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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 19/04/2012
SPC Ranitidine 150mg/10ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2 ( Qualitative and quantitative composition) Sodium has been added.
In section 10 (Date of partial revision of the text) the date has been updated to 21-Mar-2012
Updated on 03/08/2011 and displayed until 19/04/2012
Reasons for adding or 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4. Special Warnings and Special Precautions for 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 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).

4.5. Interaction with other Medicinal Products and other forms of Interaction

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, raltegravir) or a decrease in absorption (e.g. ketoconazole, itraconazole, atazanavir, delavirdine, gefitinib, lapatinib, cefpodoxime).

There is no evidence of an interaction between ranitidine and amoxicillin and metronidazole. If high doses (2g) 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.

4.8. Undesirable Effects

The table below has been reformatted

System Organ Class

Common (>1/100, <1/10)

Uncommon (>1/1000,<1/100)

Rare  (>1/10,000, <1/1000)

Very rare (<1/10,0000)

Unknown

Blood and the lymphatic system

 

 

 

Blood count changes (leucopenia, thrombocytopenia) these are usually reversible, agranulocytosis, pancytopenia (sometimes with marrow hypoplasia) or marrow aplasia

acute porphyria.

Immune system disorders

 

 

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

Anaphylactic shock. These events have been reported after a single dose.

 

Psychiatric disorders

 

 

 

Reversible mental confusion, depression and hallucinations (especially in the elderly or severely ill)

 

Nervous system disorders

 

 

 

Headache (sometimes severe), dizziness and reversible involuntary movement disorders

 

Eye disorders

 

 

 

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

 

Cardiac disorders

 

 

 

As with other H2 receptor antagonists bradycardia, A-V block

 

Vascular disorders

 

 

 

Vasculitis

 

Gastrointestinal disorders

 

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

 

Acute pancreatitis

 

Hepatobiliary disorders

 

 

Transient and reversible changes in liver function tests

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

 

Skin and subcutaneous tissue disorders

 

 

Skin rash

Erythema multiforme, alopecia

 

Musculoskeletal, connective tissue and bone disorders

 

 

 

Musculoskeletal symptoms such as arthralgia, myalgia

 

Renal and urinary disorders

 

 

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

Acute interstitial nephritis

 

Reproductive system and breast disorders

 

 

 

Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

 

System Organ Class

Common (>1/100, <1/10)

Uncommon (>1/1000,<1/100)

Rare  (>1/10,000, <1/1000)

Very rare (> <1/10,0000)

Unknown

Blood and the lymphatic system

 

 

 

Blood count changes (leucopenia, thrombocytopenia) these are usually reversible, agranulocytosis, pancytopenia (sometimes with marrow hypoplasia) or marrow aplasia

acute porphyria.

Immune system disorders

 

 

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

Anaphylactic shock. These events have been reported after a single dose.

 

Psychiatric disorders

 

 

 

Reversible mental confusion, depression and hallucinations (especially in the elderly or severely ill)

 

Nervous system disorders

 

 

 

Headache (sometimes severe), dizziness and reversible involuntary movement disorders

 

Eye disorders

 

 

 

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

 

Cardiac disorders

 

 

 

As with other H2 receptor antagonists bradycardia, A-V block

 

Vascular disorders

 

 

 

Vasculitis

 

Gastrointestinal disorders

 

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

 

Acute pancreatitis

 

Hepatobiliary disorders

 

 

Transient and reversible changes in liver function tests

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

 

Skin and subcutaneous tissue disorders

 

 

Skin rash

Erythema multiforme, alopecia

 

Musculoskeletal, connective tissue and bone disorders

 

 

 

Musculoskeletal symptoms such as arthralgia, myalgia

 

Renal and urinary disorders

 

 

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

Acute interstitial nephritis

 

Reproductive system and breast disorders

 

 

 

Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

 

10. Date of (Partial) Revision of the Text

11 Jan 2011
Updated on 17/03/2011 and displayed until 03/08/2011
Reasons for adding or 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.4 (Special Warnings and Special Precautions for Use) the following was 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).

In section 4.4 under Excipient Information the following was added in relation to the ethanol content -

Alternative formulation of ranitidine may be considered preferential in these populations.

Section 4.5 (Interaction with other Medicinal Products and other forms of Interaction) changed to -

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 action 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


bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide, raltegravir) or a decrease in absorption (e.g. ketoconazole, itraconazole, atazanavir, delavirdine, gefitinib, lapatinib, cefpodoxime).

Section 4.8 Undesirable Effects. The table containing the undesirable effects was expanded to include common, uncommon and unknown categories of events.
Updated on 25/11/2009 and displayed until 17/03/2011
Reasons for adding or 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 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1: Added indications for Children (3 to 18 years) to include short term treatment of peptic ulcer and treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. A cross reference to section 4.4.  has been added.

Section 4.2: Updated dosage for Children (3 to 11 years) to include a cross reference to section 5.2. The ethanol content has been added with additional text to consider an alternative formulation of ranitidine for at risk-groups, including children. The dosing text has been edited for treatment of peptic ulcer acute treatment and added for gastro-oesophageal reflux.

Section 4.4 Added a reference to section 4.2 in excipient information.

Section 5.2: Added special patient populations (Children 3 years and above)

Section 10: Date of partial revision of the text updated to Nov-2009
Updated on 28/09/2007 and displayed until 25/11/2009
Reasons for adding or 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 4.4 - 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 2: Composition

Amounts reworded as per 10ml

 

Section 4.1: Therapeutic Indications

Reworded sections.

Prevention of NSAID associated ulcers expanded to include aspirin

 

Section 4.2: Posology

Reworded sections

Dosage for maintenance therapy for duodenal and gastric ulcers added

Guidance added on routine monitoring of patients on long term treatment

Treatment of haemorrhaging reworded to prophylaxis of haemorrhaging and dosage advice provided

Guidance added on dosage requirements for those with renal insufficiency

 

Section 4.4 Special Warnings

Guidance added on patients who require regular monitoring whilst taking ranitidine

Immune system reactions added

Ethanol warning expanded to warn on effects on driving on using machinery

Sodium Content added

 

Section 4.5 Interactions

Barbiturates and hypoglycaemic drugs added

 

Section 4.6 Pregnancy and Lactation

Warning added on not using in pregnancy and lactation unless considered essential by the physician

 

Section 4.7 Effects on ability to drive and use machinery

Warning added to warn on effects on driving on using machinery due to alcohol content

 

Section 4.8 Undesirable Effects

Tiredness, diarrhoea, constipation, nausea, pruritus, acute porphyria, reversible mental confusion, depression, hallucinations, headache, dizziness, reversible blurred vision, acute pancreatitis, acute interstitial nephritis added

Some side effects have moved categories with respect to seriousness i.e. rare, very rare

A statement on safety in children has been added.

 

Section 5.1 Pharmacodynamic properties

ATC Code added

 

Section 5.3 Preclinical Safety Dat.

Section reworded

 

Section 6.2 Incompatibilities

Reworded

 

Section 6.3 Shelf Life

Section reworded

 

Section 6.5 Nature and content of container

Not all pack sizes may be marketed added

 

Section 10: Date of  revision of the text

Date revised
Updated on 26/09/2005 and displayed until 28/09/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 25/09/2002 and displayed until 26/09/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  ranitidine hydrochloride