If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Opokan may adversely affect your unborn baby. It is not recommended to use the drug during the first and second trimesters of pregnancy, unless the doctor considers it absolutely necessary. If Opokan is taken by women during the first and second trimesters of pregnancy, the dose should be kept as low and for the shortest possible time.
• Opokan must not be used in the last 3 months of pregnancy (third trimester).
• Opokan passes into breast milk, so you must not breast-feed while using this drug.
• Opokan may adversely affect female fertility and make it difficult to get pregnant. Do not use in women who are having difficulty conceiving or undergoing infertility testing.

Overdosage

If you take more than the prescribed dose, tell your doctor or pharmacist immediately.

Symptoms of overdose may occur:

• nausea, vomiting, abdominal pain
• headache, dizziness, insomnia or sleepiness
• hypertension,
• kidney problems
• liver dysfunction
• decrease in breathing rate or shortness of breath, respiratory arrest,
• coma,
• seizures
• cardiac arrest
• allergic reaction

Other medicines and Opokan

Tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about any drugs you plan to take.
Opokan should not be used together with the following medicines:

• other non-steroidal anti-inflammatory drugs, including salicylates (e.g. acetylsalicylic acid in a single dose of 1 g and a daily dose of 3 g), concomitant use with Opokan may increase the risk of gastrointestinal ulceration and bleeding,
• diuretics (which increase urine production, e.g. furosemide), concomitant use with Opokan may cause severe renal failure in dehydrated patients.Patients receiving Opokan and diuretics concomitantly should be given plenty of fluid (to drink and / or via intravenous drips). Before starting treatment, the doctor will check the function of the kidneys,
• oral anticoagulants (used to prevent blood clots); simultaneous use with Opokan may increase bleeding,
• drugs to lower blood pressure:
  • angiotensin converting enzyme inhibitors (e.g. captopril, enalapril),
  • angiotensin II receptor antagonists (so-called sartans),
  • beta blockers.

Concomitant use of the above-mentioned drugs with Opokan may cause severe impairment of kidney function and reduce their therapeutic effect.

• ciclosporin (a medicine used in organ transplant patients); your doctor will check your kidneys regularly,
• contraceptives intrauterine; Opokan may reduce their effectiveness.You need to use an additional method of contraception, such as using a condom,
• glucocorticosteroids (hormones of the adrenal cortex); simultaneous use with Opokan may increase the risk of gastrointestinal ulceration and bleeding,
• lithium (a medicine used to treat certain mental illnesses),
• methotrexate (a cytostatic drug used to treat cancer)
• oral medications to treat diabetes
• cholestyramine (a medicine to lower cholesterol in the blood).

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur.
Common (affects 1 to 10 in 100 people):

• nausea, vomiting, abdominal pain, gas,
• constipation, diarrhea
• anemia,
• a feeling of emptiness in the head,
• headaches,
• rash (itchy red lumps on the skin)
• swelling, including in the ankles.

Uncommon (affects 1 to 10 in 1,000 people):

• gastrointestinal bleeding (vomiting containing blood or coffee grounds – similar to coffee grounds, black stools or blood in stools)
• gastric ulcer and / or duodenal ulcer,
• esophagitis,
• inflammation of the oral mucosa,
• transient liver dysfunction
• reduction in the number of white blood cells
• reduction in blood platelets (may increase risk of bleeding and bruising)
• decrease in the number of granulocytes (a type of white blood cell that may decrease your immunity)
• dizziness, tinnitus,
• -somnolence,
• feeling your heart beating fast
• increase in blood pressure
• reddening of the face with a feeling of heat,
• hives (pale pink, itchy blisters on the skin)
• kidney problems (e.g. increased levels of creatinine or urea in the blood).

Rare (affects 1 to 10 in 10,000 people):

• gastritis,
• ulcerative colitis,
• hepatitis,
• allergic reaction for up to 20 minutes after taking the medicine (rash, severe swelling of the face, mouth or throat, difficulty breathing, speaking or swallowing, a sharp drop in blood pressure, slow or fast heart rate, paleness, restlessness, sweating, dizziness, loss of consciousness) stopping breathing and heart beat)
• mood changes
• insomnia, nightmares,
• disorientation (confusion),
• visual disturbances (e.g. blurred vision)
• asthma attacks (wheezing, coughing, difficulty breathing)
• occurrence of blisters on the skin and / or mucous membranes that, when ruptured, form painful wounds, often at the same time as fever, muscle and joint pain (this is called Stevens-Johnson syndrome)
• exfoliation of large areas of the epidermis and its necrosis,
• erythema multiforme (glaucous red patches on the skin, sometimes with blisters)
• sensitivity to light,
• an allergic reaction which causes swelling of the face, throat and limbs (called angioedema)
• kidney failure (manifested by decreased urine output, blood in the urine, cloudy urine, ankle swelling, nausea, vomiting).

Exacerbation of symptoms may occur especially in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and in the elderly. Opokan may cause a slightly increased risk of a heart attack or stroke.