TRUSOPT Preservative-Free 20 mg/ml eye drops, solution

Section 4: AE add: increased heart rate, increased blood pressure, frequency unknown.

Section 6:

Manufacturer: Fareva Mirabel, Route de Marsat, Riom, 63963 Clermont-Ferrand, Cedex 9, France

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland

This leaflet was last revised in January 2023 June 2021

Section 4.2 / Method of administration / bullet point 8

8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body.

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 15 December 2021

3.How to use TRUSOPT Preservative-Free

...

Instructions for use:

The solution from one individual single- dose container of TRUSOPT Preservative-Free is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single- dose container is opened, a new container must be opened prior to each use and must be discarded immediately after administration. Each single- dose container contains enough solution for both eyes.

Every time you use TRUSOPT Preservative-Free

[NEW IMAGES INSERTED]

1. Wash your hands.
2. Take the strip of containers from the sachet.
3. Detach one single-dose container from the strip.
4. Put the remaining strip back in the sachet and fold the edge to close the sachet.
5. To open the container, twist off the tab. (Picture A).
6. Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger. (Picture B).
7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye. (Picture C). Do not blink while applying the drop to your eye. Each single-dose container contains enough solution for both eyes.
8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body. (Picture D).
9. Wipe off any excess solution from the skin around the eye

1.Open the foil sachet which contains the individual single dose containers.

2.First wash your hands then break off one single dose container from the strip and twist open the top of the single dose container as shown.

[IMAGES DELETED]

3.Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye as shown.

[IMAGES DELETED]

4. Put one drop in the affected eye(s) as directed by your doctor.

5. After putting the drop into the eye, throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution.

10. Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor.

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6.Contents of the pack and other information

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This medicineal product is authorised in the Member States of the EEAEuropean Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Sweden, United Kingdom (Northern Ireland)

TRUSOPT Preservative-Free

This leaflet was last revised in FebruaryJune 2021.

Unither [080]

1.         NAME OF THE MEDICINAL PRODUCT

TRUSOPT Preservative-Free 20 mg/ml eye drops, solution, in single-dose container

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent withto 20 mg of dorzolamide and one drop contains approximately 0.8 mg of dorzolamide hydrochloride equivalent to 0.7 mg of dorzolamide.

For the full list of excipients, see section 6.1.

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4.2     Posology and method of administration

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Method of administration

1. Wash your hands.

2. Take the strip of containers from the sachet.

3. Detach one single-dose container from the strip.

4. Put the remaining strip back in the sachet and fold the edge to close the sachet.

5. To open the container, twist off the tab.

6. Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger.

7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye. Do not blink while applying the drop to your eye. Each single-dose container contains enough solution for both eyes.

8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body.

9. Wipe off any excess solution from the skin around the eye.

10. Store the remaining single-dose containers in the sachet; the remaining single-dose containers must be used within 15 days after opening of the sachet.

1. Open the sachet which contains the individual single-dose containers.
2. First wash your hands then break off one single-dose container from the strip and twist open the top.
3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye.
4. Instill one drop in the affected eye(s) as directed by the physician.
5. After instillation, discard the used single-dose container even if there is solution remaining.
6. Store the remaining single-dose containers in the sachet; the remaining single-dose containers must be used within 15 days after opening of the sachet.

...........

10.     DATE OF REVISION OF THE TEXT

​​​​​​​January 2020 15 December 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 Pharmacovigilence, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Wwebsite: www.hpra.ie., e-mail: medsafety@hpra.ie

Section 6

Manufacturer: Laboratories Merck Sharp & Dohme, Chibret (MIRABEL PLANT) Fareva Mirabel, Route de Marsat, RiomIOM, 63963 Clermont-Ferrand, Cedex 9, France.

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland.

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

Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Portugal, Sweden, UK

TRUSOPT Preservative-Free

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

Section 6

...

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in UK/Ireland:

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer:

Laboratories Merck Sharp & Dohme, Chibret (MIRABEL PLANT), Route de Marsat, RIOM, 63963 Clermont-Ferrand Cedex 9, France

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland

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

Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Portugal, Sweden, UK

TRUSOPT Preservative-Free

This leaflet was last revised in JanuaryMarch 2020.

Section 4

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

This leaflet was last revised in May 2018January 2020.

Section 4.8 Undesirable effects

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Cardiac disorders:

Not known: palpitations

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Section 10 DATE OF REVISION OF THE TEXT

July 2019January 2020

6.3    Shelf life

2 years 30 months.

After first opening the sachet: TRUSOPT should be used no longer than 15 days. Discard any unused single-dose containers after that time.

Discard the opened single dose container immediately after first use.

10.    DATE OF REVISION OF THE TEXT

2 August 2018     29 July 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 are is 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 Preservative-Free 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 a result of metabolic acidosis. In rabbits given maternotoxic doses of dorzolamide associated with metabolic acidosis, malformation 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 a therapeutic dose of dorzolamide.

4.2    Posology and method of administration

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Method of administration:

1. Open the sachet which contains 15 the individual single-dose containers. . There are three strips of 5 single-dose containers each in the sachet.
    
2. First wash your hands then break off one single-dose container from the strip and twist open the top.

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6.5    Nature and contents of container

 Preservative-Free TRUSOPT is available in 0.2 ml in low density polyethylene single-dose containers in an aluminum sachet containing 15 single-dose containers .

 Pack sizes:

30 x 0.2ml (2 sachets with 15 single dose containers or 3 sachets with 10 single-dose containers).

60 x 0.2ml (4 sachets with 15 single dose containers or 6 sachets with 10 single-dose containers).

120 x 0.2ml (8 sachets with 15 single dose containers or 12 sachets with 10 single-dose containers).

 Not all pack sizes may be marketed.

10.    DATE OF REVISION OF THE TEXT

April 2017 9 April 2018

Section 4.8

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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

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10.    DATE OF REVISION OF THE TEXT

July 2015April 2017