Qutenza 179mg Cutaneous Patch

  • Name:

    Qutenza 179mg Cutaneous Patch

  • Company:
    info
  • Active Ingredients:

    Capsaicin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/04/19

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Summary of Product Characteristics last updated on medicines.ie: 4/4/2019

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Grunenthal Pharma Ltd.

Grunenthal Ltd

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Medicine Name Palexia SR 250 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 50 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Qutenza 179mg Cutaneous Patch Active Ingredients Capsaicin
Medicine Name Versatis 700 mg medicated plaster Active Ingredients Lidocaine
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Medicine Name Zydol SR 150mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 200mg Prolonged Release Tablets Active Ingredients Tramadol Hydrochloride
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1 - 0 of 22 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 4 April 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 4 April 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

(new text ; deletions)

Section 4.1:

Amended as follows:

Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain.

 

Section 4.2:

The topical anaesthetic or oral analgesic should be used in accordance with the medicinal product’s instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol. The Topical anaesthetics cream should be removed prior to applying Qutenza and the skin washed and dried thoroughly.

...

It is advisable to administer Qutenza in a well ventilated treatment area.

..

Patients experiencing pain during and after patch application should be provided with supportive treatment (see section 4.4)

Acute pain during and following the procedure should be treated with local cooling (such as a cool compress) and oral analgesics (e.g. short-acting opioids).

 

 

Section 4.4:

 

Health care professionals should wear nitrile gloves when handling patches and when cleansing treatment areas (see section 4.2). It is advisable to administer Qutenza in a well ventilated treatment area.

 

Dermal assessment

Qutenza should must be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp......

.....

 

Treatment-related discomfort

Patients experiencing pain during and after patch application should be provided with supportive treatment such as local cooling (such as a cool compress) or oral analgesics (i.e. short acting opioids).

 

 

Section 4.8:

Summary of the safety profile

Of the 1826 patients treated with Qutenza in randomized controlled trials, 1089  (59.6%) reported adverse reactions considered related to the medicinal product by the investigator. The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus.  Adverse reactions were transient, self limiting and usually mild to moderate in intensity. In all controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% for patients receiving control.

 

Description of selected adverse reactions

Adverse reactions were transient, self limiting and usually mild to moderate in intensity. In controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% for patients receiving control.

 

 

Section 6.1:

Backing layer

Polyethylene Terephthalate (PET) Film, inner side siliconized polyester backing film

printing ink containing Pigment White 6

 

Removable protective layer (release liner)

polyester film, fluoropolymer-coated  release liner

 

 

Section 6.5:

 

The Qutenza cutaneous patch is stored in a paper coated aluminium foil sachet with polyacrylnitril acrylnitrile-acrylic acid copolymer heat seal layer.

The cleansing gel is supplied in a high density polyethylene tube with a polypropylene cap.

Qutenza is available in a kit packs containing one or two sachets of individually sealed Qutenza cutaneous patches and a 50 g tube of cleansing gel.

 

 

Updated on 30 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 August 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 May 2017 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: Marketing authorisation holder

Following transfer of marketing authorisation, changed to

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Section 10: Date of revision of the text
04 May 2017

Updated on 12 May 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 August 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

4.1 Therapeutic indications

Addition of indication in diabetic patients

 

4.2 Posology and method of administration

Addition of instruction in the treatment of painful diabetic peripheral neuropathy
Clarification on the recommendation to use a mask and protective glasses during application & removal

4.4 Special warnings and precautions for use


The following text has been added:

It is advisable to administer Qutenza in a well ventilated treatment area.

 

Dermal assessment

 

In patients with painful diabetic peripheral neuropathy, a careful visual examination of the feet should be undertaken prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency.

 

Sensory function

Reductions in sensory function have been reported following administration of Qutenza. Decreases in sensory functions are generally minor and temporary (including to thermal and sharp stimuli), however, a single case of persistent hypoesthesia has been reported in clinical studies in painful diabetic neuropathy. For this case a relationship with Qutenza could not be excluded. Caution should be exercised in patients with reduced sensation in the feet and in those at increased risk for such changes in sensory function. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory loss to prior to each application of Qutenza. If sensory loss is detected or worsens, Qutenza treatment should be reconsidered.

Increase in blood pressure

 

Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

 

Treatment-related discomfort is now a separate subsection

The following text has been deleted from section 4.4:

Though no treatment-related reductions in neurological function have been observed in clinical trials with Qutenza, minor and temporary changes in sensory function (e.g., heat detection) have been reported following administration of capsaicin. Patients with increased risk for adverse reactions due to minor changes in sensory function should be cautious when using Qutenza. .

Diabetic neuropathy

There is only limited experience with Qutenza in patients with Painful Diabetic Neuropathy (PDN). Repeated treatments with Qutenza in patients with PDN have not been studied.

4.8 Undesirable Events
The summary of the safety profile has been updated to reflect the latest data from clinical trials and to include reactions in patients with painful diabetic neuropathy
The tabulated list of reactions has also been updated to reflect the updated occurrence of "burning sensation" and "pain in extremity" as common reactions rather than uncommon as previously stated.

5.1 Pharmacodynamic properties

The section on clinical safety and efficacy has been updated to reflect the updated data in diabetic patients.

 

6.6 Special precautions for disposal and other handling

The recommendation to use a mask and protective glasses has been clarified

10. DATE OF REVISION OF THE TEXT

Updated to 20 August 2015

Updated on 26 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications
  • Change of special precautions for disposal
  • Change to, or new use for medicine

Updated on 28 May 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 28 May 2015 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

HPRA contact details revised in section 4.8 regarding reporting of side-effects
Date of revision is updated to May 2015

Updated on 27 May 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 21 May 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

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

Free text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 280 cm2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin
per cm2 of patch (8% w/w).

 

4.2     Posology and method of administration

 

The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.

 

Posology

 

Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches).  The painful area should be determined by the physician and marked on the skin.  Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia).  Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain.

                           

The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician. Direct contact with Qutenza, used gauze or used cleansing gel should be avoided: See below Method of administration - Precaution to be taken before manipulating or administering the product.

 

Patches should not be held near eyes or mucous membranes.

 

 

If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave). The treatment area(s) should be gently washed with soap and water.  Following hair removal and washing, the skin should be thoroughly dried.

The treatment area might may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of Qutenza to reduce potential application related discomfort.  The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm. The topical anaesthetic or oral analgesic should be used in accordance with the medicinal product’s instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol. The anaesthetic cream should be removed prior to applying Qutenza and the skin washed and dried thoroughly.

 

Paediatric population

 

The safety and efficacy of Qutenza in children from birth to 18 years has not been established.  No data are available.

 

Patients with Renal and/or hepatic impairment

 

No dose adjustment is required for patients with renal or hepatic impairment.

 

Paediatric population

 

The safety and efficacy of Qutenza in children from birth to 18 years has not been established.  No data are available.

 

Method of administration

 

Cutaneous use only.

 

Precautions to be taken before manipulating handling or administering the medicinal product

 

Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection. Use of mask and protective glasses should also be considered, particularly during the removal of the patch.

 

These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. This may result in transient erythema and burning sensation (with mucous membranes being particularly susceptible), eye pain, eye and throat irritation and cough.

 

Patches should not be held near eyes or mucous membranes.

 

If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave). The treatment area(s) should be gently washed with soap and water. Following hair removal and washing, the skin should be thoroughly dried.

 

Instructions for use

Used patches should be disposed of immediately after use in an appropriate medical waste container.

For instructions on handling and disposal of the treatment materials see section 6.6.

 

4.4     Special warnings and precautions for use

 

Health care professionals should wear nitrile gloves when handling patches and when cleansing treatment areas(see section 4.2, Method of administration - Precaution to be taken before manipulating or administering the product.

 

4.6     Fertility, pregnancy and lactation

 

Fertility

 

There is no data in humans available on fertility. A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).

 

4.8     Undesirable effects

 

Summary of the safety profile

 

Of the 1,327 patients treated with Qutenza in randomized controlled trials, 883 (67%) reported adverse reactions considered related to the medicinal product by the investigator. The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus.  Adverse reactions were transient, self limited limiting and usually mild to moderate in intensity. In all controlled trials, the discontinuation rate due to adverse reactions was 0.8% for patients receiving Qutenza and 0.6% for patients receiving control (0.04% w/w cutaneous patch).

 

Tabulated list of adverse reactions

 

In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with postherpetic neuralgia (PHN) and painful Human Imunnodeficiency Virus – Associated Neuropathy (HIV-AN), are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data).

                                                                                                  

No treatment-related reductions in neurological function, as evaluated by Quantitative Sensory Testing (QST) and neurological examinations, have been observed during clinical trials in patients with peripheral neuropathic pain

 

Description of selected adverse reactions

 

Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in clinical trials with healthy volunteers.

 

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 Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Anaesthetics, Oother local anaesthetics, ATC code: N01BX04

 

Clinical Eefficacy and safety

 

6.3     Shelf life

 

Unopened sachet 4 years

 

6.6    Special precautions for disposal and other handling

 

Used and unused patches and all other materials that have been in contact with the treated area should be disposed of immediately after use by sealing them in a polyethylene medical waste bag and placing in an appropriate medical waste container

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 15 may 2009

Date of latest renewal: 15 May 2014

 

 

10.     DATE OF REVISION OF THE TEXT

 

 March 2013 April 2014

Updated on 2 April 2013 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to MA holder contact details

Updated on 26 March 2013 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

 

Posology

 

 

The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician. Direct contact with Qutenza, used gauze or used cleansing gel should be avoided: See below Method of administration - Precaution to be taken before manipulating or administering the product.

 

Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas.  Latex gloves should NOT be worn as they do not provide adequate protection.

 

Patches should not be held near eyes or mucous membranes.

 

Direct contact with Qutenza, used gauze or used cleansing gel should be avoided.

 

 Method of administration

 

Precautions to be taken before manipulating or administering the product

Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection. Use of mask and protective glasses should also be considered, particularly during the removal of the patch.

 

These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. This may result in transient erythema and burning sensation (with mucous membranes being particularly susceptible), eye pain, eye and throat irritation and cough.

 

Instructions for use

Qutenza is a single use patch and can be cut to match the size and shape of the treatment area. Qutenza should be cut prior to removal of the release liner. The release liner should NOT be removed until just prior to application. There is a diagonal cut in the release liner to aid in its removal. A section of the release liner should be peeled and folded and the adhesive side of the printed patch placed on the treatment area. The patch should be held in place. The release liner should slowly and carefully be peeled from underneath with one hand while the patch should simultaneously be smoothed onto the skin with the other to ensure that there is complete contact between the patch and the skin, with no air bubbles and no moisture.

 

Used patches should be disposed of immediately after use in an appropriate medical waste container.

 

 4.4     Special warnings and precautions for use

 

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. See section 4.2, Method of administration - Precaution to be taken before manipulating or administering the product.

 

 

Care must be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas.  Exposure of the skin to capsaicin results in transient erythema and burning sensation, with mucous membranes being particularly susceptible.  Inhalation of airborne capsaicin can result in coughing or sneezing. Used patches should be disposed of immediately after use in an appropriate medical waste container (see section 6.6).

Monitoring and management of application site reactions

Application site reactions, such as transient local applications site burning, pain, erythema and pruritus are common or very common. In addition, there have been reported cases  of burns, including second degree burns, in patients treated with capsaicin patches. See section 4.8. In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn.

 

 

Diabetic Neuropathy

There is only limited experience with Qutenza in patients with Painful Diabetic Neuropathy (PDN). Repeated treatments with Qutenza in patients with PDN have not been studied.

 

Cleansing gel

The cleansing gel for Qutenza contains butylhydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

 

 

4.6     Fertility, pregnancy and lactation

 

Pregnancy

 

There are no or limited amount of data from the use of capsaicin in pregnant women.

 

4.8     Undesirable effects

In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with PHN and painful HIV-AN, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data).

 

Injury, poisoning and procedural complications

 

            Not known

Burns second degree, accidental exposure (including eye pain, eye and throat irritation and cough)

 

6.6     Special precautions for disposal and other handling

 

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. The use of mask and protective glasses may also be considered, see section 4.2.

 


10.     DATE OF REVISION OF THE TEXT

         Astellas Pharma Europe B.V.
            Elisabethhof 19

2353 EW Leiderdorp

Sylviusweg 62

2333 BE Leiden

Netherlands

Updated on 24 June 2011 PIL

Reasons for updating

  • Change to MA holder contact details
  • Correction of spelling/typing errors

Updated on 7 April 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration) pretreatment with lidocaine (2.5%)/prilocaine (2.5%) has been added 

Updated on 5 October 2010 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 September 2010 PIL

Reasons for updating

  • New PIL for new product