Package leaflet: Information for the patient

Meloxicam Genoptim, 15 mg, tablets
Meloxicamum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Meloxicam Genoptim is and what it is used for
What you need to know before taking Meloxicam Genoptim
How to take Meloxicam Genoptim
Possible side effects
How to store Meloxicam Genoptim
Contents of the pack and other information

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

Meloxicam Genoptim contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and relieve joint and muscle pain.
Meloxicam Genoptim is used:

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

2. Important information before using Meloxicam Genoptim

When not to use Meloxicam Genoptim:

In pregnant women during 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 non-steroidal anti-inflammatory drugs (NSAIDs)
If the patient has experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
Wheezing, tightness in the chest, shortness of breath (asthma)
Nasal congestion due to swelling of the nasal mucosa (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 possibly make breathing difficult (angioedema)
If the patient has previously experienced the following during treatment with NSAIDs:
Bleeding from the stomach or intestines
Perforation of the stomach or intestines
If the patient currently has a peptic ulcer or bleeding from the stomach or intestines
If the patient has previously had a peptic ulcer or gastrointestinal bleeding or bleeding (peptic ulcer or bleeding occurring at least twice)
If the patient has severe liver function disorders
In non-dialysed patients with severe renal insufficiency
If the patient has recently experienced bleeding in the brain (cerebral haemorrhage)
If the patient has any other bleeding disorders
If the patient has severe heart failure
In case of intolerance to certain sugars – the product contains lactose (see also Meloxicam Genoptim contains monohydrate lactose)

If the patient is unsure whether any of the above points apply,
contact a doctor.
Warnings and precautions
Warnings
Taking medicines such as 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 use higher doses or longer treatment duration
than recommended (see section 3).
If the patient has heart problems, a history of stroke, or suspects that there is a risk
of these disorders, discuss the treatment approach 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 tobacco.

The use of Meloxicam Genoptim should be discontinued immediately upon noticing bleeding
(causing tarry stools) or gastrointestinal ulceration
(causing abdominal pain).
Serious, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Genoptim. These initially appear as red spots or round lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms.
The rash may progress to generalized blisters or detachment of the epidermis. The highest risk of severe skin reactions occurs during the first weeks of treatment.
Patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Meloxicam Genoptim must not resume treatment with meloxicam.
If a rash or the above symptoms occur, discontinue use of Meloxicam Genoptim immediately and seek medical advice without delay, 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 symptoms of infection (e.g. fever). If the patient suspects an infection, they should contact a doctor.
Precautions for use
Due to the need for treatment adjustments, consult a doctor before starting Meloxicam Genoptim in the following cases:

History of oesophagitis, gastritis, or any other gastrointestinal disorder, e.g. Crohn's disease or ulcerative colitis,
High blood pressure (hypertension),
Use in elderly patients,
Heart, liver or kidney disease,
High blood glucose (diabetes),
Reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgical procedures, or low fluid intake,
Diagnosed intolerance to certain sugars, as the medicine contains lactose,
Previously diagnosed high potassium levels in the blood.

In the above cases, the doctor will monitor the treatment outcomes.
Before starting Meloxicam Genoptim, discuss this with a doctor, pharmacist, or nurse.
Meloxicam Genoptim and other medicines
Meloxicam Genoptim may affect the action of other medicines being used, and other medicines may affect the action of Meloxicam Genoptim.
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the following medicines are being used:

Other non-steroidal anti-inflammatory drugs (NSAIDs)
Potassium salts – used to treat low potassium levels in the blood
Tacrolimus – used after organ transplantation
Trimethoprim – used to treat urinary tract infections
Anticoagulant medicines
Medicines that dissolve blood clots (thrombolytic agents)
Medicines used for heart and kidney diseases
Corticosteroids (e.g. used for anti-inflammatory or allergic reactions)
Cyclosporine – used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
Deferasirox – used to treat iron overload after frequent blood transfusions
Diuretics – the doctor may monitor kidney function when diuretics are used
Medicines used to treat high blood pressure (e.g. beta-blockers, ACE inhibitors, angiotensin II receptor antagonists)
Lithium – used to treat psychiatric disorders
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 antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood glucose levels for signs of hypoglycaemia.

If in doubt about using Meloxicam Genoptim, consult
a doctor or pharmacist.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using 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 child or cause complications during
delivery. Meloxicam Genoptim may cause kidney and heart function disorders in the
unborn child. It may increase the tendency to bleeding in both the mother and the child and
may delay or prolong labour.
During the first 6 months of pregnancy, Meloxicam Genoptim should not be used unless the doctor
considers it absolutely necessary. If treatment is required during this period or when trying to conceive,
the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy,
Meloxicam Genoptim may cause kidney function disorders in the unborn child if taken for
longer than a few days – this may lead to low levels of amniotic fluid surrounding the child (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Meloxicam Genoptim is not recommended for breastfeeding women.
Fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs, which may adversely
affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. If
the patient plans pregnancy or has difficulty conceiving, she should inform the doctor about the use of Meloxicam Genoptim.
Driving and operating machinery
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 monohydrate lactose
If intolerance to certain sugars has been previously diagnosed in the patient, the patient should
contact a doctor before taking the medicine.
Meloxicam Genoptim contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Meloxicam Genoptim

This medicine should always be used exactly as directed by your doctor. If in doubt,
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 which may be more suitable.
Do not exceed the maximum recommended dose of 15 mg per day.
If any of the conditions listed in section “Warnings and precautions” apply to the patient,
the doctor may reduce the dose to 7.5 mg per day.
Use in children and adolescents
Meloxicam Genoptim must not be used in children and adolescents under 16 years of age.
If the patient feels that the effect of Meloxicam Genoptim is too strong or too weak, or if
no improvement is felt after a few days, the patient should contact their doctor or
pharmacist.
This medicine is for oral use.
The total daily dose should be taken once daily, with water or another liquid, during a meal.
Taking more Meloxicam Genoptim than recommended
If more than the recommended dose of Meloxicam Genoptim has been taken or
overdose is suspected, seek immediate medical advice from a doctor or go to the
nearest hospital emergency department.
Symptoms of overdose with NSAIDs are usually limited to:

weakness (feeling of lack of energy),
drowsiness,
nausea and vomiting,
stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Meloxicam Genoptim. The patient may experience gastrointestinal bleeding (bleeding from the stomach or intestines).

Severe poisoning may lead to serious adverse reactions (see also section 4):

increased blood pressure (hypertension),
acute kidney failure,
liver function disorders,
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.
If there are any further doubts about the use of this medicine,
consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking Meloxicam Genoptim and consult a doctor or the nearest hospital immediately if any of the following occur:
Any allergic (hypersensitivity) reactions, which may manifest as:

Skin reactions such as itching (pruritus), blistering and peeling of the skin, which may potentially be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple rashes, or blisters on the skin. It may also appear on the lips, 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, which may make breathing difficult, swelling of the ankles and legs (peripheral edema);
Shortness of breath or asthma attack;
Hepatitis. This may cause symptoms such as:
Yellowing of the skin and whites of the eyes (jaundice),
Abdominal pain,
Loss of appetite.

Any adverse gastrointestinal symptoms, and in particular:

Bleeding (causing black, tarry stools),
Gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding, ulceration, or perforation may occasionally be severe and potentially fatal, especially in elderly patients.
If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, the patient should seek immediate medical advice, especially if elderly. The doctor may monitor the progress of treatment.
General adverse effects associated with the use of non-steroidal
anti-inflammatory drugs (NSAIDs)
The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g. heart attack or stroke), particularly when used at high doses or for prolonged periods.
Edema, hypertension, and heart failure have been reported during NSAID therapy.
The most commonly observed adverse effects involve the gastrointestinal tract (stomach and intestinal disturbances):

Peptic ulcer disease of the stomach and duodenum,
Intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse effects 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,
Vomiting blood,
Ulcerative stomatitis,
Exacerbation of gastrointestinal inflammation (e.g. flare-up of colitis or Crohn's disease).

Gastritis has been observed less frequently.
Adverse effects of meloxicam – the active substance in Meloxicam Genoptim
Very common: affecting more than 1 in 10 patients

Gastrointestinal disturbances such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, bloating, loose stools (diarrhea)
Common: affecting 1 in 100 patients
Headache
Uncommon: affecting 1 in 1,000 patients
Dizziness (feeling of emptiness in the head)
Dizziness or sensation of spinning (vestibular origin)
Somnolence (drowsiness)
Anaemia (reduced concentration of the red blood pigment - haemoglobin)
Increased blood pressure (hypertension)
Facial flushing (temporary redness of the face and neck)
Sodium and water retention
Increased potassium levels (hyperkalemia). This may lead to symptoms such as:
Heart rhythm disturbances
Palpitations (when the patient feels the heartbeat more than usual)
Muscle weakness
Regurgitation (backflow of stomach contents into the oesophagus)
Gastritis
Gastrointestinal bleeding
Inflammation of the oral mucosa
Immediate hypersensitivity reactions (allergy)
Itching
Skin rash
Fluid retention-related edema, including swelling of ankles/legs (peripheral edema)
Sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may impair breathing (angioedema)
Transient abnormalities in liver function tests (e.g. increased activity of liver enzymes such as aminotransferases or increased levels of bile pigment - bilirubin). These changes may be detected by the doctor through blood tests.
Abnormalities in kidney function laboratory tests (e.g. increased creatinine or urea levels)
Rare: affecting 1 in 10,000 patients
Mood disturbances
Nightmares
Blood morphology disorders, including:
Abnormal blood smear
Decreased white blood cell count (leukopenia)
Decreased platelet count (thrombocytopenia) These adverse effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
Tinnitus (ringing in the ears)
Palpitations (awareness of heartbeat)
Peptic ulcer disease of the stomach or duodenum
Oesophagitis
Onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs)
Skin blistering or epidermal detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis)
Urticaria (hives)
Visual disturbances, including:
Blurred vision If treatment with Meloxicam Genoptim causes visual disturbances, patients should not drive or operate machinery.
Conjunctivitis (inflammation of the eyeball or eyelids)
Colitis (inflammation of the large intestine)
Very rare: affecting fewer than 1 in 10,000 patients
Bullous skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple rashes, or blisters on the skin. It may also appear on the lips, eyes, and other moist areas of the body.
Hepatitis. This may cause symptoms such as:
Yellowing of the skin and whites of the eyes (jaundice)
Abdominal pain
Loss of appetite
Acute renal failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease
Intestinal wall perforation

Frequency unknown: frequency cannot be estimated from the available data

Confusion
Disorientation
Shortness of breath and skin reactions (anaphylactic and/or anaphylactoid), skin rashes due to exposure to sunlight (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 together with other medicines that potentially have myelosuppressive or bone marrow-damaging effects (myelotoxic drugs). This may result in:
Sudden fever
Sore throat
Infections
Pancreatitis
Infertility in women, delayed ovulation.

Adverse effects caused by non-steroidal anti-inflammatory drugs (NSAIDs),
but not yet reported after use of Meloxicam Genoptim:
Acute renal failure due to structural kidney changes:

Very rare cases of kidney inflammation (interstitial nephritis),
Death of certain kidney cells (acute necrosis of glomeruli or renal papillae),
Presence of protein in urine (nephrotic syndrome with proteinuria).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse effects can also be reported to the marketing authorization holder or its representative.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Meloxicam Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging following: EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: corn starch, pregelatinized corn starch 1500, colloidal anhydrous silica, 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, biconvex, uncoated tablets with a central break line on one side and the imprint "15" on the other side.
The break line on the tablet is intended only to facilitate breaking for ease of swallowing and does not ensure equal dose division.
Meloxicam Genoptim is available in PVC/PVDC/Al blisters in cardboard packaging.
Meloxicam Genoptim 15 mg tablets are available in packs containing 10 and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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