Gertac Tablets 150 mg & 300 mg

  • Name:

    Gertac Tablets 150 mg & 300 mg

  • Company:
    info
  • Active Ingredients:

    Ranitidine Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/08/19

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Summary of Product Characteristics last updated on medicines.ie: 16/8/2019

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Gerard Laboratories

Gerard Laboratories

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Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
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Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
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Medicine Name Diaclide MR 30 mg Modified-release Tablets Active Ingredients Gliclazide
1 - 0 of 117 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 16 August 2019 PIL

Reasons for updating

  • 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 3 - how to take/use

Updated on 16 August 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 June 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 June 2015 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 4.5 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

4.2                Posology and method of administration

 

 

Posology


Patients with renal impairment


Older people (over 50 years old) See section 5.2, Special patient populations.

 

Method of administration

For oral use.


4.4                Special warnings and precautions for use


A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone  versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI 1.26-2.64).

4.5       Interaction with other medicinal products and other forms of interactions

Interactions occur by several mechanisms including:

 1) Inhibition of cytochrome P450-linked mixed function oxygenase system: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by thisenzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline.



4.6                Fertility, pregnancy and lactation

Breast-feeding

Ranitidine is excreted in human breast milk. Like other drugs ranitidine should only be used during breast-feeding if considered essential.

 

Fertility

There are no data on the effects of ranitidine on human fertility. There were no effects on male and female fertility in animal studies (see section 5.3).


4.8                Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100 to<1/10), uncommon (≥1/1,000to<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.


4.8 table

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 HPRA Pharmacovigilance,  Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; E-mail: medsafety@hpra.ie  


4.9                Overdose

 

Symptoms

Ranitidine is very specific in action and no particular problems are expected following overdosage with ranitidine formulations.



5.                  PHARMACOLOGICAL PROPERTIES

 

5.1                Pharmacodynamic properties

Pharmacotherapeutic Group: H2-receptor antagonists

ATC Code: A02B A02

 

Mechanism of action



4.8 table

Updated on 18 June 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 9 June 2014 SmPC

Reasons for 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

sections 2.0, 4.1, 4.2, 4.3, 4.4, 4.7, 4.8, 5.2, 6.1, 6.3, 6.4, 6.5 amended.

Updated on 4 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 10 April 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

section 4.1 Therapeutic Indications updated to include Children (3 to 18 years)


section 4.2 Posology & method of administration- Paediatric Population added

section 4.3 Contraindications-Children below 15 years of age-removed

section 5.2 Pharmacokinetic properties-Special patient population added 

Updated on 8 April 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 8 April 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 30 August 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

section 4.8
MeDRA format applied

Typos corrected

Updated on 19 July 2011 SmPC

Reasons for updating

  • 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 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

updated Section 4.3 Contraindications

Ranitidine products are contraindicated in patients known to have hypersensitivity to any component of the preparation.

updated Section 4.4 Special warnings and precautions for use

 

The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer as treatment with ranitidine may mask symptoms of gastric carcinoma.

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Care should be taken with elderly patients in whom kidney function may be reduced.

The dosage should be adjusted as detailed above under Dosage and Administrationin Section 4.2 in renal impairment.

Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria. See section 4.3.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1,82 (95% CI 1,26-2,64).

 

Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly and in those with a history of peptic ulcer.

updated section 4.5 Interaction with other medicinal products and other forms of interactions

 

 

 

 

 

 

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

Interactions occur by several mechanisms including:

1) Inhibition of cytochrome P450-linked mixed function oxygenase system: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this

enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline.

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

2) Competition for renal tubular secretion: Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.

3) Alteration of gastric pH: The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).

Oral Formulations:

There is no evidence of an interaction between ranitidine and amoxicillin and metronidazole. If high doses (2 g) of sucralfate are co-administered with ranitidine the absorption of the latter may be reduced. This effect is not seen if sucralfate is taken after an interval of 2 h.

updated section 4.6 Pregnancy and lactation

 

 

 

 

 

 

 

 

 

 

Pregnancy

 

Ranitidine crosses the placenta. Like other drugs ranitidine should only be used during pregnancy if considered essential.

Lactation

Ranitidine is excreted in human breast milk. Like other drugs ranitidine should only be used during nursing if considered essential.

updated section 4.7 Effects on ability to drive and use machines
None reported

updated section 4.8 Undesirable effects
please refer to this section

updated sedction 4.9 Overdose

 

Symptoms and Signs

Ranitidine is very specific in action and no particular problems are expected following overdosage with ranitidine formulations.

Treatment

Symptomatic and supportive therapy should be given as appropriate.

 

 

 

 

 

 

 

 

 updated section 10 DATE OF REVISION OF THE TEXT

March 2011

 

Updated on 18 July 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Addition of manufacturer
  • Change to MA holder contact details

Updated on 4 March 2011 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 16 April 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 3 years to 4 years

Updated on 31 March 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 17 April 2007 PIL

Reasons for updating

  • Change of manufacturer

Updated on 31 August 2006 PIL

Reasons for updating

  • Change of inactive ingredient
  • Removal/change of distributor
  • Change to storage instructions
  • Change to date of revision

Updated on 25 August 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: 'tablets' is added to the trade name.
Section 2: 'One film-coated tablet' is added for composition. 'For excipients, see section 6.1' is added.
Section 3: Visual description is added.
Section 4.1 & 4.3: Change to the wording
Section 4.4: Warning regarding infectious complications is added.
Section 4.6: Change to the wording.
Section 4.7: 'Ranitidine has no or negligible influence on the ability to drive and use machines' is added.
Section 4.8: Undesirable effects are grouped according to MedDRA's system organ class and the MedDRA terminology for frequency classification is used.
Section 4.9, 5.1 & 5.3: Change to the wording.
Section 6.1: Excipient names are changed according to their INN titles.
Section 6.2: Change to the wording.
Section 6.4: The precaution 'to protect from light' is added.
Section 6.5: Change to the wording.
Section 9 & 10: Dates are changed.

Updated on 23 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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