Meloxicam Pensa 7.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meloxicam pensa 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 effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Meloxicam pensa 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 the joints and muscles.

Meloxicam is indicated in adults and children 16 years of age and older.

Meloxicam is used for:

• short-term treatment of osteoarthritis flare-ups

• long-term treatment of:

  • rheumatoid arthritis
  • ankylosing spondylitis.

2. What you need to know before taking Meloxicam Pensa

Do not take Meloxicam Pensa 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 or other NSAIDs:
  • wheezing, tightness in the chest, shortness of breath (asthma)
  • nasal congestion due to inflammation inside the nose (nasal polyps)
  • skin rash/urticaria
  • 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 NSAID therapy you experienced:
  • 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 gastrointestinal 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 Pensa 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 Pensa.

Warnings

Medicines like Meloxicam Pensa may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke ("cerebral infarction"). The risk is greater with higher doses and prolonged treatment. Do not take more than the recommended dose. Do not take Meloxicam Pensa for longer than prescribed (see section 3 “How to take Meloxicam Pensa”).

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 treatment with Meloxicam Pensa 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 Pensa, initially appearing as red spots or circular lesions, often with a central blister.

Other additional signs that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These potentially 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 taking Meloxicam Pensa, you must never use Meloxicam Pensa again. If you develop a rash or these skin symptoms, stop taking Meloxicam Pensa and seek immediate medical attention; inform the doctor that you are taking this medicine.

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

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

If you have ever experienced drug-induced fixed eruption (round or oval patches with redness and swelling of the skin that usually recur in the same location, blister formation, urticaria, and itching) after taking meloxicam or other oxicams (e.g., piroxicam), you should exercise caution.

Precautions for use

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

• have had inflammation of the throat (esophagitis), 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, as this medicine contains lactose
• have previously diagnosed high potassium levels in the blood. Your doctor will need to monitor your condition during treatment.

Taking Meloxicam Pensa with other medicines

Since Meloxicam Pensa 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 in the treatment of 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 medicines (“water pills”). 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 or active rheumatoid arthritis)
• pemetrexed (used in cancer treatment)
• cholestyramine (used to reduce cholesterol levels)
• oral antidiabetics (sulfonylureas, nateglinide) (used for diabetes treatment. 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 only prescribe this medicine 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 have serious or even fatal consequences for your fetus/child. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor beyond expected duration. 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 levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

If you have taken this medicine during pregnancy, you should immediately speak 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 effects. If you experience these effects, do not drive or operate machinery.

Meloxicam Pensa 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.

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

3. How to take Meloxicam pensa

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

Recommended dose:

Osteoarthritis flare-up:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

15 mg (two tablets) once daily. This may be reduced to 7.5 mg (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 elderly, 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.

Renal impairment

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

Hepatic impairment

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

Use in children and adolescents

Meloxicam must not be administered 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 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, as a single daily dose.

If you take more Meloxicam pensa 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 once meloxicam is discontinued. Gastrointestinal bleeding (bleeding in the stomach or intestines) may occur.

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

• high blood pressure (hypertension)
• acute kidney failure (renal)
• disturbances in 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 have taken more meloxicam than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Meloxicam pensa

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 Pensa and consult your doctor or 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 life-threatening skin rashes (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 swelling 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

• 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 system, especially:

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

Bleeding from the gastrointestinal tract (gastrointestinal hemorrhage), formation of ulcers, or a hole in the digestive tract (perforation) can sometimes be serious and potentially fatal, especially in elderly people.

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 while you are on 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 (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 with NSAID treatment.

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 bleeding from the digestive tract (sometimes fatal, especially in elderly people)

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 bleeding in the digestive tract (melena)
• vomiting blood (hematemesis)
• inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• worsening of inflammation in the digestive tract (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 Meloxicam Pensa

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (feeling faint)
• sensation of dizziness or spinning (vertigo)
• drowsiness (somnolence)
• anemia (reduction in the amount of the pigment in red blood cells called hemoglobin)
• increased blood pressure (hypertension)
• hot flushes (temporary reddening of the face and neck)
• water and sodium retention
• increased potassium levels (hyperkalemia). 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
• swelling due to fluid retention (edema), including swollen ankles/legs (edema of the lower limbs)
• 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). Your doctor may detect these through a blood test
• changes in kidney function laboratory tests (e.g., increased creatinine or urea)

Rare: 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 (leukopenia)
• decrease in the 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 (esophagitis)
• 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
• vision 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 people

• vesicular skin reactions (blister formation) 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.

• 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: 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 failure) has been described with NSAID treatment

• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloxicam Pensa 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 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, blister formation (urticaria), and itching.

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

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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 pensa

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 blister and the outer packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meloxicam pensa

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

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

Appearance of the product and contents of the pack

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

Meloxicam Pensa 7.5 mg tablets are available in packs containing 20 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Cinfa, S.A.
c/Olaz-Chipi, 10. 31620 Huarte- Pamplona

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

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