Leaflet: information for the user

Meloxicam Normon 7.5 mg tablets EFG

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.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMeloxicam Normonand what it is used for

2. What you need to know before starting to takeMeloxicam Normon

3. How to takeMeloxicam Normon

4. Possible side effects

5. Storage ofMeloxicam Normon

6. Contents of the pack and additional information

Meloxicambelongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce inflammation and pain in joints and muscles.

Meloxicam Normon is indicated in adults and children 16 years of age and older, for:

• short-term treatment of acute gout attacks (osteoarthritis)
• long-term treatment of
• • rheumatoid arthritis
  • ankylosing spondylitis

Do not takeMeloxicam Normon:

• if you are allergic to meloxicam or any of the other ingredients of this medicine (see section 6).
• during the last three months of pregnancy.
• children and adolescents under 16 years of age.
• if you have had any of the following conditions after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs):
• • asthma (pneumonia, chest tightness, shortness of breath).
  • nasal congestion due to inflammation of the nasal passages (nasal polyps).
  • skin rashes/urticaria.
  • sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema).
• if you have had any of the following conditions after taking NSAIDs:
• • bleeding in your stomach or intestines.
  • holes (perforations) in your stomach or intestines.
• ulcers or bleeding in your stomach or intestines.
• if you have had stomach or peptic ulcers or bleeding (ulcers or bleeding that have occurred at least twice).
• severe liver dysfunction.
• severe kidney failure not on dialysis.
• recent bleeding in the brain (cerebrovascular hemorrhage).
• any type of bleeding disorder.
• severe heart failure.
• intolerance to some sugars since this medicine contains lactose (see also "Meloxicam Normon contains lactose").

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 Normon.

If you have ever had 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 oxicam derivatives (e.g., piroxicam).

Warnings

Meloxicam Normon 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 Normon for longer than prescribed (see section 3 "How to take Meloxicam Normon").

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 (diabetes mellitus).

- have high cholesterol levels in the blood (hypercholesterolemia).

- are a smoker.

Stop taking Meloxicam Normon immediately as soon as you notice bleeding (causing black stools) or ulcers in your digestive tract (causing abdominal pain).

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been described with the use of meloxicam, appearing initially as red, circular spots, often 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 reactions often occur with flu-like symptoms. The skin reaction may progress to form widespread blisters or skin peeling. The period of highest risk of developing severe skin reactions is during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with meloxicam, you should not use meloxicam again at any time.

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

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

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

Precautions for use

As treatment will need to be adjusted, it is essential to seek advice from your doctor before taking Meloxicam Normon in the following situations:

• if you have had inflammation of the throat (esophagitis), stomach inflammation (gastritis), or a history of any other digestive tract disease, e.g., Crohn's disease, ulcerative colitis.
• high blood pressure (hypertension).
• advanced age.
• heart, liver, or kidney disease.
• high blood sugar (diabetes mellitus).
• severe blood loss (hypovolemia) that may occur after significant blood loss, 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.

Taking Meloxicam Normon with other medicines

As Meloxicam Normon 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 ("urine tablets"). 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 severe skin diseases 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 carefully monitor your blood sugar levels for hypoglycemia).

Pregnancy, breastfeeding, and 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:

You should not take meloxicam during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, meloxicam may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

During the last 3 months of pregnancy, this medicine is contraindicated: NEVER take this medicine because it may have serious or even fatal consequences for your fetus/child, especially for their heart, lungs, and/or kidneys, even with a single administration. Do not take meloxicam if you are in the last 3 months of pregnancy, as it may harm your fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

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 machinery

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 machinery.

Meloxicam Normon contains lactose and sodium

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

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

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

The recommended dose is:

Arthritis crisis (osteoarthritis):

7.5 mg (one tablet) once a day. This can be increased to 15 mg (two tablets) once a day.

Rheumatoid arthritis:

15 mg (two tablets) once a day. This can be reduced to 7.5 mg (one tablet) once a day.

Ankylosing spondylitis:

15 mg (two tablets) once a day. This can be reduced to 7.5 mg (one 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 (one tablet) once a day.

Older patients

If you are an elderly person, the recommended dose in long-term treatment for rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (one 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 (one tablet) per day.

Renal insufficiency

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

Liver insufficiency

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

Use in children and adolescents

Meloxicam Normon 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 Normon is too strong or too 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 beverage during meals.

The tablet can be divided into equal doses.

If you take moreMeloxicam Normon 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 Normon is stopped.Gastrointestinal bleeding may occur.

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

- high blood pressure (hypertension)

- acute kidney failure (renal failure)

- liver dysfunction (hepatic dysfunction)

- respiratory depression (respiratory depression)

- loss of consciousness (coma)

- seizures (convulsions)

- cardiovascular collapse (cardiovascular collapse)

- cardiac arrest (cardiac arrest)

- immediate allergic reactions (hypersensitivity), including:

- fainting

- shortness of breath

- skin reactions

If you forget to takeMeloxicam Normon

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

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

Like all medicines, Meloxicam Normon can cause side effects, although not everyone will experience them.

Stop taking Meloxicam Normon 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), mucosal 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 legs and feet (lower extremity edema)
• difficulty breathing or asthma attacks
• liver inflammation (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 the digestive tract (causing abdominal pain)

Bleeding in the digestive tract (gastrointestinal hemorrhage), ulcer formation or a hole in the digestive tract (perforation) can sometimes be severe and potentially life-threatening, especially in older people.

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

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

Side effectsof nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some NSAIDs may be associated with a slight increase in the risk of arterial occlusion (arterial thrombotic 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 commonly observed side effects affect the gastrointestinal tract (gastrointestinal events):

- stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)

- a hole in the intestinal wall (perforation) or bleeding in the digestive tract (sometimes fatal, especially in older people)

After NSAID administration, the following side effects have been reported:

- nausea and vomiting

- loose stools (diarrhea)

- flatulence

- constipation

- indigestion (dyspepsia)

- abdominal pain

- black stools due to bleeding in the digestive tract (melena)

- vomiting blood (hematemesis)

- inflammation with ulcer formation in the mouth (ulcerative stomatitis)

- worsening of gastrointestinal inflammation (e.g. exacerbation of colitis or Crohn's disease)

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

Meloxicam side effects

Very common side effects: can affect more than 1 in 10 people

Gastrointestinal side effects such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, and loose stools (diarrhea)

Common side effects: can affect up to 1 in 10 people

Headache

Rare side effects: can affect up to 1 in 100 people

• dizziness (feeling of dizziness)
• sensation of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of the pigment in red blood cells called hemoglobin)
• increase in blood pressure (hypertension)
• temporal flushing (enrojecimiento temporal in the face and neck)
• water and sodium retention
• increased potassium levels (hyperkalemia). This can cause symptoms such as:
• • abnormal heartbeats (arrhythmias)
  • palpitations (when you notice your heartbeats more than usual)
  • muscle weakness
• eructation
• stomach inflammation (gastritis)
• bleeding in the digestive tract
• mouth inflammation (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin rash
• fluid retention inflammation (edema), including swollen legs and feet (lower extremity edema)
• sudden inflammation of the skin or mucous membranes, 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. increase in liver enzyme levels such as transaminases or an increase in the pigment bilirubin). Your doctor may detect them by doing a blood test
• changes in kidney function test values (e.g. increase in creatinine or urea)

Rare side effects: can affect up to 1 in 1,000 people

• mood changes
• nightmares
• abnormal blood count, including:
• abnormal differential blood count
• decrease in the number of white blood cells (leucopenia)
• decrease in the number of platelets (thrombocytopenia)

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

• ringing in the ears (tinnitus)
• noticing your heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• throat inflammation (esophagitis)
• onset 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)
• large intestine inflammation (colitis)

Very rare side effects: can affect up to 1 in 10,000 people

• vesicular skin reactions (blistering) and multiform erythema.

Multiform erythema 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)

Side effects of unknown frequency: the frequency cannot be estimated from the 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 associated with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloxicam Normon with other drugs that may inhibit, depress, or potentially destroy a component of the bone marrow (myelotoxic drugs). This can cause:
• • sudden fever
  • sore throat
  • 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) that have not been seen after taking Meloxicam Normon

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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Vigilance 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.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofMeloxicam Normon

The active ingredient is meloxicam. Each tablet contains 7.5 mg of meloxicam

The other components (excipients) are: sodium citrate, microcrystalline cellulose (E460), lactose monohydrate, povidone, anhydrous colloidal silica, magnesium stearate, carboxymethylcellulose sodium type A (from potato).

Appearance of the product and content of the packaging

Meloxicam Normon 7.5 mg tablets are presented in the form of cylindrical, biconvex, scored, yellow tablets. The tablet can be divided into equal doses.

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos, Madrid (Spain)

Other presentations

Meloxicam Normon 15 mg tablets EFG

Last review date of this leaflet:June 2023

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