Leaflet: information for the user

meloxicam cinfa 15 mg tabletsEFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

meloxicam cinfa contains the active ingredient meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce inflammation and pain in joints and muscles.

Meloxicam is indicated for adults and children 16 years of age and older.

Meloxicam is used for:

Do not take meloxicam cinfa

If you are unsure about any of the above situations, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take meloxicam cinfa:

If you have ever experienced a fixed drug eruption (flat, oval-shaped patches with redness and swelling of the skin that usually reappear in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxycam derivatives (e.g., piroxicam).

Warnings

Medicines like meloxicam may be associated with a slight increase in the risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). Any risk is greater at high doses and with prolonged treatment. Do not take more than the recommended dose. Do not take meloxicam for longer than prescribed (see section 3 “How to take meloxicam cinfa”).

If you have heart problems, a previous stroke, or if you think you may be at risk of these diseases, you should discuss treatment with your doctor or pharmacist.

For example, if you:

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

Stop taking meloxicam as soon as you notice bleeding (causing black stools) or ulcers in your digestive system (causing abdominal pain).

Severe skin rashes that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been described with the use of meloxicam, initially appearing as red, circular spots with a central blister.

Other additional signs that may appear are mouth sores, throat, nose, genital, and conjunctivitis (swollen, red eyes).

These life-threatening skin rashes, often accompanied by flu-like symptoms, may progress to form widespread blisters or skin peeling.

The highest risk period for developing severe skin reactions is during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of meloxicam, do not use meloxicam again at any time.

If you develop a rash or these skin symptoms, stop taking meloxicam, go to a doctor immediately, and inform them that you are taking this medicine.

Meloxicam is not suitable if you need to relieve acute pain immediately.

Meloxicam may mask the symptoms of an infection (e.g., fever). If you think you may have an infection, see a doctor.

Precautions for use

Since treatment will need to be adjusted, it is essential to consult your doctor before taking meloxicam cinfa in the following cases:

• you have had inflammation of the throat (esophagitis), stomach inflammation (gastritis), or a history of any other digestive system disease, e.g., Crohn's disease, ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver, or kidney disease
• high blood sugar levels (diabetes mellitus)
• reduced blood volume (hypovolemia) that may occur if you have experienced significant blood loss or severe burns, surgery, or low fluid intake.
• diagnosed intolerance to some sugars by your doctor since this medicine contains lactose
• previously diagnosed high potassium levels in the blood by your doctor.

Your doctor will need to monitor your progress during treatment.

Other medicines andmeloxicam cinfa

Since meloxicam may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Specifically, please inform your doctor or pharmacist if you are taking/have taken or have used any of the following medicines:

• other NSAIDs
• potassium salts (used to prevent or treat low potassium levels in the blood)
• tacrolimus (used after organ transplantation)
• trimethoprim (used in the treatment of urinary tract infections)
• blood-thinning medicines
• clot-dissolving medicines (thrombolytics)
• medicines for heart and kidney diseases
• corticosteroids (e.g., used in inflammation or allergic reactions)
• ciclosporin (used after organ transplantation or for severe skin diseases, rheumatoid arthritis, or nephrotic syndrome)
• deferasirox (used to treat chronic iron overload caused by frequent blood transfusions)
• any diuretic (“water pills”). Your doctor may need to monitor your kidney function if you are taking diuretics.
• medicines for high blood pressure (e.g., beta-blockers)
• litium (used to treat behavioral disorders)
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
• metotrexate (used to treat tumors or uncontrolled skin and rheumatoid arthritis)
• pemetrexed (used in cancer treatment)
• colestiramine (used to reduce cholesterol levels)
• oral antidiabetic drugs (sulfonilureas, nateglinida) (used to treat diabetes. Your doctor will need to closely monitor your blood sugar levels for hypoglycemia)

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

During the first and second trimesters of pregnancy, your doctor will only prescribe this medicine if it is clearly necessary due to the potential risk of abortion or malformation. In this case, the dose should be kept as low as possible and the duration of treatment should be as short as possible.

During the last three months of pregnancy, this medicine is contraindicated: NEVER take this medicine because it may have severe or even fatal consequences for your fetus/child, especially for their heart, lungs, and/or kidneys, even with a single administration.

If you have taken this medicine while pregnant, you should speak to your doctor/midwife immediately so that they can consider adequate monitoring.

Breastfeeding

This medicine is not recommended during breastfeeding.

Fertility

This medicine may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant.

Driving and operating machines

This medicine may cause visual disturbances, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disturbances. If you notice these effects, do not drive or operate machines.

meloxicam cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

meloxicam cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Acute arthritis::

7.5 mg of meloxicam (half tablet) once a day. This may be increased to 15 mg of meloxicam (one tablet) once a day.

Rheumatoid arthritis:

15 mg of meloxicam (one tablet) once a day. This may be reduced to 7.5 mg of meloxicam (half tablet) once a day.

Ankylosing spondylitis:

15 mg of meloxicam (one tablet) once a day. This may be reduced to 7.5 mg of meloxicam (half tablet) once a day.

Do not exceed the maximum recommended dose of 15 mg per day.

If any of the situations described under the title “Warnings and precautions” affect you, your doctor may limit your dose to 7.5 mg (half tablet) once a day.

Older patients

If you are an older patient, the recommended dose in long-term treatment for rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (half tablet) once a day.

Patients at increased risk of adverse reactions

If you are a patient at increased risk of adverse reactions, your doctor will start treatment at a dose of 7.5 mg (half tablet) per day.

Patients with kidney problems

If you are a patient on dialysis with severe kidney problems, your dose should not exceed 7.5 mg (half tablet) per day. In patients with mild to moderate kidney problems, there is no need to reduce the dose.

Patients with liver problems

In patients with mild to moderate liver problems, there is no need to reduce the dose.

Use in children and adolescents

This medication should not be administered to children and adolescents under 16 years old.

Consult your doctor or pharmacist if you estimate that the action of meloxicam is too strong or weak, or if after several days you do not notice any improvement.

Administration form

Oral route

The tablets should be swallowed with water or another drink during meals.

The tablet can be divided into equal doses.

If you take more meloxicam cinfa than you should

If you have taken too many tablets or suspect an overdose, contact your doctor or go to the nearest hospital immediately.

The symptoms associated with acute overdose of NSAIDs are usually limited to::

• lack of energy (lethargy)
• sleep
• nausea and vomiting
• stomach pain (epigastric pain).

These symptoms usually improve when meloxicam is stopped. Gastrointestinal bleeding may occur.

Severe poisoning may cause severe adverse reactions (see section 4):

• high blood pressure (hypertension)
• acute kidney failure (renal)
• liver dysfunction (hepatic insufficiency)
• respiratory depression (respiratory depression)
• loss of consciousness (coma)
• seizures (convulsions)
• circulatory collapse (cardiovascular collapse)
• cardiac arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:
• • syncope
  • shortness of breath
  • skin reactions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take meloxicam cinfa

Do nottake a double dose to compensate for the missed doses. Simply take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking meloxicam and consult your doctor or the nearest hospital immediately if you notice:

Any allergic reaction (hypersensitivity) that may appear in the form of:

• skin reactions, such as itching (pruritus), skin blistering or peeling, which can be life-threatening skin conditions (Stevens-Johnson syndrome and toxic epidermal necrolysis), mucous membrane lesions or erythema multiforme (see section 2).
• Erythema multiforme is a severe skin allergic reaction that causes patches, red rashes or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.
• skin or mucous membrane inflammation, such as inflammation around the eyes, face, and lips, mouth or throat, possibly making it difficult to breathe, swollen ankles/legs (lower extremity edema)
• difficulty breathing or asthma attacks
• inflammation of the liver (hepatitis). This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite.

Any gastrointestinal side effect, especially:

• bleeding (causing black stools)
• ulcers in your digestive system (causing abdominal pain).

Intestinal bleeding (gastrointestinal hemorrhage), ulcer formation or a hole in the digestive system (perforation) can sometimes be severe and potentially fatal, especially in older people.

If you have previously experienced any gastrointestinal symptoms due to long-term use of NSAIDs, seek medical advice immediately, especially if you are an older person. Your doctor may monitor your progress while you are on treatment.

If you experience vision changes, do not drive or use machines.

General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial occlusion (thrombotic arterial events), such as heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and with long-term treatment.

Cases of fluid retention (edema), high blood pressure (hypertension), and heart failure (cardiac failure) have been reported associated with NSAID treatment.

The most common adverse reactions observed affect the gastrointestinal tract (gastrointestinal events):

• stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)
• a hole in the intestinal wall (perforation) or intestinal bleeding (sometimes fatal, especially in older people).

After administration of NSAIDs, the following adverse reactions have been reported:

• nausea and vomiting
• liquid stools (diarrhea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to intestinal bleeding (melena)
• vomiting blood (hematemesis)
• ulcer formation in the mouth (ulcerative stomatitis)
• exacerbation of intestinal inflammation (e.g. exacerbation of colitis or Crohn's disease).

Less frequently, gastric inflammation (gastritis) has been observed.

Side effects of meloxicam active substance of this medicine

Very common: may affect more than 1 in 10 patients

• gastrointestinal side effects such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, liquid stools (diarrhea)

Common: may affect up to 1 in 10 patients

• headache

Rare: may affect up to 1 in 100 patients

• dizziness (sense of drowsiness)
• sense of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of the pigment in red blood cells called hemoglobin)
• increased blood pressure (hypertension)
• flushing (enrojecimiento temporal in the face and neck)
• water and sodium retention
• increased potassium levels (hyperpotasemia). This can cause symptoms such as:
• • changes in heartbeats (arrhythmias)
  • palpitations (when you notice your heartbeats more than usual)
  • muscle weakness
• eructation
• gastritis (inflammation of the stomach)
• intestinal bleeding
• mouth inflammation (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen ankles/legs (lower extremity edema)
• sudden skin or mucous membrane inflammation, such as inflammation around the eyes, face, lips, mouth or throat, possibly making it difficult to breathe (angioedema)
• transient changes in liver function test values (e.g. increased levels of liver enzymes such as transaminases or increased bilirubin). Your doctor may detect them by doing a blood test
• changes in kidney function test values (e.g. increased creatinine or urea).

Rare: may affect up to 1 in 1,000 patients

• mood changes
• nightmares
• abnormal blood count, including:
• • abnormal differential blood count
  • decreased white blood cell count (leucopenia)
  • decreased platelet count (thrombocytopenia)

These side effects may increase the risk of infection and cause symptoms such as bruises or nosebleeds.

• ringing in the ears (tinnitus)
• noticing heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• throat inflammation (esophagitis)
• initiation of asthma attacks (observed in people allergic to aspirin or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• urticaria
• vision changes, including:
• • blurred vision
  • conjunctivitis (inflammation of the eye or eyelid)
• colitis (inflammation of the large intestine).

Very rare: may affect up to 1 in 10,000 patients

• vesicular skin reactions (blistering) and multiform erythema.
• Erythema multiforme is a severe skin allergic reaction that causes patches, red rashes or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.
• liver inflammation (hepatitis). This can cause symptoms such as:
• • yellowing of the skin and eyes (jaundice)
  • abdominal pain
  • loss of appetite
• acute kidney failure (renal failure) in particular in patients with risk factors such as heart disease, diabetes or kidney disease
• a hole in the intestinal wall (perforation).

Frequency not known: cannot be estimated from available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) due to exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac failure) associated with NSAID treatment has been described
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other drugs that may inhibit, depress or potentially destroy a component of the bone marrow (myelotoxic drugs). This may cause:
• • sudden fever
  • throat pain
  • infections
  • pancreatitis (inflammation of the pancreas)
  • infertility in women, delayed ovulation
  • a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same place upon re-exposure to the drug and may appear as rounded or oval plaques with redness and swelling of the skin, blistering (urticaria) and itching.

Side effects caused by other nonsteroidal anti-inflammatory drugs (NSAIDs), which have not been seen after taking meloxicam

Changes in kidney structure that cause acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)
• death of some kidney cells (acute tubular necrosis or papillary necrosis)
• protein in the urine (nephrotic syndrome with proteinuria).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of meloxicam cinfa

• The active ingredient is meloxicam. Each tablet contains 15 mg of meloxicam.
• • The other components are: sodium citrate, microcrystalline cellulose (E-460), lactose monohydrate, povidone, anhydrous colloidal silica, magnesium stearate, sodium carboxymethylcellulose (type A) (potato).

Appearance of the product and contents of the packaging

Yellow-colored, cylindrical, biconvex, scored, and marked with the code “M1” on one side.

Presented in PVC-PVDC/Aluminum blisters. Each package contains 20 or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:June 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69094/P_69094.html

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