TROPINE Eye Drops

TROPINE Eye Drops

1. Ingredients:

Each mL contains:

• Atropine sulphate USP: 0.1 mg
• Stabilised oxychloro complex: 0.05 mg
• Purified water and buffer system: q.s.

2. Intended Use:

TROPINE helps control and slow the progression of myopia in children.

3. Dosage and Administration:

Target Users:

• Adults and children over 6 years of age with myopia or progressive myopia.
• No studies evaluating use in children under 6 years of age are cited in the supplied information.

TROPINE 0.01% helps control and slow the progression of myopia in children.

Usual dose: Instil 1–2 drops into the eye daily at bedtime. Administration at bedtime may help minimise discomfort associated with adverse effects. However, the timing of administration is not considered critical.

The supplied information states that recent studies found atropine 0.01% to have no significant effect on pupil size or accommodation, with very few adverse effects.

Use atropine 0.01% for at least 6 months to allow the doctor to assess its effectiveness. Treatment may then be continued for up to 2 years. If myopia progression resumes, the treatment course may be repeated under the doctor’s guidance.

4. Contraindications:

• Hypersensitivity to atropine or any excipient in the formulation.
• Angle-closure glaucoma.
• Narrow iridocorneal angles, as the product may increase intraocular pressure and precipitate an acute attack of angle-closure glaucoma.

5. Warnings and Precautions:

• For topical ophthalmic use only. Not for injection.
• Use at the dose and for the duration advised by your doctor.
• Read the instructions on the label before use.
• Hold the dropper close to the eye without allowing it to touch the eye.
• Gently squeeze the dropper and instil the drops into the lower conjunctival sac. Wipe away any excess solution.
• Do not use while wearing contact lenses.
• Discontinue use if eye redness or itching persists, worsens or lasts for 72 hours.

6. Possible Adverse Effects:

• Acute systemic effects: Tachycardia, mood changes, dry mouth, urinary retention, constipation and skin flushing have been reported with higher concentrations of atropine. These effects are described as very rare with atropine 0.01%; the supplied information reports no cases in the studies it refers to.
• The low atropine concentration of 0.01% helps minimise ocular adverse effects. Reported reactions include local irritation, allergic dermatitis (reported incidence below 1%) and allergic conjunctivitis.
• Important: Discontinue use and inform your doctor if you experience any adverse effects while using TROPINE 0.01%.

7. Storage:

• Keep out of the sight and reach of children.
• Store upright in a dry place, protected from light, at a temperature below 30°C.
• Do not use after the expiry date printed on the bottle label. The expiry date refers to the last day of the stated month.

8. Shelf Life:

24 months.

Use within 30 days of first opening. Discard any remaining solution after this period.

9. Manufacturer, Country of Origin and Distributor:

• Manufacturer: Sion Healthcare (SHL) Limited.
  Address: No. 19, Somnath Industrial Estate, Kerala GIDC, Bavla, Ahmedabad – 382220, Gujarat, India.
• Country of Origin: India.
• Distributor in Vietnam:
  VITAONE INTERNATIONAL JOINT STOCK COMPANY
  Registered business address: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Head office: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Telephone: 077 397 2868.