TEMPERATE-MR Tablets – Diclofenac Potassium 50 mg + Paracetamol 325 mg + Chlorzoxazone 250 mg

TEMPERATE-MR Tablets are a combination formulation containing Diclofenac Potassium 50 mg, Paracetamol 325 mg and Chlorzoxazone 250 mg per uncoated tablet, as specified on the provided product artwork.

The formulation combines an NSAID, analgesic/antipyretic and centrally acting skeletal muscle relaxant, making it intended for symptomatic management of painful musculoskeletal conditions where pain, inflammation and muscle spasm may occur together.

The artwork shows a 10 × 10 Tablets pack.

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Composition of TEMPERATE-MR Tablets

Product Information

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What are TEMPERATE-MR Tablets Used For?

TEMPERATE-MR Tablets are formulated for the symptomatic management of painful musculoskeletal conditions associated with inflammation and muscle spasm.

The three active ingredients provide complementary actions:

• Diclofenac Potassium – reduces pain and inflammation
• Paracetamol – provides additional analgesic and antipyretic activity
• Chlorzoxazone – acts as a skeletal muscle relaxant

It may be prescribed for conditions such as:

• Acute musculoskeletal pain
• Back pain associated with muscle spasm
• Neck pain and stiffness
• Muscle sprains and strains
• Sports-related musculoskeletal injuries
• Painful muscle spasm
• Soft-tissue injuries
• Acute inflammatory musculoskeletal conditions
• Other painful conditions involving muscle spasm, as determined by the physician

TEMPERATE-MR is intended for symptomatic relief and should not be described as a cure for the underlying musculoskeletal condition.

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How Does TEMPERATE-MR Work?

TEMPERATE-MR contains three active ingredients with different pharmacological actions.

Diclofenac Potassium → Anti-inflammatory + Analgesic

Paracetamol → Analgesic + Antipyretic

Chlorzoxazone → Skeletal Muscle Relaxant

Combined action:

Inflammation + Pain + Muscle Spasm

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Diclofenac + Paracetamol + Chlorzoxazone

↓

Reduction in pain, inflammatory symptoms and muscle spasm

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1. Diclofenac Potassium – 50 mg

Diclofenac potassium belongs to the non-steroidal anti-inflammatory drug (NSAID) class.

It helps reduce the production of prostaglandins involved in pain and inflammation.

Diclofenac provides:

• Anti-inflammatory activity
• Analgesic activity
• Reduction of inflammation-associated pain
• Relief of tenderness and discomfort

Simplified mechanism:

Diclofenac → Reduced prostaglandin synthesis → Reduced inflammatory response → Reduced pain and inflammation

Diclofenac therefore provides the primary anti-inflammatory component of TEMPERATE-MR.

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2. Paracetamol – 325 mg

Paracetamol, also known as acetaminophen, is an analgesic and antipyretic medicine.

It provides additional pain-relieving activity and can reduce fever.

Paracetamol provides:

• Analgesic activity
• Antipyretic activity
• Additional pain control

Simplified action:

Paracetamol → Analgesic/antipyretic effect → Reduced pain and fever

Its inclusion complements the analgesic action of diclofenac.

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3. Chlorzoxazone – 250 mg

Chlorzoxazone is a centrally acting skeletal muscle relaxant used as an adjunct to rest and physical therapy for acute painful musculoskeletal conditions.

It acts primarily at the level of the central nervous system to reduce excessive muscle spasm.

Chlorzoxazone may help with:

• Painful muscle spasm
• Muscle stiffness
• Restricted movement associated with muscle spasm
• Musculoskeletal discomfort associated with acute muscle injury

Simplified action:

Chlorzoxazone → Central muscle-relaxant action → Reduced muscle spasm → Improved movement and comfort

It is important to note that chlorzoxazone is not simply another analgesic; its role in this combination is primarily related to muscle relaxation.

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Combined Action of TEMPERATE-MR

The three components provide complementary therapeutic actions.

Overall therapeutic concept

Inflammation

→ Diclofenac

Pain

→ Diclofenac + Paracetamol

Muscle Spasm

→ Chlorzoxazone

Therefore:

TEMPERATE-MR = Pain Relief + Anti-inflammatory Action + Muscle Relaxation

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Therapeutic Benefits / Role of TEMPERATE-MR

1. Pain Relief

Diclofenac and paracetamol provide complementary analgesic activity for selected painful musculoskeletal conditions.

2. Anti-inflammatory Support

Diclofenac helps reduce inflammatory symptoms associated with musculoskeletal injuries and other painful inflammatory conditions.

3. Muscle Relaxation

Chlorzoxazone helps reduce muscle spasm and associated stiffness.

4. Improved Mobility

Reduction in pain and muscle spasm may help patients move the affected area more comfortably.

5. Support in Acute Musculoskeletal Conditions

The combination is particularly suited to situations where pain, inflammation and muscle spasm occur together.

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Common Clinical Applications

1. Acute Back Pain

Acute back pain can be associated with inflammation, muscle spasm, stiffness and restricted movement.

TEMPERATE-MR may be prescribed for symptomatic management when muscle spasm is an important component of the patient’s condition.

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2. Neck Pain and Stiffness

Neck muscle strain or other acute musculoskeletal conditions may result in:

• Pain
• Muscle tightness
• Stiffness
• Restricted movement

The combination of an analgesic, anti-inflammatory and muscle relaxant may be used when considered appropriate by the physician.

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3. Muscle Sprains and Strains

Sprains and strains may cause:

• Pain
• Inflammation
• Muscle spasm
• Tenderness
• Restricted movement

TEMPERATE-MR may provide symptomatic support through its three complementary components.

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4. Sports-Related Injuries

Sports-related musculoskeletal injuries may involve pain, inflammation and muscle spasm.

The formulation can be considered for short-term symptomatic treatment under medical supervision.

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5. Musculoskeletal Pain

Various acute musculoskeletal conditions may involve both inflammatory pain and muscle spasm.

TEMPERATE-MR provides:

Anti-inflammatory action + analgesic action + muscle relaxation

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6. Painful Muscle Spasm

When muscle spasm contributes significantly to pain and restricted movement, chlorzoxazone provides the muscle-relaxant component of the formulation.

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Suggested Use

TEMPERATE-MR Tablets should be taken strictly according to the prescription of a qualified healthcare professional.

The appropriate dosage and duration depend on:

• Severity and type of pain
• Degree of muscle spasm
• Patient age
• Medical history
• Kidney function
• Liver function
• Gastrointestinal history
• Cardiovascular risk
• Other medicines being taken

Since the provided artwork does not specify a recommended dosage schedule, an exact number of tablets per day should not be invented for the product page.

Administration

• Take orally with water.
• Follow the dosage prescribed by the physician.
• Do not exceed the prescribed dose.
• Use for the duration recommended by the healthcare professional.
• Do not take additional paracetamol-containing medicines without checking the total daily intake.
• Do not combine with another NSAID unless specifically advised.

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Important: Drowsiness and Driving

Because chlorzoxazone can cause drowsiness, dizziness or reduced alertness, patients should exercise caution when:

• Driving
• Operating machinery
• Working at heights
• Performing tasks requiring mental alertness

Alcohol may increase central nervous system depression and should be avoided unless the treating healthcare professional advises otherwise.

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Possible Side Effects

Possible adverse effects of TEMPERATE-MR may include:

Gastrointestinal

• Nausea
• Vomiting
• Indigestion
• Abdominal discomfort
• Heartburn
• Diarrhea
• Constipation

Nervous System

• Dizziness
• Drowsiness
• Headache
• Reduced alertness

Other

• Skin rash
• Allergic reactions
• Increased liver enzymes

Individual responses vary and not every patient experiences these effects.

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Important Serious Side Effects

Because the formulation contains diclofenac and chlorzoxazone, serious adverse effects are possible, although uncommon.

These may include:

• Gastrointestinal bleeding
• Peptic ulceration
• Severe allergic reactions
• Liver injury
• Kidney injury
• Cardiovascular events
• Severe skin reactions

Patients should seek medical attention if severe or unusual symptoms develop.

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Precautions & Warnings

1. Gastrointestinal Precautions

Diclofenac, like other NSAIDs, can increase the risk of:

• Gastric ulceration
• Gastrointestinal bleeding
• Gastrointestinal perforation

Risk may be higher in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

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2. Cardiovascular Precautions

NSAIDs such as diclofenac may increase the risk of serious cardiovascular events.

Particular caution may be necessary in patients with:

• Heart disease
• High blood pressure
• Previous stroke
• Cardiovascular risk factors

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3. Kidney Precautions

Diclofenac may affect kidney function, particularly in susceptible individuals.

Extra caution may be required in patients with:

• Kidney disease
• Dehydration
• Heart failure
• Older age
• Medicines affecting kidney function

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4. Liver Precautions

This formulation contains both diclofenac and paracetamol, so patients with liver disease should consult their healthcare professional before use.

Chlorzoxazone also has important hepatic safety considerations.

Patients should inform their doctor if they have:

• Liver disease
• Previous abnormal liver-function tests
• History of hepatitis
• Regular/high alcohol consumption

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5. Chlorzoxazone-Related Precautions

Patients should report symptoms that could indicate liver problems, such as:

• Yellowing of skin or eyes
• Dark urine
• Persistent nausea
• Unusual fatigue
• Loss of appetite
• Upper abdominal discomfort

Medical evaluation may be required if such symptoms develop.

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Paracetamol-Related Precaution

TEMPERATE-MR contains Paracetamol 325 mg.

Patients should carefully check other medicines they are taking for paracetamol/acetaminophen.

Taking multiple paracetamol-containing products can unintentionally result in excessive total intake and increase the risk of liver injury.

Particular caution is appropriate in patients with:

• Liver disease
• Heavy alcohol consumption
• Malnutrition
• Multiple paracetamol-containing medicines

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Drug & Medicine Interactions

Patients should inform their healthcare professional about all prescription medicines, OTC medicines, supplements and herbal products they are taking.

Particular attention may be required with:

• Other NSAIDs
• Aspirin
• Anticoagulants
• Antiplatelet medicines
• Corticosteroids
• ACE inhibitors
• ARBs
• Diuretics
• Methotrexate
• Lithium
• Digoxin
• Other paracetamol-containing medicines
• Sedative medicines
• CNS depressants
• Alcohol

Important

Do not combine TEMPERATE-MR with another diclofenac-containing medicine or another NSAID unless specifically advised by a healthcare professional.

Also check other medicines for paracetamol/acetaminophen.

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Alcohol and TEMPERATE-MR

Alcohol should preferably be avoided during treatment unless otherwise advised by the physician.

This is particularly relevant because:

• Chlorzoxazone can contribute to CNS depression and drowsiness.
• Paracetamol requires caution with excessive alcohol consumption because of potential liver toxicity.
• Diclofenac can increase gastrointestinal risks.

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Pregnancy & Breastfeeding

Pregnant or breastfeeding women should consult their healthcare professional before using TEMPERATE-MR.

Diclofenac and other NSAIDs require particular consideration during pregnancy, especially later in pregnancy.

The use of chlorzoxazone during pregnancy and breastfeeding should also be determined by the treating physician based on the individual risk-benefit assessment.

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Use in Elderly Patients

Older patients may be more susceptible to adverse effects associated with NSAIDs and muscle relaxants.

Particular attention may be required for:

• Gastrointestinal complications
• Kidney function
• Liver function
• Dizziness
• Drowsiness
• Falls
• Drug interactions

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Use in Kidney or Liver Disease

Patients with kidney or liver disease should inform their physician before taking TEMPERATE-MR.

The physician may evaluate:

• Renal function
• Liver function
• Concomitant medicines
• Patient age
• Overall risk-benefit profile

before prescribing the medicine.

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When Should Medical Attention Be Sought?

Patients should seek prompt medical attention if they develop:

• Black or bloody stools
• Vomiting blood
• Severe abdominal pain
• Chest pain
• Difficulty breathing
• Facial or throat swelling
• Severe skin rash
• Yellowing of the skin or eyes
• Dark urine
• Significant reduction in urine
• Severe dizziness or loss of consciousness
• Unusual or severe bleeding

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Storage

Store TEMPERATE-MR Tablets:

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

Follow the storage conditions printed on the final approved product packaging.

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Key Product Features

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Why Choose TEMPERATE-MR Tablets?

TEMPERATE-MR combines three pharmacological components in a single oral dosage form:

Diclofenac Potassium 50 mg

Provides anti-inflammatory and analgesic activity.

Paracetamol 325 mg

Provides additional analgesic and antipyretic activity.

Chlorzoxazone 250 mg

Provides skeletal muscle-relaxant activity for painful muscle spasm.

Overall formulation:

Pain + Inflammation + Muscle Spasm

→ TEMPERATE-MR

The combination is intended for short-term symptomatic management of selected painful musculoskeletal conditions where muscle spasm and inflammation are present together.