Opokan max: detailed information

Package leaflet: Information for the patient

Opokan max, 15 mg, tablets
Meloxicamum
Please read this 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 directed by
the physician or nurse.

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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

What is Opokan max and what is it used for
Important information before taking Opokan max
How to take Opokan max
Possible side effects
How to store Opokan max
Contents of the pack and other information

1. What is Opokan max and what is it used for

Opokan max contains the active substance meloxicam. Meloxicam belongs to a group of drugs known as
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 use of Opokan max:
Opokan max is indicated in adults when a 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 in bone, joint, and muscular pain (e.g. spinal, back, knee pain) associated with rheumatic and degenerative joint diseases.
Do not use for longer than 7 days without consulting a doctor.
WARNING: Opokan max may only be taken by patients in whom a 7.5 mg dose of meloxicam did not provide the expected pain relief.

2. Important information before taking Opokan max

When not to take Opokan max

if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
if, during treatment with other non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin), the following occurred: wheezing, tightness in the chest, shortness of breath (asthma), skin rash (urticaria), nasal congestion due to swelling of the nasal mucosa (nasal polyps), sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may potentially make breathing difficult (angioedema);
if the patient has severe liver failure;
if the patient has severe renal impairment and is not undergoing dialysis;
if the patient has severe heart failure;
if, during treatment with anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding or perforation of the stomach or intestines occurred;
if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum (the patient has experienced at least two episodes of confirmed ulceration or bleeding);
if the patient has had a haemorrhagic stroke (stroke) or other bleeding, e.g. from the gastrointestinal tract;
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 is unsure whether any of the above points apply, they should
contact a doctor.
Warnings and precautions
Opokan max is intended for patients in whom the 7.5 mg dose of meloxicam
did not provide the expected pain relief.
Before starting treatment with Opokan max, discuss this with your doctor or pharmacist if:

the patient has experienced a sudden allergic reaction (so-called anaphylactic shock) occurring within 20 minutes of taking the medicine (see section 4: Possible side effects);
the patient has peptic ulcer disease of the stomach and/or duodenum or inflammation of the oesophageal or gastric mucosa. This medicine may be given to patients whose condition has been completely resolved;
the patient has diabetes;
the patient has elevated blood cholesterol levels;
the patient has hypertension, as this increases the risk of heart attack or stroke;
the patient has mild or moderate heart failure (manifesting, among others, as oedema);
the patient has ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, as this increases the risk of arterial thrombosis;
the patient has intestinal diseases (ulcerative colitis or Crohn's disease), as this increases the risk of gastrointestinal bleeding. If gastrointestinal bleeding occurs, the medicine should be discontinued immediately;
the patient has impaired kidney function. Kidney function should then be monitored regularly. A lower-strength Opokan formulation (7.5 mg tablets) is available, which may be more suitable;
the patient has reduced circulating blood volume (hypovolemia), which may occur in cases of significant blood loss or burns, after surgery, or due to low fluid intake;
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 is elderly, as the risk of kidney, liver and heart dysfunction increases. The doctor will order regular tests;
the patient plans pregnancy or has difficulty conceiving, as the medicine may adversely affect fertility. The medicine should then be discontinued;
the patient has previously diagnosed high blood potassium levels;
the patient has ever experienced a persistent drug-induced rash (erythema multiforme) after taking meloxicam or other oxicams (e.g. piroxicam) [round or oval,

reddened and swollen skin patches, usually recurring in the same location(s),
blisters, urticaria and itching].
If in doubt whether the above circumstances apply to the patient, consult a
doctor before starting treatment with Opokan max.
Treatment with Opokan max should be discontinued immediately upon noticing
bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain).
Taking medicines such as Opokan 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. Do not use higher doses or longer treatment duration than recommended (see section 3:
How to take Opokan max).
In case of heart dysfunction, previous stroke or suspected risk of such conditions (e.g. high
blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with
your doctor or pharmacist.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of Opokan max. These initially appear as red
spots or round patches on the trunk, often with central blisters.
Additional symptoms may include mouth, throat, nose or genital ulcers 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 epidermal detachment. The highest risk of severe skin reactions occurs during the first weeks of treatment. Treatment with meloxicam must not be resumed in patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Opokan max.
If a rash or the above symptoms occur, discontinue Opokan max immediately and seek medical advice without delay, informing the doctor about taking this medicine.
Special considerations for patients with impaired kidney function
Patients undergoing dialysis with severe renal impairment should not take a dose higher than 7.5 mg
of meloxicam per day.
Opokan max is not recommended for use during acute pain attacks.
Opokan max may mask signs of infection (e.g. fever). If the patient suspects an infection, they should contact a doctor.
Children and adolescents
Opokan max should not be used in children and adolescents under 18 years of age.
Elderly patients
If the patient is elderly, they should use Opokan max with particular caution due to an increased risk of adverse effects. Consultation with a doctor is recommended.
Opokan max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Opokan max together with the following medicines:

other non-steroidal anti-inflammatory drugs, including salicylates (e.g. acetylsalicylic acid at a single dose of 500 mg and daily dose of 3000 mg); concurrent use with Opokan max may increase the risk of gastrointestinal ulcers and bleeding;
diuretics (medicines that increase urine production, e.g. furosemide); concurrent use with Opokan max may cause severe kidney failure in dehydrated patients. Patients receiving both Opokan max and diuretics should receive adequate fluid intake (orally and/or intravenously via infusion). Before starting treatment, the doctor will assess kidney function;
oral or parenteral anticoagulants (medicines used to prevent blood clot formation); concurrent use with Opokan max may increase bleeding risk;
thrombolytic and antiplatelet agents (medicines that dissolve blood clots);
antihypertensive medicines: angiotensin-converting enzyme inhibitors (e.g. captopril, enalapril); angiotensin II receptor antagonists (so-called sartans); beta-blockers; concurrent use of these medicines with Opokan max may cause severe kidney dysfunction and reduce their therapeutic effect;
cyclosporine, tacrolimus (medicines used in organ transplant patients or in severe skin diseases, rheumatoid arthritis or nephrotic syndrome); the doctor will monitor kidney function regularly;
trimethoprim (a medicine used to treat urinary tract infections);
potassium salts (medicines used to treat low blood potassium levels);
intrauterine contraceptive devices; Opokan max may reduce their effectiveness. An additional method of contraception, e.g. using a condom, is necessary;
corticosteroids (e.g. used anti-inflammatory or for allergic reactions); concurrent use with Opokan max may increase the risk of gastrointestinal ulcers and bleeding;
lithium (a medicine used to treat certain psychiatric disorders);
selective serotonin reuptake inhibitors (SSRIs) – used to treat depression;
methotrexate (a cytostatic medicine used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis);
cholestyramine (a medicine that lowers blood cholesterol levels);
deferasirox – used to treat chronic iron overload;
pemetrexed – used to treat cancers;
oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood glucose levels for hypoglycaemia.

Opokan max with food and drink
Opokan max should be taken during a meal, with water.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Opokan max if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour. Opokan max should not be used during the first six months of pregnancy unless the doctor considers its use 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, Opokan max may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Opokan max is contraindicated in breastfeeding women.
Fertility
This medicine may impair fertility. Inform the doctor if the patient plans pregnancy or has difficulty conceiving.
Driving and operating machinery
If side effects such as dizziness, visual disturbances including blurred vision, drowsiness or other central nervous system disorders occur, do not drive or operate machinery.
Opokan 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 this medicine.
Sodium
The medicine contains 4.69 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Opokan max

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.
Taking Opokan 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.
Opokan max may only be used in patients in whom prior treatment with 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 immediately.
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 advised when using Opokan max in elderly patients and in patients at increased risk of adverse reactions. Consultation with a doctor is recommended. If pharmacological treatment is decided by a doctor, a dose of 7.5 mg may be prescribed. Depending on the efficacy and tolerability of the medicine, the doctor may increase the dose to 15 mg meloxicam.
Renal function impairment: Patients undergoing dialysis with severe renal impairment should not take a dose higher than 7.5 mg meloxicam per day.
Hepatic function impairment: Dose reduction is not necessary in patients with mild or moderate hepatic impairment.
Use in children and adolescents: Opokan max should not be used in children and adolescents under 18 years of age.
If the patient feels the effect of Opokan max is too strong or too weak, or if no improvement is felt after 3 days, consult a doctor or pharmacist.
Method of administration:

Take the medicine during a meal, with water.
Opokan max should be taken once daily (as a single dose).
The maximum daily dose is 15 mg (1 tablet).

Taking more Opokan max than recommended
If more than the recommended dose of Opokan max has been taken or 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 Opokan max. Gastrointestinal bleeding (gastrointestinal hemorrhage) may occur.

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

elevated blood pressure (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;
skin reactions.

Missed dose of Opokan max
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You must stop taking Opokan max 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 skin allergic reaction causing spots, red or violet rashes, or blisters on the skin. It may also appear 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, inside the 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 particularly:

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

Gastrointestinal bleeding, ulceration, or gastrointestinal 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.
If taking Opokan max causes visual disturbances, do not drive or operate machinery.

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 (arterial blood clots), such as myocardial infarction or stroke, particularly when used at high doses and 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 following NSAID administration:

Nausea and vomiting;
Loose stools (diarrhea);
Flatulence with gas release;
Constipation;
Dyspepsia, abdominal pain;
Tarry 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 Opokan max – are as follows:

Very common: may affect more than 1 in 10 people

Gastrointestinal disturbances such as dyspepsia, nausea and vomiting, abdominal pain, constipation, bloating, loose stools (diarrhea).

Common: may affect less than 1 in 10 people

Headache.

Uncommon: may affect less than 1 in 100 people

Dizziness (feeling of emptiness in the head);
Dizziness or vertigo (of labyrinthine origin);
Somnolence (drowsiness);
Anaemia (reduced concentration of the red blood pigment haemoglobin);
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 (backflow of stomach contents into the oesophagus);
Gastritis;
Gastrointestinal bleeding;
Inflammation of the oral mucosa;
Immediate hypersensitivity reactions;
Pruritus, skin rash;
Fluid retention-related edema, including swelling of ankles/legs (peripheral edema);
Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, potentially impairing breathing (angioedema);
Transient abnormalities in liver function tests (e.g. increased activity of liver enzymes such as aminotransferases, or increased levels of the bile pigment bilirubin). These changes may be detected by the doctor through blood tests;
Renal function laboratory test abnormalities (e.g. increased creatinine or urea levels).

Rare: may affect less than 1 in 1,000 people

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;
Visual disturbances, including: blurred vision, conjunctivitis (inflammation of the eyeball or eyelids);
Colitis.

Very rare: may affect less than 1 in 10,000 people

Bullous skin reactions and erythema multiforme. Erythema multiforme is a severe skin allergic reaction causing spots, red or violet rashes, or blisters on the skin. It may also appear 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;
Complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Opokan max together with other medicines that potentially have myelosuppressive or myeloablative effects (myelotoxic drugs). This may cause:
Sudden fever;
Sore throat;
Infections.

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

Confusion, disorientation;
Dyspnoea and skin reactions (anaphylactic and/or anaphylactoid), skin rashes caused by 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-administration of the drug, and may appear as itchy, round or oval, red and swollen skin patches, or blisters (urticaria).

Adverse effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet reported after use of Opokan max:

Acute renal failure due to structural kidney changes;
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, 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
Tel.: +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 authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Opokan max

Keep this medicine out of sight and reach of children.
Store in the original, tightly closed packaging, at a temperature not exceeding 25°C, in a dry place.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
Lot – batch number
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Opokan max contains

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

What Opokan max looks like and contents of the pack
Opokan max is in the form of tablets.
The pack contains 10 tablets. The tablets are packed in a blister pack placed in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów