Areloger 7.5mg & 15mg Tablets

  • Name:

    Areloger 7.5mg & 15mg Tablets

  • Company:
    info
  • Active Ingredients:

    Meloxicam

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/10/17

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Summary of Product Characteristics last updated on medicines.ie: 5/10/2017
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Gerard Laboratories

Gerard Laboratories

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Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
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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
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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 5 October 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 5 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 October 2017 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

4. CLINICAL PARTICULARS

4.5 Interaction with other medicinal products and other forms of interaction


Calcineurin inhibitors (e.g. cyclosporineciclosporin, tacrolimus):
Nephrotoxicity of calcineurin inhibitors may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured. A careful monitoring of the renal function is recommended, especially in the elderly.

4.8 Undesirable effects

Gastrointestinal disorders
Very common: Gastrointestinal disorders such as dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea
Uncommon: Occult or macroscopic gastrointestinal haemorrhage*, stomatitis, gastritis, eructation
Rare: Colitis, gastroduodenal ulcer, oesophagitis
Very rare: Gastrointestinal perforation*
Not Known: Pancreatitis

10.       DATE OF REVISION OF THE TEXT

 

January 2016June 2017

 

Updated on 5 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 January 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 February 2016 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 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.
  •  If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, mMeloxicam treatment should be discontinued.
  •  The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.
  •  If the patient has developed SJS or TEN with the use of
  • mMeloxicam, mMeloxicam must not be re-started in this patient at any time.  

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

Free text change information supplied by the pharmaceutical company

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Areloger 7.5 mg tablets
Each tablet contains 7.5 mg meloxicam.
Excipient

 

with known effect:
Each tablet contains 40.85 mg lactose (as lactose monohydrate).

 

Areloger 15 mg

 

Ttablets
Each tablet contains 15.0 mg of meloxicam.
Excipient
with known effect:
Each tablet contains 81.7 mg lactose (as lactose monohydrate).

 

For

 

thea full list of excipients, see section 6.1.

 

 

3. PHARMACEUTICAL FORM

 

Tablet

 

s.

 

7.5 mg: Pale yellow, round

 

, flat bevelled tablet with a score line on one side. Approximately 7 mm in diameter.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

 

15 mg: Pale yellow, round

 

, flat bevelled tablet with a breakscore line on one side. Approximately 10 mm in diameter.
The tablet can be divided into equal doseshalves.

 

 

4. CLINICAL PARTICULARS

 

4.1 Therapeutic Indications

Areloger is indicated in adults and adolescents over 16 years of age for:
-

 

 

Short-term symptomatic treatment of exacerbations of osteoarthrosis.
- Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

 


 

4.2. Posology and method of administration

 

Oral use

The total daily amount should be taken as a single dose, with water or another liquid, during a meal.

Posology

 

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

 


Special populations

Elderly patients and patients with increased risks for adverse reaction

s (see section 5.2):

 

The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day (see section 4.4).

Patients with rR

 

Renal impairment (see section 5.2):
In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day.

 

No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min). (For patients with non-dialysed severe renal failure, see section 4.3).

Patients with hH

 

Hepatic impairment (see section 5.2):
No dose reduction is required in patients with mild to moderate hepatic impairment (Ffor patients with severely impaired liver function, see section 4.3).

 

Paediatric population

 

Children and adolescents:
Areloger is contraindicated in children and adolescents aged under 16 years (see section 4.3).

 

This medicinal product exists in other strengths, which may be more appropriate.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Method of administration

For oral use.
The total daily amount should be taken as a single dose, with water or another liquid, during a meal.


4.3 Contraindications

Areloger is contra

 

-indicated in the following situations:
- Third trimester of pregnancy (
sSee section 4.6 ‘Fertility, pregnancy and lactation’)
- Children and adolescents aged under 16 years
- Hypersensitivity to the active substancemeloxicam or to anyone of the excipients listed in section 6.1, or hypersensitivity to substances with a similar action, e.g. NSAID’s, aspirin. Areloger should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other NSAID’s
- Severely impaired liver function
- Non-dialysed severe renal failure
- Gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders
- History of gastro
-intestinal bleeding or perforation, related to previous NSAIDs therapy
- Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Severe heart failure.

 

4.4 Special warnings and

special precautions for use

 

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below).

The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, nor should an additional NSAID be added to the therapy because this may increase the toxicity while therapeutic advantage has not been proven.

 

In the absence of improvement after several days, the clinical benefit of the treatment should be reassessed. The use of Areloger, with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

 

Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with meloxicam. Attention should routinely be paid to the possible onset of a recurrence in patients treated with Areloger and with a past history of this type.

Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain.

In the absence of improvement after several days, the clinical benefit of the treatment should be reassessed.

Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with meloxicam. Attention should routinely be paid to the possible onset of a recurrence in patients treated with meloxicam and with a past history of this type.

Gastrointestinal

eEffects

 

Caution should be advised i

 

In patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as heparin as curative treatment or given in geriatrics, oral corticosteroids, anticoagulants such as warfarin, selective serotonin -reuptake inhibitors or anti -platelet agents such as aspirin, or other non-steroidal anti-inflammatory drugs, including or acetylsalicylic acid given at anti-inflammatory doses (1g500 mg as single intake or ≥ 3 g as total daily amount), the combinations with meloxicam is not recommended (see section 4.5).

 

When GI bleeding or ulceration occurs in patients receiving Areloger, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (see section 4.8

– undesirable effects).

 

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical monitoring of blood pressure for patients at risk is recommended at baseline and especially during treatment initiation with Areloger.

Clinical trial and epidemiological data suggest that use of some NSAIDs including

 

Areloger meloxicam (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Arelogermeloxicam.

 


Skin reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Meloxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with the use of

 

mMeloxicam..

 

  • Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.
  • If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, mMeloxicam treatment should be discontinued.
  • The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.
  •  If the patient has developed SJS or TEN with the use of
  • mMeloxicam, mMeloxicam must not be re-started in this patient at any time.

     

    •  

       

     

     

    Functional renal failure

     

    NSAIDs, by inhibiting the vasodilating effect of renal prostaglandins, may induce a functional renal failure by reduction of glomerular filtration. This adverse event is dose-dependantdependent. At the beginning of the treatment, or after dose increase, careful monitoring of diuresis and renal function is recommended in patients with the following risk factors:

    - Elderly
    -
    Concomitant treatments such as ACE inhibitors, angiotensin-II antagonists, sartans, diuretics (see section 4.5)
    - Hypovolaemia (whatever the cause)
    - Congestive heart failure
    - Renal failure
    - Nephrotic syndrome
    - Lupus nephropathy
    - Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >10)

    In rare instances, NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndrome.

    The dose of meloxicam in patients with end-stage renal failure on haemodialysis should not be higher than 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (
    i.e. in patients with a creatinine clearance of greater than 25 ml/min).

     

     

     

     

     

     

    Combination with pemetrexed

     

    In patients with mild to moderate renal insufficiency receiving pemetrexed, meloxicam should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).

     

    Other warnings and precautions

    Adverse reactions are often less well tolerated in elderly, fragile or weakened individuals, who therefore require careful monitoring. As with other NSAIDs, particular caution is required in the elderly, in whom renal, hepatic and cardiac functions are frequently impaired. The elderly have an increased frequency of adverse reactionsevents to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).

     

     

    Areloger, as any other NSAID may mask symptoms of an underlying infectious disease.

     

    The use of Areloger, as with any drug known to inhibit cyclooxygenase/prostaglandin syntheses, may impair

    female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of Areloger should be considered (see section 4.6).

     

    Areloger contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

     

     

     

    4.5 Interaction with other medicinal products and other forms of interaction

     

    Interaction studies have only been performed in adults.

     

     

     

    Risks related to hyperkalaemia:

     

    Certain medicinal products or therapeutic groups may promote hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs, (low-molecular-weight or unfractionated) heparins, ciclosporin, tacrolimus and trimethoprim.

    The onset of hyperkalaemia may depend on whether there are associated factors.

    This risk is increased when the above-mentioned medicinal products are co-administered with meloxicam.

     

     

     

     

     

    Pharmacodynamic

    iInteractions:

     

     

    Other non steroidal anti-inflammatory drugs (NSAIDs) amdand acetylsalicyclic acid ≥ 3g/d:
    Combination (see section 4.4) with other non steroidal anti-inflammatory drugs, including acetylsalicylic acid given at anti-inflammatory doses (1g 500 mg as single intake or ≥ 3 g as total daily amount) is not recommended. Administration of several NSAIDs together may increase the risk of gastrointestinal ulcers and bleeding, via a synergistic effect.

     

     

     

    Corticosteroids (e.g. gGlucocorticoids):
    The concomitant use with corticosteroids requests caution because of an increased risk of bleeding or gastrointestinal ulceration.

     

     

    Anticoagulants or heparin administered in geriatrics or at curative doses:
    Considerably increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4), direct thrombin inhibitors (e.g. dabigatran) or factor Xa inhibitors (e.g. apixaban). The concomitant use of NSAIDs and anticoagulants or heparin administered in geriatrics or at curative dose is not recommended (see section 4.4).
    In remaining cases (e.g. preventative doses) of heparin use caution is necessary due to an increased bleeding risk.

     

     

     

     

    Calcineurin inhibitors (e.g

    . cyclosporin, tacrolimus):
    Nephrotoxicity of calcineurin inhibitorscyclosporin may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured. A careful monitoring of the renal function is recommended, especially in the elderly.

     

     

     

    Deferasirox:
    The concomitant administration of meloxicam with deferasirox may increase the risk of gastro-intestinal adverse reactions. Caution should be exercised when combining these medicinal products. 
    Intrauterine devices: 
    A decrease of the efficacy of intrauterine devices by NSAIDs has been previously reported but needs further confirmation.

     

     

     

     

     

    Pemetrexed:

     

     

     

    For the concomitant use of meloxicam with pemetrexed in patients with mild to moderate renal impairment (creatinine clearance from 45 to 79 ml/min), the administration of meloxicam should be paused for 5 days before, on the day of, and 2 days following pemetrexed administration. If a combination of meloxicam with pemetrexed is necessary, patients should be closely monitored, especially for myelosuppression and gastro-intestinal adverse reactions. In patients with severe renal impairment (creatinine clearance below 45 ml/min) the concomitant administration of meloxicam with pemetrexed is not recommended.

    In patients with normal renal function (creatinine clearance 80 ml/min), doses of 15 mg meloxicam may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events. Therefore, caution should be exercised when administering 15 mg meloxicam concurrently with pemetrexed to patients with normal function (creatinine clearance 80 ml/min).

     

     

     

     

    4.6

    . Fertility, pregnancy and lactation

     

     

     

    Consequently,

    meloxicamAreloger is contraindicated during the third trimester of pregnancy.

     

     

    Fertility
    The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered.

     

     

     

     

     

    4.7 Effects on ability to drive and use machines

     

     

    N

     

     

    There are no specific studies on the effect on the ability to drive and use machineries have been performedey. However, on the basis of the pharmacodynamic profile and reported adverse drug reactions, meloxicam is likely to have no or negligible influence on these abilities. However, when visual disturbances including blurred vision, dizziness,or drowsiness, vertigo or other central nervous system disturbances occur, it is advisable to refrain from driving and operating machinery.

     

     

     

     

    4.8 Undesirable effects

     

     

    a)

     

    Summary of the safety profileGeneral Description

     

     

     

     

     

    Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

    Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

    The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.

     

     

     

    Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4).

     

     

     

     

    The frequencies of adverse drug reactions given below are based on corresponding occurrences of reported adverse events in 27 clinical trials with a treatment duration of at least 14 days. The information is based on clinical trials involving 15197 patients who have been treated with daily oral doses of 7.5 or 15 mg meloxicam tablets

    (or capsules) over a period of up to one year.

     

    Adverse drug reactions that have come to light as a result of reports received in relation to administration of the marketed product are included.

    Adverse reactions have been ranked under headings of frequency using the following convention:

    Very common (

    > 1/10);
    Ccommon (> 1/100, to < 1/10);
    Uuncommon (> 1/1,000, to < 1/100);
    Rrare (> 1/10,000, to < 1/1,000);
    Vvery rare (< 1/10,000),; not known (cannot be estimated from the available data).

     

     

     

    b) Tab

     

    ulated listle of adverse reactions

     

     

     

     

    Blood and

    the lymphatic system disorders
    UncCommon: Anaemia
    RareUncommon: Blood count abnormal (including differential white cell count), leukopenia;, thrombocytopenia
    Very rare
    : cases of agranulocytosis have been reported (Ssee section c).

     

    Immune system disorders
    Uncommon: Allergic reactions other than anaphylactic or anaphylactoid reactions
    Not

    Kknown: Anaphylactic reaction, /anaphylactoid reactions

     

     

     

    Nervous system disorders
    Common:

    Hheadache
    Uncommon:
    Ddizziness, somnolence

     

    Cardiac disorders

    RareUncommon: Palpitations
    Not know: Cardiac failure has been reported in association with NSAID treatment

     

     

     

    Vascular disorders
    Uncommon: Blood pressure increased (see section 4.4), flush

    inges
    Very rare: Risk of arterial thrombotic events (for example myocardial infraction or stroke)

     

     

     

     

    Gastrointestinal disorders
    Very common:

    Gastrointestinal disorders such as Ddyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea
    Uncommon: Occult or macroscopic gastrointestinal haemorrhage
    *, stomatitis, gastritis, eructation
    Rare: Colitis, gastroduodenal ulcer, oesophagitis
    Very rare: Gastrointestinal perforation
    *

     

     

     

     

    Gastrointestinal haemorrhage, ulceration or perforation may sometimes be severe and potentially fatal, especially in elderly (see section 4.4).

     

     

     

    Skin and subcutaneous tissue disorders
    Uncommon: Angioedema , pruritus, rash
    Rare:

    Urticaria, Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome, (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4). Dermatitis bullouts, erythema multiforme, urticarial
    Very rare: Dermatitis bullous, erythema multiforme
    Not known: Photosensitivity reaction

     

     

    Renal and urinary disorders
    Uncommon: Sodium and water retention, hyperkalaemia (see section
    s 4.4 and section 4.5), renal function test abnormal (increased serum creatinine and/or serum urea)
    Very rare: Acute functional renal failure in patients with risk factors (see section 4.4)
    General disorders and administration site conditions
    UncCommon: Oedema including oedema of the lower limbs

    *Gastrointestinal haemorrhage, ulceration or perforation may sometimes be severe and potentially fatal, especially in elderly (see section 4.4).

     

     

     

     

    c)

    Information Characterising Individual Serious and/or Frequently Occurring Adverse ReactionsDescription of selected adverse reactions

     

     

     

     

    Very rare cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic drugs (see section 4.5).

     

     

     

    d) Adverse reactions which have not been observed yet in relation to the product, but which are generally accepted as being attributable to other compounds

    inof the class

     

     

     

    Organic renal injury probably resulting in acute renal failure:

     

    very rareisolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, and papillary necrosis have been reported (see section 4.4).

     

     

     

     

    Reporting of suspected adverse reactions

     

    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 FREE; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

     

     

     

    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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

     

     

     

    4.9 Overdose

     

     

     

    Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur.

    Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest.
    Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.

    Patients should be managed with symptomatic and supportive care following an NSAID overdose. Accelerated removal

    of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.

     

     

     

    5. PHARMACOLOGICAL PROPERTIES

    5.1 Pharmacodynamic properties

     

     

    Pharmacotherapeutic group:

     

    Non Steroidal Non Steroidal Anti-inflammatory drugs and antirheumatic products, non steroids, (Oxicams), ATC cCode: M01AC06.

     

    Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties.

     

     

     

    Mechanism of action

     

     

    The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, its precise mechanism of action remains unknown. However, there is at least one common mode of action shared by all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

     

     

     

     

    5.2 Pharmacokinetic properties

     

     

    Absorption

    Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of

     

    about 90 89% following oral administration (capsule). Tablets, oral suspension and capsules were shown to be bioequivalent. Page 13 of 16

     

     

     

     

    Following single dose administration of meloxicam, me

     

    dianan maximum plasma concentrations are achieved within 2 hours for the suspension and within 5-6 hours with solid oral dosage forms (capsules and tablets).

     

    With multiple dosing, steady state conditions were reached within 3 to 5 days. Once daily dosing leads to

     

    mean drug plasma concentrations with a relatively small peak-trough fluctuation in the range of 0.4-1.0 g/ml for 7.5 mg doses and 0.8 – 2.0 g/ml for 15 mg doses, respectively (Cmin and Cmax at steady state, respectively). Mean mMaximum plasma concentrations of meloxicam at steady state are achieved within five to six hours for the tablet, capsule and the oral suspension, respectively. Continuous treatment for periods of more than one year results in similar drug concentrations to those seen once steady state is first achieved. Extent of absorption for meloxicam following oral administration is not altered by concomitant food intake or the use of inorganic compoundsantacids.

     

     

     

     

    Distribution
    Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam penetrates into synovial fluid to give concentrations approximately half of those in plasma.

    Volume of distribution is low, i.e. approx. 11 L after i.m. or i.v. administration, and shows interindividual variation in the order of 7 - 20%. The volume of distribution following administration of multiple oral doses of meloxicam (7.5 to 15 mg) is about 16 L with coefficients of variation ranging from 11 to 32%.

     

     

     

     

    Volume of distribution is low, on average 11 litres. Interindividual variation is the order of 30-40%

     

     

     

    Elimination

    Meloxicam is excreted predominantly in the form of metabolites and occurs to equal extents in urine and faeces. Less than 5% of the daily dose is excreted unchanged in faeces, while only traces of the parent compound are excreted in urine.

     

     

    The mean elimination half-life varies between 13 and 25 hours after oral,

     

    i.m. and i.v. administration. Total plasma clearance amounts about 7 -12 mL/min following single doses orally, intravenously or rectally administered.

     

     

     

     

    The mean elimination half-life is about 20 hours. Total plasma clearance amounts on average 8 ml /min.

     

     

     

    Special populations

     

     

    Hepatic/renal

     

    iInsufficiency:
    Neither hepatic, nor mild tonor moderate renal insufficiency has a substantial effect on meloxicam pharmacokinetics. Subjects with moderate renal impairment had significant higher total drug clearance. A reduced protein binding is observed in patients with terminal renal failure. In terminal renal failure, the increase in the volume of distribution may result in higher free meloxicam concentrations, and a daily dose of 7.5 mg must not be exceeded (Sssee section 4.2).

     

     

     

    Elderly:

     

    Elderly male subjects exhibited similar mean pharmacokinetic parameters compared to those of young male subjects. Elderly female patients showed higher AUC-values and longer elimination half-lives compared to those of young subjects of both genders. Mean plasma clearance at steady state in elderly subjects was slightly lower than that reported for younger subjects.

     

     

     

    6. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

     

     

    Cellulose, m

     

     

    Microcrystalline Cellulose
    Pregelatinised mMaize sStarch
    Lactose
    mMonohydrate
    Maize
    sStarch
    Sodium
    cCitrate
    Silica, cColloidal aAnhydrous Silica
    Magnesium sStearate

     

     

     

     

    6.4 Special precautions for storage

     

     

    This medicinal product should be

     

     

    Sstored in the original package in order to protect from moisture.

     

     

     

     

    6.6

    Instructions Special precautions for disposal and other handling

     

     

     

     

    No special requirements.

     

    Any unused product or waste material should be disposed of in accordance with local requirements.

     

     

     

     







     

    Updated on 25 February 2016 PIL

    Reasons for updating

    • Change to, or new use for medicine
    • Change of contraindications
    • Change to instructions about overdose
    • Change to storage instructions
    • Change to side-effects
    • Change to drug interactions
    • 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
    • Change to dosage and administration
    • Addition of manufacturer

    Updated on 22 May 2015 SmPC

    Reasons for updating

    • 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 - 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 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

    Extensive list of changes. Pls refer to tracked document

    Updated on 19 May 2015 PIL

    Reasons for updating

    • Change to, or new use for medicine
    • Change to warnings or special precautions for use
    • Change to storage instructions
    • Change to side-effects
    • Change to information about pregnancy or lactation
    • Change to date of revision
    • Addition of information on reporting a side effect.

    Updated on 13 August 2010 SmPC

    Reasons for updating

    • Correction of spelling/typing errors
    • Improved electronic presentation

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

    Free text change information supplied by the pharmaceutical company

    Section 1: Name of Medicinal Product
    Areloger® 7.5 mg Tablets
    Areloger 7.5 mg Tablets

    Areloger® 15 mg Tablets
    Areloger 15 mg Tablets

    Updated on 26 November 2009 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 4.4 - 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 6.4 - Special precautions for storage
    • 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: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company


    SPC & PIL updated following approval of the renewal.
    In addition, the renewal incorporated 1) change product information being harmonised and aligned to QRD & 2) The PIL Bridging report (DK/H/814/001-002) was assessed during the renewal procedure

    Updated on 23 November 2009 PIL

    Reasons for updating

    • Change to warnings or special precautions for use
    • Change to side-effects
    • Change to drug interactions
    • Change to date of revision
    • Change to dosage and administration
    • Change due to harmonisation of PIL
    • Change due to user-testing of patient information

    Updated on 8 February 2008 PIL

    Reasons for updating

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

    Updated on 6 November 2006 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 4.4 - Special warnings and precautions for use
    • 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 5.3 - Preclinical safety data
    • Change to section 6.4 - Special precautions for storage

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

    Free text change information supplied by the pharmaceutical company

     
     
     Type II variation to update with regards to NSAIDS and use in pregnancy
     Update to sections; 2;4.2;4.3;4.4;4.5;4.6;4.8;5.3;6.4

    Updated on 25 August 2006 SmPC

    Reasons for updating

    • Improved electronic presentation

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

    Updated on 16 August 2005 SmPC

    Reasons for updating

    • New SPC for medicines.ie

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

    Updated on 28 June 2005 PIL

    Reasons for updating

    • New PIL for medicines.ie