Meloxicam Apteo Med

Leaflet attached to the packaging: patient information

Meloxicam APTEO MED, 7.5 mg, tablets

Meloxicam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If additional advice or more information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Meloxicam APTEO MED and what is it used for
• 2. Important information before taking Meloxicam APTEO MED
• 3. How to take Meloxicam APTEO MED
• 4. Possible side effects
• 5. How to store Meloxicam APTEO MED
• 6. Contents of the pack and other information

1. What is Meloxicam APTEO MED and what is it used for

Meloxicam APTEO MED contains the active substance meloxicam. Meloxicam belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) used to reduce inflammation and pain in joints and muscles.

Meloxicam APTEO MED is used:

• for short-term symptomatic treatment of exacerbations of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis (also known as Bechterew's disease).

2. Important information before taking Meloxicam APTEO MED

When not to take Meloxicam APTEO MED:

• In the last three months of pregnancy
• In children and adolescents under 16 years of age
• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• If the patient is allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
• If the patient has experienced any of the following symptoms after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs):
• wheezing, feeling of tightness in the chest, shortness of breath (asthma)
• nasal congestion due to swelling of the nasal mucosa (nasal polyps)
• skin rash (hives)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema)
• If the patient has experienced:
• gastrointestinal bleeding or perforation
• If the patient currently has peptic ulcer or gastrointestinal bleeding
• If the patient has a history of peptic ulcer or gastrointestinal bleeding (peptic ulcer or bleeding that has occurred at least twice)
• If the patient has severe liver dysfunction
• In patients with severe renal impairment who are not on dialysis
• If the patient has recently experienced cerebral bleeding (cerebral hemorrhage)
• If the patient has experienced any other bleeding
• If the patient has severe heart failure
• In case of intolerance to some sugars - the product contains lactose (see also Meloxicam APTEO MED contains lactose monohydrate)

If the patient is unsure whether any of the above points apply to them, they should consult their doctor.

Warnings and precautions

Warnings

Taking medicines like Meloxicam APTEO MED may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Higher doses and longer treatment periods than recommended (see section 3) should not be used.

In case of heart problems, a history of stroke, or suspected risk of these disorders, the treatment should be discussed with a doctor or pharmacist.

For example, when:

• the patient has high blood pressure (hypertension)
• the patient has high blood sugar levels (diabetes)
• the patient has high cholesterol levels (hypercholesterolemia)
• the patient smokes

Meloxicam APTEO MED should be stopped immediately if bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain) occurs.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam APTEO MED, initially appearing as red spots or circular patches on the torso, often with central blisters. Additional symptoms that may be observed include mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may develop into generalized blisters or skin shedding. The highest risk of severe skin reactions occurs in the first few weeks of treatment.

In patients who have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Meloxicam APTEO MED, meloxicam treatment should not be restarted.

If a rash or the above symptoms occur, Meloxicam APTEO MED should be discontinued and medical advice should be sought immediately, informing the doctor about the use of this medicine.

Meloxicam APTEO MED is not recommended for the treatment of acute pain attacks.

Meloxicam APTEO MED may mask the symptoms of infection (e.g., fever). If the patient suspects an infection, they should consult their doctor.

Precautions for use

Due to the need to modify treatment, a doctor should be consulted before starting Meloxicam APTEO MED in the following cases:

• if the patient has a history of esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis,
• high blood pressure (hypertension),
• use in elderly patients,
• heart, liver, or kidney disease,
• high blood sugar levels (diabetes),
• reduced blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake,
• intolerance to certain sugars diagnosed by a doctor, as the medicine contains lactose,
• high potassium levels in the blood, previously diagnosed by a doctor. In these cases, the doctor will monitor the treatment results.

Before starting Meloxicam APTEO MED, the patient should discuss it with their doctor, pharmacist, or nurse.

Meloxicam APTEO MED and other medicines

Meloxicam APTEO MED may affect the action of other medicines, and other medicines may affect the action of Meloxicam APTEO MED.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, the doctor or pharmacist should be informed if the patient is taking any of the following medicines:

• other nonsteroidal anti-inflammatory drugs (NSAIDs)
• potassium salts - used to treat low potassium levels in the blood
• tacrolimus - used after organ transplants
• anticoagulants
• medicines that dissolve blood clots (thrombolytic agents)
• medicines used for heart and kidney diseases
• corticosteroids (e.g., used anti-inflammatory or to treat allergic reactions)
• cyclosporine - used after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• deferazirox - used to treat iron overload after frequent blood transfusions
• diuretics - the doctor may monitor kidney function when taking diuretics
• medicines used to treat high blood pressure (e.g., beta-blockers, ACE inhibitors, angiotensin II receptor antagonists)
• lithium - used to treat mental illnesses
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression
• methotrexate - used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis
• pemetrexed - used to treat cancer
• cholestyramine - used to reduce cholesterol levels
• trimethoprim - used to treat urinary tract infections
• oral anti-diabetic drugs (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for the occurrence of hypoglycemia.

In case of doubts about the use of Meloxicam APTEO MED, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Meloxicam APTEO MED should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Meloxicam APTEO MED may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor.

In the first 6 months of pregnancy, Meloxicam APTEO MED should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Meloxicam APTEO MED may cause kidney problems in the unborn baby if taken for more than a few days - this can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Meloxicam APTEO MED is not recommended for use in breastfeeding women.

Fertility

This medicine belongs to a group of nonsteroidal anti-inflammatory drugs that may adversely affect female fertility. This effect is temporary and reverses after stopping treatment. If the patient plans to become pregnant or is having problems becoming pregnant, they should inform their doctor about the use of Meloxicam APTEO MED.

Driving and using machines

Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders may occur after taking Meloxicam APTEO MED. If these symptoms occur, the patient should not drive or operate machinery.

Meloxicam APTEO MED contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

Meloxicam APTEO MED contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Meloxicam APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

The recommended dose is 1 tablet per day. The dose should not exceed 7.5 mg per day.

Without consulting a doctor, the patient should not take the medicine for more than 7 days.

Use in children and adolescents

Meloxicam APTEO MED should not be used in children and adolescents under 16 years of age.

If the patient thinks the effect of Meloxicam APTEO MED is too strong or too weak, or if they do not feel any improvement after a few days, they should consult their doctor or pharmacist.

The medicine is taken orally.

The total daily dose should be taken once, with water or another liquid, during a meal.

The dividing line on the tablet only facilitates breaking it, to facilitate swallowing, and not dividing it into equal doses.

Taking a higher dose of Meloxicam APTEO MED than recommended

In case of taking a higher dose of Meloxicam APTEO MED than recommended or suspected overdose, the patient should immediately consult a doctor or go to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy)
• drowsiness
• nausea and vomiting
• abdominal pain (in the upper abdomen). These symptoms usually resolve after stopping Meloxicam APTEO MED. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

Severe poisoning can lead to serious side effects of the medicine (see also section 4):

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

Missing a dose of Meloxicam APTEO MED

A double dose should not be taken to make up for a missed dose.

The next dose should be taken at the scheduled time.

In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Meloxicam APTEO MED can cause side effects, although not everybody gets them.

The patient should stop taking Meloxicam APTEO MED and consult their doctor or the nearest hospital immediately if they experience:

Any allergic reactions (hypersensitivity), which may manifest as:

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist body parts.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, and lips, mouth, or throat, which may make breathing difficult, swelling of the feet and ankles (peripheral edema)
• shortness of breath or asthma attack
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any symptoms of adverse reactions from the gastrointestinal tract, in particular:

• bleeding (causing black stools)
• ulceration of the gastrointestinal tract (causing abdominal pain).

Gastrointestinal bleeding, ulceration, or perforation can sometimes be severe and potentially life-threatening, especially in elderly patients. If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor the treatment progress.

Common side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (arterial occlusion), such as myocardial infarction or stroke, especially when used in high doses and for long-term treatment.

NSAID treatment has been associated with the occurrence of edema, hypertension, and heart failure.

The most commonly observed adverse reactions are related to the gastrointestinal tract (stomach and intestine disorders):

• peptic ulcer disease
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhea
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• vomiting blood
• mouth ulcers
• worsening of inflammatory bowel disease (e.g., exacerbation of ulcerative colitis or Crohn's disease)

Rarely, gastritis has been observed.

Side effects of meloxicam - the active substance of Meloxicam APTEO MED

Very common: occurring in more than 1 in 10 patients

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

Common: occurring in 1 to 10 patients in 100

• headaches

Uncommon: occurring in 1 to 10 patients in 1,000

• dizziness (feeling of emptiness in the head)
• dizziness or feeling of spinning (vertigo)
• drowsiness (somnolence)
• anemia (reduced hemoglobin levels)
• high blood pressure (hypertension)
• flushing (temporary flushing of the face and neck)
• fluid and sodium retention
• high potassium levels (hyperkalemia). This can lead to symptoms such as:
• heart rhythm disorders
• palpitations (feeling of heartbeat more than usual)
• muscle weakness
• reflux (regurgitation of food from the stomach into the esophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• edema caused by fluid retention, including swelling of the feet and ankles (peripheral edema)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema)
• temporary liver function test abnormalities (e.g., increased liver enzyme activity or bilirubin levels). The doctor may detect these changes with a blood test.
• abnormal kidney function test results (e.g., increased creatinine or urea levels)

Rare: occurring in 1 to 10 patients in 10,000

• mood disorders
• nightmares
• blood morphology disorders, including:
• abnormal blood smear
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia) These side effects may increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• feeling of heartbeat (palpitations)
• peptic ulcer disease
• esophagitis
• asthma attacks (in patients allergic to aspirin or other NSAIDs)
• blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• visual disturbances, including:
• blurred vision If Meloxicam APTEO MED causes visual disturbances, the patient should not drive or operate machinery.
• conjunctivitis (inflammation of the eye or eyelids)
• colitis (inflammation of the colon)

Very rare: occurring in less than 1 in 10,000 patients

• skin reactions with blisters and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes, and other moist body parts.
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure, particularly in patients with risk factors such as heart disease, diabetes, or kidney disease
• perforation of the intestinal wall

Frequency not known: frequency cannot be estimated from the available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid), sun-induced skin reactions (photosensitivity reactions)
• heart failure reported in association with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloxicam APTEO MED with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic drugs). This can cause:
• sudden fever
• throat pain
• infections
• pancreatitis
• infertility in women, delayed ovulation.

Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Meloxicam APTEO MED:

Acute kidney failure due to changes in kidney structure:

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

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Meloxicam APTEO MED

The medicine should be stored out of sight and reach of children.

This medicine should not be used after the expiry date stated on the blister and outer packaging after: EXP. The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Meloxicam APTEO MED contains

• The active substance of the medicine is meloxicam. One tablet contains 7.5 mg of meloxicam.
• The other ingredients are: cornstarch, pregelatinized cornstarch, sodium citrate, colloidal anhydrous silica, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

What Meloxicam APTEO MED looks like and contents of the pack

Meloxicam APTEO MED, 7.5 mg, tablets are yellow, round, flat, scored, uncoated tablets with a central dividing line on one side and the inscription 7.5 on the other side.

The dividing line on the tablet only facilitates breaking it, to facilitate swallowing, and not dividing it into equal doses.

Meloxicam APTEO MED is available in PVC/PVDC/Al blisters in a cardboard box.

Meloxicam APTEO MED, 7.5 mg, tablets are available in packs containing 10 and 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

tel.: 22 32 16 240

Importer:

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

Date of last revision of the leaflet: