Adcirca

  • Name:

    Adcirca

  • Company:
    info
  • Active Ingredients:

    Tadalafil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/03/17

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Summary of Product Characteristics last updated on medicines.ie: 25/4/2017
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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ABASAGLAR 100 units/mL solution for injection in cartridge Active Ingredients Insulin glargine
Medicine Name ABASAGLAR 100 units/mL solution for injection in pre-filled pen Active Ingredients Insulin glargine
Medicine Name Adcirca Active Ingredients Tadalafil
Medicine Name Alimta Active Ingredients Pemetrexed disodium
Medicine Name Cialis 10mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 2.5mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 20mg Tablets Active Ingredients Tadalafil
Medicine Name Cialis 5mg Tablets Active Ingredients Tadalafil
Medicine Name Cymbalta Active Ingredients duloxetine hydrochloride
Medicine Name Cyramza 10 mg/ml concentrate for solution for infusion Active Ingredients Ramucirumab
Medicine Name Forsteo Active Ingredients Teriparatide
Medicine Name Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml Kwikpen soluton for injection Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in cartridge (3ml) (insulin lispro) Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in vial Active Ingredients Insulin lispro
Medicine Name Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in vial Active Ingredients Human Insulin
Medicine Name Humulin I KwikPen 100 IU/ml suspension for injection Active Ingredients Human Insulin
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in vial Active Ingredients Insulin human
1 - 0 of 41 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 25 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 25 April 2017 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Added (bold), Deleted (strikethrough):

 

4.2       Posology and method of administration

 

 

Paediatric population

The safety and efficacy of ADCIRCA in individuals below 18 years of agethe paediatric population has not yet been established.  No data are availableCurrently available data are described in section 5.1.

 

 

5.1          Pharmacodynamic properties

 

Paediatric population

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen. The randomised, double‑blind, placebo‑controlled, parallel, 3‑arm study of tadalafil was conducted in 331 boys aged 7‑14 years with DMD receiving concurrent corticosteroid therapy. The study included a 48‑week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was ‑51.0 meters (m) in the placebo group, compared with ‑64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and ‑59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.

 

The European Medicines Agency has deferred the obligation to submit the results of studies with ADCIRCA in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).

 

 

6.6       Special precautions for disposal

 

No special requirements.

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

 

10.          DATE OF REVISION OF THE TEXT

 

23 MarchFebruary 2017

               

 

 

*ADCIRCA (tadalafil) is a trademark of Eli Lilly and Company.                                                                                    AD112M

Updated on 22 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 March 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 March 2017 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Added (bold), Deleted (strikethrough):

 

4.4       Special warnings and precautions for use

 

 

Vision

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, tThe patient should be advised that in case of sudden visual defect, he should stop taking ADCIRCA andto consult a physician immediately (see section 4.3). Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical studies, and use in these patients is not recommended.

 

Updated on 10 March 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Changes

 

Added (bold), Deleted (strikethrough):

 

4.4       Special warnings and precautions for use

 

 

Decreased or sudden hearing loss

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

 

Renal and hepatic impairment

 

 

10.       DATE OF REVISION OF THE TEXT

 

01 January 201623 February 2017

Updated on 6 March 2017 PIL

Reasons for updating

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

Updated on 15 January 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Changes

 

Added (bold), Deleted (strikethrough):

 

 

 

7.         MARKETING AUTHORISATION HOLDER

 

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht Grootslag 1-5, NL-3991 RA, Houten
The Netherlands

 

 

10.       DATE OF REVISION OF THE TEXT

 

20 August 201501 January 2016

Updated on 11 January 2016 PIL

Reasons for updating

  • Change of licence holder
  • Change to date of revision

Updated on 21 September 2015 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

*ADCIRCA (tadalafil) is a trademark of Eli Lilly and Company. AD78M

Updated on 3 September 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 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Changes

 

Added (bold), Deleted (strikethrough):

 

4.3          Contraindications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Acute myocardial infarction within the last 90 days.

 

Severe hypotension (<90/50 mm Hg).

 

-          In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).

 

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

 

Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Riociguat

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were

combined with riociguat.  In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5

inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied.

Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).

 

4.8          Undesirable effects

 

Description of selected adverse reactions

 

1 Events not reported in registration studies and cannot be estimated from the available data.  The adverse

reactions have been included in the table as a result of postmarketing or clinical study data from the use of

tadalafil in the treatment of erectile dysfunction.

2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.

 

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 UK: www.mhra.gov.uk/yellowcard or Ireland: HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:

www.hpra.ie; E-mail: medsafety@hpra.ie.

 

10.          DATE OF REVISION OF THE TEXT

 

20 August 2015

Updated on 27 August 2015 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 31 May 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Note: document re-ordered throughout due to QRD template changes affecting placement, alternative wording and layout throughout document

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Added (bold) deleted (strikethrough):

 

Each film-coated tablet contains 20 mg tadalafil.

 

Excipient with known effect:
Each film-coated tablet contains 245 233 mg lactose (as monohydrate).

 

 

 

3.         PHARMACEUTICAL form

 

Added (bold):

Orange and almond shaped film-coated tablets, marked "4467" on one side.

 

 

 

4.         Clinical particulars

4.6       Fertility, pregnancy and lactation

 

Added:

 

Fertility

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).

 

4.7       Effects on ability to drive and use machines

 

Added (bold) deleted (strikethrough):

 

ADCIRCA has negligible influence on the ability to drive or use machines. No studies on the effect on the ability to drive and use machines have been performed.

 

4.8       Undesirable effects

 

Deleted:

Cardiac disorders

 

 Chest pain2 Palpitations2, 5

Sudden cardiac death2, 5, Tachycardia2, 5

 

 

Unstable angina pectoris,

Ventricular arrhythmia,

Myocardial Infarction2

 

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1       Pharmacodynamic properties

 

Added (bold):

 

Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.

 

 

Added :

 

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with ADCIRCA in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).

 

 

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Added:

Date of latest renewal: 1 October 2013

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

               

22 May 2013

 

                Added:

 

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

 

Updated on 29 May 2013 PIL

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 30 January 2013 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.         Clinical particulars

4.8       Undesirable effects

 

Added (bold) deleted (strikethrough):

 

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1000 to <1/100)

Rare

(≥1/10,000 to <1/1000)

Not known1

Nervous System disorders

Headache67

Syncope, Migraine5

Seizures5,

Transient amnesia5

 

Stroke2 (including haemorrhagic events)

 

Ear and labyrinth disorders

 

 

Tinnitus

 

Sudden hearing loss6

Renal and urinary disorders

 

 

Haematuria

 

 

Reproductive system and breast disorders

 

Increased uterine bleeding4

Priapism5, Penile haemorrhage, Haematospermia

 

Prolonged erections

 

(6) Sudden decrease or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including tadalafil.

(7) (6) See section c)

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

               

                17 January 2013

Updated on 28 January 2013 PIL

Reasons for updating

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

Updated on 3 September 2012 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.         Clinical particulars

4.8       Undesirable effects

 

Added (bold):

 

Very common (1/10)

Common (1/100 to <1/10)

Uncommon (1/1000 to <1/100)

Rare

(1/10,000 to <1/1000)

Not known1

Immune system disorders

 

Hypersensitivity reactions5

 

 

Angioedema

Nervous System disorders

Headache7

Syncope, Migraine5

Seizures5,

Transient amnesia5

 

Stroke2 (including haemorrhagic events)

 

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

               

                23 August 2012

Updated on 31 August 2012 PIL

Reasons for updating

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

Updated on 24 December 2010 PIL

Reasons for updating

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

Updated on 12 November 2010 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 October 2010 PIL

Reasons for updating

  • New PIL for new product