Twynsta 80 mg/5 mg tablets
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 July 2023
File name
80 mg- 5 mg-Stradis-IAin-PIL annex text.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 31 May 2023
File name
80 mg-5 mg-II-0046 - PIL annex text.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 May 2023
File name
T1;80 mg_5 mg-E-SPC-15.docx .pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 SmPCs includes the addition of ADR “hyponatraemia” related to telmisartan in section 4.8, addition of sodium statement in section 4.4, addition of the risk of non-cardiogenic pulmonary oedema for amlodipine in case of overdose in section 4.9 (in alignment with the updated reference label), editorial changes and implementation of QRD v10.3. In addition, the term antagonists/antagonist has been changed to blockers/blocker throughout the SmPC and Twynsta replaced by amlodipine.
The following sections of the SmPCs have been updated:
- Section 4.2: update to text under sub-headings - Add on therapy; Renal impairment; Method of administration.
- Section 4.4: update to text under sub-heading Renal impairment and kidney transplantation. Updated sub-headings - Volume and/or sodium depleted patients and Ischaemic heart disease
- Section 4.7: revised wording
- Section 4.8: addition of ADR “hyponatraemia” related to telmisartan; update to wording for angioedema
- Section 4.9: addition of the risk of non-cardiogenic pulmonary oedema for amlodipine in case of overdose under ‘Symptoms’ and an additional statement for amlodipine under ‘Treatment’
- Section 6.4: deletion of statement ‘Remove the tablets from the blister only directly prior to intake.’
- Section 6.6: update to heading and inclusion of text linked to handling.
- Section 10: Date of revision of the text.
Updated on 02 March 2023
File name
T1;80 mg_5 mg-E-SPC-14..pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 December 2021
File name
80 mg-5 mg - 1B-0043 - PIL annex text.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 December 2021
File name
T1;80 mg_5 mg-E-SPC-14..pdf
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 7 - Marketing authorisation holder
- 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
- Sections 2, 3, 4.2, 4.3 4.4, 4.5, 4.7, 5.1, 5.3 and 9: Minor editorial changes.
- Section 2: Information related to the excipient ‘sodium’ has been moved to section 4.4.
- Section 4.8: Update to the Irish AE reporting details.
- Section 7: Minor update to the MA Holder address (removal of “D-” from the zip code).
- Section 10: Date of revision has been updated
Updated on 05 July 2019
File name
80 mg-5 mg - 1B-0039 - PIL annex text.pdf
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 03 July 2019
File name
T1;80 mg_5 mg-E-SPC-13.pdf
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 05 June 2018
File name
T1;80 mg_5 mg-E-SPC-12.docx
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 05 June 2018
File name
T1;80mg_5mg-E-PIL-1.pdf
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
File name
PIL_14867_904.pdf
Reasons for updating
- New PIL for new product
Updated on 18 August 2017
Reasons for updating
- Improved presentation of PIL
Updated on 03 July 2017
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 June 2017
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
Updated on 20 December 2016
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
Updated on 11 May 2016
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 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 04 May 2016
Reasons for updating
- Change to appearance of the medicine
Updated on 21 September 2015
Reasons for updating
- Improved electronic presentation
Updated on 09 September 2015
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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 09 September 2015
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 03 October 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 30 September 2014
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 5.1 - Pharmacodynamic properties
- 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 30 October 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 13 September 2013
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
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
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
Updated on 03 December 2012
Reasons for updating
- 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
- 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
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 03 December 2012
Reasons for updating
- Change to drug interactions
- Change to further information section
- Change to date of revision
Updated on 16 July 2012
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
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 5.3 - Preclinical safety data
- 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
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
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 11 July 2011
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 05 January 2011
Reasons for updating
- New PIL for new product
Updated on 01 January 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)