Telmisartan Mylan 20mg 40mg 80mg Tablets

  • Name:

    Telmisartan Mylan 20mg 40mg 80mg Tablets

  • Company:
    info
  • Active Ingredients:

    Telmisartan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/12/16

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 11/1/2017
print

Print ViewKeyword Search SmPC

Gerard Laboratories

Gerard Laboratories

Company Products

Medicine NameActive Ingredients
Medicine Name Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Active Ingredients Abacavir hydrochloride, Lamivudine
Medicine Name Agerdex 1mg Film Coated Tablets Active Ingredients Anastrozole
Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atazanavir Mylan 300 mg hard capsules Active Ingredients Atazanavir sulfate
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
1 - 0 of 116 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 11 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 January 2017 SmPC

Reasons for updating

  • 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

6.5 Nature and contents of container

HDPE bottle with polypropylene cap containing desiccant.
Pack sizes: 56, 60, 84, 90, 98, 280, 500, 1000 tablets

OPA/AI/PVC/Aluminium foil blisters in cartons
Pack sizes: 14, 28, 30, 56, 60, 84, 90, 98, 100 tablets. Calendar pack size of 28 tablets. Multipack containing 98 (2 packs of 49) tablets for 80 mg only.

Not all pack sizes may be marketed.

 

Updated on 20 December 2016 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 December 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

section 4.1

Cardiovascular prevention

 

Reduction of cardiovascular morbidity in adults with:

section 4.2

Patients with renal impairment

 

Limited experience is available in patients with severe renal impairment or haemodialysis. A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment is required for patients with mild to moderate renal impairment.

 

 

Patients with hepatic impairment:

In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).Telmisartan is contraindicated in patients with severe hepatic impairment (see section 4.3).

 

Older people

 

No dose adjustment is necessary for elderly patients.

 

Paediatric population

 

The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.



section 4.3

The concomitant use of Telmisartan Mylan with aliskiren containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections  4.5 and 5.1).


section 4.4

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

 

 

There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of  hypotension,  hyperkalaemia, and decreased  renal function (including acute renal failure) Dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).

 

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent  close monitoring of renal function electrolytes and blood pressure.

 

ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

 

section 4.5

4.5     Interaction with other medicinal products and other forms of interaction

 

 

 

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).

 

Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine. Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.

 

section 4.7
 

4.7     Effects on ability to drive and use machines

 

 When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan Mylan

section 4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517: Website: www.hpra.ie; e-mail: medsafety@hpra.ie



section 5.1

 

Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.

 

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. For more detailed information see above under the heading “Cardiovascular prevention”.VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.

 

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.

 

ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.

 

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.



section 5.3

No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offsprings such as lower body weight, and delayed eye opening was observed.

section 6.5

 

6.5     Nature and contents of container

 

HDPE bottle with polypropylene cap containing desiccant.

Updated on 29 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 9 July 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 3 July 2015 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.3

The concomitant use of Telmisartan Mylan with aliskiren containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).

 

section 4.4

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

 

The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).

 

There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of  hypotension,  hyperkalaemia, and decreased  renal function (including acute renal failure) Dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).

 

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function electrolytes and blood pressure.

 

ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

section 4.5

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).

section 4.8

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517: Website: www.hpra.ie; e-mail: medsafety@hpra.ie


section 5.1

Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.

 

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.

 

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.

 

ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.

 

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.



section 10

 

June 2015

Updated on 29 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 August 2014 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

Section 6.3:
Shelf-life updated from 2 years to 3 years.

Updated on 3 April 2014 SmPC

Reasons for updating

  • 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

Section 6.5

Added Calendar pack size of 28.

Revision date updated.

Updated on 11 March 2014 PIL

Reasons for updating

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

Updated on 11 March 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 January 2014 SmPC

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 7 January 2014 PIL

Reasons for updating

  • New PIL for new product