Twynsta 80 mg/10 mg tablets

  • Name:

    Twynsta 80 mg/10 mg tablets

  • Company:
    info
  • Active Ingredients:

    Amlodipine besilate, Telmisartan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/07/19

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Summary of Product Characteristics last updated on medicines.ie: 3/7/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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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 5 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 July 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

 

The SmPC has been updated in sections 2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.3 and section 10

Updated on 5 June 2018 SmPC

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 4.7 - Effects on ability to drive and use machines
  • 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)

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 18 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 August 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 3 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 29 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 June 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

The update concerns only very minor editorial/formatting changes in sections 4.2, 5.2 and 9.  Section 10 - Date of revision of the text 20 June 2017

Updated on 20 December 2016 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Addition of last renewal date 

Updated on 11 May 2016 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 3, minor change to the description of the tablet (no actual change to appearance)

Section 4.2

The following paragraphs entered under "Concomittant use to be taken into account " for Interactions linked to amlodipine:

Tacrolimus
There is a risk of increased tacrolimus blood levels when co-administered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. In order to avoid toxicity of tacrolimus, administration of amlodipine in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.

Cyclosporine
No drug interaction studies have been conducted with cyclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% - 40%) of cyclosporine were observed. Consideration should be given for monitoring cyclosporine levels in renal transplant patients on amlodipine, and cyclosporine dose reductions should be made as necessary.

In "Others" paragraph "ciclosporin" deleted.

Section 10

Date of revision amended.

Updated on 4 May 2016 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 21 September 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 9 September 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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

Throughout the document the word “Twynsta” has been deleted and replaced with either “telmisartan/amlodipine” or “this medicinal product”.

 

Section 4.1

Strength added in.

 

Section 4.2

Maximum daily dose clarified by changing from “…is Twynsta 80 mg/10 mg, one tablet per day.” to “…is one tablet 80 mg telmisartan/10 mg amlodipine per day.”

 

Wording “e.g. to enhance convenience or compliance deleted from paragraph headed “Replacement Therapy”.

 

In paragraph headed “Special Populations” (> 65 years) added after Elderly Patients.

 

In paragraph headed “Patients with renal impairment” statement “No posology adjustment is required for patients with mild to moderate renal impairment” has been moved from the beginning of the paragraph to the end of the paragraph.

 

In paragraph headed “Patients with hepatic impairment” statement “Twynsta is contraindicated in patients with severe hepatic impairment (see section 4.3)” has been moved from the end of the paragraph to the beginning of the paragraph.

 

In the paragraph headed “Method of Administration” “Oral use.” has been added.

 

Section 4.3

The contraindication “severe hypotension” has been deleted.

 

Section 4.4

In the paragraph headed “Renovascular hypertension” “(RAAS)” has been added to the end.

 

Section 4.5

Editorial changes only.

 

Section 4.6

In the paragraph headed “Pregnancy” “no adequate data” amended to “limited data”

 

Section 4.7

Editorial changes only.

 

Section 4.8

Statement “The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.”  moved from “Summary of the safety profile” to “Tabulated list of adverse reactions”.

Statement “Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period.” added.

 

Adverse Reaction tables amended – instead of separate tables for “Twynsta”, “telmisartan” alone and “amlodipine” alone; there is now one table for all three variants together.

 

Additional footer to the table added “3: cases of interstitial lung disease (predominantly interstitial pneumonia and eosinophilic pneumonia) have been reported from post-marketing experience with telmisartan”

 

Detailed adverse event reporting details added.

 

Section 5.1

Abbreviations “(SBP)” and “(DBP)” deleted, plus editorial changes.

 

Section 5.2

Abbreviation “(FDC)” deleted, plus editorial changes.

 

Section 5.3

Minor editorial changes only.

 

Section 6.1

“(prepared from maize starch)” added to “Pregelatinised starch.

 

Section 9

Date of last renewal added.

 

Section 10

Date of revision of text amended.

Updated on 3 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 September 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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 4.2, Section 4.3, Section 4.4 and Section 4.5
These sections of the SPC have been revised to take into account the updated wording for concomitant use with ARBs or aliskiren in the contraindications, warning and interactions section of the SPC following conclusion of the EU Art 31 Referral Procedure on RAS acting agents - class labelling request.

Section 5.1
Clinical trial details have been added.

Section 10
Date of revision amended to September 2014.

Updated on 29 October 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 13 September 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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 4.4 has been updated with a warning statement that concomitant use of Telmisartan with aliskiren is contraindicated in patients with diabetes or renal impairment under the subheading ‘Dual blockade of the Renin-Angiotensin-Aldosterone System’.
Related statements have also been included in sections 4.2, 4.3 and 4.5
4.5
Section 4.5 also includes new information on co-administration of telmisartan with digoxin


Section 10 Date of revision has been updated to 08/2013

Updated on 12 September 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 3 December 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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
A minor editorial change has been made to section 4.2.

4.5 Interaction with other medicinal products and other forms of interaction
Update to section 4.5 to include a statement on interaction between amlodipine and simvastatin when used concomitantly.

10. DATE OF REVISION OF THE TEXT
The date of revision of the SPCs has also been updated.

Updated on 3 December 2012 PIL

Reasons for updating

  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 16 July 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to MA holder contact details

Updated on 27 June 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 4.4
Inclusion of a warning for diabetic patients when treated with insulin or oral antidiabetics and a warning on Renin-Angiotensin-Aldosterone System blockage in patients with uncontrolled blood pressure

Minor editorial changes have been made to other sections of the SPC.

Section 10 has been updated.

Updated on 14 July 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 11 July 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

A new paragraph regarding grapefruit and grapefruit juice has been added as a final paragraph to the Concomitant use requiring caution sub-heading under the Interactions linked to amlodipine sub-heading of this section.

 

What previously was the last paragraph regarding concomitant administration of 240 ml of grapefruit juice in the Concomitant use to be taken into account sub-heading of the Interactions linked to amlodipine sub-heading has been deleted from this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

The first four sentences of the Fertility sub-heading of this section have been added as new text.

 

Section 4.8 Undesirable Effects

New adverse reaction details [Rare: Hypoglycaemia (in diabetic patients)] have been added to the Metabolism and Nutrition Disorders frequency grouping for Telmisartan in this section.

 

A figure 2 (in superscript) has been added to the end of the Rare adverse reaction details of the Hepato-biliary Disorders frequency grouping for Telmisartan.  Subsequent details regarding hepatic function abnormal/liver disorder and Japanese patients has been added as supporting text at the end of the Telmisartan disorders frequency grouping list.

 

The text … (with fatal outcome) has been added to the Rare adverse reaction details of the Skin and Subcutaneous Tissues Disorders frequency grouping for Telmisartan.

 

The text Peripheral neuropathy has been deleted from the Very Rare adverse reaction details of the Nervous System Disorders frequency grouping for Amlodipine, as has the Uncommon adverse reaction details. 

 

Section 5.3 Preclinical Safety Data

The last but one paragraph of the Telmisartan sub-heading of this section regarding teratogenic effect has been reworded/amended including deletion of the reference to animal studies.

 

Section 10 Date of Revision of the Text

The date of 14 June 2011 has been added to this section.

Updated on 5 January 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 January 2011 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