Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets

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 28 June 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 31 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 May 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 5 June 2018 SmPC

Reasons for updating

  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use (text removed- updated)
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine
4.6 Fertility, pregnancy and lactation
Fertility (text removed- updated)

A study in rats did not reveal any impact on fertility at an oral dose of 160 mg/kg (containing 6.4 mg/kg cetirizine and 153.6 mg/kg pseudoephedrine), producing systemic exposure to cetirizine 2  to 3 fold higher than the therapeutic exposure in humans (section 5.3).  There are no available data on fertility in humans.
4.8 Undesirable effects (text added-updated)
Cardiac disorders:
Common: tachycardia
Rare: arrhythmia

Not Known: palpitations
5.3 Preclinical safety data (text removed- updated)

Fertility in male and female rats was unimpaired at oral doses up to 160 mg/kg/day (1:24) in reproduction toxicology studies, which represents a systemic exposure between 2- 3  fold the therapeutic exposure in humans to cetirizine. Overall, the cetirizine/pseudoephedrine combination did not produce any adverse effects on embryo-foetal viability and development of the offspring, at clinically relevant doses. 
10. Date of Revision of the text (updated)
{11/2017}05/2018

Updated on 9 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 9 November 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update section 4.8 of the SmPC as follows:

·         To update hypersensitivity to “hypersensitivity reactions (including anaphylactic shock)”

·         To add “acute generalized exanthematous pustulosis”


 

Update section 10 of the SmPC to amend the date of revision to November 2017.

Updated on 7 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 July 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 22 July 2016 PIL

Reasons for updating

  • Deletion of a pack size
  • Introduction of new pack/pack size

Updated on 11 July 2016 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

2.           QUALITATIVE AND QUANTITATIVE COMPOSITION

·       Editorial changes to text.

4.2.        Posology and Method of Administration

·       Some text added and deleted.

4.3         Contraindications

·       Some text added and deleted.

4.4         Special warnings and precautions for use

  • Text updated.

4.5         Interaction with other medicinal products and other forms of interaction

·       Some text added and deleted.

4.6         Fertility, pregnancy and lactation

·       Some text added and deleted.

4.7         Effects on ability to drive and use machines

  • Text updated.

4.9         Overdose

·       Some text added and deleted.

5.3         Preclinical safety data

  • Text updated.

6.6         Special precautions for disposal and other handling

  • Text updated.

10          DATE OF REVISION OF THE TEXT

·       Date of revision updated.

Updated on 5 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to information about driving or using machinery
  • Change to how the medicine works

Updated on 25 November 2014 PIL

Reasons for updating

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

Updated on 4 September 2014 SmPC

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Updated on 5 December 2013 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 18 November 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 
4.2 Posology and method of administration
Posology
1 tablet two times a day (morning and evening), corresponding to the maximum recommended dose of 10 mg of cetirizine dihydrochloride and 240 mg of pseudoephedrine hydrochloride daily.
Paediatric population
Children over 12 years of age: 1 tablet two times a day (morning and evening).
The safety and efficacy of Zirtek Plus Decongestant in children less than 12 years of age have not yet been established. No data are available.
Special populations
Renal impairment
The dose should be reduced to 1 tablet daily in patients with moderate renal insufficiency.
Hepatic impairment
The dose should be reduced to 1 tablet daily in patients with moderate hepatic insufficiency.
Duration of treatment
The duration of treatment should not exceed the period of symptoms and in no way should it be longer than 2 to 3 weeks at the recommended dose (1 tablet twice daily).
After disappearance of nasal symptoms, treatment can be continued with an antihistamine alone.
Method of administration
Tablets should be swallowed whole with a little liquid, without crunching or chewing them. They may be taken with or without food.


4.3 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with the combination cetirizine-pseudoephedrine.
In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.
Concomitant use of Zirtek Plus Decongestant and MAOI or ß-blockers can cause blood pressure to increase. Given the long duration of action of MAOI, this interaction is still possible 2 weeks after discontinuation of such treatment.

4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Zirtek Plus Decongestant in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Zirtek Plus Decongestant is not recommended during pregnancy.
Lactation
Cetirizine and pseudoephedrine are excreted into human milk. Therefore, Zirtek Plus Decongestant is not recommended during breast-feeding.
Fertility
A study in animals has demonstrated that the combination of cetirizine:pseudoephedrine (1:24) has no impact on fertility at a dose of up to 10 times the recommended dose.
There are no available data on fertility in humans.


4.8 Undesirable effects
The following table lists the undesirable effects by body system and by frequency.
The frequencies are defined as follows: very common (1/10); common (1/100, <1/10); uncommon (1/1000, <1/100); rare (1/10000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).

General disorders and administration site conditions:
Common: asthenia
Renal and urinary disorders:
Rare: dysuria
Skin and subcutaneous tissue disorders:
Rare: dry skin, rash, sweating increased, urticaria
Very rare: angioneurotic oedema, fixed drug eruption
Eye disorders:
Not known: accommodation disorder, blurred vision, mydriasis, eye pain, visual impairment, photophobia
Respiratory, thoracic and mediastinal disorders:
Not known: dyspnoea

5.3 Preclinical safety data
Fertility in male and female rats was unimpaired at doses up to 160 mg/kg/day (1:24) in reproduction toxicology studies, which represents an estimated systemic exposure to pseudoephedrine 12 times higher than the therapeutic exposure in humans.

Updated on 7 December 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 23 November 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2: Replace hydrochloride with dihydrochloride

Updated on 9 June 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Renewal changes: Rewording to section 2, 6.3 & 6.4 (meaning does not change)

Updated on 23 September 2009 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Correction to section 6.1, add extra pack size, omitted in error in original SPC uploaded

Updated on 17 September 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 September 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided