Meloxicam Genoptim

Leaflet accompanying the packaging: patient information

Meloxicam Genoptim, 15 mg, tablets

Meloxicam

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Meloxicam Genoptim 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 Genoptim is used:

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

2. Important information before taking Meloxicam Genoptim

When not to take Meloxicam Genoptim:

• 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 any of the following after previous NSAID therapy:
• stomach or intestinal bleeding
• perforation of the stomach or intestine
• If the patient currently has stomach or intestinal ulcers or bleeding
• If the patient has had stomach or intestinal ulcers or bleeding (ulcer disease or bleeding that has occurred at least twice)
• If the patient has severe liver dysfunction
• In patients with severe kidney impairment who are not on dialysis
• If the patient has recently experienced bleeding in the brain (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 Genoptim 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 Genoptim 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. Do not exceed the recommended dose and duration of treatment (see section 3).

In case of heart problems, a history of stroke, or suspected risk of these disorders, consult a doctor or pharmacist.

For example, if:

• 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.

Stop taking Meloxicam Genoptim immediately if bleeding (causing black stools) or gastrointestinal ulcers (causing stomach pain) occur.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Genoptim, 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, genital, and conjunctival inflammation (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 peeling. 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 Genoptim, meloxicam treatment should not be restarted.

If a rash or the above symptoms occur, stop taking Meloxicam Genoptim and seek medical attention immediately, informing the doctor about the use of this medicine.

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

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

Precautions for use

Due to the need to modify treatment, consult a doctor before starting Meloxicam Genoptim 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,
• previously diagnosed high potassium levels in the blood.

In these cases, the doctor will monitor the treatment results.

Before starting Meloxicam Genoptim, consult a doctor, pharmacist, or nurse.

Meloxicam Genoptim and other medicines

Meloxicam Genoptim may affect the action of other medicines, and other medicines may affect the action of Meloxicam Genoptim.

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

In particular, inform the doctor or pharmacist 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
• trimethoprim - used to treat urinary tract infections
• anticoagulant medicines
• medicines that dissolve blood clots (thrombolytic medicines)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g., used as anti-inflammatory or to treat allergic reactions)
• cyclosporine - used after organ transplants or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• deferazirox - used to treat iron overload after frequent blood transfusions
• diuretic medicines - the doctor may monitor kidney function when taking diuretic medicines
• 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
• oral anti-diabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood sugar levels to detect hypoglycemia.

In case of doubts about taking Meloxicam Genoptim, consult a 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 a doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Meloxicam Genoptim if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Meloxicam Genoptim 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.

During the first 6 months of pregnancy, do not take Meloxicam Genoptim unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Meloxicam Genoptim 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 Genoptim 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 trouble conceiving, they should tell their doctor about taking Meloxicam Genoptim.

Driving and using machines

Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders, may occur after taking Meloxicam Genoptim.

If these symptoms occur, do not drive or operate machinery.

Meloxicam Genoptim contains lactose monohydrate

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

Meloxicam Genoptim 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 Genoptim

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

Recommended doses:

Exacerbations of osteoarthritis:

7.5 mg once daily. The dose may be increased to 15 mg once daily.

Rheumatoid arthritis:

15 mg once daily. The dose may be reduced to 7.5 mg (once daily).

Ankylosing spondylitis:

15 mg once daily. The dose may be reduced to 7.5 mg (once daily).

This medicine is also available in other strengths that may be more suitable.

Do not exceed the recommended maximum dose of 15 mg per day.

If any of the conditions listed in the "Warnings and precautions" section apply to the patient, the doctor may reduce the dose to 7.5 mg per day.

Use in children and adolescents

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

If the patient thinks that the effect of Meloxicam Genoptim 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.

Take the medicine orally.

Take the entire daily dose once, with water or another liquid, during a meal.

Taking a higher dose of Meloxicam Genoptim than recommended

In case of taking a higher dose of Meloxicam Genoptim than recommended or suspected overdose, seek medical attention immediately 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,
• stomach pain (in the abdomen). These symptoms usually disappear after stopping Meloxicam Genoptim. The patient may experience stomach or intestinal bleeding (gastrointestinal bleeding).

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 Genoptim

Do not take a double dose to make up for a missed dose.

Take the next dose at the scheduled time.

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking Meloxicam Genoptim and consult a doctor or the nearest hospital immediately if:

Any allergic reactions (hypersensitivity) occur, 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), tissue damage (mucosal lesions), or erythema multiforme (see also 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 ankles and feet (peripheral edema);
• shortness of breath or asthma attack;
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• stomach pain,
• loss of appetite.

Any symptoms of gastrointestinal side effects, in particular:

• bleeding (causing black stools),
• ulcers in the gastrointestinal tract (causing stomach pain).

Gastrointestinal bleeding, ulcers, 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 a doctor, especially if they are elderly. The doctor may monitor the treatment progress.

General 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 (e.g., heart attack or stroke), especially when used in high doses and for long-term treatment.

NSAID treatment has been associated with reports of edema, high blood pressure, and heart failure.

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

• stomach or duodenal ulcers,
• perforation of the intestine or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting,
• diarrhea,
• gas and bloating,
• constipation,
• indigestion (dyspepsia),
• stomach 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).

Liver inflammation has been observed less frequently.

Side effects of meloxicam - the active substance of Meloxicam Genoptim

Very common: occurring in more than 1 in 10 patients

• gastrointestinal disorders, such as indigestion (dyspepsia), nausea (nausea), and vomiting, stomach pain, constipation, bloating, 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 in the blood (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 ankle and foot swelling (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.
• kidney function test abnormalities (e.g., increased creatinine or urea levels)

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

• mood disorders
• nightmares
• blood disorders, including:
• abnormal blood smear
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia) These side effects can increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• palpitations (feeling of heartbeat more than usual)
• stomach or duodenal ulcers
• 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 Genoptim causes visual disturbances, do 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)
• stomach pain
• loss of appetite
• acute kidney failure, particularly in patients with risk factors such as heart disease, diabetes, or kidney disease
• perforation of the intestine

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 Genoptim with other medicines that may have a bone marrow suppressive effect (myelotoxic medicines). This can cause:
• sudden fever
• throat pain
• infections
• pancreatitis
• infertility in women, delayed ovulation.

Side effects of nonsteroidal anti-inflammatory drugs (NSAIDs) not yet reported with Meloxicam Genoptim:

Acute kidney failure due to changes in kidney structure:

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 or its representative.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Meloxicam Genoptim

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

Do not use this medicine 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. Ask the 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 Genoptim contains

• The active substance is meloxicam. One tablet contains 15 mg of meloxicam.
• The other ingredients are: cornstarch, pregelatinized cornstarch, colloidal silicon dioxide, sodium citrate, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

What Meloxicam Genoptim looks like and contents of the pack

Meloxicam Genoptim, 15 mg, tablets are yellow, round, flat, scored, uncoated tablets with a central division line on one side and the inscription "15" on the other side.

The division line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.

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

Meloxicam Genoptim, 15 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: