DIFORTAN 7.5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Difortan TABS, 7.5 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Difortan TABS and what is it used for
   1. Indications for use of Difortan TABS
4. Important information before taking Difortan TABS
   1. When not to take Difortan TABS
   2. Warnings and precautions
   3. Warnings
   4. Precautions for use
   5. Children and adolescents
   6. Difortan TABS and other medicines
   7. Difortan TABS with food and drink
   8. Pregnancy, breastfeeding, and fertility
   9. Pregnancy
   10. Breastfeeding
   11. Fertility
   12. Driving and using machines
   13. Difortan TABS contains lactose monohydrate and sodium
5. How to take Difortan TABS
   1. Recommended dose
   2. Use in adults
   3. Use in children and adolescents
   4. Special patient groups
   5. Overdose of Difortan TABS
   6. Missed dose of Difortan TABS
6. Possible side effects
   1. The patient should stop taking Difortan TABS and consult their doctor or the nearest hospital in case of:
   2. General side effects of NSAIDs
   3. The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):
   4. Side effects of meloxicam - the active substance of Difortan TABS
   5. Very common (more than 1 in 10 patients):
   6. Common (between 1 in 100 and 1 in 10 patients):
   7. Uncommon (between 1 in 1,000 and 1 in 100 patients):
   8. Rare (between 1 in 10,000 and 1 in 1,000 patients):
   9. Very rare (less than 1 in 10,000 patients):
   10. Frequency not known (frequency cannot be estimated from available data):
   11. Side effects caused by NSAIDs but not yet reported with Difortan TABS:
   12. Reporting side effects
7. How to store Difortan TABS
8. Contents of the packaging and other information
   1. What Difortan TABS contains
   2. What Difortan TABS looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. Marketing authorization holder
   5. Importer
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Difortan TABS, 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 advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should consult your pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Difortan TABS and what is it used for

Difortan TABS contains the active substance meloxicam, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic, and antipyretic effects. Meloxicam is used to reduce inflammation and pain in the joints and muscles.

Indications for use of Difortan TABS

As a pain reliever and anti-inflammatory agent used in musculoskeletal and joint pain in the course of rheumatoid and degenerative joint diseases.
Short-term treatment of exacerbations of degenerative joint disease, rheumatoid arthritis, or ankylosing spondylitis.
If there is no improvement after 7 days or if the patient feels worse, they should consult their doctor.

2. Important information before taking Difortan TABS

When not to take Difortan TABS

• If the patient is in the last three months of pregnancy.
• If the patient is 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 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 cause difficulty breathing (angioedema).
• If the patient has experienced gastrointestinal bleeding or perforation after previous NSAID treatment.
• If the patient has had stomach or duodenal ulcers or bleeding (ulcer disease 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 is unsure whether any of the above points apply to them, they should consult their doctor.

Warnings and precautions

Warnings

Before starting treatment with Difortan TABS, the patient should consult their doctor or pharmacist.
Taking medicines like Difortan TABS 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. The patient should not exceed the recommended dose and duration of treatment.
In case of heart problems, previous stroke, or suspected risk of these disorders, the patient should discuss their treatment with their doctor or pharmacist. For example, if the patient has high blood pressure (hypertension), high blood sugar (diabetes), high cholesterol (hypercholesterolemia), or smokes, they should consult their doctor or pharmacist.
In case of severe allergic reactions, the patient should stop taking Difortan TABS after the first symptoms of skin rash, soft tissue damage (mucosal lesions), or any other allergic symptoms and consult their doctor.
Before starting treatment with Difortan TABS, the patient should discuss it with their doctor or pharmacist if they have ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam), which are round or oval, red, and swollen spots on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.
The patient should stop taking Difortan TABS immediately if they notice bleeding (causing black stools) or abdominal pain (which may be a sign of gastrointestinal ulceration).
Difortan TABS is not recommended for the treatment of acute pain attacks.
The patient should not take this medicine with other nonsteroidal anti-inflammatory drugs (NSAIDs).
Difortan TABS may mask the symptoms of infection (e.g., fever). If the patient suspects they have an infection, they should consult their doctor.
Difortan TABS may make it difficult to get pregnant. The patient should inform their doctor if they plan to get pregnant or have problems getting pregnant.

Precautions for use

The patient should consult their doctor before taking Difortan TABS if:

• they have a history of esophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, 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), e.g., due to significant blood loss or burns, surgery, or low fluid intake,
• they have high potassium levels in the blood.

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

Children and adolescents

Difortan TABS should not be used in children and adolescents under 16 years of age.

Difortan TABS and other medicines

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.
The patient should always consult their doctor when taking the following medicines:

• other nonsteroidal anti-inflammatory drugs (NSAIDs),
• anticoagulants,
• medicines that dissolve blood clots (thrombolytics),
• medicines used to treat heart and kidney diseases,
• corticosteroids (e.g., used as anti-inflammatory or to treat allergic reactions),
• cyclosporine - used after organ transplantation or to treat severe skin diseases, rheumatoid arthritis, or nephrotic syndrome,
• diuretics; the doctor may recommend monitoring 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, severe uncontrolled skin disease, or active rheumatoid arthritis,
• cholestyramine - used to reduce cholesterol levels,

Difortan TABS with food and drink

The medicine should be taken during meals, with a glass of water or another liquid.

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

Difortan TABS should not be taken during the last three months of pregnancy, as it may have a serious effect on the fetus, especially on its cardiovascular and respiratory systems, as well as its kidneys, even after a single dose.
The patient should not take Difortan TABS if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Difortan TABS may cause kidney and heart problems in the unborn child.
It may increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Difortan TABS should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to get pregnant, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Difortan TABS may cause kidney problems in the unborn child if taken for more than a few days - this can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct in the child's heart.
If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Difortan TABS is not recommended for use in breastfeeding women.

Fertility

See section Warnings and precautions.

Driving and using machines

After taking Difortan TABS, the patient may experience vision disturbances, drowsiness, dizziness, or other central nervous system disorders. In this case, they should not drive or operate machinery.

Difortan TABS contains lactose monohydrate and sodium

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

3. How to take Difortan TABS

This medicine should always be taken exactly as described in this patient leaflet or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.

Recommended dose

Use in adults

The recommended dose is 1 tablet (7.5 mg) per day. The patient should not exceed the dose of 1 tablet per day (7.5 mg). The medicine should notbe taken for more than 7 dayswithout consulting a doctor.
The medicine should be taken during meals, with a glass of water or another liquid.

Use in children and adolescents

Difortan TABS should not be used in children and adolescents under 16 years of age.

Special patient groups

Patients who are elderly and patients with an increased risk of side effects
The recommended dose is 1 tablet per day.
Patients with renal impairment
In patients with severe renal impairment who are on dialysis, the dose should not exceed 1 tablet per day.
Patients with liver dysfunction
In patients with mild to moderate liver dysfunction, dose reduction is not necessary. In patients with severe liver dysfunction, the use of this medicine is contraindicated.

Overdose of Difortan TABS

In case of overdose or suspected overdose of Difortan TABS, the patient should immediately consult their doctor or go to the nearest hospital emergency department.
Overdose symptomsare usually limited to weakness (feeling of lack of energy), drowsiness, nausea, or vomiting, abdominal pain (which may be a sign of gastrointestinal ulceration). These symptoms usually resolve after discontinuation of Difortan TABS. The patient may experience gastrointestinal bleeding.
Severe poisoning can lead to serious side effects:high blood pressure (hypertension), acute kidney 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, or skin reactions.

Missed dose of Difortan TABS

The patient should not take a double dose to make up for a missed dose.
The next dose should be taken at the scheduled time.

4. Possible side effects

Like all medicines, Difortan TABS can cause side effects, although not everybody gets them.

The patient should stop taking Difortan TABS and consult their doctor or the nearest hospital in case of:

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

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (mucosal lesions), or drug rash; drug rash is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which 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, swelling of the mouth or throat, which may cause difficulty breathing, 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), 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, ulceration, or perforation can sometimes be severe and potentially life-threatening, especially in the elderly.
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.
If the patient experiences vision disturbances after taking Difortan TABS, they should not drive or operate machinery.

General side effects of NSAIDs

The use of some NSAIDs may be associated with a small increased risk of arterial thrombosis (arterial thrombosis), such as myocardial infarction or stroke, especially when the medicine is used 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 intestine disorders):

gastric and duodenal ulcers, perforation of the gastrointestinal tract, or gastrointestinal bleeding(sometimes fatal, especially in the elderly).
The following side effects have been reported with NSAIDs:nausea (nausea) and vomiting, diarrhea, bloating with gas, constipation, indigestion (dyspepsia), abdominal pain, black stools due to gastrointestinal bleeding, vomiting blood, oral mucosal inflammation, exacerbation of ulcerative colitis, exacerbation of Crohn's disease. Liver inflammation has been observed less frequently.

Side effects of meloxicam - the active substance of Difortan TABS

Very common (more than 1 in 10 patients):

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

Common (between 1 in 100 and 1 in 10 patients):

• headache.

Uncommon (between 1 in 1,000 and 1 in 100 patients):

• dizziness (feeling of emptiness in the head),
• vertigo or feeling of spinning (of labyrinthine origin),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• high blood pressure (hypertension),
• flushing (temporary flushing of the face and neck),
• retention of sodium and water,
• high potassium levels (hyperkalemia); this can lead to symptoms such as arrhythmias, palpitations (when the patient feels their heartbeat more than usual), muscle weakness,
• reflux (regurgitation of stomach contents into the esophagus),
• 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 cause difficulty breathing (angioedema),
• temporary disturbances in liver function tests (e.g., increased activity of liver enzymes, such as transaminases, or increased bilirubin levels); the doctor may detect these changes with a blood test,
• kidney function disorders (e.g., increased creatinine or urea levels).

Rare (between 1 in 10,000 and 1 in 1,000 patients):

• 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 fever, sore throat,
• ringing in the ears (tinnitus),
• palpitations (feeling of heartbeat),
• gastric or duodenal ulcers,
• esophagitis,
• asthma attacks (in patients allergic to aspirin or other NSAIDs),
• blistering skin reactions or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• vision disturbances, including blurred vision, conjunctivitis (inflammation of the eye or eyelids),
• colitis.

Very rare (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, which 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, especially in patients with risk factors such as heart disease, diabetes, or kidney disease,
• perforation of the gastrointestinal tract.

Frequency not known (frequency cannot be estimated from available data):

• confusion,
• disorientation,
• shortness of breath (dyspnea) and skin reactions (anaphylactic 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 Difortan TABS with other medicines that may suppress or destroy bone marrow (myelotoxic drugs); this can cause: sudden fever, sore throat, infections,
• pancreatitis,
• 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).

Side effects caused by NSAIDs but not yet reported with Difortan TABS:

• acute kidney failure due to changes in kidney structure,
• very rare cases of kidney inflammation (interstitial nephritis),
• rare cases of kidney cell death (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 possible side effects not listed in this leaflet, they should consult their doctor or pharmacist. 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.: +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 Difortan TABS

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
The patient should not use this medicine after the expiry date stated on the carton and blister packaging (month/year). The expiry date refers to the last day of the stated month.
The labeling on the blister is: EXP - expiry date, Lot - batch number.
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. Contents of the packaging and other information

What Difortan TABS contains

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

What Difortan TABS looks like and contents of the pack

PVC/PVDC/Aluminum blister pack in a carton. The pack 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
For more 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: