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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Dorzolamide Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 31/7/2019

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Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
1 - 0 of 9 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 31 July 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 9 August 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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.

 

Updated on 27 July 2018 PIL

Reasons for updating

  • XPIL Updated

Updated on 16 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2    Posology and method of administration

 .....

 

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.

......

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

Updated on 16 July 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 25 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 April 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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 2015April 2017

 

Updated on 24 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 April 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 December 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided