We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Bayer Limited

The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 19/06/2017
SPC Levitra tablets

When a pharmaceutical company changes an SPC or PIL, 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 19/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Mar-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

In section 7: The MAH has changed to Bayer AG 51368 Leverkusen Germany

In section 10: The date of revision of text has been updated to 03/2017
Updated on 05/09/2016 and displayed until 19/06/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   01-Jul-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The individual SPCs for the following products have been combined together into one document:  

- Levitra 5 mg film-coated tablets

 

- Levitra 10 mg film-coated tablets

- Levitra 20 mg film-coated tablets

 

 

Updated on 04/01/2016 and displayed until 05/09/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   17-Dec-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 4.2     Posology and method of administration the title elderly population was changed to just elderly

In section 4.3, contraindications, the following section was included:

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

In section 4.5     Interaction with other medicinal products and other forms of interaction

Riociguat

Preclinical studies showed 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 vardenafil, is contraindicated (see section 4.3).

Updated on 04/02/2015 and displayed until 04/01/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   09-Apr-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



4.8     Undesirable effects

 

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 IMB HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.iewww.hpra.ie; Ee-mail: imbpharmacovigilance@imb.iemedsafety@hpra.ie.

 

 

Updated on 06/06/2014 and displayed until 04/02/2015
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Apr-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



4.8     Undesirable effects

 

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 IMB Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.

 

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Further information on clinical trials with vardenafil Levitra 10 mg orodispersible tablets

Efficacy and safety of vardenafil Levitra 10 mg orodispersible tablets were separately demonstrated in a broad population in two studies including 701 randomized erectile dysfunction patients who were treated up to 12 weeks. The distribution of patients in the predefined subgroups was covering elderly patients (51%), patients with history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%).

 

In pooled data from the two vardenafil Levitra10 mg orodispersible tablets trials, IIEF-EF domain scores were significantly higher with vardenafil Levitra 10 mg orodispersible tablet versus placebo.

 

A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration compared to 44% of all attempts in the placebo group. These results were also reflected in subgroups, in elderly patients (65%), in patients with history of diabetes mellitus (63%), patients with history of dyslipidemia (66%) and hypertension (70%) of all sexual attempts reported had successful penetration.

 

About 63% of all reported sexual attempts with vardenafil Levitra 10 mg orodispersible tablets were successful in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts. In the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% (patients with history of dyslipidemia) and 60% (patients with history of hypertension) of all reported attempts with vardenafil Levitra 10 mg orodispersible tablets were successful in terms of maintenance of erection.

 

Further information on clinical trials

In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 ‑ 89 years, many of whom had multiple co-morbid conditions. Over 2,500 patients have been treated with vardenafil for six months or longer. Of these, 900 patients have been treated for one year or longer.

 

The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidemia (22%), depression (5%), radical prostatectomy (9%). The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3). No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve‑sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed.

 

Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of erectile function compared to placebo. In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.

 

In fixed dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period. The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.

 

In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77‑87%), mixed erectile dysfunction (69‑83%), organic erectile dysfunction (64‑75%), elderly (52‑75%), ischaemic heart disease (70‑73%), hyperlipidemia (62‑73%), chronic pulmonary disease (74‑78%), depression (59‑69%), and patients concomitantly treated with antihypertensives (62‑73%).

 

In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.

 

In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.

 

In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo. The number of patients who returned to a normal IIEF domain score (>26) were 53% on vardenafil compared to 9% on placebo. The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p<0.001).

 

The safety and efficacy of vardenafil was maintained in long -term studies.

 

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on paediatric use.

 

5.2         Pharmacokinetic properties 

 

Bioequivalence studies have shown that vardenafil Levitra 10 mg orodispersible tablet is not bioequivalent to vardenafil Levitra 10 mg film-coated tablets; therefore, the orodispersible formulation should not be used as an equivalent to vardenafil Levitra 10 mg film-coated tablets.

 

Absorption

In vardenafil Levitra film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration. However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 15%. After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5 – 20 mg).

 

When vardenafil Levitra film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%. Vardenafil AUC is not affected. After a meal containing 30% fat, the rate and extent of absorption of vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.

 

Vardenafil is rapidly absorbed after administration of vardenafil Levitra 10 mg orodispersible tablets without water. The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets. Mean vardenafil AUC was increased by 21 to 29% (middle aged and elderly ED patients) or 44% (young healthy subjects) with 10 mg orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small amount of drug in the oral cavity. There was no consistent difference in mean Cmax between orodispersible tablets and film-coated tablets.

 

In subjects taking vardenafil Levitra 10 mg orodispersible tablets with a high fat meal no effect on vardenafil AUC and tmax was observed, while vardenafil Cmax was reduced by 35% in the fed condition. Based on these results vardenafil Levitra 10 mg orodispersible tablets can be taken with or without food.

 

If vardenafil Levitra 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax remains unchanged and median tmax is shortened by 60 minutes compared to intake without water. Vardenafil Levitra 10 mg orodispersible tablets must be taken without liquid.

 

Distribution

The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.

 

Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1). For vardenafil as well as M1, protein binding is independent of total drug concentrations.

Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more than 0.00012% of the administered dose may appear in the semen of patients.

 

Biotransformation

Vardenafil in Levitra film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms.

 

In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half-life of approximately 4 hours. Parts of M1 are in the form of the glucuronide in systemic circulation. Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%.

 

The mean terminal half-life of vardenafil in patients receiving vardenafil Levitra 10 mg orodispersible tablets ranged between 4 – 6 hours. The elimination half-life of the metabolite M1 is between 3 to 5 hours, similar to parent drug.

 

Elimination

The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 4‑5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the faeces (approximately 91‑95% of the administered dose) and to a lesser extent in the urine (approximately 2‑6% of the administered dose).

 

Pharmacokinetics in special patient groups

Elderly

Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18 ‑ 45 years). On average elderly males taking vardenafil Levitra film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2).

 

Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil Levitra orodispersible tablets were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and below. Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 years or over following once-daily dosing of vardenafil Levitra 10 mg orodispersible tablets over ten days.

 

Renal impairment

In volunteers with mild to moderate renal impairment (creatinine clearance 30 – 80 ml/min), the pharmacokinetics of vardenafil were similar to that of a normal renal function control group. In volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment. No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2). Vardenafil pharmacokinetics has not been studied in patients requiring dialysis (see section 4.3).

 

Hepatic impairment

In patients with mild to moderate hepatic impairment (Child‑Pugh A and B), the clearance of vardenafil was reduced in proportion to the degree of hepatic impairment. In patients with mild hepatic impairment (Child‑Pugh A), the mean AUC and Cmax increased 17% and 22% respectively, compared to healthy control subjects. In patients with moderate impairment (Child‑Pugh B), the mean AUC and Cmax increased by 160% and 133% respectively, compared to healthy control subjects (see section 4.2). The pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child‑Pugh C) has not been studied (see section 4.3).

 

 

10.     DATE OF REVISION OF THE TEXT

 

04/2014

 

 

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

 

Updated on 12/02/2013 and displayed until 06/06/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Jan-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8 (undesirable effects) - the following bold text was added to the table:

- System Organ Class - Renal and urinary disorders - Not Known - Haematuria
- Not Known - Penile Haemorrhage, Haematospermia

Section 4.8 (undesirable effects) - the following text was revised:

*        Sudden deafness or loss of hearing has been reported in a small number of post‑marketing and clinical trial cases with the use of all PDE5 inhibitors, including vardenafil.

 

Penile haemorrhage, penile haematoma, haematospermia and haematuria have been reported in clinical trials anda small number of spontaneous post-marketing reportsdata with the use of all and clinical trials of PDE5 inhibitors, including vardenafil. The frequency of these can not be estimated from the available data. It is not possible to determine whether these events are related directly, to micro-lesions related to sexual activity, underlying risk factors e.g. prostate disease, anticoagulant drugs, the use of vardenafil or a combination of these and other factors.

Section 10 (Date of Revision of Text) - 21 January 2013

Updated on 10/04/2012 and displayed until 12/02/2013
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   19-Mar-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The section 4.5 subsection, 'Effects of vardenafil on other medicinal products' has been updated. Please see amendment underlined below.  
In vivo studies has been updated to detail that 'Levitra may be administered at any time with tamsulosin or alfuzosin.'
Updated on 21/03/2012 and displayed until 10/04/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   21-Feb-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



2.          QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as hydrochloride).

 

For a the full list of excipients, see section 6.1.

 

4.3        Contraindications

 

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

 

 

4.4        Special warnings and precautions for use

 

………..

Concomitant use of alpha-blockers

The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets. Vardenafil may be administered at any time with tamsulosin or with alfuzosin. ……

 

 

4.5        Interaction with other medicinal products and other forms of interaction

 

…………….

Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin or, terazosin or alfuzosin therapy:

·                When vardenafil (film-coated tablets ) was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg.

·                When vardenafil 5 mg (film –coated tablets) was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension. Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours.

·                When vardenafil (film-coated tablets) was given at doses of 5 or 10 mg on a background of stable therapy with alfuzosin, compared to placebo, there was no symptomatic reduction in blood pressure. 

 

 

 

6.6        Special precautions for disposal

 

No special requirements for disposal.

 

 

9.          DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authoriszation: 6 March 2003

 

Date of latest renewal: 6 March 2008

 

 

10.        DATE OF REVISION OF THE TEXT

 

July 2011February 2012

 

Updated on 19/09/2011 and displayed until 21/03/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company





 

In section 7   ( MARKETING AUTHORISATION HOLDER)

 The MA holder name had been updated as follows: " Bayer Pharma AG 13342 Berlin Germany" . Schering has been deleted from the MA holder name.


In Section 10 
  ( DATE OF REVISION OF THE TEXT)

 

The revision date has been updated to " July 2011" , the previous  date of revision was April 2011.







 

Updated on 19/05/2011 and displayed until 19/09/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • 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 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Apr-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

SPC update following Commission Decision. EMEA/H/C/475/WS/107 and EMEA/H/C/475/IB/33G
Updated on 06/05/2010 and displayed until 19/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-Aug-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 7.0 Marketing Authorisation Holder:

Updated to: 

Bayer Schering Pharma AG
13342 Berlin
Germany


Section 10. Date Of Revision Of The Text.

Updated to:

June 2009
Updated on 21/07/2009 and displayed until 06/05/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   02-Feb-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

    

·        Section 4.2,  (Posology and method of administration), under the sub - section Use in elderly men: the following is Removed “Since vardenafil clearance is reduced in elderly patients (see section 5.2) a first dose of 5 mg should be used. Based on efficacy and tolerability the dose may be increased to 10 mg and 20 mg” and Replaced with “Dosage adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).

 

·        Section 4.4, (Special Warning and precautions for use), A new statement is added: “Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥ 65 years old) (see sections 4.2 and 4.8).”

 

·        Section 4.8 (Undesirable effects), A new statement is added: “At the 20mg dose, elderly (≥ 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (< 65 years old).

 

·        Section 10 (Date of Revision of the text), August 2008 is removed and replaced with February 2009.

Updated on 18/09/2008 and displayed until 21/07/2009
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Sections 4.2. 4.4, 4.5, 5.1: updated information on use in combination with other drugs.
Updated on 07/08/2008 and displayed until 18/09/2008
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section: 10. Date of Revision of text changed to:
"March 2008"
Updated on 14/07/2008 and displayed until 07/08/2008
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.2 - Posology and method of administration
  • Change to improve clarity and readability
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Changes to Levitra SPC

 

General changes to improve readability of text

 

Section 4.2 Posology and method of administration

Subheading: Use in children and adolescents

Addition of:

“There is no relevant indication for use of Levitra in children”

 

Section 4.7 Effects on ability to drive and use machines

Addition of:

“No studies on the effects on the ability to drive and use machines have been performed.”

 

Section 4.8 Undesirable effects

Addition of events “Seizure” and “Transient global amnesia” to the adverse reaction table.

Addition of sentence: “**Sudden deafness 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 vardenafil.”

 

Section 10 DATE OF REVISION OF TEXT

Date changed to “March 2007”

 

Updated on 20/12/2006 and displayed until 14/07/2008
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.5: to include statement "Nicorandil is a hybrid of potassium channel opener and nitrate. Due to the nitrate component it has the potential to have seious interaction with vardenafil.
Updated on 04/09/2006 and displayed until 20/12/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 5.1 : correction of typo in paragraph 7.
Updated on 31/08/2006 and displayed until 04/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 of the SPC was also updated to delete the following information: Vardenafil has not been studied in patients with spinal cord injury or other CNS disease, hypoactive sexual desire and in patients who have undergone pelvic surgery (except nerve-sparing prostatectomy), pelvic trauma or radiotherapy.

Section 5.1 has been updated to include the results of the RESPITE study - efficacy in men with ED secondary to Spinal cord injury

Updated on 31/07/2006 and displayed until 31/08/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

Section 4.3 of the SPC has been updated to contraindicate LEVITRA in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure

Section 4.4 of the SPC was also updated to include the following information: Visual defects and cases of non-arteritic ischaemic optic neuropathy (NAION) have been reported in connection with the intake of LEVITRA and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking LEVITRA and consult a physician immediately

Section 4.8 has also been updated to comply with the latest SmPC guideline in terms of format: All post marketing events reported for LEvitra are listed in the table under the frequency heading 'not known'. Text relating to a clinical trial looking at impairment of colour vision have been removed.

Updated on 30/05/2006 and displayed until 31/07/2006
Reasons for adding or 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 10 - Date of revision of the text
Updated on 16/12/2005 and displayed until 30/05/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 25/05/2005 and displayed until 16/12/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 02/07/2004 and displayed until 25/05/2005
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Updated on 29/05/2003 and displayed until 02/07/2004
Reasons for adding or updating:
  • New SPC for new product

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Vardenafil Hydrochloride