Leaflet: information for the user

Meloxicam Normon 15 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.
• If you 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 you start takingMeloxicam Normon

3. How to takeMeloxicam Normon

4. Possible side effects

5. Storage ofMeloxicamNormon

6. Contents of the pack and additional information

Meloxicambelongs to a group of medicines called nonsteroidal 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 the:

- short-term treatment of gout attacks (gouty arthritis)

- 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 (listed in 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 (wheezing, chest tightness, shortness of breath).
  • nasal congestion due to inflammation of the inside of the nose (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 previous treatment with 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 recent or recurring ulcers of the 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 of 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

Medicines like 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 levels (diabetes mellitus).

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

- are a smoker.

Stop taking Meloxicam Normon as soon as you notice bleeding (causing black stools) or ulcers in your digestive system (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 Normon, 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 reactions, often accompanied by flu-like symptoms, may progress to generalized blistering or skin peeling. The highest risk period for 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 Normon, do not use Meloxicam Normon again at any time. If you develop a rash or these symptoms on your skin, stop taking Meloxicam Normon, 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

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

- you have had inflammation of the throat (esophagitis), inflammation of the stomach (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 had 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.

Taking Meloxicam Normon with other medicines

Since 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 may need to take 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).

?trimetoprima (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 for inflammation or allergic reactions).

?ciclosporina (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).

?litio (used to treat behavioral disorders).

?selective serotonin reuptake inhibitors (SSRIs) (used to treat depression).

?metotrexato (used to treat tumors or uncontrolled severe skin and rheumatoid arthritis).

?pemetrexed (used in cancer treatment).

?colestiramina (used to reduce cholesterol levels).

?oral antidiabetic drugs (sulfonilureas, nateglinida) (used to treat diabetes. Your doctor should closely 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 six 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 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. Do not take meloxicam if you are in the last three 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 machines

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

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 with 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:

Osteoarthritis (arthrosis) crisis:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

15 mg (one tablet) once a day. This may be reduced to 7.5 mg (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 elderly person, 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.

Renal insufficiency

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

Hepatic insufficiency

In patients with mild to moderate hepatic 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)

- liver dysfunction (hepatic insufficiency)

- respiratory depression

- loss of consciousness (coma)

- seizures (convulsions)

- cardiovascular collapse

- cardiac arrest

- immediate allergic reactions (hypersensitivity), including:

- fainting

- shortness of breath

- skin reactions

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

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

Stop takingMeloxicam Normonand 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 legs and feet (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)

Bleeding in the digestive tract (gastrointestinal hemorrhage), the formation of ulcers 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 symptoms of the digestive system due to long-term 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.

Common 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 commonly observed adverse reactions affect the gastrointestinal tract (gastrointestinal events):

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

After NSAID administration, the following adverse reactions have been reported:

- nausea and vomiting

- liquid stools (diarrhea)

- flatulence

- constipation

- indigestion (dyspepsia)

- abdominal pain

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

- vomiting blood (hematemesis)

- inflammation with the appearance of ulcers in the mouth (ulcerative stomatitis)

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

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

Meloxicam side effects

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

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

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

• headache

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

• dizziness (sense of dizziness)
• 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 (hyperkalemia). 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)
• bleeding in the digestive tract
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (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 enzymes such as transaminases or an increase in the bile 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: may 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 may increase the risk of infection and cause symptoms such as bruises or nosebleeds.

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

Very rare side effects: may 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.

• inflammation of the liver (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) associated with NSAID treatment has been described
• 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
  • 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 Normon

Changes in the structure of the kidney that cause acute kidney failure:

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

Reporting of 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 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.

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.Dispose of 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 15 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 (potato).

Appearance of the product and contents of the packaging

Meloxicam Normon 15 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 7.5 mg tablets EFG

Last review date of this leaflet: June 2023

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/