Restasis^® (Drops) Instructions for Use

Marketing Authorization Holder

Allergan, Inc. (USA)

Manufactured By

Allergan Sales, LLC (USA)

ATC Code

S01XA18 (Ciclosporin)

Active Substance

Ciclosporin (Rec.INN registered by WHO)

Dosage Form

Restasis®

Eye drops 0.05%: bottle 0.4 ml 30 pcs.

Dosage Form, Packaging, and Composition

Eye drops in the form of a translucent or cloudy, homogeneous white emulsion; when viewed under a microscope: oil drops uniformly distributed in the aqueous phase.

Excipients: castor oil – 12.5 mg, glycerol – 22 mg, polysorbate 80 – 10 mg, carbomer – 0.5 mg, sodium hydroxide – 4.09 mg, water – 950 mg.

0.4 ml – single-dose LDPE bottles with a capacity of 0.9 ml (30) – polypropylene packages, sealed with aluminum foil and closed with a polystyrene cap.

Clinical-Pharmacological Group

Immunosuppressant for topical use in dry eye syndrome

Pharmacotherapeutic Group

Immunosuppressive agent

Pharmacological Action

Ciclosporin is a substance that has an immunosuppressive effect when administered systemically. In the suppression of tear production in patients with dry keratoconjunctivitis, Ciclosporin, when applied topically, has an anti-inflammatory and immunomodulatory effect.

Pharmacokinetics

The concentration of ciclosporin after topical application in adults at a concentration of 0.05% 2 times/day is below the detectable level – 0.1 ng/ml.

Indications

• Decreased tear production due to dry keratoconjunctivitis.

ICD codes

Dosage Regimen

Use topically in the eye only.

Before each use, invert the single-use bottle several times to obtain a homogeneous, opaque, white emulsion.

Instill one drop into the conjunctival sac of each affected eye twice daily, approximately every 12 hours.

Use the entire contents of the single-use bottle immediately after opening; discard any unused emulsion.

Do not allow the tip of the bottle to contact the eye or any other surface to prevent contamination.

Do not use while wearing contact lenses. Remove lenses before application and reinsert no sooner than 15 minutes after instillation.

Adhere strictly to the twice-daily dosing schedule for optimal therapeutic effect.

Adverse Reactions

When using Restasis^®, the most common (in 17% of cases) was a sensation of burning in the eye.

Frequency of adverse effects: very common (>10%), common (>1%, <10%), uncommon (>0.1%, <1%); rare (>0.01%, <0.1), very rare (<0.01%).

Very common burning in the eye.

Common eye irritation, conjunctival hyperemia, foreign body sensation in the eye, eye pain and itching, eye discharge, blurred vision, dry eye syndrome, photophobia, headache.

Uncommon keratitis with ulceration, eyelid edema and hyperemia, increased lacrimation, dizziness, nausea, rash.

Frequency unknown conjunctival and eyelid edema, hypersensitivity reactions, urticaria.

Contraindications

• Acute infectious eye diseases;
• Pregnancy;
• Lactation period;
• Age under 18 years;
• Hypersensitivity to the components of the drug.

Use with caution in patients with a history of herpetic keratitis.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies of Restasis^® in pregnant women have not been conducted. Restasis^® is not recommended for pregnant women. When administered systemically, Ciclosporin penetrates into breast milk; excretion in breast milk with topical application has not been studied. If prescribed during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

The emulsion contained in one single-use bottle must be used immediately after opening the bottle – the remaining amount of the drug after instillation must be disposed of immediately after use.

Do not allow the tip of the bottle to touch the eyes or any surface to avoid possible contamination of its contents.

Restasis^® should not be used while wearing contact lenses. Patients with reduced tear production are generally not recommended to use contact lenses. If lenses are still used, they must be removed before applying the drug and can be reinserted 15 minutes after applying Restasis^®.

Effect on the ability to drive vehicles and operate machinery

Restasis^® has a minor effect on the ability to drive vehicles and operate machinery.

If the patient’s visual acuity is temporarily reduced after using the drug, it is not recommended to drive a car or engage in activities requiring increased attention until it is restored.

Overdose

No cases of Restasis^® overdose have been reported. With topical application of the drug in the form of eye drops, an overdose is unlikely due to the low concentration of ciclosporin.

Storage Conditions

Store in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Do not use after the expiration date indicated on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.