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Indivina 1 mg/5 mg tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/02/21

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Summary of Product Characteristics last updated on medicines.ie: 4/2/2021

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Bufomix Easyhaler 160 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 320 micrograms/9 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 80 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Comtess Active Ingredients Entacapone
Medicine Name Dexdor 100 micrograms/ml concentrate for solution for infusion Active Ingredients Dexmedetomidine hydrochloride
Medicine Name Divigel 0.1% Gel Active Ingredients Estradiol Hemihydrate
Medicine Name Eldepryl 5 mg Tablets Active Ingredients Selegiline Hydrochloride
Medicine Name Fareston Active Ingredients Toremifene Citrate
Medicine Name Indivina 1 mg/2.5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate Orion 10 mg tablets Active Ingredients Methotrexate disodium
Medicine Name Methotrexate Orion 2.5 mg tablets Active Ingredients Methotrexate disodium
Medicine Name Stalevo 100 mg/25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Veramil 120 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 80 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
1 - 0 of 22 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 4 February 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Breast cancer section updated to include the results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.

4.5 Interaction with other medicinal products and other forms of interaction

Information on co-administerion of sex hormones and combinations of HIV protease inhibitors added.

4.8 Undesirable effects

Updated to include more detailed information on the risks of breast cancer associated with HRT.

Updated on 4 February 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Updated information on breast cancer risks with HRT.

Updated on 28 January 2021 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Admistrative reorganisation of documents

Updated on 7 July 2016 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 7 July 2016 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 July 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The safety information in sections 4.4 and 4.8 of the SPC in relation to the risks of ovarian cancer has been updated.

Updated on 3 September 2015 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 3 September 2015 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use has been updated to include: Hereditary angioedema in the sub- section 'Conditions which need supervision' Venous thromboembolism sub-section has been updated to include patients with a history of VTE Other conditions sub-section has been updated to include information on chloasma. Section 4.8 the table has been updated and information on myocardial infarction and gall bladder disease has been added to 'Other adverse reactions have been reported in association with estrogen/progestagen treatment'. US WHI studies - additional risk of breast cancer after 5 years’ use table is updated

Updated on 28 February 2014 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated.  the product should now be stored below 25oC (previously 30oC)

Updated on 28 February 2014 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The Storage conditions have been updated.  the product should now be stored below 25oC (previously 30oC)

Updated on 2 May 2012 SPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products

Updated on 2 May 2012 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

New individual SmPC for product (was previously in a combined SmPC).

The SmPC is updated in line with core safety text for HRT products