Zantac 75 (GSL)

  • Name:

    Zantac 75 (GSL)

  • Company:
    info
  • Active Ingredients:

    Ranitidine Hydrochloride

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/07/17

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Summary of Product Characteristics last updated on medicines.ie: 30/9/2019

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Chefaro Ireland Ltd

Chefaro Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abidec Drops Active Ingredients Ascorbic acid, nicotinamide (B3), Pyridoxine Hydrochloride (Vitamin B6), Riboflavine (Vitamin B2), Thiamine Hydrochloride (Vitamin B1), Vitamin A (Palmitate), Vitamin D2 (ergocalciferol)
Medicine Name Beconase Hayfever Active Ingredients Beclometasone Dipropionate Monohydrate
Medicine Name Buttercup Bronchostop Berry Flavour Cough Pastilles Active Ingredients Thyme herb extract
Medicine Name Buttercup Bronchostop Cough Syrup Active Ingredients Marshmallow root extract, Thyme herb extract
Medicine Name Cetirizine dihydrochloride 10mg Film-coated Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Lyclear Creme Rinse Active Ingredients Permethrin
Medicine Name Metatone Tonic Active Ingredients Calcium glycerophosphate, Manganese glycerophosphate, Potassium glycerophosphate, Sodium glycerophosphate, Thiamine Hydrochloride (Vitamin B1)
Medicine Name Milk of Magnesia Active Ingredients Magnesium Hydroxide
Medicine Name NiQuitin 14 mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 21mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 7mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 14 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 21 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 7 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin Mini 1.5mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name NiQuitin Mini 4mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name Paracetamol 500 mg Film-Coated Tablets (GSL) Active Ingredients Paracetamol
Medicine Name Paracetamol 500 mg Film-Coated Tablets (p) Active Ingredients Paracetamol
Medicine Name PrevAllergy Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Solpa-Extra Soluble Tablets Active Ingredients Caffeine, Paracetamol
Medicine Name Solpa-Plus tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name solpa-plus with caffeine soluble tablets Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Solpa-Sinus Film-coated Tablets Active Ingredients Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Solpadeine Capsules Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
1 - 25 of 33 items.Total: 2 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 30 September 2019 SmPC

Reasons for updating

  • 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 4.5 - 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 6.6 - Special precautions for disposal and other handling

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

QRD update.

4.5 Interaction with other medicinal products and other forms of interaction

[...]

Erlotinib and medicinal products altering pH

Concomitant administration of 300 mg ranitidine and erlotinib decreased erlotinib exposure [AUC] and maximum concentrations [Cmax] by 33% and 54%, respectively. However, when erlotinib was dosed in a staggered manner 2 hours before or 10 hours after ranitidine 150 mg b.i.d., erlotinib exposure [AUC] and maximum concentrations [Cmax] decreased only by 15% and 17%, respectively.

 

Updated on 24 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 24 July 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Updated address of the MAH

Updated on 24 July 2017 PIL

Reasons for updating

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

Updated on 5 May 2016 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • 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 - how to report a side effect

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

 

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.

 

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment (creatine clearance less than 50ml/min). Ranitidine products are not suitable for these patients without medical supervision.

 

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


The following patients are advised to seek their doctor’s advice before taking ranitidine products:

 

Patients with renal impairment (creatine clearance less than 50ml/min) and/or hepatic impairment. Patients under regular medical supervision.

Patients taking medications either physician prescribed or self-prescribed.

Patients of middle age or older with new or recently changed dyspeptic symptoms. Patients with unintended weight loss in association with dyspeptic symptoms.

Patients taking non-steroidal anti-inflammatory drugs, especially in those with a history of ulcer should consult their doctor prior to use.

 

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 versus those who had stopped treatment, with an observed adjusted relative risk increase of 1,82 (95% CI, 1,26 - 2,64).



4.6 Fertility, pregnancy and lactation

 

Fertility

 

There are no data on the effects of ranitidine on human fertility. In animal studies, no effect on fertility was observed.

 

Pregnancy

 

Ranitidine crosses the placenta. As with other drugs, ranitidine products should not be taken in pregnancy without consulting a doctor.

 

Lactation

 

Ranitidine is excreted in human breast milk. Women who are breastfeeding are advised to speak to their doctor before taking ranitidine products.



4.8 Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects:

Very common (2:1/10), common (2:1/100, <1/10), uncommon (2:1/1000, <1/100), rare (2:1/10,000, <1/1000), very rare ( <1/10,000). Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.



Blood & Lymphatic System Disorders

Very rare: Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.

 

Immune System Disorders

Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain). Very rare: Anaphylactic shock.

These events have been reported after a single dose.

 

Psychiatric Disorders

Very rare: Reversible mental confusion, depression and hallucinations. These have been reported predominantly in severely ill and elderly patients.

 

Nervous System Disorders

Very rare: Headache (sometimes severe), dizziness and reversible involuntary movement disorders.

 

Eye disorders

Very rare: Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change in accommodation.

 

Cardiac Disorders

Very rare: As with other H2 receptor antagonists bradycardia and A-V Block.

 

Vascular Disorders

Very Rare: Vasculitis

 

Gastrointestinal Disorders

Very Rare: Acute pancreatitis. Diarrhoea.

Uncommon: Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).

 

Hepatobiliary Disorders

Rare: Transient and reversible changes in liver function tests.

Very Rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

 

Skin and Subcutaneous Tissue Disorders

Rare: Skin Rash

Very Rare: Erythema multiforme, alopecia.

 

Musculoskeletal and Connective Tissue Disorders

Very Rare: Musculoskeletal symptoms such as arthralgia and myalgia.

 

Renal and Urinary Disorders

Very Rare: Acute interstitial nephritis

Rare: Elevation of plasma creatinine (usually slight; normalised during continued treatment)

 

Reproductive System and Breast Disorders

Very Rare: Reversible impotence and breast conditions (such as gynaecomastia and galactorrhoea)

 

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



5.2 Pharmacokinetic properties

 

The bioavailability of ranitidine is consistently about 50%. Peak concentrations in plasma, normally in the range 236- 270 ng/ml, after a 75 mg dose, occur 2-3 hours after oral administration. Concentrations of ranitidine in plasma are proportional to doses up to and including 300 mg.

 

Ranitidine is not extensively metabolised.  Elimination of the drug is primarily by tubular excretion.  The elimination half-life is 2-3 hours.

 

In balance studies with 150 mg 3H-ranitidine 93% of an intravenous dose was excreted in urine and 5% in faeces; 60- 70% of an oral dose was excreted in the urine and 26% in the faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 70% of the intravenous dose and 35% of the oral dose were eliminated unchanged. The metabolism of ranitidine is similar after both oral and intravenous dosing; about 6% of the dose being excreted in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1-2% as the furoic acid analogue.

 

Special patient populations: In patients over 50 years of age, half-life is prolonged (3-4 h) and clearance is reduced, consistent with the age-related decline of renal function. However, systematic exposure and accumulation are 50% higher. This difference exceeds the effect of declining renal function, and indicates increased bioavailability in older patients.

Updated on 11 April 2016 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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

4.4  Special warnings and precautions for use

 

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.

 

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment (creatine clearance less than 50ml/min). Ranitidine products are not suitable for these patients without medical supervision.

 

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

    The following patients are advised to seek their doctor’s advice before taking ranitidine products:

 

Patients with renal impairment (creatine clearance less than 50ml/min) and/or hepatic impairment. Patients under regular medical supervision.

Patients taking medications either physician prescribed or self-prescribed.

Patients of middle age or older with new or recently changed dyspeptic symptoms. Patients with unintended weight loss in association with dyspeptic symptoms.

Patients taking non-steroidal anti-inflammatory drugs, especially in those with a history of ulcer should consult their doctor prior to use.

 

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 versus those who had stopped treatment, with an observed adjusted relative risk increase of 1,82 (95% CI, 1,26 - 2,64).

4.6  Fertility, pregnancy and lactation

 

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.

 

Pregnancy

 

Ranitidine crosses the placenta. As with other drugs, ranitidine products should not be taken in pregnancy without consulting a doctor.

 

Lactation

 

Ranitidine is excreted in human breast milk. Women who are breastfeeding are advised to speak to their doctor before taking ranitidine products.

4.8  Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects:

Very common (2:1/10), common (2:1/100, <1/10), uncommon (2:1/1000, <1/100), rare (2:1/10,000, <1/1000), very rare ( <1/10,000). Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.


 

 

 

 

 

 

 

Blood & Lymphatic System Disorders

Very rare: Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.

 

Immune System Disorders

Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain). Very rare: Anaphylactic shock.

These events have been reported after a single dose.

 

Psychiatric Disorders

Very rare: Reversible mental confusion, depression and hallucinations. These have been reported predominantly in severely ill and elderly patients.

 

Nervous System Disorders

Very rare: Headache (sometimes severe), dizziness and reversible involuntary movement disorders.

 

Eye disorders

Very rare: Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change in accommodation.

 

Cardiac Disorders

Very rare: As with other H2 receptor antagonists bradycardia and A-V Block.

 

Vascular Disorders

Very Rare: Vasculitis

 

Gastrointestinal Disorders

Very Rare: Acute pancreatitis. Diarrhoea.

Uncommon: Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).

 

Hepatobiliary Disorders

Rare: Transient and reversible changes in liver function tests.

Very Rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

 

Skin and Subcutaneous Tissue Disorders

Rare: Skin Rash

Very Rare: Erythema multiforme, alopecia.

 

Musculoskeletal and Connective Tissue Disorders

Very Rare: Musculoskeletal symptoms such as arthralgia and myalgia.

 

Renal and Urinary Disorders

Very Rare: Acute interstitial nephritis

Rare: Elevation of plasma creatinine (usually slight; normalised during continued treatment)

 

Reproductive System and Breast Disorders

Very Rare: Reversible impotence and breast conditions (such as gynaecomastia and galactorrhoea)

5.2  Pharmacokinetic properties

 

The bioavailability of ranitidine is consistently about 50%. Peak concentrations in plasma, normally in the range 236- 270 ng/ml, after a 75 mg dose, occur 2-3 hours after oral administration. Concentrations of ranitidine in plasma are proportional to doses up to and including 300 mg.

 

Ranitidine is not extensively metabolised. Elimination of the drug is primarily by tubular excretion. The elimination half-life is 2-3 hours.

 

In balance studies with 150 mg 3H-ranitidine 93% of an intravenous dose was excreted in urine and 5% in faeces; 60- 70% of an oral dose was excreted in the urine and 26% in the faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 70% of the intravenous dose and 35% of the oral dose were eliminated unchanged. The

metabolism of ranitidine is similar after both oral and intravenous dosing; about 6% of the dose being excreted in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1-2% as the furoic acid analogue.

6.3  Shelf life

 

3 years.

6.4   Special precautions for storage

 

Store below 25°C.

Tablets should not be removed from blisters until immediately prior to use.



Updated on 4 April 2016 PIL

Reasons for updating

  • Change to name of manufacturer
  • Addition of information on reporting a side effect.

Updated on 4 March 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

6.3  Shelf life

 

3 years.

 

6.4  Special precautions for storage

 

Store below 25°C.

Tablets should not be removed from blisters until immediately prior to use.

Updated on 11 May 2015 PIL

Reasons for updating

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

Updated on 27 January 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

$04.6  Fertility, pregnancy andlactation$0$0PREVIOUS VERSION: N/A$0$0UPDATED VERSION$0$0Fertility $0$0$0$0There are no data on the effects of ranitidine onhuman fertility. There were no effects on male and female fertility in animalstudies.$0$05.1Pharmacodynamic properties$0$0PREVIOUS VERSION: Ranitidine is a specific rapidly acting histamine H2-receptor antagonist. It inhibits basal and stimulated secretion of gastric acid, reducingboth the volume and the acid and pepsin content of the secretion. Ranitidine has a long durationof action and a single 75mg dose effectively suppresses gastric acid secretionfor at least 12 hours. Clinicalstudies have shownthat Zantac 75 can relievethe symptoms during a maximumof twelve hours.$0$0$0$0$0UPDATED VERSION:$0$0ATC Code: A02BA02$0$0Pharmacotherapeutic group: H2-receptorantagonists. $0$0Ranitidineis a specific, rapidly acting histamine H2-antagonist.  It inhibits basal and stimulated secretion ofgastric acid, reducing both the volume and the acid and pepsin content of thesecretion.Rantidinehas a long duration of action and a single 75 mg dose effectively suppressesgastric acid secretion for at least 12 hours.Clinical studies have shown that Zantac 75 can relieve symptoms during amaximum of twelve hours.$0$05.3  Preclinical safety data$0$0PREVIOUS VERSION: No Particulars.$0$0UPDATED VERSIONNon-clinicaldata revealed no special hazard for humans based on conventional studies ofsafety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potentialand toxicity to reproduction and development.$0$0$010       DATE OF REVISIONOF THE TEXT$0$0$0PREVIOUS VERSION: September 2013$0$0UPDATED VERSION: 5th September 2014$0

Updated on 13 May 2014 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

$0·Sections 4.2, 4.4 and 4.8 of the SPC are updatedin line with the GSK Global data safety sheet.$0$0

Updated on 8 May 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 20 August 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7 MAH Holder address changed from GSK Ireland to:

Chefaro Ireland Limited First Floor

Block A

The Crescent Building Northwood Office Park

Dublin 9

Ireland

Section 8 Marketing Authoriation Number to:

PA 1186/013/001

Section 10 Revision date to January 2013

Updated on 6 February 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 3 December 2012 PIL

Reasons for updating

  • Change of manufacturer
  • Transfer of Marketing Authorisation Holder

Updated on 1 February 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 8 February 2011 SmPC

Reasons for updating

  • Transfer of marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 10 - date of revision is corrected

Updated on 6 December 2010 SmPC

Reasons for 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 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

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4

Formating updates

Section 4.5

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. Patients of middle age or older with new or recently changed dyspeptic symptoms, or with unintended weight loss in association with dyspeptic symptoms should consult a doctor before use.

 

Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks.  Ranitidine should therefore be avoided in not be given to patients with a history of acute porphyria.

 

Patients with severe renal/hepatic impairment, those under regular medical supervision, and those who are taking any medications (either physician or self prescribed) are advised to consult their doctor prior to use. Ranitidine is excreted through via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment.  Zantac 75 are not suitable for these patients.

 

 

The following patients are advised to seek their doctor’s advice before taking Zantac 75:

 

·         Patients with severe renal and/or hepatic impairment.

·         Patients under regular medical control.

·         Patients taking medication prescribed by a physician or self-prescribed.

·         Patients of middle age or older with new or recently changed dyspeptic symptoms.

·         Patients with unintended weight loss in association with dyspeptic symptoms.

·         Patients with a risk of developing ulcers or a history of peptic ulcer (e.g. patients taking NSAIDs).

 

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 1.63 (95% CI, 1.07–2.48) 1,82 (95% CI, 1,26–2,64).

 

Patients taking non-steroidal anti-inflammatory drugs, especially in those with a history of ulcer should consult their doctor prior to use.

 

4.5.      Interaction with other medicaments and other forms of interaction

 

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 does not inhibit the hepatic cytochrome P450-linked mixed function oxygenase system at therapeutic doses.  Accordingly, ranitidine Ranitidine in standard at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme; these include system such as diazepam, lidocaine, phenytoin, propranolol and theophylline. and warfarin.  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) 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).

 

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 hours.

 

4.6.      Pregnancy and lactation

 

Insufficient data is available to assess the possible risks of the use of ranitidine in pregnant or lactating women.  Ranitidine crosses the placenta and is also excreted in breast milk; however, the clinical relevance is not clear.  Zantac 75 should therefore not be taken during pregnancy and lactation without consulting a doctor.

 

Pregnancy

Ranitidine crosses the placenta. As with other drugs, ranitidine products should not be taken in pregnancy without consulting a doctor.

 

Lactation

Ranitidine is excreted in human breast milk.  Women who are breastfeeding are advised to speak to their doctor before taking ranitidine products.

 

4.7.      Effects on ability to drive and use machines

 

Insufficient data on the effects on ability to drive and to operate machines is available.

None reported.

 

 

4.8.      Undesirable effects

 

The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (1/10,000).

Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.

 

Blood & Lymphatic System Disorders

Very Rare:       Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with *marrow hypoplasia or marrow aplasia.

 

Immune System Disorders

Rare:                Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).

Very Rare:       Anaphylactic shock

These events have been reported after a single dose.

 

Psychiatric Disorders

Very Rare:       Reversible mental confusion, depression and hallucinations.

These have been reported predominantly in severely ill and elderly patients.

 

Nervous System Disorders

Very Rare:       Headache (sometimes severe),dizziness and reversible involuntary movement disorders.

 

Eye Disorders

Very Rare:       Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change in accommodation.

 

Cardiac Disorders

Very Rare:       As with other H2 receptor antagonists bradycardia and A-V Block.

 

Vascular Disorders

Very Rare:       Vasculitis.

 

Gastrointestinal Disorders

Very Rare:       Acute pancreatitis. Diarrhoea.

Uncommon:    Abdominal pain, constipation, nausea (these symptoms mostly improved                            during continued treatment).

 

Hepatobiliary Disorders

Rare:                Transient and reversible changes in liver function tests.

Very Rare        Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

 

Skin and Subcutaneous Tissue Disorders

Rare:                Skin Rash.

Very Rare:       Erythema multiforme, alopecia.

 

Musculoskeletal and Connective Tissue Disorders

Very Rare:       Musculoskeletal symptoms such as arthralgia and myalgia.

 

Renal and Urinary Disorders

Very rare:        Acute interstitial nephritis.

Rare:                Elevation of plasma creatinine (usually slight; normalised during continued                         treatment)

 

Reproductive System and Breast Disorders

Very Rare:       Reversible impotence. *Breast symptoms in men. and breast conditions (such                      as gynaecomastia and galactorrhoea)

 

Paediatric population

The safety of ranitidine has been assessed in children aged 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults. There are limited long term safety data available, in particular regarding growth and development.

 

4.9.      Overdose

 

Symptoms and Signs

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug ranitidine formulations. Up to 6g per day has been administered without untoward effect in patients with Zollinger-Ellison syndrome.

Treatment

In case of overdosage symptomatic and supportive therapy should be given as appropriate.

is recommended.  If necessary, the drug may be removed from the plasma by haemodialysis.

Updated on 1 September 2009 SmPC

Reasons for updating

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

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.5 - correction of formatting error

Updated on 19 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through general sale

Updated on 29 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 June 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4.
The following has been added:

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 H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.63 (95% CI, 1.07–2.48).

Updated on 22 March 2007 PIL

Reasons for updating

  • Change of manufacturer

Updated on 24 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 August 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • 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

Legal category: Supply through general sale

Updated on 20 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale