Areloger 15 mg tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Meloxicam
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
ATC code:
M01AC; M01AC06
INN (International Name):
Meloxicam
Dosage:
15 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Oxicams; meloxicam
Authorization status:
Marketed
Authorization number:
PA0577/057/002
Authorization date:
2004-09-17

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PACKAGE LEAFLET

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Package leaflet: Information for the patient

Areloger 7.5 mg Tablets

Areloger 15 mg Tablets

meloxicam

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Areloger is and what it is used for

What you need to know before you take Areloger

How to take Areloger

Possible side effects

How to store Areloger

Contents of the pack and other information

1. What Areloger is and what it is used for

Areloger contains the active ingredient meloxicam. Meloxicam belongs to the group of non-

steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of pain and inflammation in

muscles and joints.

Areloger can be used by adults and adolescents over 16 years of age for:

the short-term treatment of flare-ups of osteoarthrosis (a disease of the joints)

the long-term treatment of pain in connection with rheumatoid arthritis (inflammation of the

joints)

the long-term treatment of a similar condition called ankylosing spondylitis (inflammation of

the spine).

2. What you need to know before you take Areloger

Do not take Areloger

during the last three months of pregnancy

if you are a child or adolescent under 16 years of age

if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in

section 6)

if you are allergic to acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory

drugs (NSAIDs)

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if you have previously had symptoms of wheezing, chest tightness, breathlessness (asthma),

swellings inside the nose causing blockages (nasal polyps), swelling around the eyes, face,

lips, mouth or throat, leading to difficulty breathing (angioneurotic oedema) or a nettle rash

known as hives (urticaria) following treatment with acetylsalicylic acid or other non-steroidal

anti-inflammatory drugs (NSAIDs)

if you currently have a bleed in the stomach or bowel

if you have or have had two or more episodes of ulcers or bleeding in the stomach or bowel

if you have ever had bleeding or tears (perforations) in the stomach or bowel after using an

NSAID

if you have, or have had a bleeding disorder or bleeding in the brain (cerebrovascular

bleeding)

if you have severe liver problems

if you have severe kidney failure and are not receiving dialysis

if you suffer from severe heart failure.

Warnings and precautions

Talk to your doctor or pharmacist before taking Areloger

if you have previously had inflammation of the food pipe (oesophagitis); inflammation of the

stomach lining (gastritis) and/or a stomach ulcer as your doctor will need to check you no

longer have these before you start treatment

if you have a history of problems with your stomach or gut (such as Crohn’s disease or

ulcerative colitis)

if you are elderly (because of increased side effects)

if you have a very low blood volume (you may have had a large loss of blood, surgery or low

fluid intake)

if you have other liver, kidney or heart problems

if you have high levels of potassium in your blood

if you are trying to become pregnant or undergoing investigations of fertility

Medicines such as Areloger may be associated with a small increased risk of heart attack

(“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged

treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems (including angina or reduced circulation), previous stroke or think that

you might be at risk of these conditions (for example if you have a high blood pressure, diabetes or

high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis)

have been reported with the use of Areloger, appearing initially as reddish target-like spots or

circular patches often with central blisters on the trunk. Additional signs to look for include ulcers

in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash

may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of

serious skin reactions is within the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of

Areloger, you must not be re-started on meloxicam at any time. If you develop a rash or these skin

symptoms, stop taking Areloger, seek urgent advice from a doctor and tell them that you are taking

this medicine.

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During treatment

Speak to your doctor immediately if you get stomach or bowel problems (particularly bleeding) in

the first few days after you start taking Areloger. This may be more likely to occur if you have had

problems with your gut in the past, or if you are elderly. Bleeding in the gut may be noticed as black

tar-like stools or if you are sick, it may contain red or dark blood particles that look like coffee

grounds (see section 4).

This medicine may affect the results of certain blood or urine tests. Always tell your doctor or

hospital staff that you are taking this medicine if you need to have tests.

This medicine may mask the symptoms of certain infections. For example, it may mask fever. If

you feel unwell and think you may have an infection talk to your doctor.

Other medicines and Areloger

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines including medicines obtained without a prescription. The following medicines can affect

or be affected by Areloger:

anticoagulants (medicines used to stop your blood clotting) such as warfarin, heparin,

clopidogrel, dabigatran, apixaban and ticlopidine as meloxicam can increase their effect or

you may be more likely to bleed

other non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin) or

medicines known as ‘COX-2 inhibitors’ such as celecoxib

lithium (a medicine used for mental health conditions)

methotrexate (a medicine used for psoriasis, inflammation and some cancers)

thrombolytics (medicines used for heart conditions to dissolve blood clots)

cholestyramine (a medicine used for reducing levels of cholesterol in the blood)

calcineurin inhibitors (medicines used to treat autoimmune diseases such as rheumatoid

arthritis or used after organ transplant) such as ciclosporin or tacrolimus

diuretics (water tablets)

medicines to treat high blood pressure called ACE inhibitors, angiotensin II antagonists

(sartans) or beta blockers

corticosteroids (for asthma, inflammation and after organ transplant surgery) as you may be

more likely to have ulcers or bleeding

selective serotonin-reuptake inhibitors, (SSRIs) (medicines used for depression)

pemetrexed, a medicine used to treat certain cancers. You may need to stop taking this

medicine for at least 5 days before, during and 2 days after receiving pemetrexed

medicines which can increase levels of potassium in the blood. This includes potassium salts

or supplements, certain water tablets (diuretics e.g. spironolactone) or the antibiotic

trimethoprim

deferasirox, a medicine used to reduce levels of iron in the body

Pregnancy, breast-feeding and fertility

Pregnancy

Do not take this medicine during the last three months of pregnancy as meloxicam may have serious

effects on the heart and kidneys of your unborn child. During labour meloxicam may also affect

contractions resulting in a delayed or longer labour or cause you to bleed for longer after the

delivery. During the first 6 months of pregnancy it is not recommended to take meloxicam.

Breast-feeding

NSAIDs can pass into breast milk. You should not breast-feed whilst taking this medicine.

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Fertility

This medicine may make it more difficult to become pregnant. Tell your doctor if you are planning

to have a baby or if you are undergoing investigation of fertility.

Driving and using machines

Areloger may cause side effects that can affect a person's ability to drive and use machinery.

Examples of side effects include visual disturbances such as blurred vision, drowsiness, dizziness, a

spinning sensation (vertigo) or other problems affecting the brain. If you suffer from any of these

side effects it is advisable to refrain from driving or using machinery.

Areloger contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicine.

3. How to take Areloger

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

Your doctor will give you the lowest possible dose, for the shortest length of time, to treat your

symptoms. If your condition does not get better or you suffer from any side effects, tell your doctor.

Your doctor should monitor your condition and treatment.

Use in adults and adolescents over 16 years of age

Flare-ups of osteoarthrosis: The recommended dose is 7.5 mg once daily. This may be increased by

your doctor to 15 mg once daily if there has been no improvement.

Treatment of pain from rheumatoid arthritis or ankylosing spondylitis: The recommended dose is

15 mg once daily.

Your doctor may reduce your dose to 7.5 mg a day if your symptoms improve.

Never exceed a dose of 15 mg a day.

Kidney & liver impairment:

In dialysis patients with severe kidney failure, the recommended dose should not exceed 7.5 mg a

day.

Patients with kidney or liver problems that are not severe can be given the normal recommended

doses for adults as stated above.

Areloger are not recommended for use for patients with severe kidney failure who are not receiving

dialysis or with severe liver failure.

Use in elderly:

If you are elderly your doctor may recommend a lower dose. The recommended dose for treatment

of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg once daily.

Use in children and adolescents:

Children and adolescents under the age of 16 years must not take Areloger.

Take Areloger orally as a single dose with water or another drink and together with a meal.

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For Areloger 7.5 mg Tablets: The score line is only there to help you break the tablet if you have

difficulty swallowing it whole.

For Areloger 15 mg Tablets: The tablet can be divided into equal doses.

If you take more Areloger than you should

Contact your doctor or your nearest hospital emergency department. Take this leaflet and any

tablets you still have with you.

You may have an allergic reaction (see section 4) or feel weak, drowsy, sick (nausea) or be sick

(vomit), have stomach pains or bleeding in your stomach or bowel. More serious effects may be

high blood pressure, kidney failure, liver problems, breathing problems, coma, fits (convulsions) or

heart problems.

If you forget to take Areloger

If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next

dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Areloger

Do not to stop taking your medicine without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and immediately contact your doctor or go to your nearest hospital

emergency department if you get the following effects:

Uncommon (may affect up to 1 in 100 people)

Skin reactions such as an itchy rash or swelling of the face, eyes, mouth, lips, tongue or throat

which may cause difficulty swallowing or breathing

Bleeding in the stomach or bowel which you may see as blood in your stools, black tar-like

stools or if you are sick, it may contain red or dark blood particles that look like coffee

grounds

Rare (may affect up to 1 in 1,000 people)

An increase in infections which you may see as fevers, severe chills, sore throat or mouth

ulcers (these may indicate you have a low number of white blood cells in your body)

Potentially life threatening skin reactions such as large areas of red, blistering or peeling skin

and bleeding of the lips, eyes, genitals or mouth (which may include Stevens-Johnson

syndrome or toxic epidermal necrolysis)

Raised, red itchy skin reaction (hives)

An ulcer in the stomach or bowel. You may notice a bloated stomach, burning pain or

tenderness in your stomach or bowel area, loss of appetite, feeling sick (nausea) with or

without being sick (vomiting). You may also notice bleeding from the stomach or bowel

Very rare (may affect up to 1 in 10,000 people)

Yellowing of your skin or whites of the eyes, dark urine, pale stools and generally feeling

unwell (these may indicate you have serious problems with your liver)

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Producing little or no urine, pain or difficulty when passing urine, cloudy or dark urine, blood

in the urine or lower back pain (these may indicate serious problems with your kidneys seen

in patients with risk factors such as low blood volume, elderly, heart, kidney or serious liver

problems)

A tear in your stomach or bowel. You may have severe pain or notice bleeding from the

stomach or bowel

A severe reduction in white blood cells in your body. You may notice an increase in

infections

An extensive measles like rash across the body

Blisters forming between the layers of skin, typically on the legs and arms, which may burst

Medicines such as meloxicam may be associated with a small increased risk of heart attack or

stroke.

If you have severe chest pain, which may move into the jaw and arm, feel sweaty or short of

breath, these may be signs of a heart attack

If you have numbness or weakness on one side of the body, notice that one side of the face is

drooped, have problems talking or blurred or loss of vision, these may be signs of a stroke

Not known (frequency cannot be estimated from the available data)

Serious allergic reactions, which may cause an itchy, raised red skin rash, swelling of the face,

eyes, mouth, lips, tongue or throat which may cause difficulty swallowing or breathing,

feeling faint or lightheaded, wheezing, collapse or loss of consciousness

Other side effects include:

Very common (may affect more than 1 in 10 people)

Indigestion

Nausea (feeling sick)

Vomiting (being sick)

Stomach pain

Constipation

Wind

Diarrhoea

Common (may affect up to 1 in 10 people)

Headache

Uncommon (may affect up to 1 in 100 people)

Looking pale with headaches, shortness of breath when exercising or feeling abnormally tired

(these may indicate you have a low number of red blood cells)

Other non-serious allergic reactions, which may cause sneezing or itchy eyes

Dizziness

A spinning sensation (vertigo)

Drowsiness

Increased blood pressure

Feeling flushed

Inflammation of the stomach or bowel

Burping

High levels of potassium or sodium in the blood

Sore mouth

Changes to your kidney or liver function as seen on a blood test

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Swelling (fluid retention) especially of the feet or ankles

Rash

Rare (may affect up to 1 in 1,000 people)

Unexplained bruising or bleeding for longer than normal (these may indicate you have a low

number of platelets in the blood)

Changes to the blood as seen in a blood test

Changes in your mood

Nightmares

Ringing in your ears

Fast heart beats that feels like thumping in your chest (palpitations)

Eyesight problems such as blurred vision or itchy, runny eyes (conjunctivitis)

Chest tightness, shortness of breath or wheezing (you may have asthma particularly if you are

allergic to other NSAIDs such as aspirin)

Heartburn which may be a sign you have inflammation of the food pipe (oesophagitis)

Swelling of the large bowel, which may cause pain, cramping and diarrhoea

Not known (frequency cannot be estimated from the available data)

Skin sensitivity to light such as sunburn more easily

Confusion

Disorientation

Pancreatitis (inflammation of the pancreas)

Other side effects seen in other non-steroidal anti-inflammatory drugs (NSAIDs) but not yet seen in

meloxicam

Heart failure

Other serious kidney problems

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Areloger

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry

date refers to the last day of that month.

Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

What Areloger contains

The active substance is meloxicam. Each tablet contains 7.5 mg or 15 mg.

The other ingredients are microcrystalline cellulose, pregelatinised maize starch, lactose

monohydrate, maize starch, sodium citrate, colloidal anhydrous silica and magnesium stearate.

What Areloger looks like and contents of the pack

For Areloger 7.5 mg Tablets: Pale yellow, flat round tablets with a score line on one side.

For Areloger 15 mg Tablets: Pale yellow, flat round tablets with a break line on one side.

PVC/PVdC/Al blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500 or 1000

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange

Road, Dublin 13

Manufacturer

Generics UK Ltd, United Kingdom

McDermott laboratories t/a Gerard Laboratories, Ireland

Chanelle Medical Ltd, Ireland

Merck Farma y Quinica S.L., Spain

This medicinal product is authorised in the Member States of the EEA under the following

names:

Greece

Meloxicam / Mylan 15 mg Δισκία

Ireland

Areloger

Portugal

Meloxicam Mylan

Spain

Meloxicam MYLAN 7,5 mg and 15 mg Comprimidos EFG

This leaflet was last revised in June 2017.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Areloger 15 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 15.0 mg of meloxicam.

Excipient with known effect

Each tablet contains 81.7 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Pale yellow, round, flat bevelled tablet with a break line on one side. Approximately 10 mm in diameter.

The tablet can be divided into equal doses.

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

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.

Exacerbations of osteoarthrosis: 7.5 mg/day (one tablet of 7.5 mg or half a 15 mg tablet).

If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two tablets of 7.5 mg or 1 tablet of 15

mg).

Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two tablets of 7.5 mg or 1 tablet of 15 mg) (see also “Special

populations”).

According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one tablet of 7.5 mg or half a 15 mg tablet).

DO NOT EXCEED THE DOSE OF 15 mg/day.

Special populations

Elderly patients and patients with increased risks for adverse reactions (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).

Renal impairment (see section 5.2):

In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day.

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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).

Hepatic impairment (see section 5.2):

No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severely impaired liver

function, see section 4.3).

Paediatric population:

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.

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 contraindicated in the following situations:

- Third trimester of pregnancy(see section 4.6)

- Children and adolescents aged under 16 years

- Hypersensitivity to the active substance or to any 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 gastrointestinal 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 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. The use of Areloger, with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

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 effects

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with

or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer,

particularly if complicated with haemorrhage or perforations (see section 4.3), and in the elderly. These patients should

commence treatment on the lowest dose available.

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Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these

patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see

below and section 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI

bleeding) particularly in the initial stages of treatment.

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, other non-steroidal anti-inflammatory drugs, or acetylsalicylic acid given at

doses ≥ 500 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).

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 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 meloxicam.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial

disease, and/or cerebrovascular disease should only be treated with meloxicam after careful consideration. Similar

consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease

(e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

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 meloxicam.

- 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, meloxicam

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 meloxicam, meloxicam must not be re-started in this patient at any

time.

Parameters of liver and renal function

As with most NSAIDs, occasional increases in serum transaminase levels, increases in serum bilirubin or other liver function

parameters, as well as increases in serum creatinine and blood urea nitrogen and other laboratory disturbances, have been

reported. The majority of these instances involved transitory and slight abnormalities. Should any such abnormality prove

significant or persistent, the administration of Areloger should be stopped and appropriate investigations undertaken.

Functional renal failure

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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-dependent.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).

Sodium, potassium and water retention

Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics may occur with

NSAIDs. Furthermore, a decrease of the antihypertensive effect of antihypertensive drugs can occur (see section 4.5).

Consequently, oedema, cardiac failure or hypertension may be precipitated or exacerbated in susceptible patients as a result.

Clinical monitoring is therefore necessary for patients at risk (see sections 4.2 and 4.3).

Hyperkalaemia

Hyperkalaemia can be favoured by diabetes or concomitant treatment known to increase kalaemia (see section 4.5). Regular

monitoring of potassium values should be performed in such cases.

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 reactions 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 drugknown 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 interactions

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.

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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 interactions:

Other non steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid:

Combination (see section 4.4) with other non steroidal anti-inflammatory drugs, including acetylsalicylic acid ≥ 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. glucocorticoids):

The concomitant use with corticosteroids requests caution because of an increased risk of bleeding or gastrointestinal

ulceration.

Anticoagulants or heparin:

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.

Careful monitoring of the INR is required if it proves impossible to avoid such combination.

Thrombolytics and antiplatelet drugs:

Increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal mucosa.

Selective serotonin reuptake inhibitors (SSRIs):

Increased risk of gastrointestinal bleeding.

Diuretics, ACE inhibitors and angiotensin-II antagonists:

NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function

(e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or

angiotensin-II receptor antagonists and agents that inhibit cyclooxygenase may result in further deterioration of renal function,

including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with

caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of

renal function after initiation of concomitant therapy, and periodically thereafter (see also section 4.4).

Other antihypertensive drugs(e.g. beta-blockers):

As for the latter, a decrease of the antihypertensive effect of beta-blockers (due to inhibition of prostaglandins with

vasodilatory effect) can occur.

Calcineurin inhibitors (e.g. ciclosporin, 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.

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.

Pharmacokinetic interactions (effect of meloxicam on the pharmacokinetics of other drugs):

Lithium:

NSAIDs have been reported to increase blood lithium levels (via decreased renal excretion of lithium), which may reach toxic

values. The concomitant use of lithium and NSAIDs is not recommended (see section 4.4). If this combination appears

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necessary, lithium plasma concentrations should be monitored carefully during the initiation, adjustment and withdrawal of

Areloger treatment.

Methotrexate:

NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate. For

this reason, for patients on high dosages of methotrexate (more than 15 mg/week) the concomitant use of NSAIDs is not

recommended (see section 4.4).

The risk of an interaction between NSAID preparations and methotrexate, should be considered also in patients on low dosage

of methotrexate, especially in patients with impaired renal function. In case combination treatment is necessary blood cell

count and the renal function should be monitored. Caution should be taken in case both NSAID and methotrexate are given

within 3 days, in which case the plasma level of methotrexate may increase and cause increased toxicity.

Although the pharmacokinetics of methotrexate (15 mg/week) were not relevantly affected by concomitant meloxicam

treatment, it should be considered that the haematological toxicity of methotrexate can be amplified by treatment with NSAID

drugs (see above) (see section 4.8).

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).

Pharmacokinetic interactions (effect of other drugs on the pharmacokinetics of Areloger):

Cholestyramine:

Cholestyramine accelerates the elimination of meloxicam by interrupting the enterohepatic circulation so that clearance for

meloxicam increases by 50% and the half-life decreases to 13±3 hrs. This interaction is of clinical significance.

No clinically relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant administration of

antacids, cimetidine and digoxin.

4.6 Fertility, pregnancy and lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from

epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a

prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less

than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals,

administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and

embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been

reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, meloxicam should not be given unless clearly necessary. If meloxicam is

used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as

low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

The mother and the neonate, at the end of pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

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- inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, meloxicamis contraindicated during the third trimester of pregnancy.

Breast-feeding

While no specific experience exists for meloxicam, NSAIDs are known to pass into mother’s milk. Administration therefore is

not recommended in women who are breastfeeding.

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

No specific studies on the effect on the ability to drive and use machineries have been performed. 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, 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 profile

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); 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).

b) Tabulated list of adverse reactions

Blood and lymphatic system disorders

Uncommon: Anaemia

Rare: Blood count abnormal (including differential white cell count), leukopenia, thrombocytopenia

Very rare: cases of agranulocytosis have been reported (see section c).

Immune system disorders

Uncommon: Allergic reactions other than anaphylactic or anaphylactoid reactions

Not known: Anaphylactic reaction, anaphylactoid reactions

Psychiatric disorders

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Rare: Mood altered, nightmares

Not known: Confusional state, disorientation

Nervous system disorders

Common: Headache

Uncommon: Dizziness, somnolence

Eye disorders

Rare: Visual disturbance including blurred vision; conjunctivitis

Ear and labyrinth disorders

Uncommon: Vertigo

Rare: Tinnitus

Cardiac disorders

Rare: Palpitations

Not known: Cardiac failure has been reported in association with NSAID treatment

Vascular disorders

Uncommon: Blood pressure increased (see section 4.4), flushing

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

Respiratory, thoracic and mediastinal disorders

Rare: Asthma in individuals allergic to aspirin or other NSAIDs

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

Hepatobiliary disorders

Uncommon: Liver function disorder (e.g. raised transaminases or bilirubin)

Very rare: Hepatitis

Skin and subcutaneous tissue disorders

Uncommon: Angioedema, pruritus, rash

Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Very rare: Dermatitis bullous, erythema multiforme

Not known: Photosensitivity reaction

Renal and urinary disorders

Uncommon: Sodium and water retention, hyperkalaemia (see sections 4.4 and 4.5), renal function test abnormal (increased

serum creatinine and/or serum urea)

Very rare: Acute functionalrenal failure in patients with risk factors (see section 4.4)

General disorders and administration site conditions

Uncommon: 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) Description 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).

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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 in the class

Organic renal injury probably resulting in acute renal failure: very rare 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 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.

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 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 Anti-inflammatory drugs and antirheumatic products, non steroids, Oxicams, ATC

code: 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%

following oral administration (capsule). Tablets, oral suspension and capsules were shown to be bioequivalent.

Following single dose administration of meloxicam, median 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 microgram/ml for 7.5 mg doses and 0.8 –

2.0 microgram/ml for 15 mg doses, respectively (C

and C

at steady state, respectively). Mean maximum 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 antacids.

Distribution

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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%.

Biotransformation

Meloxicam undergoes extensive hepatic biotransformation. Four different metabolites of meloxicam were identified in urine,

which are all pharmacodynamically inactive. The major metabolite, 5’-carboxymeloxicam (60% of dose), is formed by oxidation

of an intermediate metabolite 5’-hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of dose). In

vitrostudies suggest that CYP 2C9 plays an important role in this metabolic pathway, with a minor contribution from the CYP

3A4 isoenzyme. The patient’s peroxidase activity is probably responsible for the other two metabolites, which account for 16%

and 4% of the administered dose respectively.

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.

Linearity/non-linearity

Meloxicam demonstrates linear pharmacokinetics in the therapeutic dose range of 7.5 mg and 15 mg following per oral or

intramuscular administration.

Special populations

Hepatic/renal insufficiency:

Neither hepatic, nor mild 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 (see 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.

5.3 Preclinical safety data

The toxicological profile of meloxicam has been found in preclinical studies to be identical to that of NSAIDs: gastrointestinal

ulcers and erosions, renal papillary necrosis at high doses during chronic administration in two animal species.

Oral reproductive studies in the rat have shown a decrease of ovulations and inhibition of implantations and embryotoxic

effects (increase of resorptions) at maternotoxic dose levels at 1 mg/kg and higher. Studies of toxicity on reproduction in rats

and rabbits did not reveal teratogenicity up to oral doses of 4 mg/kg in rats and 80 mg/kg in rabbits.

The affected dose levels exceeded the clinical dose (7.5 – 15 mg) by a factor of 10 to 5-fold on a mg/kg dose basis (75 kg

person). Fetotoxic effects at the end of gestation, shared by all prostaglandin synthesis inhibitors, have been described. No

evidence has been found of any mutagenic effect, either in vitro or in vivo. No carcinogenic risk has been found in the rat and

mouse at doses far higher than those used clinically.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cellulose, microcrystalline

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Pregelatinised maizestarch

Lactose monohydrate

Maize starch

Sodium citrate

Silica, colloidal anhydrous

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store in the original package.

6.5 Nature and contents of container

Blisters of PVC/PVdC and hard tempered aluminium foil.

Cartons of 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, or 1000 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0577/057/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17

September 2004

Date of latest renewal: 10

October 2008

10 DATE OF REVISION OF THE TEXT

October 2017

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