Difortan tabs

Patient Information Leaflet

Difortan TABS, 7.5 mg, tablets
Meloxicam
Please read this leaflet carefully before using 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 the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of Contents

1. What Difortan TABS is and what it is 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 pack and other information

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

Difortan TABS contains the active substance meloxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam has anti-inflammatory, analgesic, and antipyretic properties. It is used to reduce inflammation and relieve joint and muscle pain.

Indications for Difortan TABS
Difortan TABS is indicated as an analgesic and anti-inflammatory agent for bone, joint, and muscular pain associated with rheumatic and degenerative joint diseases.
Short-term treatment of exacerbations of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.

If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using Difortan TABS

When not to use 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 acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has experienced any of the following symptoms after taking aspirin or other 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 around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema).
• If the patient has previously experienced gastrointestinal bleeding or perforation of the stomach or duodenum during treatment with NSAIDs.
• If the patient has a history of peptic ulcer disease or gastrointestinal bleeding (ulcer disease or bleeding occurring at least twice).
• If the patient has severe liver function impairment.
• In non-dialysed patients with severe renal failure.
• If the patient has recently experienced bleeding in the brain (cerebral haemorrhage).
• If the patient has any other active bleeding.
• If the patient has severe heart failure.

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

Warnings and precautions

Warnings

Before starting treatment with Difortan TABS, consult a doctor or pharmacist.

Use of medicines such as 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. Do not use higher doses or longer treatment duration than recommended.

If the patient has heart problems, a history of stroke, or suspects they may be at risk of such conditions, they should discuss treatment options with a doctor or pharmacist. For example, if the patient has high blood pressure (hypertension), elevated blood glucose (diabetes), elevated blood cholesterol (hypercholesterolemia), or is a smoker, they should consult a doctor or pharmacist.

In case of serious allergic reactions, discontinue use of Difortan TABS immediately upon the first signs of skin rash, damage to soft tissues (mucosal damage), or any other allergic symptoms, and contact a doctor.

Before starting Difortan TABS, discuss with a doctor or pharmacist if the patient has ever experienced, after taking meloxicam or other oxicams (e.g. piroxicam), a persistent drug-induced erythema [circular or oval red and swollen skin lesions, usually recurring in the same location(s), blisters, urticaria, and itching].

Discontinue Difortan TABS immediately if gastrointestinal bleeding (leading to black, tarry stools) or abdominal pain (which may indicate gastrointestinal ulceration) occurs.

Difortan TABS is not recommended for the treatment of acute pain attacks.

Do not use this medicine together with other non-steroidal anti-inflammatory drugs (NSAIDs).

Difortan TABS may mask signs of infection (e.g. fever). If the patient suspects an infection, they should consult a doctor.

Difortan TABS may impair fertility. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving.

Precautions for use

Consult a doctor before using Difortan TABS if:

• The patient has previously had oesophagitis, gastritis, or any other inflammatory gastrointestinal condition, such as ulcerative colitis or Crohn's disease.
• The patient has high blood pressure (hypertension).
• The patient is elderly.
• The patient has heart, liver, or kidney disease.
• The patient has high blood glucose (diabetes).
• The patient has reduced blood volume (hypovolemia), e.g. due to significant blood loss, burns, surgery, or low fluid intake.
• The patient has been diagnosed with high blood potassium levels.

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

Children and adolescents

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

Difortan TABS and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Always consult a doctor when using any of the following medicines:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)
• Anticoagulants
• Medicines that dissolve blood clots (thrombolytics)
• Medicines used for heart or kidney diseases
• Corticosteroids (e.g. used for anti-inflammatory purposes or to treat allergic reactions)
• Cyclosporine – used after organ transplantation or in the treatment of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• Diuretics; the doctor may recommend monitoring kidney function when diuretics are used
• Medicines used to treat high blood pressure (e.g. beta-blockers)
• Lithium – used in the treatment of psychiatric disorders
• Selective serotonin reuptake inhibitors (SSRIs) – used to treat depression
• Methotrexate – used in the treatment of cancers, severe uncontrolled skin disease, or active rheumatoid arthritis
• Cholestyramine – used to reduce cholesterol levels
• If the patient uses an intrauterine contraceptive device (IUD)

Difortan TABS with food and drink

Take the medicine during a meal, with water or another liquid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Do not use Difortan TABS during the last three months of pregnancy, as the medicine may seriously affect the unborn child, particularly its cardiovascular and respiratory systems and kidneys, even after a single dose.

Do not take Difortan TABS if the patient is 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 both the mother and the child and may delay or prolong labour.

Difortan TABS should not be used during the first 6 months of pregnancy 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, Difortan TABS may cause kidney problems in the unborn child if used for more than a few days – this may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Use of Difortan TABS is not recommended in breastfeeding women.

Effect on fertility

See section Warnings and precautions.

Driving and operating machinery

After taking Difortan TABS, visual disturbances, drowsiness, dizziness, or other central nervous system disturbances may occur. In such cases, do not drive or operate machinery.

Difortan TABS contains lactose monohydrate and sodium

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

The medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 tablet), meaning the medicine is considered "sodium-free".

3. How to use Difortan TABS

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is taken orally.
Recommended dose
Use in adults
The recommended dose is 1 tablet (7.5 mg) once daily. Do not exceed a dose of 1 tablet per day
(7.5 mg). This medicine must not be taken for longer than 7 days without consulting a doctor.
Take the medicine during a meal, with water or another liquid.
Use in children and adolescents
This medicine should not be used in children and adolescents under 16 years of age.
Special patient groups
Elderly patients and patients at increased risk of adverse reactions
The recommended dose is 1 tablet per day.
Patients with renal impairment
In patients undergoing dialysis with severe renal impairment, the dose should not exceed
1 tablet per day.
Patients with hepatic impairment
Dose reduction is not required in patients with mild to moderate hepatic impairment.
This medicine is contraindicated in patients with severe hepatic impairment.
Taking more Difortan TABS than recommended
If you take more Difortan TABS than recommended, or suspect an overdose, contact a doctor
immediately or go to the nearest hospital emergency department.
Symptoms of overdose are usually limited to weakness (feeling of lack of energy), drowsiness,
nausea or vomiting, stomach pain (epigastric pain). These symptoms usually resolve after
discontinuation of Difortan TABS. Gastrointestinal bleeding (gastrointestinal hemorrhage) may occur.
Severe poisoning may lead to serious adverse effects:
elevated blood pressure (arterial hypertension), acute renal failure, hepatic 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
Do not take a double dose to make up for a missed dose.
Take the next dose at the scheduled time.

4. Possible adverse reactions

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

• Skin reactions such as itching (pruritus), blistering and peeling of the skin, which may be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), damage to soft tissues (lesions of mucous membranes), or erythema multiforme; erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin; it may also occur in the mouth, eyes and other moist areas of the body,
• Swelling of the skin or mucous membranes, e.g. swelling around the eyes, face and lips, swelling of the mouth or throat, which may make breathing difficult, swelling of the ankles and legs (peripheral oedema),
• 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 particularly bleeding (causing black, tarry stools), abdominal pain (which may indicate gastrointestinal ulceration).
Gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract may sometimes 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, particularly if the patient is elderly. The doctor may monitor the progress of treatment.
If taking Difortan TABS causes visual disturbances, do not drive or operate machinery.

General adverse reactions associated with NSAID use
The use of some NSAIDs may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke), particularly when used at high doses and for prolonged treatment.
Oedema, hypertension and heart failure have been reported during treatment with NSAIDs.

The most commonly observed adverse effects are gastrointestinal (stomach and intestinal disturbances): gastric and duodenal ulceration, intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse reactions have been reported following administration of NSAIDs: nausea and vomiting, diarrhoea, flatulence, constipation, indigestion (dyspepsia), abdominal pain, black tarry stools due to gastrointestinal bleeding, vomiting blood, oral ulceration, exacerbation of colitis, exacerbation of inflammatory bowel disease (e.g. exacerbation of ulcerative colitis or Crohn's disease). Gastritis has been observed less frequently.

Adverse reactions of meloxicam – the active substance in Difortan TABS

Very common (occurring in more than 1 in 10 patients):

• Indigestion (dyspepsia),
• Nausea and vomiting,
• Abdominal pain,
• Constipation,
• Flatulence,
• Diarrhoea.

Common (occurring in 1 to 10 in 100 patients):

• Headache.

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

• Dizziness (feeling of emptiness in the head),
• Dizziness or vertigo (vestibular origin),
• Somnolence (drowsiness),
• Anaemia (reduced haemoglobin concentration - the red pigment in blood),
• Increased blood pressure (hypertension),
• Facial flushing (transient redness of the face and neck),
• Sodium and water retention,
• Increased potassium levels (hyperkalaemia); this may lead to symptoms such as cardiac arrhythmias, palpitations (when the patient feels heartbeat more than usual), muscle weakness,
• Regurgitation (reflux of stomach contents into the oesophagus),
• Gastritis,
• Gastrointestinal bleeding,
• Inflammation of the oral mucosa,
• Immediate hypersensitivity reactions (hypersensitivity),
• Itching,
• Skin rash,
• Fluid retention-related oedema, including ankle/leg swelling (peripheral oedema),
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema),
• Transient abnormalities in liver function tests (e.g. increased liver enzyme activity such as aminotransferases, or increased levels of bile pigment - bilirubin); the doctor may detect these changes via blood tests,
• Kidney function disorders (e.g. increased creatinine or urea levels).

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

• Mood disturbances,
• Nightmares,
• Blood morphology disorders, including abnormal blood smear, reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia); these adverse reactions may lead to an increased risk of infection and symptoms such as bruising or nosebleeds,
• Tinnitus (ringing in the ears),
• Palpitations (sensation of rapid heartbeat),
• Gastric or duodenal ulcer disease,
• Oesophagitis,
• Onset of asthma attacks (in patients allergic to aspirin or other NSAIDs),
• Skin blistering or peeling of the epidermis (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• Urticaria,
• Visual disturbances, including blurred vision, conjunctivitis (inflammation of the eyeball or eyelids),
• Colitis.

Very rare (occurring in less 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 patches or blisters on the skin; it may also occur in the mouth, 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 not known (frequency cannot be estimated from available data):

• Confusion,
• Disorientation,
• Shortness of breath (dyspnoea) and skin reactions (anaphylactic or anaphylactoid reactions), skin rashes caused by 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 Difortan TABS together with other medicines that may suppress or damage bone marrow function (myelotoxic drugs); this may cause: sudden fever, sore throat, infections,
• Pancreatitis,
• A characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-exposure to the drug, and may appear as itchy, round or oval, red and swollen skin patches or blisters (urticaria).

Adverse reactions caused by NSAIDs but not yet documented after administration of Difortan TABS:

• Acute renal failure due to structural changes in the kidneys,
• Very rare cases of kidney inflammation (interstitial nephritis),
• Death of certain kidney cells (acute necrosis of glomeruli or renal papillae),
• Presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 (22) 49 21 301,
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl/
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Difortan TABS

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the outer carton and primary packaging (month/year). The expiry date refers to the last day of the specified month.
Blister pack labelling: EXP – expiry date, Lot – batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Difortan TABS contains

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

What Difortan TABS looks like and contents of the pack
PVC/PVDC/Aluminum blister in a cardboard box. The pack contains: 10 tablets (1 blister with
10 tablets); 20 tablets (2 blisters with 10 tablets each); 30 tablets (3 blisters with 10 tablets each).
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50 - 507 Wrocław
Importer
Niche Generics Limited
Unit 5, 151 Baldoyle Industrial Estate, Dublin 13
Ireland
For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35,
02 - 822 Warszawa
tel. +48 (22) 543 60 00