Package leaflet: Information for the user

Difortan tabs Max, 15 mg, tablets
Meloxicam
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 3 days, consult your doctor.

Contents of the leaflet

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

1. What Difortan tabs Max is and what it is used for

Difortan tabs Max 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.
The medicine has anti-inflammatory, analgesic, and antipyretic properties.

Indications for Difortan tabs Max:
This medicine is indicated in adults when the 7.5 mg dose of meloxicam has been insufficiently effective, for short-term treatment of flare-ups of rheumatic diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis, as an anti-inflammatory and analgesic agent for bone, joint, and muscular pain (e.g. back, spine, knee pain) associated with rheumatic and degenerative joint disorders.
Do not use for longer than 7 days without consulting a doctor.

WARNING: Difortan tabs Max should be taken only by patients in whom a dose of 7.5 mg meloxicam has not provided the expected pain relief.

2. Important information before using Difortan tabs Max

When not to use Difortan tabs Max

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 third trimester of pregnancy or is breastfeeding.
If the patient is under 18 years of age.
If the patient has experienced any of the following symptoms after taking acetylsalicylic acid (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 gastrointestinal bleeding or perforation of the stomach or intestines during treatment with NSAIDs.
If the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum (the patient has had at least two episodes of confirmed ulceration or bleeding).
If the patient has severe liver failure.
If the patient has severe renal failure and is not undergoing dialysis.
If the patient has had a haemorrhagic stroke (stroke) or any other bleeding, e.g. from the gastrointestinal tract.
If the patient has severe heart failure.
If the patient has intolerance to certain sugars – the product contains lactose (see also “Difortan tabs Max contains lactose monohydrate and sodium”).

If the patient is unsure whether any of the above points apply to them, they should
consult a doctor.
Warnings and precautions
Warnings
Difortan tabs Max is intended for patients in whom the 7.5 mg dose of meloxicam
has not provided the expected relief from pain.
Taking medicines such as Difortan tabs Max 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).
In case of heart problems, previous stroke or suspected risk of such disorders, discuss the treatment approach with a doctor or pharmacist. For example, if the patient has
high blood pressure (hypertension), elevated blood glucose levels (diabetes),
elevated blood cholesterol levels (hypercholesterolaemia), or if the patient smokes,
they should consult a doctor or pharmacist.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Difortan tabs Max, initially appearing as red spots or circular lesions on the trunk, often with central blisters.
Additional symptoms that may be observed include mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to generalized blisters or skin detachment. 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 Difortan tabs Max must not resume treatment with meloxicam.
If a rash or the above symptoms occur, discontinue use of Difortan tabs Max immediately and seek medical advice without delay, informing the doctor about taking this medicine.
Before starting Difortan tabs Max, discuss this with a doctor if the patient has ever experienced persistent drug eruption (erythema) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval, red and swollen skin lesions, usually recurring in the same location(s), blisters, urticaria, and itching].
Discontinue Difortan tabs Max immediately if gastrointestinal bleeding (causing black, tarry stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
Difortan tabs Max is not recommended for the treatment of acute pain attacks.
Do not use this medicine with other non-steroidal anti-inflammatory drugs (NSAIDs).
Difortan tabs Max may mask signs of infection (e.g. fever).
If the patient suspects an infection, they should consult a doctor.
Precautions for use
Consult a doctor or pharmacist before using Difortan tabs Max if:

The patient has experienced a sudden allergic reaction (anaphylactic shock) occurring within 20 minutes of taking the medicine (see section 4: Possible side effects),
The patient has previously had oesophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, e.g. ulcerative colitis, Crohn's disease, as this increases the risk of gastrointestinal bleeding. If gastrointestinal bleeding occurs, discontinue the medicine immediately.
The patient has hypertension, as this increases the risk of myocardial infarction or stroke,
The patient has elevated blood cholesterol levels,
The patient has mild or moderate heart failure (manifested, among others, by oedema),
The patient has ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease, as this increases the risk of arterial embolism,
The patient has reduced circulating blood volume (hypovolaemia), which may occur due to significant blood loss or burns, surgical procedures, or low fluid intake,
The patient has previously diagnosed high blood potassium levels,
The patient has diabetes,
The patient has impaired liver function; the medicine may cause slight, transient increases in liver enzyme activity in the blood (AspAT and AlAT),
The patient has impaired kidney function. Kidney function should then be monitored regularly. A medicine containing a lower dose of meloxicam (7.5 mg) may be more appropriate.
The patient is elderly, as the risk of kidney, liver, and heart function disorders increases. The doctor will order regular examinations.

If in doubt whether the above circumstances apply to the patient, consult a doctor
before starting Difortan tabs Max.
Children and adolescents
Do not use Difortan tabs Max in children and adolescents under 18 years of age.
Elderly patients
If the patient is elderly, they should use Difortan tabs Max with particular
caution due to an increased risk of adverse effects. Consultation with a doctor is recommended.
Difortan tabs Max and other medicines
Difortan tabs Max may affect the action of other medicines being used, and other
medicines may affect the action of Difortan tabs Max.
Inform your doctor or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to use.
Do not use Difortan tabs Max simultaneously with the following medicines:

Other non-steroidal anti-inflammatory drugs (NSAIDs), including salicylates (e.g. acetylsalicylic acid at single doses of 500 mg and above, and daily doses of 3000 mg and above) – concomitant use with Difortan tabs Max may increase the risk of gastrointestinal ulcers and bleeding;
Anticoagulants administered orally or parenterally (used to prevent blood clot formation) – concomitant use with Difortan tabs Max may increase bleeding;
Thrombolytics and antiplatelet agents (medicines that dissolve blood clots);
Corticosteroids (e.g. used for anti-inflammatory or allergic reaction treatment) – concomitant use with Difortan tabs Max may increase the risk of gastrointestinal ulcers and bleeding;
Cyclosporine (a medicine used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome) – the doctor will regularly monitor kidney function;
Tacrolimus (used after organ transplantation);
Diuretics (increasing urine production, e.g. furosemide) – concomitant use with Difortan tabs Max may cause severe kidney failure in dehydrated patients. Patients receiving both Difortan tabs Max and diuretics should receive adequate fluids (to drink and/or administered intravenously). Before starting treatment, the doctor will assess kidney function;
Medicines used to treat hypertension (beta-blockers, angiotensin-converting enzyme inhibitors such as captopril, enalapril, angiotensin II receptor antagonists AT1, so-called sartans) – concomitant use of these medicines with Difortan tabs Max may cause severe kidney dysfunction and reduce their therapeutic effect;
Lithium (used in the treatment of certain psychiatric disorders);
Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression);
Methotrexate (used in the treatment of cancer, severe uncontrolled skin disease, or active rheumatoid arthritis);
Cholestyramine (used to reduce cholesterol levels);
Intrauterine contraceptive devices – Difortan tabs Max may reduce their effectiveness. Additional contraceptive methods, e.g. using a condom, are necessary;
Trimethoprim (a medicine used to treat urinary tract infections);
Potassium salts (medicines used to treat low blood potassium levels);
Deferasirox (used to treat chronic high iron levels in the body);
Pemetrexed (used in cancer treatment);
Oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) (used in diabetes treatment). The doctor should ensure systematic monitoring of the patient's blood glucose levels for hypoglycaemia.

Use of Difortan tabs Max with food and drink
Food does not reduce absorption of the medicine.
Pregnancy, breastfeeding and effects on 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 Difortan tabs Max if the patient is in the last three months of pregnancy,
as it may harm the unborn child or cause complications during delivery.
Difortan tabs Max may cause kidney and heart function disorders in the unborn
child. It may increase the tendency to bleeding in both the mother and child and may cause delayed or prolonged labour. Do not use Difortan tabs Max 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, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Difortan tabs Max, if taken for longer than a few days, may cause kidney function disorders in the unborn child (which 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 is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Difortan tabs Max is contraindicated in breastfeeding women.
Effect on fertility
Difortan tabs Max may make it difficult to conceive. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving.
Driving and operating machinery
After taking Difortan tabs Max, visual disturbances may occur, including blurred vision, drowsiness, dizziness, or other central nervous system disorders.
In such cases, do not drive or operate machinery.
Difortan tabs Max contains lactose monohydrate and sodium.
Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult a doctor before taking the medicine.
Sodium
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 take Difortan tabs Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Taking Difortan tabs Max for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Recommended dose:
Adults, if necessary: 1 tablet (15 mg meloxicam) once daily. The maximum recommended dose is 1 tablet once daily.
Difortan tabs Max may only be used in patients in whom a previous dose of 7.5 mg meloxicam did not provide the expected pain relief.
If symptoms do not improve after 3 days of treatment, or if symptoms worsen despite taking the medicine, the patient should seek medical advice without delay.
Do not use for longer than 7 days without consulting a doctor.
Elderly patients and patients at increased risk of adverse reactions: Special caution is required when using Difortan tabs Max in elderly patients and in patients at increased risk of adverse reactions. Consultation with a doctor is recommended. If a doctor decides to initiate pharmacological treatment, a dose of 7.5 mg meloxicam may be prescribed. Depending on the efficacy and tolerability of the medicine, the doctor may increase the dose to 15 mg meloxicam.
Renal impairment: Patients undergoing dialysis with severe renal impairment should not take a dose higher than 7.5 mg meloxicam per day. The medicine is contraindicated in non-dialysed patients with severe renal impairment.
Hepatic impairment: Dose reduction is not necessary in patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, the use of Difortan tabs Max is contraindicated.
Use in children and adolescents: Difortan tabs Max must not be used in children and adolescents under 18 years of age.
If the patient feels that the effect of Difortan tabs Max is too strong or too weak, or if there is no improvement after 3 days, the patient should contact a doctor or pharmacist.
Method of administration:
Oral use.
The medicine should be taken during a meal, with water.
Difortan tabs Max should be taken once daily (as a single dose).
The maximum daily dose is 15 mg (1 tablet).
Taking more Difortan tabs Max than recommended
If more than the recommended dose of Difortan tabs Max has been taken or if overdose is suspected, seek immediate medical advice from a 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,
stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Difortan tabs Max. Gastrointestinal bleeding (bleeding from the gastrointestinal tract) may occur in the patient.

Severe poisoning may lead to serious adverse effects of the medicine (see section 4):

increased blood pressure (hypertension),
acute renal failure,
liver function disorders,
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.

Missed dose of Difortan tabs Max
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 regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must immediately stop taking Difortan tabs Max and immediately consult a doctor or the nearest hospital 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 and 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 occur on the lips, eyes and other moist parts 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 oedema);
- Shortness of breath or asthma attack;
Hepatitis (liver inflammation), which may cause symptoms such as: yellowing of the skin and whites of the eyes (jaundice), abdominal pain, loss of appetite.
Any adverse gastrointestinal symptoms, particularly bleeding (causing black, tarry stools), abdominal pain (which may indicate gastrointestinal ulceration). Gastrointestinal bleeding, ulceration or perforation 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 immediately consult a doctor.

General adverse effects associated with use of non-steroidal anti-inflammatory drugs (NSAIDs)
The use of some NSAIDs may be associated with a small increased risk of arterial thrombosis (arterial blockage), 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 NSAID therapy.

The most commonly observed adverse effects are gastrointestinal (stomach and intestinal disturbances): peptic ulceration 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 (diarrhoea), flatulence, constipation, indigestion (dyspepsia), abdominal pain, black tarry stools due to gastrointestinal bleeding, vomiting blood, ulcerative stomatitis, exacerbation of gastrointestinal inflammation (e.g. exacerbation of colitis or Crohn's disease). Gastritis has been observed less frequently.

Adverse effects of meloxicam – the active substance in Difortan tabs Max

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

Indigestion (dyspepsia),
Nausea and vomiting,
Abdominal pain,
Constipation,
Flatulence,
Loose stools (diarrhoea).

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

Headache.

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

Dizziness (feeling of emptiness in the head),
Dizziness or sensation of spinning (vertigo),
Somnolence (drowsiness),
Anaemia (reduced haemoglobin concentration - red blood pigment),
Increased blood pressure (hypertension),
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,
Itching, skin rash,
Fluid retention-related oedema, including ankle/leg swelling (peripheral oedema),
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 liver enzyme activity - aminotransferases or increased levels of bile pigment - bilirubin); these changes may be detected by the doctor through blood tests,
Abnormalities in laboratory tests assessing kidney function (e.g. increased creatinine or urea levels).

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

Mood disturbances,
Nightmares,
Blood morphology disorders, including: abnormal blood smear, reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia);

These adverse effects may lead to 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,
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, conjunctivitis (inflammation of the eyeball or eyelids),
Colitis (inflammation of the large intestine).

Very rare (may affect up to 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 occur on the lips, eyes and other moist parts 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,
Dyspnoea and skin reactions (anaphylactic and/or anaphylactoid), skin rashes due to exposure to sunlight (photosensitivity reactions),
Heart failure reported in association with NSAID therapy,
Pancreatitis,
Infertility in women, delayed ovulation;
A characteristic allergic skin 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, blisters (urticaria).
Complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Difortan tabs Max together with other medicines that potentially have bone marrow suppressive or destructive effects (myelotoxic drugs). This may result in: sudden fever, sore throat, infections.

Adverse effects caused by NSAIDs but not yet reported after use of Difortan tabs Max:

Acute renal failure due to structural changes in the kidneys,
Very rarely, 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 effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Difortan tabs Max

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the outer carton and
on the immediate packaging (month/year). The expiry date refers to the last day of the stated month.
Blister labelling: EXP – expiry date, Lot – batch number.
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 Difortan tabs Max contains

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

What Difortan tabs Max looks like and contents of the pack
Light yellow, round, biconvex tablets with bevelled edges, embossed with
B and 19 on one side, smooth on the other side, with a breakline on one side.
PVC/PVDC/Aluminium blister in a cardboard box.
Pack contents: 10 tablets (1 blister containing 10 tablets).

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 representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02 - 822 Warszawa
tel. +48 (22) 543 60 00

Difortan tabs max