Aertal tab 100mg #60

Airtal Tablet 100 mg
Composition:

Each tablet contains:

Active ingredient:

• Aceclofenac 100 mg

Excipients:

• Core: Glycerol distearate, sodium croscarmellose, povidone, microcrystalline cellulose.

• Coating: Sepifilm 752 white (hydroxypropyl methylcellulose, microcrystalline cellulose, titanium dioxide (E171), macrogol stearate, type I).

Indications:

Used in cases of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and other painful conditions of the musculoskeletal system (e.g., shoulder periarthritis and other non-articular manifestations of rheumatism).
Also indicated for pain relief (e.g., lower back pain, toothache, and primary dysmenorrhea).

Contraindications:

• Hypersensitivity to the active ingredient or any of the excipients listed in section 6.1.

• Patients with a history of hypersensitivity reactions (e.g., asthma, bronchospasm, acute rhinitis, or urticaria) induced by aspirin or other NSAIDs.

• Patients with a history of gastrointestinal bleeding or ulcers due to NSAIDs.

• Patients with active or recurrent gastric or duodenal ulcers or bleeding (two or more confirmed episodes of ulcer or bleeding).

• Patients with active bleeding or bleeding disorders (e.g., hemophilia or coagulation disorders).

• Severe heart failure or significant hepatic or renal impairment.

• Pregnancy, particularly the third trimester, unless absolutely necessary. In such cases, the minimum effective dose should be used.

Dosage and Administration:

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Airtal 100 mg film-coated tablets are for oral administration.
The tablet should be swallowed with at least half a glass of water. It can be taken with food.

Adults:The maximum recommended dose is 200 mg per day, taken as 100 mg twice daily (one tablet in the morning and one in the evening).

Children:
There are no safety and efficacy data available for use in children.

Elderly:
Dose reduction is generally not required, but caution is advised.
In patients with mild to moderate liver impairment, the dose of aceclofenac should be reduced. The recommended starting dose is 100 mg per day.

Renal impairment:
No dose adjustment is required in patients with mild renal dysfunction, but caution is advised when using Airtal 100 mg film-coated tablets.

Effects on Driving and Operating Machinery:

Patients experiencing symptoms such as fatigue, dizziness, vertigo, nausea, or other CNS-related side effects while taking NSAIDs should avoid driving or operating potentially dangerous machinery.

Storage Conditions:

Store below 25°C.
Keep out of the reach of children.