TRUSOPT 20 mg/ml eye drops, solution

Change to revision date in printed PL

Removal of information relating to ocumeter bottle from sections 4.4 and 6.5. Consequential change to revision date in section 10.

Section 4.2 / Method of administration / bullet point 5 Add: When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Section 4.8 Add following AEs Not known:  tachycardia, Not known: hypertension

Section 10 26 January 2023 2 July 2021

Section 4.2 Method of administration point 5 Add: When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Section 4.8 Add following AEs: Not known: tachycardia, Not known: hypertension

 Section 10 26 January 2023 2 July 2021

6.3       Shelf-life

2 years3 years.

After first opening the container, TRUSOPT should be used no longer than 28 days.

10.     DATE OF REVISION OF THE TEXT

18 November 2020 2 July 2021

Section 4

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland: HPRA Pharmacovigilance, website: www.hpra.ie.

Section 6

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Portugal, Spain, Sweden, UK:

TRUSOPT

This leaflet was last revised in  October 2020.February 2021.

trusopt-md-ie-APPR 20210312 [079 Fareva]

Section 2: TRUSOPT contains benzalkonium chloride

This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.075 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.TRUSOPT contains the preservative benzalkonium chloride.  This preservative may be deposited in soft contact lenses and may possibly discolour the lenses.  If you wear contact lenses, you should consult your doctor before using this medicine.

Section 4: Reporting of side effects

....

Ireland: HPRA Pharmacovigilaence, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Wwebsite: www.hpra.ie, e-mail: medsafety@hpra.ie.

This leaflet was last revised in March 2020October 2020.

Section 2: TRUSOPT contains benzalkonium chloride

This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.075 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.TRUSOPT contains the preservative benzalkonium chloride.  This preservative may be deposited in soft contact lenses and may possibly discolour the lenses.  If you wear contact lenses, you should consult your doctor before using this medicine.

Section 4: Reporting of side effects

.....

Ireland: HPRA Pharmacovigilaence, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Wwebsite: www.hpra.ie, e-mail: medsafety@hpra.ie.

This leaflet was last revised in March 2020October 2020.

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent with 20 mg of dorzolamide.

Excipient with known effect:

One ml of eye drops solution contains 0.075 mg benzalkonium chloride and one drop contains about 0.002 mg of benzalkonium chloride.

For the full list of excipients, see section 6.1.

4.4     Special warnings and precautions for use

Benzalkonium chloride

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

Contact Lens Use

TRUSOPT contains benzalkonium chloride as preservative. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

TRUSOPT contains the preservative benzalkonium chloride, which may cause eye irritation. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

4.8     Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance,  Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Wwebsite: www.hpra.ie; E-mail: medsafety@hpra.ie.

10.     DATE OF REVISION OF THE TEXT

January 2020 18 November 2020

Marketing Authorisation Holder and Manufacturer in UK and Ireland

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer

Santen Oy

Niittyhaankatu 20 33720, Kelloportinkatu 1,

33100 Tampere

Finland

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Portugal, Spain, Sweden, UK:

TRUSOPT

This leaflet was last revised in JanuaryMarch 2020

Correction of typo in XPIL to align with PIL text (Section 4 - addition of 'frequency')

Not known: (frequency cannot be estimated from the available data)

Shortness of breath, foreign body sensation in eye (feeling that there is something in your eye), forceful heartbeat that may be rapid or irregular (palpitations).

Section 4 Possible side effects

Not known: (frequency cannot be estimated from the available data)

Shortness of breath, foreign body sensation in eye (feeling that there is something in your eye), forceful heartbeat that may be rapid or irregular (palpitations).

Section 6 Contents of the pack and other information

This leaflet was last revised in November 2018January 2020

Section 4.8 Undesirable effects

…..

Cardiac disorders:

Not known: palpitations

……

Section 10. DATE OF REVISION OF THE TEXT

March 2019January 2020

duplicate manufacturer heading removed from XPIL

3. How to use TRUSOPT

 Instructions for use replaced with instructions for new bottle.

6. Contents of the pack and other information
 What TRUSOPT contains

What TRUSOPT looks like and contents of the pack

TRUSOPT is a clear, colourless to nearly colourless slightly viscous solution.

TRUSOPT is filled into a white translucent plastic container with 5 ml of solution. The plastic container is closed with a white screw cap.

The OCUMETER Plus Ophthalmic Dispenser consists of a translucent high-density polyethylene container containing 5 ml of solution.

Tamper evidence is provided by a safety strip on the container label.

 Pack sizes:

1 x 5.0 ml (single 5 ml container)

3 x 5.0 ml (three 5 ml containers)

6 x 5.0 ml (six 5 ml containers)

 Not all pack sizes may be marketed.

 Marketing Authorisation Holder and Manufacturer

 Marketing Authorisation Holder in UK and Ireland: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

 Manufacturer: Merck Manufacturing Division, Laboratoires Merck Sharp & Dohme-Chibret, Mirabel Plant, Route de Marsat, Riom 63963 Clermont Ferrand Cedex 9, France.Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

4.2     Posology and method of administration

 Posology

 When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily.

 When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s) two times daily.

 When substituting dorzolamide for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper dosing on one day, and start dorzolamide on the next day.

 If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

 Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.

 Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

 Patients should be informed of the correct handling of the containersOCUMETER PLUS bottles.

 Paediatric population

Limited clinical data in paediatric patients with administration of dorzolamide three times a day are available. (For information regarding paediatric dosing see section 5.1.)

 Method of administration

1.  Wash your hands
2. Open the container. Take special care that the tip of the dropper container does not touch your eye, the skin around your eye or your fingers.
3. Tilt your head backwards and hold the container upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one drop fall into the space between the lower eyelid and the eye.
5. Press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stops the medicine from getting into the rest of the body.
6. Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
7. Put the cap back on and close the container tightly.
   
   OCUMETER PLUS containers only

1. Before using the medication for the first time, be sure the Safety Strip on the front of the containerbottle is unbroken. A gap between the containerbottle and the cap is normal for an unopened containerbottle.
2. First wash your hands then tear off the Safety Strip to break the seal.
3. To open the containerbottle, unscrew the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the containerbottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye.
5. Invert the containerbottle, and press lightly with the thumb or index finger over the “Finger Push Area” until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
6. If drop dispensing is difficult after opening for the first time, replace the cap on the containerbottle and tighten (Do not overtighten) and then remove by turning the cap in the opposite directions as indicated by the arrows on the top of the cap.
7. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
8. Replace the cap by turning until it is firmly touching the containerbottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the containerbottle label for proper closure. Do not overtighten or you may damage the containerbottle and cap.
9. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
10. After you have used all doses, there will be some TRUSOPT left in the containerbottle. You should not be concerned since an extra amount of TRUSOPT has been added and you will get the full amount of TRUSOPT that your doctor prescribed. Do not attempt to remove the excess medicine from the containerbottle.

6.5     Nature and contents of container

 TRUSOPT container contains 5 ml of solution. Two alternate containers may be marketed.

White translucent low-density polyethylene (LDPE) container with a transparent linear LDPE dropper tip and a white polypropylene (PP) cap

or The OCUMETER Plus Ophthalmic Dispenser consists of a translucent, high-density polyethylene container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2-piece cap assembly. The 2-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label. The OCUMETER Plus Ophthalmic Dispenser contains 5 ml of solution.

 TRUSOPT is available in the following packaging configurations:

1 x 5 ml (single 5-ml container)

3 x 5 ml (three 5-ml containers)

6 x 5 ml (six 5-ml containers)

 Not all pack sizes may be marketed.

10.     DATE OF REVISION OF THE TEXT

August 201806.03.2019

4.6    Fertility, pregnancy and lactation

 Pregnancy

Dorzolamide should not be used during pregnancy. There are no or limited amount of data from the use of dorzolamide in pregnant women. No adequate clinical data in exposed pregnancies are available. In rabbits, dorzolamide produced teratogenic effects at maternotoxic doses (see Ssection 5.3).

 Breast-feeding

It is not unknown whether dorzolamide/metabolites areis excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dorzolamide/metabolites in milk.In lactating rats, decreases in the body weight gain of offspring were observed. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from TRUSOPT therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. If treatment with dorzolamide is required, then lactation is not recommended.A risk to the newborns/infants cannot be excluded.

Fertility

Animal data do not suggest an effect of treatment with dorzolamide on male and female fertility. Human data are lacking.

5.3    Preclinical safety data

 The main findings in animal studies with dorzolamide hydrochloride administered orally were related to the pharmacological effects of systemic carbonic anhydrase inhibition. Some of these findings were species-specific and/or were result of metabolic acidosis. In rabbits given maternotoxic doses of dorzolamide associated with metabolic acidosis, malformations of the vertebral bodies were observed. In lactating rats, decreases in the body weight gain of offspring were observed. No adverse effects upon fertility were observed in male and female rats given dorzolamide prior to and throughout mating.

 In clinical studies, patients did not develop signs of metabolic acidosis or serum electrolyte changes that are indicative of systemic CA inhibition. Therefore, it is not expected that the effects noted in animal studies would be observed in patients receiving therapeutic dose of dorzolamide.

Section 4.8

…………

The following adverse effects have been reported either during clinical trials or during post-marketing experience with dorzolamide:

[Very Common: (³1/10), Common: (³1/100 to <1/10), Uncommon: (³1/1,000 to <1/100), Rare: (³1/10,000 to <1/1,000), Not known: (frequency cannot be estimated from the available data)]

Nervous system disorders:

Common: headache

Rare: dizziness, paraesthesia

Eye disorders:

Very Common: burning and stinging

Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision

Uncommon: iridocyclitis

Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery

Not known: foreign body sensation in eye

Respiratory, thoracic, and mediastinal disorders:

Rare: epistaxis

Not known: dyspnoea

……..

10.       DATE OF REVISION OF THE TEXT

July 2015  April 2017