IP 100 mg
• Paracetamol IP 325 mg
• Serratiopeptidase IP 15 mg
• 30,000 units of serratiopeptidase enzyme activity

The formulation is intended to provide a combined approach to pain, inflammation and selected inflammatory swelling, when considered appropriate by a healthcare professional.