MELOXICAM NORMON 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

Meloxicam Normon 15 mg Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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 Normon is indicated in adults and children over 16 years of age for the:

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

2. What you need to know before you take Meloxicam Normon

Do not take Meloxicam Normon:

• if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• in the last three months of pregnancy
• children and adolescents under 16 years of age
• if you have had any of the following disorders after taking acetylsalicylic acid (aspirin) or other NSAIDs:
• • wheezing (bronchospasm), chest tightness, shortness of breath (asthma)
  • nasal polyps
  • skin rash/urticaria
  • sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema)
• if you have had:
• • stomach or intestinal bleeding
  • holes (perforations) in your stomach or intestines
• stomach or intestinal ulcers
• if you have had stomach or duodenal ulcers or bleeding (ulcers or bleeding that have occurred at least twice)
• severe liver function impairment
• severe non-dialysed renal failure
• recent cerebral bleeding (cerebrovascular haemorrhage)
• any type of bleeding disorder
• severe heart failure
• intolerance to some sugars, as this medicine contains lactose (see also "Meloxicam Normon contains lactose")

If you are not sure about any of the above, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting Meloxicam Normon.

If you have ever experienced a fixed drug eruption (rounded or oval patches with redness and swelling of the skin that usually recur in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxicams (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 you have been prescribed (see section 3 "How to take Meloxicam Normon").

If you have heart problems, previous stroke, or 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 (hypercholesterolemia)
• are a smoker

Stop taking Meloxicam Normon immediately if you notice bleeding (which causes black stools) or ulcers in your digestive system (causing abdominal pain).

Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Normon, initially appearing as red spots or patches, often with a central blister. Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The risk of severe skin reactions is highest during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Meloxicam Normon, you should not take Meloxicam Normon again at any time. If you develop a rash or these symptoms, stop taking Meloxicam Normon and seek medical attention immediately.

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 your doctor's advice before taking Meloxicam Normon if 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
• have high blood pressure (hypertension)
• are elderly
• have heart, liver, or kidney disease
• have high blood sugar levels (diabetes mellitus)
• have reduced blood volume (hypovolemia) that may occur if you have suffered significant blood loss or severe burns, surgery, or low fluid intake
• have been diagnosed with intolerance to some sugars by your doctor, as this medicine contains lactose
• have previously been diagnosed with 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 recently taken, or might take any other medicines.

In particular, 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 for treating 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 medicine ("water tablets"). Your doctor may monitor your kidney function if you are taking diuretics.

? medicines for treating 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)

? colestyramine (used to reduce cholesterol levels)

? oral antidiabetics (sulfonylureas, nateglinide) (used to treat diabetes. Your doctor should carefully monitor your blood sugar levels for hypoglycemia)

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

You should not take meloxicam during the first 6 months of pregnancy unless clearly necessary and as directed 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 the 20th week of pregnancy, meloxicam may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of the fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductal constriction) 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 and your baby's ability to clot and prolong or delay delivery more than expected.

If you have taken this medicine while pregnant, you should talk to your doctor/midwife immediately so that adequate monitoring can be considered.

Breast-feeding:

This medicine is not recommended during breast-feeding.

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 are having trouble becoming pregnant.

Driving and using machines

This medicine may cause changes in vision, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders. If you experience these effects, do not drive or use machines.

Meloxicam Normon contains lactose and sodium

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

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

3. How to take Meloxicam Normon

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

Osteoarthritis (arthrosis) flare-ups:

7.5 mg (half a 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 a tablet) once a day.

Ankylosing spondylitis:

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

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 (half a tablet) once a day.

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 (half a 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 a tablet) per day.

Renal impairment

If you are a patient on dialysis with severe renal impairment, your dose should not exceed 7.5 mg (half a tablet) per day. In patients with mild to moderate renal impairment, no dose reduction is necessary.

Hepatic impairment

In patients with mild to moderate hepatic impairment, no dose reduction is necessary.

Use in children and adolescents

Meloxicam Normon should not be administered to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you think the effect of Meloxicam Normon is too strong or too weak or if you do not notice any improvement after several days.

Method of administration:

Oral use.

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

The tablet can be divided into equal doses.

If you take more Meloxicam Normon than you should

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

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

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

These symptoms usually improve when you stop taking Meloxicam Normon. Gastrointestinal bleeding may occur.

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

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

If you forget to take Meloxicam Normon

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

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

4. Possible Adverse Effects

Like all medicines, Meloxicam Normon can cause adverse effects, although not all people suffer from 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), blistering of the skin or peeling, which can be 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 severe allergic skin reaction that causes spots, red patches or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.

• inflammation of the skin or mucous membranes such as inflammation around the eyes, face, and lips, mouth or throat, possibly making breathing difficult, swollen ankles/legs (edema of the lower limbs)
• 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 adverse effect of the digestive system, especially:

• bleeding (causing black stools)
• ulcers of the digestive system (causing abdominal pain)

Gastrointestinal bleeding (gastrointestinal hemorrhage), the formation of ulcers or a hole in the digestive system (perforation) can sometimes be severe and potentially life-threatening, especially in elderly people.

If you have previously suffered from any digestive system 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 being treated.

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

General Adverse Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

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

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

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

• stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)
• a hole in the intestine wall (perforation) or gastrointestinal bleeding (sometimes life-threatening, especially in elderly people)

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

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

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

Adverse Effects of Meloxicam

Very Common Adverse Effects: may affect more than 1 in 10 people

• gastrointestinal adverse reactions such as indigestion (dyspepsia), nausea, and vomiting, abdominal pain, constipation, flatulence, diarrhea

Common Adverse Effects: may affect up to 1 in 10 people

• headache

Uncommon Adverse Effects: may affect up to 1 in 100 people

• dizziness (feeling of dizziness)
• feeling of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of hemoglobin in red blood cells)
• increased blood pressure (hypertension)
• hot flashes (temporary redness of 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
• belching
• stomach inflammation (gastritis)
• gastrointestinal bleeding
• mouth inflammation (stomatitis)
• allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen ankles/legs (edema of the lower limbs)
• sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, possibly making breathing difficult (angioedema)
• transient changes in liver function values (e.g., increased liver enzyme levels such as transaminases or increased bilirubin). Your doctor may detect them by performing a blood test
• changes in kidney function laboratory tests (e.g., increased creatinine or urea)

Rare Adverse 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 adverse effects can increase the risk of infection and cause symptoms such as bruising or nosebleeds.

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

Very Rare Adverse Effects: may affect up to 1 in 10,000 people

• vesicular skin reactions (blistering) and multiforme erythema.

Multiforme erythema is a severe allergic skin reaction that causes spots, red patches, 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 intestine wall (perforation)

Adverse 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 sun exposure (photosensitivity reactions)
• heart failure (heart 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 can potentially inhibit, depress, or destroy a component of the bone marrow (myelotoxic drugs). This can cause:
• • sudden fever
  • throat pain
  • infections
• pancreas inflammation (pancreatitis)
• infertility in women, delayed ovulation
• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same location in case of re-exposure to the drug and can appear as rounded or oval plaques 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 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 of Adverse Effects

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

5. Storage of Meloxicam Normon

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofMeloxicam Normon

The active ingredient is meloxicam. Each tablet contains 15 mg of meloxicam

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

Appearance of the Product and Package Contents

Meloxicam Normon 15 mg tablets are presented in the form of cylindrical, biconvex, scored tablets of yellow color. The tablet can be divided into equal doses.

Each package contains 20 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos, Madrid (Spain)

Other Presentations

Meloxicam Normon 7.5 mg tablets EFG

Date of the Last Revision of this Leaflet: June 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69366/P_69366.html