Meloxicam Cinfa 7.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

meloxicam cinfa 7.5 mg tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What meloxicam cinfa is and what it is used for

meloxicam cinfa 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 joints and muscles.

Meloxicam is indicated in adults and adolescents aged 16 years and older.

Meloxicam is used for:

• short-term treatment of osteoarthritis flare-ups (osteoarthrosis)
• long-term treatment of
  • rheumatoid arthritis
  • ankylosing spondylitis

2. What you need to know before taking meloxicam cinfa

Do not take meloxicam cinfa

• 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 16 years of age

• if you have previously experienced any of the following conditions after taking acetylsalicylic acid (aspirin) or other NSAIDs:

• wheezing, tightness in the chest, shortness of breath (asthma)

• nasal congestion due to inflammation of the inside of the nose (nasal polyps)

• skin rash/hives

• sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (angioedema)

• if after previous NSAID therapy you experienced:

• bleeding in your stomach or intestines

• holes (perforations) in your stomach or intestines

• ulcers or bleeding in your stomach or intestines

• if you have recently had or have ever had stomach or peptic ulcers or bleeding (ulcers or bleeding that have occurred at least twice)

• severe impairment of liver function

• severe renal failure not on dialysis

• recent bleeding in the brain (cerebrovascular hemorrhage)

• any type of bleeding disorders

• severe heart failure

• intolerance to certain sugars, as this medicine contains lactose (see also “meloxicam cinfa contains lactose”).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking meloxicam cinfa:

If you have ever experienced drug-induced fixed drug eruption (round or oval-shaped red and swollen skin patches that usually reappear in the same location, blistering, hives, and itching) after taking meloxicam or other oxicams (e.g., piroxicam).

Warnings

Medicines such as meloxicam may be associated with a slight increase in the risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). The risk is greater with high doses and 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 history of stroke, or think you may be at risk of developing these conditions, 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 immediately if you notice bleeding (causing black stools) or ulcers in your digestive tract (causing abdominal pain).

Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with meloxicam use, initially appearing as red, circular spots or patches, often with a central blister.

Other possible symptoms include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen, red eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

The highest risk of severe skin reactions occurs during the first weeks of treatment. If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis with meloxicam, you must never take meloxicam again.

If you develop a skin rash or any of these symptoms, stop taking meloxicam immediately, seek medical help right away, and inform your doctor that you are taking this medicine.

Meloxicam is not suitable if you need immediate relief from acute pain.

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

Precautions for use

Since treatment may need to be adjusted, it is important to consult your doctor before taking meloxicam cinfa if you have:

• previously had inflammation of the throat (esophagitis), inflammation of the stomach (gastritis), or a history of any other gastrointestinal disorder, 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), which may occur after significant blood loss, severe burns, surgery, or low fluid intake
• diagnosed sugar intolerance, as this medicine contains lactose
• previously diagnosed high potassium levels in the blood.

Your doctor will need to monitor your condition during treatment.

Other medicines and meloxicam cinfa

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

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 to treat urinary tract infections)
• medicines that prevent blood clotting
• medicines that dissolve blood clots (thrombolytics)
• medicines to treat heart and kidney diseases
• corticosteroids (e.g., used for inflammation or allergic reactions)
• cyclosporine (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 medicines (“water tablets”). Your doctor may monitor kidney function if you are taking diuretics.
• medicines for high blood pressure (e.g., beta-blockers)
• lithium (used to treat behavioral disorders)
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
• methotrexate (used to treat tumors or severe uncontrolled skin diseases and active rheumatoid arthritis)
• pemetrexed (used in cancer treatment)
• cholestyramine (used to lower cholesterol levels)
• oral antidiabetic medicines (sulfonylureas, nateglinide) (used to treat diabetes. Your doctor must carefully monitor your blood sugar levels for hypoglycemia)

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

During the last three months of pregnancy, this medicine is contraindicated: NEVER take this medicine, as it may cause serious or even fatal consequences for your fetus/child, particularly affecting the heart, lungs, and/or kidneys, even after a single dose.

If you have taken this medicine during pregnancy, contact your doctor/midwife immediately so appropriate monitoring can be considered.

Breastfeeding

Use of this medicine during breastfeeding is not recommended.

Fertility

This medicine may make it more difficult for you to become pregnant. Inform your doctor if you are planning to become pregnant or if you are having difficulty conceiving.

Driving and using machines

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

meloxicam cinfa contains lactose

This medicine contains lactose. If your doctor has diagnosed you with 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; hence, it is essentially “sodium-free.”

3. How to take meloxicam cinfa

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Osteoarthritis flare-up:

7.5 mg of meloxicam (one tablet) once daily. This may be increased to 15 mg of meloxicam (two tablets) once daily.

Rheumatoid arthritis:

15 mg of meloxicam (two tablets) once daily. This may be reduced to 7.5 mg of meloxicam (one tablet) once daily.

Ankylosing spondylitis:

15 mg of meloxicam (two tablets) once daily. This may be reduced to 7.5 mg of meloxicam (one tablet) once daily.

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

If any of the situations described under the heading "Warnings and precautions" apply to you, your doctor may limit your dose to 7.5 mg (one tablet) once daily.

Elderly patients

If you are an elderly patient, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (one tablet) once daily.

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 (one tablet) daily.

Patients with kidney problems

If you are a patient on dialysis with severe kidney problems, your dose should not exceed 7.5 mg (one tablet) daily. In patients with mild to moderate kidney problems, dose reduction is not necessary.

Patients with liver problems

In patients with mild to moderate liver problems, dose reduction is not necessary.

Use in children and adolescents

This medicine must not be given to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you think that the effect of meloxicam is too strong or too weak, or if you notice no improvement after several days.

Method of administration

Oral use

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

The tablet may 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.

Symptoms associated with acute overdose of NSAIDs are usually limited to:

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

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

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

• high blood pressure (hypertension)
• acute kidney failure (renal)
• impaired liver function (hepatic failure)
• reduced or stopped breathing (respiratory depression)
• loss of consciousness (coma)
• seizures (convulsions)
• circulatory collapse (cardiovascular collapse)
• cardiac arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:
  • fainting
  • shortness of breath
  • skin reactions.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take meloxicam cinfa

Do not take a double dose to make up for missed doses. Simply take the next dose at your usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Any allergic reaction (hypersensitivity), which may appear as:

• skin reactions such as itching (pruritus), blistering or peeling of the skin, which may include life-threatening skin rashes (Stevens-Johnson syndrome and 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 rashes, or purple areas with blisters. It may also affect the mouth, eyes, and other moist areas of the body.
• swelling of the skin or mucous membranes, such as around the eyes, face, and lips, or in the mouth or throat, possibly making breathing difficult, swollen ankles/legs (peripheral edema).
• difficulty breathing or asthma attacks
• inflammation of the liver (hepatitis). This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite.

Any adverse effect affecting the digestive tract, especially:

• bleeding (causing black stools)
• ulcers in the digestive tract (causing abdominal pain).

Bleeding from the digestive tract (gastrointestinal haemorrhage), formation of ulcers, or a hole in the digestive system (perforation) can sometimes be severe and potentially fatal, particularly in elderly patients.

If you have previously experienced any symptoms affecting the digestive tract due to prolonged use of NSAIDs, seek immediate medical advice, especially if you are elderly. Your doctor may monitor your condition while you are receiving treatment.

If you experience disturbances in vision, do not drive or operate machinery.

General adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs)

The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial blood vessel blockage (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (cerebrovascular accident), particularly at high doses and with long-term treatment.

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

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

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

The following adverse reactions have been reported after administration of NSAIDs:

• nausea and vomiting
• loose stools (diarrhoea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to bleeding in the digestive tract (melaena)
• vomiting blood (haematemesis)
• inflammation with development of mouth ulcers (ulcerative stomatitis)
• worsening of digestive tract inflammation (e.g. exacerbation of colitis or Crohn's disease).

Less frequently, inflammation of the stomach (gastritis) has been observed.

Adverse effects of meloxicam, the active substance in this medicine

Very common: may affect more than 1 in 10 patients

• gastrointestinal adverse effects such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, loose stools (diarrhoea)

Common: may affect up to 1 in 10 patients

• headache

Uncommon: may affect up to 1 in 100 patients

• dizziness (feeling faint)
• sensation of dizziness or spinning (vertigo)
• drowsiness (somnolence)
• anaemia (reduction in the amount of the red blood cell pigment called haemoglobin)
• increased blood pressure (hypertension)
• hot flushes (temporary reddening of the face and neck)
• fluid and sodium retention
• increased potassium levels (hyperkalaemia). This may cause symptoms such as:
  • changes in heart rhythm (arrhythmias)
  • palpitations (when you notice your heartbeat 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 (pruritus)
• skin reaction
• fluid retention causing swelling (oedema), including swollen ankles/legs (peripheral oedema)
• sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, possibly making breathing difficult (angioedema)
• transient abnormalities in liver function tests (e.g. increased levels of liver enzymes such as transaminases or increased levels of the bile pigment bilirubin). Your doctor may detect these through a blood test
• abnormalities in kidney function laboratory tests (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
    • reduced number of white blood cells (leucopenia)
    • reduced number of platelets (thrombocytopenia)

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

• ringing in the ears (tinnitus)
• awareness of heartbeat (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• inflammation of the throat (oesophagitis)
• onset of asthma attacks (observed in people allergic to acetylsalicylic acid (aspirin) or other NSAIDs)
• severe blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• urticaria
• visual disturbances including:
  • blurred vision
  • conjunctivitis (inflammation of the eye or eyelid)
• inflammation of the large intestine (colitis).

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

• blistering skin reactions (vesicular eruptions) and redness (erythema) multiforme.

Erythema multiforme is a serious allergic skin reaction causing spots, red rashes, or purple areas with blisters. It may also affect the mouth, eyes, and other moist areas of the body.

• inflammation of the liver (hepatitis). This may cause symptoms such as:
  • yellowing of the skin and 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
• 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) has been described with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), particularly in patients taking meloxicam together with other drugs that may inhibit, suppress, or potentially destroy components of the bone marrow (myelotoxic drugs). This may cause:
  • sudden fever
  • sore throat
  • infections
  • inflammation of the pancreas (pancreatitis)
  • infertility in women, delayed ovulation
  • a characteristic drug-related skin allergic reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the drug and may present as round or oval patches with redness and swelling of the skin, blistering (urticaria), and itching.

Adverse effects caused by other non-steroidal anti-inflammatory drugs (NSAIDs) that have not yet been observed after taking meloxicam

Changes in kidney structure leading to 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of meloxicam cinfa

Keep this medicine out of sight and reach of children.

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of meloxicam cinfa

• The active substance is meloxicam. Each tablet contains 7.5 mg of meloxicam.
• The other components are: sodium citrate, microcrystalline cellulose (E-460), lactose monohydrate, povidone, colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (type A) (from potato).

Appearance of the product and pack contents

Yellow, cylindrical, biconvex, scored tablets marked with the code “M7” on one side.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69093/P_69093.html

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