Lenzetto 1.53 mg/spray, Transdermal Spray, Solution *
Pharmacy Only: Prescription

  • Company:

    Gedeon Richter Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 10 May 2022

File name

627a9e2ea714f.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

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

Updated on 10 May 2022

File name

627a9ac122764.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2, Warnings and Precautions - inclusion of reference to angioedema and an update under the subheading 'Stop using Lenzetto and see a doctor immediately'

-                hereditary and acquired angioedema.

Stop using Lenzetto and see a doctor immediately

-                swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema;

Section 2, Other Medicines - inclusion of reference to medicines for Hepatitis C virus

-            Medicines for Hepatitis C virus (HCV) (such as combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as regimen glecaprevir/pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol. Lenzetto contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme can occur when using Lenzetto with this HCV combination regimen. Your doctor will advise you.

Section 4, Reporting of Side Effects - inclusion of reference to Northern Ireland

Section 6, Date of Revision - updated to April 2022

Updated on 06 August 2021

File name

Lenzetto 1.53 mg-spray, transdermal spray, solution_SmPC_en_PA1330-017-001_1628268391.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Free text change information supplied by the pharmaceutical company

Section 2 Update:

Each spray delivers 90 microliter of transdermal spray, solution containing 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).

Excipient with known effect: each spray contains 65.47 mg ethanol.

For the full list of excipients, see section 6.1

Section 4.4 Update:

Under subhead Other conditions  deletion of :

Alcohol-based products are flammable

Avoid fire, flame or smoking until the spray has dried.

Addition of a new subheading and associated text:

Excipient

This medicine contains 65.47 mg of alcohol (ethanol) in each dose which is equivalent to 72.74%w/v. It may cause burning sensation on damaged skin.

Alcohol-based products are flammable. Keep away from fire. While using the device, open flame, lit cigarette or use of some hot devices (e.g. hairdryers) should be avoided, until the spray has dried on the skin.

Section 6.6 Update:

After delivery of 56 sprays, the container must be discarded even if there is some leftover solution in it. The number of sprays made should be marked using the table on the carton. 

As drug residue will remain in the used up containers, they should not be disposed of via household waste. Empty containers should be returned to the pharmacy for destruction.

This medicinal product may pose a risk to the environment (see section 5.3).

Updated on 06 August 2021

File name

Lenzetto 1.53 mg-spray, transdermal spray, solution_PIL_en_PA1330-017-001_1628267548.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update to Section 2, Lenzetto contains alcohol:

This medicine contains 65.47 mg of alcohol (ethanol) in each dose which is equivalent to 72.74%w/v. It may cause burning sensation on damaged skin.  Alcohol-based liquids are flammable. Keep away from fire. Avoid fire  open flame, lit cigarette or smoking some hot devices (e.g. hairdryers) while applying the spray to your skin, until the spray has dried.

Update to Section 6, date of revision

March 2021

Updated on 27 November 2020

File name

Lenzetto_SmPC_en_PA1330-017-001_1606492850.pdf

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 4.8 - 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 5.3 - Preclinical safety data
  • 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

- Amendment to the spelling of oestrogen across the various updated sections.

Product information modified according to the PRAC recommendation for Hormone Replacement Therapy (HRT) products on breast cancer.

Updated on 27 November 2020

File name

Lenzetto_PIL_en_PA1330-017-001_1606492314.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

- Update throughtout the PIL to amend the spelling of estrogen to oestrogen. 

Product information updated according to PRAC recommendation for Hormone Replacement Therapy (HRT) products on breast cancer.

Updated on 30 September 2020

File name

Lenzetto_SmPC_en_PA1330-017-001-clean_1601468630.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change to the fill volume 

Updated on 30 September 2020

File name

Lenzetto_PIL_en_PA1330-017-001_1601468514.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Change in the overall fill volume from 8.1 ml to 6.5 ml.

Updated on 17 September 2020

File name

Lenzetto_SmPC_en_PA1330-017-001-2020_02_1600350198.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 17 September 2020

File name

Lenzetto_PIL_en_PA1330-017-001-2018-06-12_1600350124.pdf

Reasons for updating

  • New PIL for new product