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Mezzopram 20 mg Dispersible Gastro-resistant Tablets

Last Updated on eMC 19-Jan-2016 View document  | Sandoz Limited Contact details

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-Jan-2016 and displayed until Current

Reasons for adding or updating:

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

Date of revision of text on the SPC: 02-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4         Special warnings and precautions for use

 

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

 

Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

 

Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.  This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

 

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.

 

 

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

 

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors 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 proton pump inhibitor.

For patients expected to be on prolonged treatment or who take proton pump inhibitors with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting proton pump inhibitor 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 fracture 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 health care professional should consider stopping Mezzopram. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

 

Interactions with investigations of neuroendocrine tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. To avoid this effect, treatment with omeprazole should be temporarily discontinued at least five days before the CgA measurements.

 

Some children with chronic illnesses may require long-term treatment although it is not recommended.

 

As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

 

Mezzopram Dispersible gastro-resistant tablets contain sucrose and glucose. Patients with rare fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

4.8         Undesirable effects

 

The most common side effects (1‑10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

 

The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing. None was found to be dose-related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency categories are defined according to the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

 

SOC/frequency

 

Adverse reaction

Blood and lymphatic system disorders

Rare:

Leukopenia, thrombocytopenia

Very rare:

Agranulocytosis, pancytopenia

Immune system disorders

Rare:

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

Metabolism and nutrition disorders

Rare:

Hyponatraemia

Not known:

Hypomagnesaemia (see section 4.4). Severe hypomagnesaemia may result in hypocalcaemia.

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/vomiting

Rare:

Dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis

Very rare:

Dyspepsia

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-Johnson 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

 

Paediatric population

The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.

 

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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).

 

 

Updated on 28-Feb-2014 and displayed until 19-Jan-2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following text in bold has been added. Text crossed out has been removed.

Section 2

For a the full list of excipients, see section 6.1.



Section 3

Pink, oval film-coated tablet with a breaking notch on both sides. The tablet can be divided into equal halves (14.2 x 7.2 mm).



Section 4.2

Posology in children paediatric population



Section 4.3

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1.



Section 4.4

Some children with chronic illnesses may require long term treatment although it is not recommended.

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

 

Interactions with investigations of neuroendocrine tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. To avoid this effect, treatment with omeprazole should be temporarily discontinued at least five days before the CgA measurements.

 

Some children with chronic illnesses may require long-term treatment although it is not recommended.




Section 4.5

Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole (80 mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of 46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%.

 

Inconsistent data on the clinical implications of a PK/PD interaction of omeprazole in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged (see section 4.4).

In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together. In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.

 

Methotrexate

When methotrexate is given together with proton pump inhibitors, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of omeprazole may need to be considered.




Section 4.6
Fertility, pPregnancy and lactation

Pregnancy

Breast-feeding



Section 4.8

Severe hypomagnesaemia may result in hypocalcaemia.

microscopic colitis

Very rare: Dyspepsia


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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).




Section 5.1

Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella, and Campylobacter and Clostridium difficile.

 

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 indicate that proton pump inhibitor treatment should be stopped at least 5 days before CgA measurement. If CgA and gastrine 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.



Section 5.2
Metabolism Biotransformation

Excretion Elimination



Section 9

Date of first authorisation: 05 July /07/ 2010

Date of latest renewal: 22 January 2013



Section 10

23/08/2012 11/2013

 

Updated on 04-May-2011 and displayed until 28-Feb-2014

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Sandoz Limited

Company image
Address

200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Fax

+44 (0) 1276 698324

Medical Information Fax

+44 (0) 1276 698468

Telephone

+44 (0) 1276 698020

Medical Information e-mail

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?

Active ingredients

omeprazole magnesium

Legal categories

POM - Prescription Only Medicine

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