MELOXICAM 15 mg Tablets

Зміст інструкції

1. MELOXICAM ZENTIVA 15 mg tablets
   1. What is Meloxicam Zentiva and what is it used for
   2. What you need to know before taking Meloxicam Zentiva
   3. How to take Meloxicam Zentiva
   4. Possible side effects
   5. How to store Meloxicam Zentiva
   6. Package contents and other information

Meloxicam Zentiva

MELOXICAM ZENTIVA 15 mg tablets

Generic medicine

Read this leaflet carefully before you start using this medicineas 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Meloxicam Zentiva is and what it is used for
• 2. What you need to know before you take Meloxicam Zentiva
• 3. How to take Meloxicam Zentiva
• 4. Possible side effects
• 5. How to store Meloxicam Zentiva
• 6. Contents of the pack and other information

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

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

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

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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;
• children and adolescents under the age of 16 years;
• allergy (hypersensitivity) to aspirin or other anti-inflammatory medicines (NSAIDs);
• if you have experienced any of the following signs after taking aspirin or other NSAIDs:
• wheezing, chest tightness, shortness of breath (asthma);
• nasal obstruction due to swelling of the nasal mucosa (nasal polyps);
• skin rash/urticaria;
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat that can make breathing difficult (angioedema).
• after a previous therapy with NSAIDs and a history of bleeding in the stomach or intestines;
• perforations in the stomach or intestines;
• ulcer or bleeding in the stomach or intestines;
• recent history of peptic ulcer or bleeding in the stomach (ulceration or bleeding that has occurred at least twice);
• severe liver disease;
• severe kidney disease not treated with dialysis;
• recent bleeding in the brain (cerebrovascular hemorrhage);
• any bleeding disorder;
• severe heart disease. If you think any of these apply to you, contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Meloxicam Zentiva.
Warnings
Medicines like Meloxicam Zentiva may be associated with a modest increase in the risk of
heart attack (myocardial infarction) or stroke (apoplexy). Any risk is more likely with high
doses and prolonged treatments. 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,
you should discuss your therapy 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.

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Stop taking Meloxicam Zentiva immediately as soon as you experience
bleeding (causing tarry stools) or ulceration of the digestive tract (causing abdominal pain).
Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Zentiva, they initially manifest as reddish spots similar to targets or circular spots often with central blisters
on the trunk.
Additional signs include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and
swollen eyes).
These life-threatening skin reactions are often accompanied by
flu-like symptoms.
The rash may progress with the formation of widespread blisters or peeling of the
skin.
The highest risk of developing severe skin reactions occurs within the first weeks of
treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of
Meloxicam Zentiva, you should no longer reuse Meloxicam Zentiva.
If you develop a rash or these skin symptoms, stop using Meloxicam Zentiva,
urgently contact your doctor and tell them that you are taking this medicine.
Meloxicam Zentiva is not indicated when immediate relief from acute pain is required.
Meloxicam Zentiva may mask the symptoms (e.g. fever) of an ongoing infection. If you think you have
contracted an infection, consult your doctor.

Precautions for use
Because the treatment may need to be adjusted, it is important that you ask your doctor
before taking Meloxicam Zentiva in case of:

• a history of inflammation of the esophagus (esophagitis), inflammation of the stomach (gastritis) or a history of any other disease of the digestive tract, e.g. 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 can occur in case of severe blood loss or a burn, surgery or poor fluid intake;
• high levels of potassium in the blood, previously diagnosed by the doctor. The doctor will need to monitor your progress during treatment.

Other medicines and Meloxicam Zentiva
Because Meloxicam Zentiva can affect or be affected by other medicines, tell your
doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist if you are taking/ have taken, or are using any
of the following medicines:
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• other NSAIDs;
• medicines that prevent blood clotting;
• medicines that break up blood clots (thrombolytics);
• medicines for the treatment of heart and kidney diseases;
• corticosteroids (e.g. used against inflammation or allergic reactions);
• cyclosporine - used after organ transplants, or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome;
• any diuretic (water tablets). The doctor may monitor your kidney function if you are taking diuretics.
• medicines for the treatment of 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 tumors or severe uncontrolled skin diseases and active rheumatoid arthritis;
• cholestyramine - used to lower cholesterol levels;
• if you are a woman using an intrauterine device (IUD), commonly known as a coil.

Meloxicam Zentiva with food and drink
Absorption is not affected by the concomitant intake of food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If necessary during the first six months of pregnancy, your doctor may prescribe this medicine.
During the last three months of pregnancy, do not use this medicine, because Meloxicam Zentiva
can have serious effects on the baby, especially on the cardiopulmonary and renal systems, even after
a single administration.

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, drowsiness, vertigo or other disturbances of the
central nervous system may occur when taking this medicine. If you experience
such effects, do not drive vehicles or use machinery.

Meloxicam Zentiva contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.
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3. How to take Meloxicam Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:

Flare-ups of osteoarthritis
7.5 mg (half a tablet of Meloxicam Zentiva) once a day. The dose may be
increased to 15 mg (one tablet of Meloxicam Zentiva) once a day.

Rheumatoid arthritis
15 mg (one tablet of Meloxicam Zentiva) once a day. The dose may be reduced to 7.5
mg (half a tablet of Meloxicam Zentiva) once a day.

Ankylosing spondylitis
15 mg (one tablet of Meloxicam Zentiva) once a day. The dose may be reduced to
7.5 mg (half a tablet of Meloxicam Zentiva) once a day.
The tablets should be swallowed with water, or other liquid, during a meal.
The 15 mg tablet of Meloxicam Zentiva can be divided into two equal doses.

Do not exceedthe maximum recommended dose of 15 mg per day.
If any of the conditions listed in the “Warnings and precautions” section applies to
your case, your doctor may reduce your dose to 7.5 mg (half a tablet of Meloxicam Zentiva) once
a day.

Use in children and adolescents
Meloxicam Zentiva should not be given 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 after several days you do not feel any improvement.

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. The symptoms of acute NSAID overdose usually are
limited to:

• lack of energy (lethargy);
• drowsiness;
• feeling unwell (nausea) and state of illness (vomiting);
• pain in the stomach area (epigastric pain), these symptoms are generally reversible by stopping the intake of Meloxicam Zentiva. You may experience bleeding from the stomach or intestines (gastrointestinal bleeding);
• a severe overdose can induce serious adverse drug reactions (see section 4);

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Meloxicam Zentiva

• high blood pressure (hypertension);
• acute kidney failure;
• liver (hepatic) dysfunction;
• reduction/flattening or cessation of breathing (respiratory depression);
• loss of consciousness (coma);
• convulsions;
• collapse of blood circulation (cardiovascular collapse);
• heart arrest (cardiac arrest);
• 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 a missed dose. Take the next dose
at the usual time.
If you have any questions about using 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 immediately consult a doctor or the nearest hospital if you notice:
Anyallergic reaction (hypersensitivity), which may manifest in the form of:

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

Anyadverse effect of the digestive tract, especially:

• bleeding (causing tarry stools);
• ulceration of the digestive tract (causing abdominal pain);

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Meloxicam Zentiva

• gastrointestinal bleeding, the formation of ulcers or perforations in the digestive tract can sometimes be serious and potentially fatal, especially in elderly patients.

If you have previously suffered from symptoms of the digestive tract due to long-term use of
NSAIDs, inform your doctor immediately, especially if you are elderly. The doctor may monitor the
improvement during treatment.
If you experience vision disturbances, do not drive vehicles or use 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 blockage of the arteries (thrombotic arterial events), e.g. heart attack (myocardial
infarction) or stroke (apoplexy), particularly at high doses and for long periods of treatment.
Fluid retention (edema), high blood pressure (hypertension) and heart failure (cardiac insufficiency) have been reported in association with treatment with NSAIDs.
The most commonly observed side effects affect the digestive tract (gastrointestinal events):

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

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

• feeling unwell (nausea) and general malaise (vomiting);
• loose stools (diarrhea);
• flatulence;
• constipation;
• indigestion (dyspepsia);
• abdominal pain;
• tarry stools due to bleeding in the digestive tract (melena);
• vomiting blood (hematemesis);
• inflammation with ulceration in the mouth (ulcerative stomatitis);
• worsening of inflammation of the digestive tract (such as exacerbation of colitis or Crohn's disease). Less frequently, inflammation of the stomach (gastritis) has been observed.

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

• gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and general malaise (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhea).

Common (may affect up to 1 in 10 people)

• headache.

Uncommon (may affect up to 1 in 100 people)

• dizziness (mental confusion);
• feeling of spinning or whirling (vertigo);
• drowsiness (torpor);
• anemia (reduction in hemoglobin concentration, the pigment of red blood cells);
• increased blood pressure (hypertension);
• hot flush (temporary redness of the face and neck);
• sodium and water retention;
• increased potassium levels (hyperkalemia), which can lead to symptoms such as: changes in heartbeat (arrhythmia); palpitations (when the heartbeat is felt more than usual); muscle weakness.
• belching;
• inflammation of the stomach (gastritis);
• bleeding from the digestive tract;
• inflammation of the mouth (stomatitis);
• immediate allergic reactions (hypersensitivity);
• itching;
• skin rash;
• swelling caused by fluid retention (edema), including swelling of the ankles/legs (edema of the lower limbs);
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat which can make breathing difficult (angioedema);
• temporary changes in liver function tests (e.g. increased liver enzymes such as transaminases or an increase in bilirubin, bile pigment). The doctor can check this by means of a blood test;
• changes in kidney function tests (e.g. increased 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 (leukopenia);

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

• ringing in the ears (tinnitus);
• feeling of heartbeat (palpitations);
• ulcers of the stomach or the upper part of the small intestine (peptic/gastroduodenal ulcer);
• inflammation of the esophagus (esophagitis);
• onset of asthma attacks (found 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 severe allergic skin reaction that causes spots, red blisters or purplish or blistering areas. It can also affect the mouth, eyes and other moist areas of the body surface;
• inflammation of the liver (hepatitis), which can cause symptoms such as: yellowing of the skin or eyes (jaundice); abdominal pain; loss of appetite.
• acute kidney failure (renal insufficiency) particularly in patients with risk factors such as heart disease, diabetes or kidney disease;
• perforation in the wall of the intestine.

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

• state of confusion;
• sense of disorientation;
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions), skin rash caused by exposure to sunlight (photosensitivity reactions);
• heart failure (cardiac insufficiency) has been reported associated with treatment with NSAIDs;
• total loss of a specific type of white blood cells (agranulocytosis), especially in patients taking Meloxicam Zentiva in combination with other medicines that are potentially inhibitors, suppressors or destructive of a component of the bone marrow (myelotoxic medicines). This can cause: sudden fever; sore throat; infections.
• inflammation of the pancreas (pancreatitis). Pag. 9to 11

Meloxicam Zentiva

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

• changes in the structure of the kidney that determine renal insufficiency: very rare cases of kidney inflammation (interstitial nephritis) death of some cells within the kidney (acute tubular or papillary necrosis); proteins in the urine (nephrotic syndrome with proteinuria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not use this medicine if you notice any defect or if the tablets are broken, chipped. Bring them to the pharmacist for advice before taking them.
• Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Meloxicam Zentiva contains
Each tablet contains 15 mg of meloxicam as the active ingredient.
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 package contents
Meloxicam Zentiva 15 mg tablets are light yellow, round, biconvex, with bevelled edges, with the characters “B” and “19” imprinted on either side of the fracture line on one side and with the back side smooth.
Pack sizes:
Meloxicam Zentiva 15 mg tablets are available in blisters in packs 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
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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 Member States of the European Economic Area with the
following denominations:
FR Meloxicam Zentiva 7.5 mg, tablets
Meloxicam Zentiva 15 mg breakable tablets
IT MELOXICAM ZENTIVA
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