Meloxicam Normon 15 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Meloxicam Normon 15 mg Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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. Do not pass it on to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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 Normon is indicated in adults and children aged 16 years and older 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 taking 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).
• during the last three months of pregnancy
• in children and adolescents under 16 years of age
• if you have ever experienced any of the following conditions after taking acetylsalicylic acid (aspirin) or other NSAIDs:
  • wheezing, tightness in the chest, shortness of breath (asthma)
  • nasal blockage due to inflammation of the inner nasal lining (nasal polyps)
  • skin rash/hives
  • sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema)
• if after previous treatment with NSAIDs you developed:
  • bleeding in your stomach or intestine
  • holes (perforations) in your stomach or intestine
• ulcers or bleeding in your stomach or intestine
• 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 haemorrhage)
• any type of bleeding disorders
• severe heart failure
• intolerance to certain sugars, as 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

Talk to your doctor or pharmacist before taking Meloxicam Normon.

If you have ever experienced drug-induced fixed drug eruption (round or oval-shaped patches with redness and swelling of the skin 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 Normon may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). Any risk is greater at high doses and during long-term 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, have had a previous stroke, or think you may be at risk of developing either of 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 treatment with Meloxicam Normon 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 the use of Meloxicam Normon, initially appearing as red or circular spots, often with a central blister. Other additional symptoms that may occur include 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 period of highest risk for severe skin reactions is during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using Meloxicam Normon, you must never use Meloxicam Normon again. If you develop a rash or these skin symptoms, stop taking Meloxicam Normon immediately, seek medical attention right away, and inform the doctor that you are taking this medicine.

Meloxicam Normon is not suitable if you need immediate relief from acute pain. Meloxicam Normon may mask symptoms of infection (e.g., fever).

If you think you may have an infection, you should see a doctor.

Precautions for use

As treatment may need to be adjusted, it is important to seek advice from your doctor before taking Meloxicam Normon if you:

• have previously had inflammation of the throat (oesophagitis), inflammation of the stomach (gastritis), or a history of any other gastrointestinal 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), which may occur after significant blood loss or severe burns, surgery, or low fluid intake
• have been diagnosed with intolerance to certain sugars by your doctor, as this medicine contains lactose
• have previously diagnosed high levels of potassium in the blood

Your doctor will need to monitor your condition 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 recently taken, or might need to take any other medicines.

Specifically, please inform your doctor or pharmacist if you are taking/have taken or 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 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 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 behavioural disorders)

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

? methotrexate (used to treat tumours 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 should carefully monitor your blood sugar levels for hypoglycaemia)

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:

You should not take meloxicam during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, meloxicam may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring. During the last three months of pregnancy, this medicine is contraindicated: NEVER take this medicine, as it may have serious or even fatal consequences for your unborn child, particularly affecting the heart, lungs, and/or kidneys, even after a single dose. Do not take meloxicam during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby’s tendency to bleed and may delay or prolong labour beyond expected duration.

If you have taken this medicine while pregnant, you should speak immediately with your doctor/midwife so that 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. You should 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 disturbances in vision including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disturbances. If you experience these effects, do not drive or operate machinery.

Meloxicam Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him/her 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

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

The recommended dose is:

Osteoarthritis flare-up (osteoarthritis):

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

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

Elderly patients

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

Renal impairment

If you are a patient undergoing dialysis with severe renal impairment, your dose must not exceed 7.5 mg (half a tablet) daily. In patients with mild to moderate renal impairment, dose reduction is not required.

Hepatic impairment

In patients with mild to moderate hepatic impairment, dose reduction is not required.

Use in children and adolescents

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

Consult your doctor or pharmacist if you feel that the effect of Meloxicam Normon 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 meals.

The tablet may be divided into equal doses.

If you take more Meloxicam 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.

Symptoms associated with acute NSAID overdose are usually limited to:

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

These symptoms usually improve when Meloxicam Normon is discontinued. Bleeding in the stomach or intestines (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

If you forget to take Meloxicam Normon

Do not take a double dose to make up for missed doses. Simply take the next dose at the 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, Meloxicam Normon may cause adverse effects, although not everyone experiences them.

Stop taking Meloxicam Normon and consult your doctor or go to the nearest hospital immediately 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 skin rashes that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), lesions in soft tissues (mucosal lesions), or erythema multiforme (see section 2).

Erythema multiforme is a serious skin allergic 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
• liver inflammation (hepatitis). This may cause symptoms such as:
  • yellowing of the skin and eyes (jaundice)
  • abdominal pain
  • loss of appetite

Any adverse effect related to the digestive system, especially:

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

Gastrointestinal bleeding, ulcer formation, or a hole in the digestive tract (perforation) may sometimes be severe and potentially fatal, particularly in elderly patients.

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

If you experience vision disturbances, 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 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 (edema), high blood pressure (hypertension), and heart failure (cardiac failure) have been reported with NSAID therapy.

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

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

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

• nausea and vomiting
• loose stools (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 gastrointestinal 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, loose stools (diarroea)

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 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)
• water and sodium retention
• increased potassium levels (hyperkalaemia). This may cause symptoms such as:
  • changes in heart rhythm (arrhythmias)
  • palpitations (feeling your heartbeat more than usual)
  • muscle weakness
• belching
• stomach inflammation (gastritis)
• gastrointestinal bleeding
• mouth inflammation (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• fluid retention-related 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 changes in liver function test values (e.g., increased levels of liver enzymes such as transaminases or increased levels of the bile pigment bilirubin). These may be detected by your doctor through 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
  • decreased number of white blood cells (leucopenia)
  • decreased 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)
• throat inflammation (oesophagitis)
• 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)
• urticaria
• vision disturbances 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

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

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

• liver inflammation (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)

Adverse effects with unknown frequency: frequency 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 insufficiency) has been reported with NSAID therapy
• complete loss of certain types of white blood cells (agranulocytosis), particularly in patients taking Meloxicam Normon together with other drugs that may inhibit, suppress, or potentially destroy a component 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 typically recurs at the same site upon re-exposure to the drug and may appear as round or oval-shaped patches with redness and swelling of the skin, blistering (urticaria), and itching

Adverse effects caused by other non-steroidal anti-inflammatory drugs (NSAIDs), not yet observed after taking Meloxicam Normon

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, talk to your doctor, pharmacist, or nurse, 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 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 expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meloxicam Normon

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

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

Appearance of the product and contents of the pack

Meloxicam Normon 15 mg tablets are presented as cylindrical, biconvex, scored yellow tablets. The tablet can be divided into equal doses.

Each pack contains 20 tablets.

Marketing Authorisation 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 most recent revision of this leaflet: June 2023

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