ANGINAC-TH PLUS Tablets – Aceclofenac 100 mg + Paracetamol 325 mg + Thiocolchicoside 4 mg

ANGINAC-TH PLUS Tablets by Amcare Pharmaceuticals are a prescription fixed-dose combination containing Aceclofenac IP 100 mg, Paracetamol IP 325 mg and Thiocolchicoside IP 4 mg per film-coated tablet. The product is intended for physician-directed symptomatic management where pain, inflammation and muscle spasm occur together.

Composition of ANGINAC-TH PLUS Tablets

Product Information

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What are ANGINAC-TH PLUS Tablets Used For?

ANGINAC-TH PLUS combines an NSAID, analgesic/antipyretic and muscle-relaxant component. It may be prescribed for short-term symptomatic management of painful musculoskeletal conditions associated with muscle spasm.

Physician-directed applications may include:

• Acute musculoskeletal pain
• Pain associated with muscle spasm
• Acute low-back pain with muscle spasm
• Painful spinal/musculoskeletal conditions
• Sprains and strains
• Other acute painful conditions where muscle spasm is present

Aceclofenac is used for symptomatic relief of pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Thiocolchicoside is used as an adjunct muscle relaxant for painful muscle contractures in certain spinal conditions.

The exact indication should be determined by the prescribing physician.

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How Does ANGINAC-TH PLUS Work?

1. Aceclofenac – 100 mg

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

It reduces the production of inflammatory mediators involved in pain and inflammation, thereby providing:

• Analgesic action
• Anti-inflammatory action
• Relief of painful musculoskeletal symptoms

2. Paracetamol – 325 mg

Paracetamol provides analgesic and antipyretic activity and can provide additional pain relief.

Because ANGINAC-TH PLUS already contains paracetamol, patients should not take additional paracetamol-containing medicines unless advised by a healthcare professional. Excessive paracetamol exposure can cause serious liver injury.

3. Thiocolchicoside – 4 mg

Thiocolchicoside is a muscle relaxant used as an adjunct in painful muscle contractures. Regulatory information recommends systemic thiocolchicoside only for short-term use in appropriate patients.

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Combined Action of ANGINAC-TH PLUS

Aceclofenac → Anti-inflammatory + analgesic action

Paracetamol → Additional analgesic + antipyretic action

Thiocolchicoside → Muscle-relaxant action

This combination may therefore be considered when pain, inflammation and muscle spasm occur together.

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Benefits / Therapeutic Role

1. Pain Relief

Aceclofenac and paracetamol provide complementary analgesic activity.

2. Anti-inflammatory Action

Aceclofenac helps manage inflammatory pain.

3. Muscle Relaxation

Thiocolchicoside provides a muscle-relaxant component for painful muscle contractures/spasm.

4. Combination Therapy

Three active components are provided in a single oral tablet when all are clinically appropriate.

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Dosage & Administration

ANGINAC-TH PLUS should be taken only according to the prescription of a qualified healthcare professional.

The appropriate dose and treatment duration depend on:

• Diagnosis
• Severity of pain and muscle spasm
• Age
• Kidney function
• Liver function
• Gastrointestinal history
• Cardiovascular risk
• Other medicines being taken

Do not automatically use the standard dose of any individual ingredient as the dosing instruction for this combination.

Administration

• Take exactly as prescribed.
• Swallow the tablet with water.
• Do not exceed the prescribed dose.
• Do not take another NSAID unless specifically advised.
• Do not take additional paracetamol-containing medicines without professional advice.
• Use for the shortest duration recommended by your physician.

Important Thiocolchicoside Duration Restriction

Systemic thiocolchicoside has specific safety restrictions. EMA information recommends a maximum oral treatment duration of 7 consecutive days and states that it should not be used for long-term treatment of chronic conditions.

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Possible Side Effects

Aceclofenac-related

Possible effects include:

• Indigestion
• Nausea
• Vomiting
• Stomach discomfort
• Diarrhea
• Dizziness
• Headache
• Fluid retention

NSAIDs can also cause serious gastrointestinal, kidney, liver and cardiovascular adverse effects.

Paracetamol-related

Paracetamol is generally well tolerated at recommended doses, but excessive intake can cause serious liver damage.

Thiocolchicoside-related

Possible adverse effects can include:

• Gastrointestinal discomfort
• Drowsiness
• Allergic reactions
• Seizures/convulsions in susceptible individuals
• Rare liver-related adverse reactions

Regulatory reviews have identified important safety concerns associated with systemic thiocolchicoside and have therefore restricted its dose and duration of use.

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Serious Symptoms Requiring Medical Attention

Seek urgent medical attention if the patient develops:

Gastrointestinal symptoms

• Vomiting blood
• Black/tarry stools
• Severe abdominal pain

Allergic symptoms

• Difficulty breathing
• Swelling of face, lips or throat
• Severe skin rash

Liver-related symptoms

• Yellowing of skin or eyes
• Dark urine
• Persistent nausea or vomiting
• Severe unexplained fatigue

Neurological symptoms

• Seizure or convulsion
• Severe dizziness or unusual loss of alertness

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Precautions & Warnings

1. Gastrointestinal Risk

Aceclofenac, as an NSAID, can cause stomach ulceration and gastrointestinal bleeding. Risk can be higher in susceptible patients.

2. Kidney Function

NSAIDs can affect kidney function, particularly in people with:

• Existing kidney disease
• Dehydration
• Heart failure
• Older age
• Concurrent medicines affecting kidney function

3. Liver Function

Because the formulation contains paracetamol and aceclofenac, patients with liver disease should consult their doctor before use.

Excessive paracetamol exposure can cause serious liver injury.

4. Cardiovascular Risk

NSAIDs can increase cardiovascular risks, particularly with prolonged use. The lowest effective dose for the shortest appropriate duration should be considered.

5. Seizure Risk

Patients with epilepsy or an increased risk of seizures should inform their doctor before using systemic thiocolchicoside.

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Who Should Avoid or Use ANGINAC-TH PLUS With Caution?

Medical assessment is particularly important for patients with:

• Previous stomach ulcer or GI bleeding
• Kidney disease
• Liver disease
• Heart disease
• High blood pressure
• Heart failure
• NSAID allergy
• NSAID-related asthma
• Bleeding disorders
• Epilepsy or seizure history
• Significant alcohol consumption
• Dehydration
• Previous adverse reaction to NSAIDs
• Concurrent anticoagulant therapy

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Drug Interactions

Inform your doctor about all prescription medicines, OTC medicines and supplements.

Particular attention may be required with:

• Other NSAIDs
• Aspirin
• Anticoagulants such as warfarin
• Antiplatelet medicines
• Corticosteroids
• ACE inhibitors
• ARBs
• Diuretics
• Lithium
• Methotrexate
• Other medicines affecting kidney function
• Other paracetamol-containing medicines

Avoid Duplicate Paracetamol

ANGINAC-TH PLUS contains 325 mg paracetamol per tablet.

Before taking another medicine, check whether it contains:

• Paracetamol
• Acetaminophen
• APAP

Taking multiple paracetamol-containing products can unintentionally increase total exposure and cause liver injury.

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Pregnancy & Breastfeeding

ANGINAC-TH PLUS should not be used during pregnancy or breastfeeding unless specifically directed by an appropriate healthcare professional.

Systemic thiocolchicoside is contraindicated during pregnancy and lactation under the EMA safety framework, and women of childbearing potential are subject to specific contraception requirements.

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Driving & Operating Machinery

Some patients may experience dizziness, drowsiness or reduced alertness.

If the medicine affects concentration or coordination, avoid driving or operating machinery.

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Alcohol & ANGINAC-TH PLUS

Alcohol should be minimized or avoided unless your healthcare professional advises otherwise.

Particular concerns include:

• Increased gastrointestinal irritation associated with NSAIDs
• Additional liver concerns with excessive paracetamol exposure
• Potential worsening of dizziness or reduced alertness

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Storage

Store ANGINAC-TH PLUS Tablets:

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

Follow the storage conditions printed on the approved product packaging.

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Key Product Features

Why Choose ANGINAC-TH PLUS by Amcare Pharmaceuticals?

ANGINAC-TH PLUS combines:

• Aceclofenac IP – 100 mg
• Paracetamol IP – 325 mg
• Thiocolchicoside IP – 4 mg

The formulation brings together analgesic, anti-inflammatory and muscle-relaxant components for physician-directed management of appropriate painful musculoskeletal conditions.