Meloximed Forte

Leaflet attached to the packaging: patient information

MeloxiMed Forte, 15 mg, tablets

Meloxicam

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is MeloxiMed Forte and what is it used for
• 2. Important information before taking MeloxiMed Forte
• 3. How to take MeloxiMed Forte
• 4. Possible side effects
• 5. How to store MeloxiMed Forte
• 6. Package contents and other information

1. What is MeloxiMed Forte and what is it used for

MeloxiMed Forte contains the active substance meloxicam. Meloxicam belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.
MeloxiMed Forte is intended for adults and adolescents aged 16 and over.
MeloxiMed Forte is used:

• for short-term treatment of exacerbations of osteoarthritis,
• for long-term treatment of:
• rheumatoid arthritis,
• ankylosing spondylitis.

2. Important information before taking MeloxiMed Forte

When not to take MeloxiMed Forte

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• If the patient is in the last three months of pregnancy.
• If the patient is under 16 years of age.
• If the patient has experienced any of the following symptoms after taking aspirin or other non-steroidal 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 after previous NSAID treatment.
• If the patient currently has peptic ulcer or gastrointestinal bleeding.
• If the patient has had peptic ulcer or gastrointestinal bleeding (ulcer or bleeding that has occurred at least twice).
• If the patient has severe liver dysfunction.
• In non-dialyzed patients with severe renal impairment.
• 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.
• If the patient has intolerance to some sugars - the product contains lactose (see also "MeloxiMed Forte contains lactose monohydrate and sodium").

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 MeloxiMed Forte 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, previous stroke or suspected risk of these disorders, the patient should discuss the treatment with their doctor or pharmacist. For example, if the patient has high blood pressure (hypertension), high blood sugar (diabetes), high cholesterol (hypercholesterolemia), or if the patient smokes, they should consult their doctor or pharmacist.
With the use of MeloxiMed Forte, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red spots or round patches on the torso, often with central blisters.
Additional symptoms that may be observed include oral 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 shedding. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome, toxic epidermal necrolysis while taking MeloxiMed Forte, meloxicam treatment should not be resumed.
In case of rash or the above symptoms, the patient should stop taking MeloxiMed Forte and seek medical attention immediately, informing their doctor about taking this medicine.
Before starting MeloxiMed Forte, the patient should discuss it with their doctor if they have ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam).
The patient should stop taking MeloxiMed Forte immediately if they notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
MeloxiMed Forte is not recommended for the treatment of acute pain attacks.
The patient should not take this medicine with other non-steroidal anti-inflammatory drugs (NSAIDs).
MeloxiMed Forte may mask infection symptoms (e.g., fever).
If the patient suspects an infection, they should consult their doctor.
MeloxiMed Forte may affect fertility. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Precautions for use

Due to the need to modify treatment, the patient should consult their doctor before starting MeloxiMed Forte if:

• they have a history of esophagitis, gastritis, or any other gastrointestinal disease, such as ulcerative colitis, Crohn's disease,
• they have high blood pressure (hypertension),
• they are elderly,
• they have heart, liver, or kidney disease,
• they have high blood sugar (diabetes),
• they have decreased blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake,
• they have high potassium levels in the blood, previously diagnosed by a doctor
• they have intolerance to some sugars, diagnosed by a doctor, as the medicine contains lactose.

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

MeloxiMed Forte and other medicines

MeloxiMed Forte may affect the action of other medicines taken, and other medicines may affect the action of MeloxiMed Forte.
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 patient should inform their doctor or pharmacist if they are taking:

• other non-steroidal 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;
• anticoagulants;
• medicines that dissolve blood clots (thrombolytic agents);
• medicines used to treat heart and kidney diseases;
• corticosteroids (e.g., used 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;
• diuretics - the doctor may monitor kidney function when taking diuretics;
• medicines used to treat high blood pressure (e.g., beta-blockers);
• 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 drugs (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels to detect potential hypoglycemia.

Taking MeloxiMed Forte with food and drink

Food does not reduce the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should not take MeloxiMed Forte if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
MeloxiMed Forte may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not take MeloxiMed Forte unless their doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, MeloxiMed Forte, if taken for more than a few days, may cause kidney problems in the unborn child (which may lead to low amniotic fluid levels around the baby) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is required for a longer period than a few days, the doctor may recommend additional monitoring.
Breastfeeding
This medicine is not recommended for women who are breastfeeding.
Fertility
See section "Warnings and precautions".

Driving and using machines

After taking MeloxiMed Forte, the patient may experience vision disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders.
The patient should not drive or operate machinery in such cases.

MeloxiMed Forte contains lactose monohydrate and sodium

Lactose monohydrate
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), which means the medicine is considered "sodium-free".

3. How to take MeloxiMed Forte

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended doses:

Exacerbations of osteoarthritis:

7.5 mg once a day. The dose may be increased to 15 mg once a day.

Rheumatoid arthritis:

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

Ankylosing spondylitis:

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

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

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

Elderly patients

The recommended dose for elderly patients in long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg per day.

Patients at increased risk of side effects

In patients at increased risk of side effects, treatment should be started with a dose of 7.5 mg per day.

Renal impairment

In dialyzed patients with severe renal impairment, the dose should not exceed 7.5 mg per day. Dose reduction is not necessary in patients with mild or moderate renal impairment.

Hepatic impairment

Dose reduction is not necessary in patients with mild or moderate hepatic impairment.

Use in children and adolescents

MeloxiMed Forte should not be used in children and adolescents under 16 years of age.
If the patient thinks the effect of MeloxiMed Forte 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.
Method of administration
Oral use.
The tablets should be swallowed with water, during a meal.
The tablet can be divided into equal doses.

Taking a higher dose of MeloxiMed Forte than recommended

In case of taking a higher dose of MeloxiMed Forte than recommended or suspected overdose, the patient should immediately consult their 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 disappear after stopping MeloxiMed Forte. The patient may experience gastrointestinal bleeding.

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

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

Missing a dose of MeloxiMed Forte

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose at the scheduled time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, MeloxiMed Forte can cause side effects, although not everybody gets them.

The patient should stop taking MeloxiMed Forte immediately 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 and 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 may also occur on the lips, eyes, and other moist body parts;
• skin or mucous membrane swelling, 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, which may cause symptoms such as: yellowing of the skin and eyes (jaundice), abdominal pain, loss of appetite.
• any symptoms of gastrointestinal side effects, in particular bleeding (causing black stools), abdominal pain (which may be a sign of gastrointestinal ulceration). Gastrointestinal bleeding, ulcers, or perforation may have a severe course and can be 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.

Common side effects of NSAIDs

The use of some NSAIDs may be associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke), especially when taken in high doses and for long-term treatment.
NSAID treatment has been associated with reports of edema, hypertension, and heart failure.

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

gastrointestinal disorders:gastric or duodenal ulcer, perforation of the gastrointestinal tract, or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).
The following side effects have been reported with NSAIDs:nausea (nausea) and vomiting, diarrhea, flatulence, bloating, constipation, indigestion (dyspepsia), abdominal pain, black stools due to gastrointestinal bleeding, vomiting blood, oral ulcers, exacerbation 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 MeloxiMed Forte

Very common(may occur in more than 1 in 10 patients):

• indigestion (dyspepsia),
• nausea (nausea) and vomiting,
• abdominal pain,
• constipation,
• bloating,
• diarrhea.

Common(may occur in up to 1 in 10 patients):

• headache.

Uncommon(may occur in up to 1 in 100 patients):

• dizziness (feeling of emptiness in the head),
• dizziness or feeling of spinning (vertigo),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• increased blood pressure (hypertension),
• flushing (transient flushing of the face and neck),
• sodium and water retention,
• increased potassium levels in the blood (hyperkalemia); This may lead to symptoms such as arrhythmias, palpitations (when the patient feels their heartbeat more than usual), muscle weakness,
• belching,
• gastritis,
• gastrointestinal bleeding,
• oral mucosal inflammation,
• 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 changes in liver function tests (e.g., increased liver enzyme activity, such as transaminases, or increased bilirubin levels); the doctor may detect these changes with a blood test,
• abnormal kidney function tests (e.g., increased creatinine or urea levels).

Rare(may occur in up to 1 in 1,000 patients):

• mood disorders,
• nightmares,
• blood 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),
• palpitations (feeling of heartbeat),
• gastric or duodenal ulcer,
• esophagitis,
• asthma attacks (in patients allergic to aspirin or other NSAIDs),
• blistering skin reactions or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• vision disturbances, including: blurred vision, conjunctivitis (inflammation of the eye or eyelids),
• colitis (inflammation of the colon).

Very rare(may occur in up to 1 in 10,000 patients):

• blistering skin reactions and erythema multiforme; Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin; it may also occur on the lips, eyes, and other moist body parts.
• liver inflammation; This may cause symptoms such as: yellowing of the skin and eyes (jaundice), abdominal pain, loss of appetite,
• acute renal 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) rash caused by exposure to sunlight (photosensitivity reactions),
• heart failure reported with NSAID use,
• pancreatitis,
• female infertility, delayed ovulation;
• a characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same place (in the same places) after re-administration of the medicine and may appear as itchy, round or oval, red and swollen spots on the skin, blisters (hives).
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking MeloxiMed Forte with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic drugs).
  This may cause: sudden fever, sore throat, infections.

  Side effects caused by NSAIDs but not yet reported with MeloxiMed Forte:

  • acute renal failure due to changes in kidney structure,
  • very rarely, 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
  Al. Jerozolimskie 181C,
  02-222 Warsaw,
  tel.: +48 (22) 49 21 301,
  fax: +48 (22) 49 21 309
  website: https://smz.ezdrowie.gov.pl/
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, it is possible to gather more information on the safety of the medicine.

  5. How to store MeloxiMed Forte

  The medicine should be stored out of sight and reach of children.
  There are no special storage instructions for the medicine.
  Do not use this medicine after the expiry date stated on the carton and blister pack (month/year). The expiry date refers to the last day of the month.
  The labeling used for the blister is: EXP - expiry date, Lot - batch number.
  The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

  6. Package contents and other information

  What MeloxiMed Forte contains

  • The active substance of the medicine is meloxicam. Each tablet contains 15 mg of meloxicam.
  • The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium citrate, crospovidone Type A.

  What MeloxiMed Forte looks like and contents of the pack

  PVC/PVDC/Aluminum blister pack in a cardboard box.
  The package contains: 10 tablets (1 blister of 10); 20 tablets (2 blisters of 10); 30 tablets (3 blisters of 10).

  Marketing authorization holder and importer

  Marketing authorization holder

  US Pharmacia Sp. z o.o.
  Ziębicka 40

  • 50 - 507 Wrocław

  Importer

  Niche Generics Limited
  Unit 5, 151 Baldoyle Industrial Estate, Dublin 13
  Ireland
  To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
  USP Zdrowie Sp. z o.o.
  Poleczki 35

  • 02 - 822 Warsaw tel. +48 (22) 543 60 00

  Date of last revision of the leaflet: