Opokan Fast

Leaflet attached to the packaging: patient information

Opokan FAST, 15 mg/1.5 mL, solution for injection

Meloxicam

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Opokan fast contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam is used to reduce inflammation and pain in the joints and muscles.
Opokan fast is used in:

• short-term treatment of symptoms associated with exacerbation of rheumatoid arthritis or ankylosing spondylitis, also known as Bechterew's disease (a type of arthritis that causes pain and stiffness in the spine) when the medicine cannot be given orally or rectally;
• short-term symptomatic treatment of flare-ups of osteoarthritis.

2. Important information before using Opokan fast

When not to use Opokan fast

• if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), i.e. if you have ever had any of the following symptoms after taking these medicines:
• -wheezing, feeling of tightness in the chest, shortness of breath (asthma),
• -nasal congestion due to swelling of the nasal mucosa (nasal polyps),
• -skin rash and/or urticaria,
• -sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema);
• if you have had bleeding from the stomach or intestines or perforation of the stomach or intestines after using NSAIDs;
• if you currently have (or have had two or more episodes of) stomach or intestinal ulcers or bleeding;
• if you have severe liver dysfunction;
• if you have severe kidney dysfunction and are not on dialysis;
• if you have recently had bleeding in the brain (cerebral hemorrhage);
• if you have had any other bleeding;
• if you have severe heart failure;
• in the last three months of pregnancy;
• in children and adolescents under 18 years of age;
• in patients being treated with anticoagulant medicines (due to the risk of hematoma).

If you are not sure if any of the above points apply to you, consult your doctor.

Warnings and precautions

Before starting treatment with Opokan fast, discuss it with your doctor or pharmacist.
This is especially important if:

• you have ever had esophagitis, gastritis or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis;
• you have high blood pressure (hypertension);
• you are elderly. There is an increased risk of side effects in elderly patients, so your doctor may reduce the dose and closely monitor your heart, liver, and kidney function during treatment;
• you have heart, liver, or kidney disease;
• you have high blood sugar levels (diabetes);
• you have decreased blood volume (hypovolemia), which may occur with significant blood loss or burns, surgery, or low fluid intake;
• you have high potassium levels in the blood;
• you have ever had a persistent rash (drug eruption) after taking meloxicam or other oxicams (e.g. piroxicam). This is a skin reaction that can recur in the same place (in the same places) after re-administration of the medicine, with symptoms such as redness, swelling, and blistering of the skin, and itching.

Opokan fast is not recommended for immediate relief of acute pain attacks.
Opokan fast may mask the symptoms of infection, such as fever, pain, swelling, redness. You may mistakenly think you are feeling better or that the infection is not serious. If you suspect you have an infection, consult your doctor.
Skin reactions
Meloxicam has been associated with potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), which can start as red spots or circular patches on the torso, often with central blisters.
Additional symptoms that may be observed include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash can develop into generalized blisters or peeling of the skin.
The highest risk of severe skin reactions occurs in the first few weeks of treatment.
In patients who have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam, meloxicam treatment should not be restarted.
If a rash or the above skin symptoms occur, stop using Opokan fast and seek medical attention immediately, informing your doctor that you are taking this medicine.
Cardiovascular reactions
Taking medicines like Opokan fast 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 exceed the recommended dose or duration of treatment.
In case of heart disorders, stroke, or suspected risk of these disorders, discuss your treatment with your doctor or pharmacist. For example, if you have:

• high blood pressure (hypertension);
• high blood sugar levels (diabetes);
• high cholesterol levels (hypercholesterolemia);
• you smoke.

Opokan fast and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Opokan fast may affect the action of other medicines. There are several medicines that should not be taken with Opokan fast. In some cases, the dose of other medicines may need to be modified while taking Opokan fast.
Inform your doctor or pharmacist especially if you are taking or have taken any of the following medicines:

• acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• potassium salts (used to treat low potassium levels in the blood);
• trimethoprim (used to treat urinary tract infections);
• oral or parenteral anticoagulants;
• thrombolytic medicines (which dissolve blood clots);
• medicines used to treat heart and kidney diseases;
• medicines used to treat high blood pressure (e.g. beta-blockers);
• diuretics. Your doctor may monitor your kidney function if you are taking diuretics;
• corticosteroids (used to treat inflammatory or allergic diseases);
• certain antidepressant medicines: selective serotonin reuptake inhibitors (SSRIs) or lithium;
• methotrexate (used to treat certain cancers, severe uncontrolled skin diseases, and active rheumatoid arthritis);
• pemetrexed (used to treat certain cancers);
• deferazirox (used to treat chronic iron overload due to multiple blood transfusions);
• cyclosporin (used after transplantation or to treat autoimmune diseases, such as severe cases of certain skin diseases, rheumatoid arthritis, or kidney disease called nephrotic syndrome);
• tacrolimus (used after transplantation);
• cholestyramine (used to lower cholesterol levels);
• oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) - used to treat diabetes. Your doctor should ensure regular monitoring of your blood sugar levels to avoid the risk of hypoglycemia;

In case of doubts about the use of these medicines, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Opokan fast if you are in the last three months of pregnancy, as it may harm your unborn baby or cause complications during delivery. It may cause kidney or heart problems in the unborn baby. It may increase the risk of bleeding in you and your baby and prolong or delay labor. During the first six months of pregnancy, do not take Opokan fast unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
From the 20th week of pregnancy, Opokan fast, if used for more than a few days, may cause narrowing of the blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Opokan fast is not recommended for use in breastfeeding women.
Fertility
Opokan fast may make it more difficult to become pregnant. Inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Visual disturbances, including blurred vision, dizziness, drowsiness, feeling of spinning or loss of balance, or other central nervous system disorders may occur after taking this medicine. If these symptoms occur, do not drive or operate machinery.

Opokan fast contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule (1.5 mL), i.e. the medicine is considered "sodium-free".

3. How to use Opokan fast

This medicine is administered only by experienced medical personnel. The medicine is usually given as a slow injection, deep into the patient's buttock. If more than one injection is necessary, the medicine will be injected into the other buttock. If the patient has a hip prosthesis, the medicine will be administered on the other side of the body. If the patient feels severe pain during the injection, the administration of the medicine should be stopped.
The recommended dose is a single injection. In exceptional cases (e.g. when tablets or suppositories cannot be used), the doctor may decide to extend the treatment to 2-3 days.
Do not exceed the maximum dose of 15 mg per day.
Patient over 65 years of age and patients with increased risk of side effects
The recommended dose is 7.5 mg (half an ampoule) per day.
Patient with kidney and liver disorders
If the patient has severe kidney disease and is on dialysis, do not administer more than 7.5 mg (half an ampoule) per day.
If the patient has mild to moderate kidney or liver disease, the patient may receive the usual adult dose.

Use in children and adolescents

Opokan fast is not recommended for children and adolescents under 18 years of age.

Overdose of Opokan fast

In case of overdose or suspected overdose, seek medical attention immediately or go to the nearest hospital.
Symptoms of overdose may include: weakness (feeling of lack of energy), drowsiness, nausea, and vomiting, abdominal pain, bleeding from the stomach or intestines. In case of severe poisoning, the following symptoms may occur: high blood pressure, acute kidney failure, liver dysfunction, slow or weak breathing, loss of consciousness (coma), seizures, circulatory failure, cardiac arrest, immediate allergic reactions, including fainting, shortness of breath, and skin reactions.

Missed dose of Opokan fast

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop using Opokan fast and consult your doctor or the nearest hospital immediately if you experience:

• Any allergic reactions (hypersensitivity), which may manifest as:
• -skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (mucosal lesions) or erythema multiforme (a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin). Erythema multiforme can also occur on the lips, eyes, and other mucous membranes;
• -swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult, swelling of the ankles or feet (peripheral edema);
• -shortness of breath or asthma attack.
• Any symptoms of hepatitis, in particular:
• -yellowing of the skin and eyes (jaundice);
• -abdominal pain;
• -loss of appetite.
• Any symptoms of gastrointestinal disorders, in particular:
• -bleeding (causing black stools or vomiting blood);
• -ulcers in the gastrointestinal tract (causing abdominal pain). Gastrointestinal bleeding, ulcers, or perforation can be serious and potentially life-threatening, especially in elderly patients.

If you have previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, you should immediately consult your doctor, especially if you are elderly. Your doctor may monitor your progress.
If using Opokan fast causes visual disturbances, do not drive or operate machinery.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g. heart attack or stroke), especially when used in high doses and for long-term treatment.
The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• gastric or duodenal ulcers,
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported after taking NSAIDs:

• nausea (nausea) and vomiting, diarrhea, bloating with gas, constipation, indigestion (dyspepsia), abdominal pain,
• black stools due to gastrointestinal bleeding, vomiting blood,
• mouth ulcers,
• gastrointestinal inflammation (colitis).

Rarely, gastritis has been observed.

Side effects of meloxicam - the active substance of Opokan fast Very common: may occur more frequently than 1 in 10 people

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

Common: may occur less frequently than 1 in 10 people

• headache,
• thickening at the injection site, pain at the injection site.

Uncommon: may occur less frequently than 1 in 100 people

• dizziness (feeling of emptiness in the head),
• dizziness or feeling of spinning (of labyrinthine origin),
• drowsiness (drowsiness),
• anemia (reduced red blood cell count, which can cause pale skin, weakness, and fatigue),
• increased blood pressure (hypertension),
• flushing (temporary redness of the face and neck),
• retention of sodium and water,
• increased potassium levels in the blood (hyperkalemia). This can lead to symptoms such as:
• arrhythmias (heart rhythm disorders),
• palpitations (feeling of heartbeat more than usual),
• muscle weakness,
• reflux (regurgitation of stomach contents into the esophagus),
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions (hypersensitivity),
• itching (pruritus),
• skin rash,
• edema caused by fluid retention, including ankle or foot swelling (peripheral edema),
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema),
• temporary changes in liver function tests (e.g. increased liver enzyme activity, such as transaminases, or increased bilirubin levels). Your doctor may detect these changes with a blood test,
• changes in kidney function tests (e.g. increased creatinine or urea levels).

Rare: may occur less frequently than 1 in 1,000 people

• mood disorders,
• nightmares,
• blood disorders, including: abnormal blood smear, decreased white blood cell count (leukopenia), decreased platelet count (thrombocytopenia). These side effects can increase the risk of infection and symptoms such as sudden fever, sore throat, infections,
• ringing in the ears (tinnitus),
• feeling of heartbeat (palpitations),
• gastric or duodenal ulcers,
• esophagitis,
• asthma attacks (in people allergic to aspirin or other NSAIDs),
• blistering skin reactions or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• hives,
• visual disturbances, including: blurred vision, conjunctivitis (red and swollen eyes),
• colitis (inflammation of the colon).

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

• blistering skin reactions and erythema multiforme,
• hepatitis,
• acute kidney failure, especially in patients with risk factors such as heart disease, diabetes, or kidney disease,
• perforation of the intestinal wall.

Frequency not known: frequency cannot be estimated from available data

• confusion, disorientation,
• anaphylactic shock (drop in blood pressure), shortness of breath, and skin reactions (anaphylactic and/or anaphylactoid), photosensitivity reactions (reactions to sunlight),
• heart failure reported in association with NSAID treatment,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Opokan fast with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic medicines). This can lead to:
• sudden fever,
• sore throat,
• infections,
• pancreatitis,
• a characteristic skin allergic reaction known as fixed drug eruption, which usually recurs in the same place (in the same places) after re-administration of the medicine, with symptoms such as round or oval, red and swollen patches on the skin, blisters (hives), itching,
• infertility in women, delayed ovulation.

Side effects of non-steroidal anti-inflammatory drugs (NSAIDs) not yet reported with Opokan fast:

Acute kidney failure due to changes in kidney structure;

• -very rarely, cases of kidney inflammation (interstitial nephritis),
• -necrosis of some kidney cells (acute tubular necrosis or renal papillary necrosis),
• -presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
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 fast

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage precautions.
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 fast contains

• The active substance is meloxicam. One mL of solution contains 10 mg of meloxicam. Each ampoule (1.5 mL solution for injection) contains 15 mg of meloxicam.
• The other ingredients are: meglumine, glycine, poloxamer 188, glycofurol, sodium chloride, sodium hydroxide (to adjust pH), water for injections.

What Opokan fast looks like and contents of the pack

Opokan fast is a clear, yellow or yellow-green liquid.
The pack contains a blister with 3 or 5 ampoules made of colorless glass (type I) containing 1.5 mL of solution for injection, and a patient information leaflet, packed in a cardboard box.

Marketing authorization holder and importer

Marketing authorization holder:
Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151,
95-200 Pabianice,
phone: (42) 22-53-100
Importer:
Farmak International Sp. z o.o.
Piłsudskiego Avenue 141,
92-318 Łódź,
Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

PL: Opokan fast
Date of last revision of the leaflet:08.07.2024