Opokan-forte

Leaflet attached to the packaging: patient information

Opokan forte, 15 mg, orally disintegrating tablets
Meloxicam

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Opokan forte contains the active substance meloxicam. Meloxicam belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles. The mechanism of anti-inflammatory action of meloxicam involves the preferential inhibition of cyclooxygenase COX-2 compared to COX-1.
Indications for use of Opokan forte:

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

2. Important information before taking Opokan forte

When not to take Opokan forte

• if the patient is hypersensitive to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if the patient is hypersensitive to another non-steroidal anti-inflammatory drug (NSAID), e.g. acetylsalicylic acid;
• if, during the use of other non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid), the following have occurred: asthma attacks or bronchospasm, hives, nasal polyps or angioedema;
• if the patient has severe liver dysfunction;
• if the patient has severe renal impairment and is not undergoing dialysis;
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum;
• if the patient has had a stroke;
• if the patient has experienced any bleeding, e.g. from the gastrointestinal tract;
• if the patient has severe heart failure;
• in women in the third trimester of pregnancy and during breastfeeding;
• in children and adolescents under 16 years of age.

Warnings and precautions

Taking such medicines as Opokan forte may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended (see section 3).

Opokan forte is not recommended for the treatment of acute pain attacks.

Before starting treatment with Opokan forte, discuss it with your doctor or pharmacist:

• if the patient has experienced an anaphylactic reaction (anaphylactic shock), occurring within 20 minutes of taking the medicine (see section 4: Possible side effects);
• if the patient has peptic ulcer disease of the stomach and/or duodenum or esophageal inflammation. This medicine can be given to patients who have been completely cured of the disease;
• if the patient has asthma, as the medicine may cause bronchospasm;
• if the patient has diabetes, high cholesterol, and hypertension, as the risk of heart attack or stroke increases;
• if the patient has mild or moderate heart failure (manifested by, among other things, edema);
• if the patient has coronary artery disease, peripheral artery disease, or cerebrovascular disease, as the risk of arterial thrombosis increases. The doctor will order appropriate tests;
• if the patient has intestinal diseases (ulcerative colitis or Crohn's disease), as the risk of gastrointestinal bleeding increases. If gastrointestinal bleeding occurs, the medicine should be discontinued immediately;
• if the patient has kidney or liver dysfunction - the doctor will regularly monitor kidney function;
• if the patient has liver dysfunction - the medicine may cause mild, transient increases in liver enzymes in the blood (ASAT and ALAT);
• if the patient is over 65 years old, as the risk of kidney, liver, and heart disorders increases. The doctor will order regular tests;
• Opokan forte may mask (hide) symptoms of an existing infection (e.g. fever). If the patient suspects an infection, they should contact their doctor.

In connection with the use of meloxicam, potentially life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as red spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include oral ulcers, pharyngeal ulcers, nasal ulcers, or genital ulcers, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may develop into generalized blisters or skin exfoliation. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Opokan forte, meloxicam should not be restarted. In case of a rash or the above-mentioned symptoms, the medicine should be discontinued and medical advice should be sought immediately, informing the doctor about the use of this medicine.

Children and adolescents

Do not use in children and adolescents under 16 years of age.

Opokan forte and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Opokan forte at the same time as the following medicines:

• - other non-steroidal anti-inflammatory drugs, including salicylates(e.g. acetylsalicylic acid), as concomitant use with Opokan forte may increase the risk of ulcers and gastrointestinal bleeding;
• - diuretics(increasing urine production, e.g. furosemide) - concomitant use with Opokan forte may cause severe renal impairment in dehydrated patients.

Patient taking Opokan forte and diuretics should receive plenty of fluids (to drink and/or administered intravenously in infusions). Before starting treatment, the doctor will check kidney function;

• - oral anticoagulants(used to prevent blood clots) - concomitant use with Opokan forte may increase the risk of bleeding;
• - thrombolytic agents(medicines that dissolve blood clots);
• - blood pressure lowering medicines:ACE inhibitors (e.g. captopril, enalapril), angiotensin II receptor antagonists (so-called sartans), beta-adrenergic blockers;
• - cyclosporine, tacrolimus(a medicine used in patients after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome) - the doctor will regularly monitor kidney function;
• - intrauterine contraceptives- Opokan forte may reduce their effectiveness;
• - glucocorticosteroids(adrenal cortex hormones) - concomitant use with Opokan forte may increase the risk of ulcers and gastrointestinal bleeding;
• - lithium(a medicine used to treat certain mental illnesses);
• - 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);
• - oral medicines used to treat diabetes;
• - cholestyramine- a medicine that lowers cholesterol levels in the blood;
• - deferiprone- used to treat chronic high iron levels in the body;
• - pemetrexed- used to treat cancer.

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
Opokan forte should not be used during the first and second trimesters of pregnancy, unless the doctor considers it absolutely necessary. If Opokan forte is taken by women during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible time.
Opokan forte should not be usedduring the last 3 months of pregnancy (third trimester), as it may have serious effects on the fetus, particularly on its cardiovascular and respiratory systems, as well as the kidneys, even after a single dose.
Breastfeeding
Opokan forte passes into breast milk, so breastfeeding should be avoidedduring treatment with this medicine.
Fertility
Opokan forte may have a negative effect on female fertility and make it more difficult to become pregnant. It should not be used in women who have difficulty becoming pregnant or who are undergoing fertility tests.

Driving and using machines

In case of side effects such as dizziness, vision disturbances, drowsiness, or disorientation, do not drive or operate machinery.

Opokan forte contains aspartame

The medicine contains 5.4 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

3. How to take Opokan forte

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dosage and duration of treatment are determined by the doctor, depending on the type of disease and the patient's response to the medicine.

Recommended dose

7.5 mg to 15 mg per day (one 7.5 mg tablet or one 15 mg tablet).
Elderly patients:7.5 mg per day.
Patient with renal impairment:do not exceed the dose of 7.5 mg per day.
Patient with hepatic impairment:do not exceed the dose of 7.5 mg per day.

Method of administration:

• The tablet should be placed in the mouth, on the tongue, and allowed to dissolve (about 5 minutes), then swallowed. The tablets should not be chewed or swallowed whole. Taking Opokan forte does not require drinking water or any other liquid.
• Opokan forte should be taken once a day (in a single dose).
• The maximum daily dose is 15 mg (one orally disintegrating tablet).

Use in children and adolescents

Do not use Opokan forte in children and adolescents under 16 years of age.
Taking a higher dose of Opokan forte than recommended
If a higher dose of the medicine than recommended is taken, the doctor or pharmacist should be informed immediately.
Overdose symptoms may occur:

• weakness (feeling of lack of energy);
• nausea, vomiting;
• abdominal pain;
• drowsiness. These symptoms usually resolve after discontinuation of the medicine. The patient may experience gastrointestinal bleeding.

In case of severe poisoning, the following may occur:

• hypertension;
• acute renal failure;
• liver dysfunction;
• shallow breathing or respiratory arrest (respiratory depression);
• coma;
• seizures;
• cardiovascular collapse (acute circulatory failure);
• cardiac arrest;
• allergic reaction (see section 4: Possible side effects).

Missing a dose of Opokan forte

Do not take a double dose to make up for a missed dose.
If a dose of the medicine is missed, it should be taken as soon as possible and treatment continued as recommended.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Opokan forte can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience:

• an allergic reaction occurring within 20 minutes of taking the medicine (hives, severe swelling of the face, lips, or throat, difficulty breathing, speaking, or swallowing, a sudden drop in blood pressure, slow or fast heart rate, pallor, anxiety, sweating, dizziness, loss of consciousness, respiratory or cardiac arrest);
• angioedema (a severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing or breathing;
• the appearance of blisters on the skin and/or mucous membranes, which, after rupture, form painful sores, often accompanied by fever, muscle pain, and joint pain (this is called Stevens-Johnson syndrome);
• 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. It may also occur on the lips, eyes, and other moist areas of the body.

General side effects resulting from the use of non-steroidal anti-inflammatory drugs (NSAIDs)

The severity of symptoms may increase, especially in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, as well as in the elderly.
Opokan forte may cause a small increase in the risk of heart attack or stroke.
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increase in the risk of arterial thrombosis (e.g. heart attack or stroke), especially when the medicine is used in high doses and for long-term treatment.
Non-steroidal anti-inflammatory drugs (NSAIDs) have been reported to cause edema, hypertension, and heart failure.
The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• peptic ulcer disease of the stomach and duodenum;
• perforation of the gastrointestinal tract or gastrointestinal bleeding (sometimes fatal, especially in the elderly).

The following side effects have been reported after the administration of NSAIDs:

• nausea and vomiting;
• diarrhea;
• flatulence;
• constipation;
• indigestion;
• abdominal pain;
• tarry stools due to gastrointestinal bleeding;
• bloody vomiting;
• stomatitis;
• worsening of gastrointestinal disease (e.g. exacerbation of ulcerative colitis or Crohn's disease).

Side effects that may occur after taking Opokan forte

Opokan forte

Very common:occur in more than 1 in 10 patients

• gastrointestinal disorders such as indigestion, nausea, and vomiting, abdominal pain, bloating, constipation, diarrhea.

Common:occur in 1 to 10 patients in 100

• headache.

Uncommon:occur in 1 to 10 patients in 1,000

• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in stools);
• gastritis;
• reflux esophagitis;
• stomatitis;
• liver dysfunction (e.g. increased liver enzyme activity, such as transaminases, or increased bilirubin levels);
• immediate allergic reactions (hypersensitivity);
• dizziness (feeling of emptiness in the head);
• drowsiness (somnolence);
• increased blood pressure;
• flushing;
• itching;
• skin rash;
• edema caused by fluid retention, including ankle/foot edema (peripheral edema);
• hyperkalemia (elevated potassium levels). This can cause: cardiac arrhythmias, palpitations (when the patient feels their heartbeat more than usual), muscle weakness;
• abnormal kidney function tests (e.g. increased creatinine or urea levels in the blood);
• anemia (reduced hemoglobin levels in the blood).

Rare:occur in 1 to 10 patients in 10,000

• colitis;
• gastric and/or duodenal ulceration;
• esophagitis;
• blood disorders, including: - abnormal blood smear - decreased white blood cell count (leukopenia) - decreased platelet count (thrombocytopenia) (may increase the risk of bleeding and bruising);
• mood disorders;
• nightmares;
• vision disturbances (including blurred vision, conjunctivitis);
• tinnitus;
• palpitations (feeling of rapid heartbeat);
• asthma attacks (wheezing, coughing, difficulty breathing);
• blistering skin reactions or exfoliative dermatitis (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• urticaria.

Very rare:occur in less than 1 in 10,000 patients

• perforation of the gastrointestinal tract;
• hepatitis - may cause symptoms such as: yellowing of the skin and eyes (jaundice), abdominal pain, loss of appetite;
• acute renal failure (manifested by decreased urine output, blood in urine, cloudy urine, ankle edema, nausea, vomiting), especially in patients with risk factors such as heart disease, diabetes, or kidney disease.

Frequency not known:frequency cannot be estimated from the available data

• confusional state;
• disorientation;
• skin reactions (anaphylactic and/or anaphylactoid) photosensitivity reactions (reactions to sunlight);
• heart failure reported in connection with NSAID treatment;
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Opokan forte with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic medicines). This can cause:
• sudden fever;
• throat pain;
• infections;
• pancreatitis;
• photosensitivity.

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet reported with Opokan forte:

• acute renal failure due to changes in kidney structure;
• very rarely, cases of interstitial nephritis (tubulointerstitial nephritis);
• renal cell necrosis (acute necrosis of renal tubules or papillae);
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Opokan forte

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Opokan forte contains

• -The active substance of the medicine is meloxicam. One orally disintegrating tablet contains 15 mg of meloxicam.
• The other ingredients are: mannitol, granulated mannitol, anhydrous colloidal silica, povidone 30, microcrystalline cellulose, crospovidone (Type A), aspartame (E 951), orange flavor 0471034, magnesium stearate.

What Opokan forte looks like and contents of the pack
Opokan forte is a light yellow, round, flat, bilayer tablet with an orange odor, with a diameter of 10.7 mm to 11.3 mm. The packaging contains 20 orally disintegrating tablets. Peel-off blisters made of paper/aluminum/PE/PVC/aluminum/OPA are packaged in a cardboard box.

Marketing authorization holder and importer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22 -53-100

Date of last revision of the leaflet: