Meloxicam Zentiva: detailed information

Meloxicam Zentiva

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

MELOXICAM ZENTIVA 15 mg tablets

Generic medicine
Please read this leaflet carefully before using this medicine
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Meloxicam Zentiva is and what it is used for
What you need to know before taking Meloxicam Zentiva
How to take Meloxicam Zentiva
Possible side effects
How to store Meloxicam Zentiva
Package contents and other information

1. What Meloxicam Zentiva is and what it is used for

Meloxicam Zentiva contains the active substance meloxicam.
Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.
Meloxicam Zentiva is indicated for:

short-term treatment of exacerbations of osteoarthritis
long-term treatment of:
- rheumatoid arthritis
- ankylosing spondylitis (also known as Bechterew's disease).

Meloxicam Zentiva

2. What you need to know before taking Meloxicam Zentiva

Do not take Meloxicam Zentiva:

if you are allergic to meloxicam or to any of the other ingredients of this medicine (listed in section 6);
during the last three months of pregnancy;
in children and adolescents under 16 years of age;
if you have an allergy (hypersensitivity) to aspirin or other anti-inflammatory medicines (NSAIDs);
if you have previously experienced any of the following symptoms after taking aspirin or other NSAIDs:
- wheezing, tightness in the chest, shortness of breath (asthma);
- nasal congestion due to swelling of the nasal mucosa (nasal polyps);
- skin rash/urticaria;
- sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema).
if you have previously had NSAID therapy associated with gastrointestinal bleeding;
perforation of the stomach or intestine;
ulcer or bleeding in the stomach or intestine;
recent history of peptic ulcer or gastrointestinal bleeding (ulceration or bleeding occurring at least twice);
severe liver disease;
severe kidney disease not treated with dialysis;
recent brain bleeding (cerebrovascular haemorrhage);
any condition related to bleeding;
severe heart disease. If you think any of the above conditions apply to you, contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Meloxicam Zentiva.
Warnings
Medicines such as Meloxicam Zentiva may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose. Do not take Meloxicam Zentiva for longer than prescribed (see section 3 “How to take Meloxicam Zentiva”).
If you have heart problems, a history of stroke, or think you may be at risk for these conditions, discuss your treatment with your doctor or pharmacist. For example, if:

you have high blood pressure (hypertension);
you have high blood sugar levels (diabetes mellitus);
you have high cholesterol levels in the blood (hypercholesterolemia);
you are a smoker.

Meloxicam Zentiva
Stop treatment with Meloxicam Zentiva immediately if you experience any gastrointestinal bleeding (which may cause black, tarry stools) or ulceration of the digestive tract (which may cause abdominal pain).
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Zentiva. These initially appear as red, target-like spots or circular patches, often with central blisters, typically on the trunk.
Additional signs include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes).
These potentially life-threatening skin reactions are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin.
The highest risk of severe skin reactions occurs within the first few weeks of treatment.
If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Meloxicam Zentiva, you must not use this medicine again.
If you develop a skin rash or these skin symptoms, stop taking Meloxicam Zentiva immediately, contact your doctor urgently, and inform them that you are taking this medicine.
Meloxicam Zentiva is not indicated when immediate relief from acute pain is required.
Meloxicam Zentiva may mask symptoms (e.g. fever) of an ongoing infection. If you suspect you have an infection, consult your doctor.
Precautions for use
Because dosage adjustments may be necessary, it is important to consult your doctor before taking Meloxicam Zentiva if you have:

a history of inflammation of the oesophagus (oesophagitis), inflammation of the stomach (gastritis), or any other gastrointestinal disorder, such as Crohn’s disease or ulcerative colitis;
high blood pressure (hypertension);
advanced age;
heart, liver, or kidney disease;
high blood sugar levels (diabetes mellitus);
reduced blood volume (hypovolemia), which may occur following severe blood loss, burns, surgery, or inadequate fluid intake;
previously diagnosed high potassium levels in the blood. Your doctor may need to monitor your condition during treatment.

Other medicines and Meloxicam Zentiva
Since Meloxicam Zentiva may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking, have taken, or are using any of the following medicines:

Meloxicam Zentiva

other NSAIDs;
medicines that prevent blood clotting;
medicines that break down blood clots (thrombolytics);
medicines used to treat heart and kidney diseases;
corticosteroids (e.g. used for inflammation or allergic reactions);
cyclosporine – used after organ transplants, or for severe skin disorders, rheumatoid arthritis, or nephrotic syndrome;
any diuretics (water tablets). Your doctor may monitor your kidney function if you are taking diuretics.
medicines for high blood pressure (e.g. beta-blockers);
lithium – used to treat mood disorders;
selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
methotrexate – used to treat cancer, severe uncontrolled skin disorders, or active rheumatoid arthritis;
colestyramine – used to lower cholesterol levels;
if you are a woman using an intrauterine contraceptive device (IUD), commonly known as a coil.

Meloxicam Zentiva with food and drink
Absorption is not affected by taking the medicine with food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor may prescribe this medicine during the first six months of pregnancy if necessary.
During the last three months of pregnancy, do not use this medicine, as Meloxicam Zentiva may cause serious effects on the unborn baby, particularly on the heart, lungs, and kidneys, even after a single dose.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
Meloxicam Zentiva may make it more difficult to become pregnant.
Driving and using machines
Visual disturbances, including blurred vision, dizziness, somnolence, vertigo, or other central nervous system disorders may occur while taking this medicine. If you experience such effects, do not drive or operate machinery.
Meloxicam Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Meloxicam Zentiva

3. How to take Meloxicam Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Exacerbations of osteoarthritis
7.5 mg (half a Meloxicam Zentiva tablet) once daily. The dose may be
increased to 15 mg (one Meloxicam Zentiva tablet) once daily.
Rheumatoid arthritis
15 mg (one Meloxicam Zentiva tablet) once daily. The dose may be reduced to 7.5
mg (half a Meloxicam Zentiva tablet) once daily.
Ankylosing spondylitis
15 mg (one Meloxicam Zentiva tablet) once daily. The dose may be reduced to
7.5 mg (half a Meloxicam Zentiva tablet) once daily.
The tablets should be swallowed with water or another liquid during a meal.
The 15 mg Meloxicam Zentiva tablet may be divided into two equal doses.
Do not exceed the maximum recommended daily dose of 15 mg.
If any of the conditions listed in the section "Warnings and precautions" apply to you, your doctor may reduce your dose to 7.5 mg (half a Meloxicam Zentiva tablet) once daily.
Use in children and adolescents
Meloxicam Zentiva must not be administered to children and adolescents under 16 years of age.
Contact your doctor or pharmacist if you feel that the effect of Meloxicam Zentiva is too strong or too weak, or if you do not experience any improvement after several days.
If you take more Meloxicam Zentiva than you should
If you have taken too many tablets or suspect an overdose, contact your doctor or go immediately to the nearest hospital. Symptoms of acute NSAID overdose usually include:

lack of energy (lethargy);
drowsiness;
feeling unwell (nausea) and illness (vomiting);
stomach pain (epigastric pain); these symptoms are generally reversible by stopping the intake of Meloxicam Zentiva. You may experience gastrointestinal bleeding (gastrointestinal haemorrhage);
a severe overdose may lead to serious adverse drug reactions (see section 4):

Meloxicam Zentiva

high blood pressure (hypertension);
acute renal failure;
liver dysfunction (hepatic);
reduced/flat or stopped breathing (respiratory depression);
loss of consciousness (coma);
seizures;
circulatory collapse (cardiovascular collapse);
cardiac arrest (arrest cardiaco);
immediate allergic reactions (hypersensitivity), including:
fainting;
shortness of breath;
skin reactions.

If you forget to take Meloxicam Zentiva
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you have any questions about how to use 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 Meloxicam Zentiva and contact your doctor or the nearest hospital immediately if you notice:
Any allergic reaction (hypersensitivity), which may manifest as:

skin reactions such as itching, blistering or peeling, which may be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue lesions (mucosal lesions) or erythema multiforme (see section 2);
erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters or blistered areas. It may also affect the mouth, eyes and other moist areas of the body surface;
swelling of the skin or mucosa, such as swelling around the eyes, face and lips, mouth or throat, which may make breathing difficult, swollen ankles or legs (lower limb oedema);
shortness of breath or asthma attack;
inflammation of the liver (hepatitis). This may cause symptoms such as:
yellowing of the skin and eyes (jaundice);
abdominal pain;
loss of appetite.

Any side effect affecting the digestive tract, especially:

bleeding (causing tar-coloured stools);
ulceration of the digestive tract (causing abdominal pain);

Meloxicam Zentiva

gastrointestinal bleeding, formation of ulcers or perforations in the digestive tract may occasionally be severe and potentially fatal, particularly in elderly patients.

If you have previously experienced digestive symptoms due to long-term use of NSAIDs, inform your doctor immediately, especially if you are elderly. Your doctor may monitor your progress during treatment.
If you experience visual disturbances, do not drive or operate machinery.
General side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs)
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial blockage (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and with long-term treatment.
Fluid retention (oedema), high blood pressure (hypertension) and heart failure (cardiac failure) have been reported in association with NSAID treatment.
The most commonly observed side effects are gastrointestinal (gastrointestinal events):

ulcers of the stomach and upper part of the small intestine (peptic/gastroduodenal ulcers);
a perforation in the intestinal wall or bleeding in the digestive tract (sometimes fatal, especially in the elderly).

The following side effects have been reported after administration of NSAIDs:

feeling unwell (nausea) and being unwell (vomiting);
loose stools (diarrhoea);
flatulence;
constipation;
indigestion (dyspepsia);
abdominal pain;
tar-coloured stools due to bleeding in the digestive tract (melena);
vomiting blood (haematemesis);
inflammation with ulcer formation in the mouth (ulcerative stomatitis);
worsening of digestive tract inflammation (such as exacerbation of colitis or Crohn's disease). Less frequently observed is inflammation of the stomach (gastritis).

Meloxicam Zentiva
Side effects associated with meloxicam – the active substance in Meloxicam Zentiva:
Very common (may affect more than 1 in 10 people)

gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and being unwell (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhoea).

Common (may affect up to 1 in 10 people)

headache.

Uncommon (may affect up to 1 in 100 people)

dizziness (confusion of the mind);
sensation of spinning or dizziness (vertigo);
drowsiness (lethargy);
anaemia (reduction in haemoglobin concentration, the pigment in red blood cells);
increased blood pressure (hypertension);
flush (temporary redness of the face and neck);
sodium and water retention;
increased potassium levels (hyperkalaemia), which may lead to symptoms such as: changes in heart rhythm (arrhythmia); palpitations (when the heartbeat is felt more than usual); muscle weakness;
eructation;
inflammation of the stomach (gastritis);
gastrointestinal bleeding;
inflammation of the mouth (stomatitis);
immediate allergic reactions (hypersensitivity);
itching;
skin rash;
swelling due to fluid retention (oedema), including swelling of the ankles/legs (lower limb oedema);
sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema);
transient alteration of liver function tests (e.g. increase in liver enzymes such as transaminases or an increase in bilirubin, a bile pigment). Your doctor can check this with a blood test;
alteration of kidney function tests (e.g. increase in creatinine or urea).

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

mood swings;
nightmares;
altered blood cell count, including:
altered differential blood cell count; reduced number of white blood cells (leucopenia);

Meloxicam Zentiva
reduced number of platelets (thrombocytopenia). These side effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.

ringing in the ears (tinnitus);
sensation of feeling the heartbeat (palpitations);
ulcers of the stomach or upper part of the small intestine (peptic/gastroduodenal ulcer);
inflammation of the oesophagus (oesophagitis);
onset of asthma attacks (observed in people who are allergic to aspirin or other NSAIDs);
severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis);
urticaria;
visual disturbances including:
blurred vision;
conjunctivitis (inflammation of the eyes or eyelids);
inflammation of the large intestine (colitis).

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

blistering of the skin (bullous reactions) and erythema multiforme. Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters or blistered areas. It may also affect the mouth, eyes and other moist areas of the body surface;
inflammation of the liver (hepatitis), which may cause symptoms such as: yellowing of the skin or eyes (jaundice); abdominal pain; loss of appetite;
acute kidney failure (renal failure), particularly in patients with risk factors such as heart disease, diabetes or kidney disease;
perforation in the intestinal wall.

Frequency not known (frequency cannot be estimated from the available data)

confusion;
disorientation;
shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions), skin rash caused by exposure to sunlight (photosensitivity reactions);
heart failure (cardiac failure) has been reported in association with NSAID treatment;
complete loss of a specific type of white blood cells (agranulocytosis), particularly in patients taking Meloxicam Zentiva in combination with other medicines that are potentially inhibitory, suppressive or destructive to a component of the bone marrow (myelotoxic medicines). This may cause: sudden fever; sore throat; infections;
inflammation of the pancreas (pancreatitis).

Meloxicam Zentiva
Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet observed after taking Meloxicam Zentiva:

changes in kidney structure leading to kidney failure: very rare cases of kidney inflammation (interstitial nephritis), death of some cells within the kidney (acute tubular or papillary necrosis); protein in the urine (nephrotic syndrome with proteinuria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meloxicam Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any defects or if the tablets are broken or chipped; return them to your pharmacist for advice before taking.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meloxicam Zentiva contains
Each tablet contains 15 mg of meloxicam as the active substance.
Each tablet also contains sodium citrate, lactose monohydrate, microcrystalline cellulose,
crospovidone, anhydrous colloidal silica and magnesium stearate.
Description of the appearance of Meloxicam Zentiva and pack contents
Meloxicam Zentiva 15 mg tablets are light yellow, round, biconvex, with bevelled edges, marked with the characters “B” and “19” on either side of the breakline on one side, and the reverse side smooth.
Pack sizes:
Meloxicam Zentiva 15 mg tablets are available in blisters in pack sizes of 1, 2, 7, 10,
14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, 1,000 tablets.
Marketing Authorisation Holder:
Zentiva Italia S.r.l., Viale Bodio 37/B - 20158 Milano
Meloxicam Zentiva
Manufacturers:
Sanofi-Aventis Sp. Z.o.o., ul. Lubelska 52, 35-233 Rzeszow (Poland)
Zentiva k.s., U. Kabelovny 130, 102 37 Praha – Dolni Mecholupy (Czech Republic)
This medicinal product is authorised in the European Economic Area Member States under the
following names:
FR Meloxicam Zentiva 7.5 mg, tablets
Meloxicam Zentiva 15 mg, scored tablets
IT MELOXICAM ZENTIVA