Package Leaflet: Information For The User

TRIESENCE® 40 mg/ml, suspension for injection

Triamcinolone acetonide

What is in this leaflet

1.    What TRIESENCE is and what it is used for

2.    What you need to know before you are given TRIESENCE

3.    How TRIESENCE is given_

1. | What TRIESENCE is and what it is used for

TRIESENCE is a suspension that helps make the structures inside the eye more visible during your eye surgery. This medicine is for diagnostic use only. It is not

used to treat any condition.

What you need to know before you are given TRIESENCE

You should NOT be given TRIESENCE

•    if you are allergic (hypersensitive) to triamcinolone or any other ingredients in TRIESENCE. Tell your doctor if you think that this may apply to you.

•    If you have active herpes simplex infection in the eye Warnings and precautions

Tell your doctor before you are given TRIESENCE

•    if you have had a reaction to triamcinolone before. Another option might be considered by your surgeon.

•    if you have increased pressure in the eye.

•    if you are diabetic please consult your doctor. The risk of corticosteroid-induced increase of pressure in the eye and /or cataract formation (progressive cloudiness of the normal eye lens) is increased in diabetic patients.

•    if you have recent or ongoing infections in the eye.

If the above applies to you, or if you are not sure, please tell your doctor before you are given TRIESENCE.

Children and adolescents

Do not give this medicine to children below the age of 18 years because the safety and efficacy has not been established.

Other medicines and TRIESENCE

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breast feeding and fertility

Tell your doctor if you are pregnant or are planning to become pregnant. Little is known about the use of TRIESENCE suspension in pregnant women. Your doctor will carefully consider your condition and weigh the risks of using TRIESENCE suspension against its benefits.

Tell your doctor if you are breast feeding. The safety and effectiveness of TRIESENCE suspension in nursing mothers have not been established.

Driving and using machines

Eye surgery can temporarily affect your vision and your ability to drive or use machines. Do not drive or use machinery until your vision has returned to normal.

How TRIESENCE is given

TRIESENCE will be given by your doctor. Depending on your condition your doctor may modify the dose.

The usual dose is 1 to 4 mg of the medicine, given by injection inside your eye during your surgery. The TRIESENCE is removed during the surgical procedure.

If you have any further questions about how TRIESENCE is given, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side-effects have been observed in clinical studies undertaken with TRIESENCE.

Uncommon

(may affect up to 1 in 100 people)

Effects in the eye: Increased pressure in eye, injury to the back of the eye.

The following side-effects have also been observed during use.

Not known

(frequency cannot be estimated from the available data)

Effects in the eye. inflammation and pain with or without infection inside the eye, reduced vision.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website. www.mhra.gov.uk/yellowcard

How to store TRIESENCE

• Keep out of the sight and reach of children.

Your doctor or nurse knows how to store TRIESENCE:

Do not use TRIESENCE after the expiry date which is stated on the label and outer carton after ‘Exp'. The expiry date refers to the last day of that month.

Storage conditions:

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not use TRIESENCE if the vial is cracked or damaged in any way.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

| Contents of the pack and other information |

What TRIESENCE contains

The active substance is triamcinolone acetonide. 1 ml of suspension for injection contains 40 mg triamcinolone acetonide. The other ingredients are sodium chloride, carmellose sodium, polysorbate 80, potassium chloride, calcium chloride (dihydrate), magnesium chloride (hexahydrate), sodium acetate (trihydrate), sodium citrate, water for injection. Sodium hydroxide and hydrochloric acid are used to adjust the pH to 6.2 to 7.9.

What TRIESENCE looks like and contents of the pack

This medicinal product is a white suspension for injection. It is available in a pack containing 1 vial of 1 ml suspension for injection.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley,

Surrey, GU16 7SR,

United Kingdom.

Manufacturer

S.A.Alcon-Couvreur N.V. Rijksweg 14, B - 2870, Puurs Belgium

This medicinal product is authorised in the following Member States under the name. TRIESENCE 40 mg/ml suspension for injection. Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, United Kingdom VISTREC 40 mg/ml suspension for injection. Netherlands

This leaflet was last revised in April 2015.

© 2011,2014, 2015 Novartis

Alcori

a Novartis company

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