Omeprazole Mylan 10mg, 20mg, 40mg gastro-resistant capsules, hard

  • Name:

    Omeprazole Mylan 10mg, 20mg, 40mg gastro-resistant capsules, hard

  • Company:
    info
  • Active Ingredients:

    Omeprazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/06/17

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Summary of Product Characteristics last updated on medicines.ie: 13/6/2017
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Gerard Laboratories

Gerard Laboratories

Company Products

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Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
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
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
Medicine Name Diaclide MR 30 mg Modified-release Tablets Active Ingredients Gliclazide
Medicine Name Diaclide MR 60mg modified-released tablets Active Ingredients Gliclazide
1 - 0 of 116 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 13 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 June 2017 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • 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. CLINICAL PARTICULARS

4.1 Therapeutic indications
 
 

Omeprazole is indicated in adults and children over 1 year of age and ³ 10kg.

 

Omeprazole gastro-resistant capsules are indicated infor:

4.3 Contraindications

Hypersensitivity to the active substanceomeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1.
Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir (see section 4.5).

4.4 Special warnings and precautions for use

Each 40mg Gastro-resistant capsule, hard contains Sunset Yellow (E110) and Allura red (E129). These may cause allergic reactions.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients possibly also Clostridium difficile (see section 5.1).

4.6 Fertility, pregnancy and lactation

Breast-fFeeding

4.8 Undesirable effects

SOC/ Frequency

Adverse reaction

Blood and lymphatic system disorders

Rare:

Leukopenia, thrombocytopenia

Very rare:

Pancytopenia, agranulocytosis

Immune system disorders

Rare:

Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/ shock

Metabolism and nutrition disorders

Rare:

Hyponatraemia

Not Known:

Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia

Hypomagnesaemia may also be associated with hypokalaemia.

Psychiatric disorders

Uncommon:

Insomnia

Rare:

Agitation, confusion, depression

Very Rare:

Aggression, hallucinations.

Nervous system disorders

Common:

Headache

Uncommon:

Dizziness, paraesthesia, somnolence

Rare:

Taste disturbance

Eye disorders

 Rare:

Blurred vision

Ear and labyrinth disorders

 Uncommon:

Vertigo

Respiratory, thoracic and mediastinal disorders

Rare:

Bronchospasm

Gastrointestinal disorders

Common:

Abdominal pain, constipation, diarrhoea, flatulence, nausea and vomiting, fundic gland polyps (benign)

Rare:

Dry mouth, stomatitis, gastrointestinal candidiasis

Not known:

Microscopic colitis

Hepatobiliary disorders

Uncommon:

Increased liver enzymes

Rare:

Hepatitis with or without jaundice

Very Rare:

Hepatic failure, encephalopathy in patients with pre-existing liver disease

Skin and subcutaneous tissue disorders

Uncommon:

Dermatitis, pruritus, rash, urticaria

Rare:

Alopecia, photosensitivity

Very Rare:

Erythema multiforme, 

Stevens-Johnsons syndrome, toxic epidermal necrolysis (TEN)

 Not known

Subacute cutaneous lupus erythematosus (see section 4.4)S

Musculoskeletal and connective tissue disorders

Uncommon:

Fracture of the hip, wrist or spine (see section 4.4)

Rare:

Arthralgia, myalgia

Very Rare:

Muscular weakness

Renal and urinary disorders:

Rare:

Interstitial nephritis

Reproductive System and breast disorders:

Very Rare:

Gynaecomastia

General disorders and administration site conditions

Uncommon:

Malaise, peripheral oedema

Rare:

Increased sweating.

 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties


Other effects related to acid inhibition
During long-term treatment gastric glandular cysts have been reported in somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.

10. DATE OF REVISION OF THE TEXT

March November 20176

Updated on 8 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 June 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 30 May 2017 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • 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. CLINICAL PARTICULARS

4.1 Therapeutic indications


Omeprazole is indicated in adults and children over 1 year of age and 10kg.

Omeprazole gastro-resistant capsules are indicated infor:

4.3 Contraindications

Hypersensitivity to the active substanceomeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1.
Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir (see section 4.5).


Interference with laboratory tests

Each 40mg Gastro-resistant capsule, hard contains Sunset Yellow (E110) and Allura red (E129). These may cause allergic reactions.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients possibly also Clostridium difficile (see section 5.1).

4.6 Fertility, pregnancy and lactation

Breast-fFeeding
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

4.8 Undesirable effects

Gastrointestinal disorders

Common:

Abdominal pain, constipation, diarrhoea, flatulence, nausea and vomiting, fundic gland polyps (benign)


5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties


Other effects related to acid inhibition
During long-term treatment gastric glandular cysts have been reported in somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.

10. DATE OF REVISION OF THE TEXT

March November 20176




Updated on 26 May 2017 PIL

Reasons for updating

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

Updated on 25 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 January 2017 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
  • 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

Special Populations:
RPatients with renal impairment
Dose adjustment is not required in patients with impaired renal function (see section 5.2).

HPatients with hepatic impairment
In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient (see section 5.2).

ElderlyOlder people (> 65 years)
Dose adjustment is not required in the elderly (see section 5.2).

4.4 Special warnings and precautions for use

Hypomagnesaemia
Severe hypomagnesaemia has been reported in patients treated with PPIs like omeprazole for at least three
months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and
discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or other medicines that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping omeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping omeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped for at least five days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

4.8 Undesirable effects

SOC/ Frequency

Adverse reaction

Blood and lymphatic system disorders

Rare:

Leukopenia, thrombocytopenia

Very rare:

Pancytopenia, agranulocytosis

Immune system disorders

Rare:

Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/ shock

Metabolism and nutrition disorders

Rare:

Hyponatraemia

Not Known:

Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia

Hypomagnesaemia may also be associated with hypokalaemia.

Psychiatric disorders

Uncommon:

Insomnia

Rare:

Agitation, confusion, depression

Very Rare:

Aggression, hallucinations.

Nervous system disorders

Common:

Headache

Uncommon:

Dizziness, paraesthesia, somnolence

Rare:

Taste disturbance

Eye disorders

 Rare:

Blurred vision

Ear and labyrinth disorders

 Uncommon:

Vertigo

Respiratory, thoracic and mediastinal disorders

Rare:

Bronchospasm

Gastrointestinal disorders

Common:

Abdominal pain, constipation, diarrhoea, flatulence, nausea and vomiting

Rare:

Dry mouth, stomatitis, gastrointestinal candidiasis

Not known:

Microscopic colitis

Hepatobiliary disorders

Uncommon:

Increased liver enzymes

Rare:

Hepatitis with or without jaundice

Very Rare:

Hepatic failure, encephalopathy in patients with pre-existing liver disease

Skin and subcutaneous tissue disorders

Uncommon:

Dermatitis, pruritus, rash, urticaria

Rare:

Alopecia, photosensitivity

Very Rare:

Erythema multiforme, 

Stevens-Johnsons syndrome, toxic epidermal necrolysis (TEN)

 Not known

Subacute cutaneous lupus erythematosus (see section 4.4)

Musculoskeletal and connective tissue disorders

Uncommon:

Fracture of the hip, wrist or spine (see section 4.4)

Rare:

Arthralgia, myalgia

Very Rare:

Muscular weakness

Renal and urinary disorders:

Rare:

Interstitial nephritis

Reproductive System and breast disorders:

Very Rare:

Gynaecomastia

General disorders and administration site conditions

Uncommon:

Malaise, peripheral oedema

Rare:

Increased sweating.


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 directly 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

5.1  Pharmacodynamic properties

Other effects related to acid inhibition
During long-term treatment gastric glandular cysts have been reported in somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.

Literature reports indicateAvailable published evidence suggests that proton pump inhibitors treatment should be discontinued between stopped at least 5 days and 2 weeks prior to before CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range. If CgA and gastrin levels have not normalised after 5 days, measurements should be repeated 14 days after cessation of omeprazole treatment.

An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in some patients (both children and adults) during long term treatment with omeprazole. The findings are considered to be of no clinical significance.


 

Updated on 24 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

 

4.4 Special warnings and precautions for use

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping omeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.


 

4.8 Undesirable effects

Rare:

 

Agitation, confusion, depression

 

Very Rare:

 

Aggression, hallucinations

.

Nervous system disorders

 

 

Common:

 

Headache

 

Uncommon:

 

Dizziness, paraesthesia, somnolence

 

Rare:

 

Taste disturbance

 

Eye disorders

 

 

Rare:

Blurred vision

 

Ear and labyrinth disorders

 

 

Uncommon:

Vertigo

 

Respiratory, thoracic and mediastinal disorders

 

 

Rare:

 

Bronchospasm

 

Gastrointestinal disorders

 

 

Common:

 

Abdominal pain, constipation, diarrhoea, flatulence, nausea and vomiting

 

Rare:

 

Dry mouth, stomatitis, gastrointestinal candidiasis

 

Not known:

 

Microscopic colitis

 

Hepatobiliary disorders

 

 

Uncommon:

 

Increased liver enzymes

 

Rare:

 

Hepatitis with or without jaundice

 

Very Rare:

 

Hepatic failure, encephalopathy in patients with pre-existing liver disease

 

Skin and subcutaneous tissue disorders

 

 

Uncommon:

 

Dermatitis, pruritus, rash, urticaria

 

Rare:

 

Alopecia, photosensitivity

 

Very Rare:

 

Erythema multiforme,

Stevens-Johnsons syndrome, toxic epidermal necrolysis (TEN)

 

Not known

 

 

Subacute cutaneous lupus erythematosus (see section 4.4)

 

 

Musculoskeletal and connective tissue disorders

 

 

Uncommon:

 

Fracture of the hip, wrist or spine (see section 4.4)

 

Rare:

 

Arthralgia, myalgia

 

Very Rare:

 

Muscular weakness

 

Renal and urinary disorders:

 

 

Rare:

 

Interstitial nephritis

 

Reproductive System and breast disorders:

 

 

Very Rare:

 

Gynaecomastia

 

General disorders and administration site conditions

 

 

Uncommon:

 

Malaise, peripheral oedema

 

Rare:

 

Increased sweating.

 

SOC/ Frequency

 

Adverse reaction

 

Blood and lymphatic system disorders

 

Rare:

 

 

Leukopenia, thrombocytopenia

 

 

Very rare:

 

 

Pancytopenia, agranulocytosis

 

 

Immune system disorders

 

Rare:

 

 

Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/ shock

 

 

Metabolism and nutrition disorders

 

Rare:

 

 

Hyponatraemia

 

 

Not Known:

 

 

Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia

Hypomagnesaemia may also be associated with hypokalaemia

 

.

Psychiatric disorders

 

Uncommon:

 

 

Insomnia

 

 











Updated on 26 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 29 October 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 17 August 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.8 Undesirable effects

Metabolism and nutrition disorders

Rare:

Hyponatraemia

Not Known:

Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia

Hypomagnesaemia may also be assoiated with hypokalaemia.


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 directly 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

Updated on 29 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 24 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • 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 2: Qualitative and quantitative  composition
'Each 20mg Gastro-resistant capsules, hard contains 0.0029mg Tartrazine(E102) and 0.0104mg ALlura red (E129)....removed text

Section 4.4: Special warnings and precautions for use
'Each 20mg Gastro-resistant capsule, hard contains Tartrazine (E102) and Allura red (E129).....removed text

Section 4.8: Undesirable effects-Reporting of suspected adverse reactions..updated

Section 6: Pharmaceutical Particulars
6.1. List of excipients
20mg
Shell cap
Titanium dioxide(E171), Iron oxide black, Iron Oxide red(E172), Tartrazine (E102), Brilliant blue(E133), Allura red(E129), Gelatin, Sodium lauryl sulphate.

Updated on 22 July 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 June 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 8 November 2013 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Sections 4.2, 4.4, 4.5, 4.8, 5.1 and 10 updated with numerous changes.

Updated on 6 November 2013 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 further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Product/presentation re-marketed

Updated on 9 May 2013 SmPC

Reasons for updating

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

section 4.4:text added

Interference with laboratory tests

Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped five days before CgA measurements.

 

section 6.5: text updated to remove (hospital packaging)

Round wide mouth white coloured HDPE bottle with white opaque PP screw cap induction sealing line.

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 112 200, 500 in bottles

2 x 50

250 (dose dispensing in hospitals – bottle only)

 

Aluminium/Polyamide/PVC blister.

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 98, 100, 112, 200, 500 in blisters

2 x 50

 


Updated on 7 May 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 3 May 2013 PIL

Reasons for updating

  • Change to further information section

Updated on 8 March 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions

Updated on 1 March 2012 PIL

Reasons for updating

  • Change to further information section

Updated on 17 January 2012 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 December 2011 PIL

Reasons for updating

  • New PIL for new product