Anginac-TH Tablets – Aceclofenac 100 mg + Thiocolchicoside 4 mg

Anginac-TH Tablets by Amcare Pharmaceuticals are a prescription fixed-dose combination containing Aceclofenac IP 100 mg and Thiocolchicoside IP 4 mg per film-coated tablet. The formulation combines an NSAID for pain and inflammation with a centrally acting muscle-relaxant medicine. The product artwork specifies a pack size of 10 × 10 tablets.

Composition of Anginac-TH Tablets

Product Information

What are Anginac-TH Tablets Used For?

Anginac-TH may be prescribed for short-term symptomatic management of painful musculoskeletal conditions associated with muscle spasm, where both an anti-inflammatory analgesic and muscle relaxant are considered appropriate.

Physician-directed applications may include:

• Acute musculoskeletal pain
• Pain associated with muscle spasm
• Low-back pain with muscle spasm
• Painful spinal/musculoskeletal conditions
• Sprains and strains
• Other acute painful conditions involving muscle spasm

Aceclofenac is established for symptomatic relief of pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The exact indication should be determined by the prescribing physician.

How Does Anginac-TH Work?

1. Aceclofenac – 100 mg

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID). It reduces the production of prostaglandins involved in pain and inflammation.

It therefore provides:

• Analgesic action
• Anti-inflammatory action
• Relief from painful joint and musculoskeletal symptoms

Aceclofenac product information recommends using the lowest effective dose for the shortest necessary duration to reduce adverse effects.

2. Thiocolchicoside – 4 mg

Thiocolchicoside is a muscle relaxant used for painful muscular conditions. It acts on receptors involved in regulation of muscle function.

Its inclusion in Anginac-TH provides a muscle-relaxant component when painful muscle contracture or spasm is present.

Combined Action

Aceclofenac → Pain relief + anti-inflammatory action

Thiocolchicoside → Muscle-relaxant action

Together, the formulation provides a combination approach for painful musculoskeletal conditions where pain, inflammation and muscle spasm occur together.

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Benefits / Therapeutic Role

1. Pain Relief

Aceclofenac provides analgesic activity for painful musculoskeletal conditions.

2. Reduction of Inflammation

Aceclofenac helps reduce inflammatory symptoms associated with painful conditions.

3. Muscle Relaxation

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

4. Combination Therapy

Two active medicines are incorporated into a single oral tablet when both components are clinically appropriate.

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Dosage & Administration

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

The appropriate dose and duration depend on factors such as:

• Diagnosis and severity of symptoms
• Age
• Kidney function
• Liver function
• Gastrointestinal history
• Cardiovascular risk
• Other medicines being taken

For aceclofenac alone, one established product information source lists 200 mg/day divided into two 100 mg doses for adults, but this should not automatically be treated as the dosing instruction for Anginac-TH, because the combination also contains thiocolchicoside.

Administration

• Take exactly as prescribed.
• Swallow the tablet with water.
• Do not exceed the prescribed dose.
• Do not take another NSAID unless advised by your doctor.
• Use for the shortest duration recommended by your healthcare professional.

Important Thiocolchicoside Duration Restriction

Systemic thiocolchicoside has important dose and duration restrictions. EMA recommendations limit oral treatment to short-term use, with a maximum of 7 consecutive days under the referenced European safety framework.

Therefore, Anginac-TH should not be promoted as a long-term muscle-relaxant treatment.

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Possible Side Effects

Possible side effects may include:

Aceclofenac-related

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

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

Thiocolchicoside-related

Possible adverse reactions can include:

• Drowsiness
• Gastrointestinal discomfort
• Allergic reactions
• Convulsions, particularly in people with epilepsy or seizure risk
• Rare liver injury

Regulatory pharmacovigilance information has specifically identified convulsions, anaphylactic reactions and drug-induced liver injury as important safety concerns for systemic thiocolchicoside.

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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 the face, lips or throat
• Severe skin rash

Liver-related symptoms

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

Neurological symptoms

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

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Precautions & Warnings

1. Gastrointestinal Risk

Aceclofenac, like other NSAIDs, can cause ulceration and gastrointestinal bleeding, particularly in susceptible patients.

Extra caution is required in patients with:

• Previous stomach ulcer
• Previous gastrointestinal bleeding
• Older age
• Concurrent anticoagulant or corticosteroid therapy

2. Kidney Function

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

3. Liver Function

Patients with liver disease should inform their doctor before taking Anginac-TH. Thiocolchicoside has also been associated with reported liver injury.

4. Cardiovascular Risk

NSAIDs may increase cardiovascular risks, particularly with prolonged treatment. The lowest effective dose for the shortest necessary duration should be used.

5. Seizure Risk

Thiocolchicoside requires particular caution in patients with epilepsy or an increased risk of seizures.

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Who Should Avoid or Use Anginac-TH 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

Thiocolchicoside-containing systemic medicines are contraindicated during pregnancy and breastfeeding under the EMA safety framework.

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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

Aceclofenac product information identifies clinically relevant interactions with several of these medicine groups.

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Pregnancy & Breastfeeding

Do not use Anginac-TH during pregnancy or breastfeeding unless specifically instructed by an appropriate healthcare professional.

Thiocolchicoside has specific reproductive-safety restrictions, including contraindication during pregnancy and lactation under the EMA safety framework.

Women who may become pregnant should discuss appropriate contraception and treatment alternatives with their doctor.

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Driving & Operating Machinery

Thiocolchicoside-containing medicines may cause effects such as drowsiness or dizziness in some patients.

If Anginac-TH affects your alertness, coordination or concentration, avoid driving or operating machinery.

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Alcohol & Anginac-TH

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

Particular consideration is required because:

• NSAIDs can increase gastrointestinal irritation and bleeding risk.
• Alcohol can add to liver-related concerns when medicines affecting the liver are involved.

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Storage

Store Anginac-TH Tablets:

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

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

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Key Product Features

Why Choose Anginac-TH by Amcare Pharmaceuticals?

Anginac-TH combines:

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

The formulation provides complementary analgesic, anti-inflammatory and muscle-relaxant actions when prescribed for an appropriate painful musculoskeletal condition.