NEO-NIDAL^®

COMPOSITION: Each tablet contains :

Aceclofenac.................. 100 mg

Excipients: Mannitol, Microcrystalline cellulose 101, Hypromellose E6, Croscarmellose sodium, Sucralose, Magnesium stearate, Opadry II white, Ponceau 4R lake, Purified water q.s. one tablet.

INDICATIONS:

Short-term treatment of post traumatic pain, post operative pain, inflammation and swelling following dental or orthopedic surgery, painful and inflammation conditions such as primary dysmenorrhea, rheumatism, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis,...

DOSAGE AND ADMINISTRATION:

- Adult: Usual dosage: 100 mg twice daily.

- Children: There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.

- The initial oral dose of Aceclofenac should be reduced to 100 mg daily in patients with hepatic impairment.

- NEO-NIDAL^® should be taken within or after meals

CONTRAINDICATIONS:

- Hypersensitivity to any component(s) of drug.

- Bronchospasm caused by aspirin or other NSAIDs.

- Severe hepatic impairment or severe renal impairment.

- Gastric and duodenal ulcer.

- Pregnancy (in the last trimester of pregnancy).

THẬN TRỌNG:

- Gastro-intestinal bleeding or ulceration / perforation can occur at any time during treatment, with or without warning symptoms or a previous history.

- As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions can occur in rare cases without earlier exposure to the drug.

- Like other NSAIDs, Aceclofenac may mask the symptoms of infections due to its pharmacodynamic properties.

PREGNANCY AND LACTATING WOMAN:

- Aceclofenac should be used in pregnancy only when it is judged absolutely necessary. It is not recommended in the last trimester of pregnancy (risk of inhibition uterine contractions and premature closing of ductus arteriosus).

- There is no information on the secretion of Aceclofenac to breast milk. NSAIDs, if possible, be avoided when breastfeeding.

PRESENTATION: Blisters of 10 tablets, box of 3 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and Distributed by: AMPHARCO U.S.A PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc, Nhon trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203