Opokan fast

Patient Information Leaflet

Opokan FAST, 15 mg/1.5 mL, solution for injection
Meloxicam
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Opokan FAST is and what it is 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 Opokan FAST is and what it is 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 joints and muscles.
Opokan FAST is used for:

• short-term treatment of symptoms during flare-ups of rheumatoid arthritis or ankylosing spondylitis (also known as Bechterew's disease – a type of arthritis causing pain and stiffness in the spine), when oral or rectal administration is not possible;
• short-term symptomatic treatment of exacerbations of osteoarthritis.

2. Important information before using Opokan fast

When not to use Opokan fast

• if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), meaning if the patient has ever experienced any of the following symptoms after taking these medicines:
  • wheezing, 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 around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema);
• if the patient has previously experienced gastrointestinal bleeding or perforation of the stomach or intestines while taking NSAIDs;
• if the patient currently has (or has had two or more episodes of) peptic ulcer disease (ulcer of the stomach or intestines) or gastrointestinal bleeding;
• if the patient has severe liver function disorders;
• if the patient has severe renal insufficiency and is not undergoing dialysis;
• if the patient has recently experienced intracranial bleeding (cerebral haemorrhage);
• if the patient has any other bleeding disorders;
• if the patient has severe heart failure;
• in pregnant women during the last three months of pregnancy;
• in children and adolescents under 18 years of age;
• in patients treated with anticoagulant medicines (due to the risk of intramuscular haematomas).

If the patient is unsure whether any of the above points apply, they should
contact their doctor.
Warnings and precautions
Before starting treatment with Opokan fast, discuss this with your doctor or pharmacist.
This is particularly important if:

• the patient has ever had oesophagitis, gastritis or any other gastrointestinal disorder, e.g. Crohn's disease or ulcerative colitis;
• the patient has high blood pressure (hypertension);
• the patient is elderly. There is an increased risk of adverse effects in elderly patients, therefore the doctor may reduce the dose and closely monitor cardiac, liver and kidney function during treatment;
• the patient has heart, liver or kidney disease;
• the patient has high blood glucose (sugar) levels (diabetes);
• the patient has reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss, burns, surgery or low fluid intake;
• the patient has elevated potassium levels in the blood;
• the patient has ever developed a persistent drug-induced rash (erythema) after taking meloxicam or other oxicams (e.g. piroxicam) (circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria and itching).

Opokan fast is not recommended for immediate relief of acute pain attacks.
Opokan fast may mask symptoms of infection such as fever, pain, swelling,
and redness. The patient may mistakenly believe they feel better or that the infection is not
serious. If the patient suspects an infection, they should contact their doctor.
Skin reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of meloxicam. These initially appear as red spots or circular patches on the trunk, often with central blisters.
Additional symptoms may include mouth ulcers, throat or nasal ulcers, genital lesions 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.
Patients who have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam must not resume treatment with meloxicam.
If a skin rash or any of the above skin symptoms occur, the use of Opokan fast must be discontinued and medical advice must be sought immediately, informing the doctor about the use of this medicine.
Cardiovascular reactions
Taking medicines such as 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 use higher doses or for longer than recommended.
If the patient has heart problems, has had a stroke or suspects they are at risk of such conditions, they should discuss treatment options with their doctor or pharmacist. For example, if the patient has:

• high blood pressure (hypertension);
• high blood glucose levels (diabetes);
• high blood cholesterol levels (hypercholesterolemia);
• is a smoker.

Opokan fast and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Opokan fast may affect the action of other medicines. There are several medicines that should not be taken together with Opokan fast. In some cases, dose adjustments of other medicines may be necessary during treatment with Opokan fast.
Inform your doctor or pharmacist especially if the patient is using or receiving 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);
• anticoagulant medicines taken orally or parenterally;
• medicines that dissolve blood clots (thrombolytic agents);
• medicines used for heart and kidney diseases;
• medicines used to treat high blood pressure (e.g. beta-blockers);
• diuretics. The doctor may monitor kidney function when diuretics are used;
• corticosteroids (used to treat inflammatory or allergic conditions);
• certain antidepressants: 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);
• deferasirox (used to treat chronic iron overload due to multiple blood transfusions);
• cyclosporine (used after organ transplantation or to treat autoimmune diseases, i.e. severe cases of certain skin diseases, rheumatoid arthritis or kidney disease known as nephrotic syndrome);
• tacrolimus (used after organ transplantation);
• cholestyramine (used to lower cholesterol levels);
• oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood glucose levels due to the risk of hypoglycaemia;
• if the patient uses an intrauterine contraceptive device, commonly known as an IUD.

If in doubt about using these medicines, consult your doctor
or pharmacist.
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 her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Opokan fast 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. During the first 6 months of pregnancy, Opokan fast should not be used unless the doctor considers it 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 fast, if used for longer than a few days, may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney dysfunction, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, the 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. The patient should inform the doctor if she plans to become pregnant or is having difficulty conceiving.
Driving and operating machinery
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or loss of balance, or other central nervous system disorders may occur after using this medicine. If these symptoms occur, the patient should 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), meaning 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 intramuscular injection deeply into the patient's buttock. If more than one injection is required, the medicine will be administered into the other buttock. If the patient has a hip prosthesis, the injection will be given on the opposite side of the body. If the patient experiences severe pain during the injection, administration of the medicine must be stopped.

The recommended dose is a single injection. In exceptional cases (e.g. when tablets or suppositories cannot be used), the physician may decide to extend treatment for 2–3 days. The maximum daily dose of 15 mg must not be exceeded.

Elderly patients and patients at increased risk of adverse reactions
The recommended dose is 7.5 mg (half an ampoule) per day.

Patients with renal or hepatic impairment
If the patient has severe kidney disease and is undergoing dialysis, no more than 7.5 mg (half an ampoule) per day should be administered.
If the patient has mild to moderate kidney or liver disease, the standard adult dose may be given.

Use in children and adolescents
Opokan FAST is not recommended for children and adolescents under 18 years of age.

Use of a higher than recommended dose of Opokan FAST
In case of overdose or suspected overdose of Opokan FAST, seek immediate medical advice from a doctor or go to the nearest hospital.
Symptoms of overdose may include: weakness (feeling of lack of energy), drowsiness, nausea and vomiting, abdominal pain, gastrointestinal bleeding. In cases of severe poisoning, the following symptoms may occur: high blood pressure, acute kidney failure, liver function disorders, slow or weak breathing, loss of consciousness (coma), seizures, circulatory failure, sudden cardiac arrest, immediate allergic reactions including fainting, shortness of breath, and skin reactions.

Missed dose of Opokan FAST
If a dose is missed, take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The use of Opokan fast must be discontinued and immediate consultation with a doctor or the nearest hospital is required 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), damage to soft tissues (lesions of mucous membranes), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches, or blisters on the skin. It may also affect the lips, eyes, and other moist areas of the body;
  • Swelling of the skin or mucous membranes, such as swelling around the eyes, face and lips, mouth or throat, possibly causing breathing difficulties, swelling of the ankles or legs (peripheral oedema);
  • Shortness of breath or asthma attack.
• Any symptoms of liver inflammation, particularly:
  • Yellowing of the skin and whites of the eyes (jaundice);
  • Abdominal pain;
  • Loss of appetite.
• Any adverse gastrointestinal symptoms, particularly:
  • Bleeding (resulting in black, tarry stools or vomiting blood);
  • Gastrointestinal ulceration (causing abdominal pain). 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 seek immediate medical advice, especially if elderly. The doctor may monitor the progress of treatment.
If use of Opokan fast causes visual disturbances, driving or operating machinery should be avoided.
General adverse reactions 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 thrombotic events (e.g. myocardial infarction or stroke), particularly when used at high doses and for prolonged periods.
Oedema, hypertension, and heart failure have been reported during NSAID therapy.
The most commonly observed adverse effects involve the gastrointestinal tract (stomach and intestinal disturbances):

• Gastric and duodenal ulcer disease,
• Intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse reactions have been reported after administration of NSAIDs:

• Nausea and vomiting, diarrhoea, flatulence with passage of gas, constipation, indigestion (dyspepsia), abdominal pain,
• Black, tarry stools due to gastrointestinal bleeding, vomiting blood,
• Oral ulcerative inflammation,
• Exacerbation of gastrointestinal inflammatory disease (e.g. exacerbation of colitis or Crohn's disease).

Gastritis has been observed less frequently.
Adverse reactions of meloxicam – the active substance in Opokan fast
Very common: may affect more than 1 in 10 people

• Gastrointestinal disorders such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, loose stools (diarrhoea).

Common: may affect less than 1 in 10 people

• Headache,
• Thickening at the injection site, pain at the injection site.

Uncommon: may affect less than 1 in 100 people

• Dizziness (feeling of emptiness in the head),
• Dizziness or sensation of spinning (vestibular origin),
• Somnolence (drowsiness),
• Anaemia (reduced number of red blood cells, which may cause paleness of the skin, weakness and fatigue),
• 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:
  • Heart rhythm disturbances (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 (hypersensitivity),
• Itching (pruritus),
• Skin rash,
• Fluid retention-related oedema, including swelling of ankles/legs (peripheral oedema),
• Sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (angioedema),
• Transient abnormalities in liver function tests (e.g. increased liver enzyme activity such as aminotransferases, or increased levels of the bile pigment bilirubin). These changes may be detected by the doctor through blood tests,
• Abnormalities in kidney function laboratory tests (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, reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia). These adverse reactions may increase the risk of infection and symptoms such as bruising or nosebleeds,
• Ringing in the ears (tinnitus),
• Palpitations (sensation of heart beating),
• Gastric or duodenal ulcer disease,
• Oesophagitis,
• Onset of asthma attacks (in individuals hypersensitive to aspirin or other NSAIDs),
• Skin blistering or peeling of the epidermis (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,
• Hepatitis,
• 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,
• Anaphylactic shock (drop in blood pressure), 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,
• Complete loss of certain types of white blood cells (agranulocytosis), particularly in patients taking Opokan fast together with other medicines that potentially have bone marrow suppressive or destructive effects (myelotoxic drugs). This may result in:
  • Sudden fever,
  • Sore throat,
  • Infections,
• Pancreatitis,
• A characteristic allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-administration of the drug, and which may appear as round or oval, red and swollen skin patches, blisters (urticaria), itching,
• Infertility in women, delayed ovulation.

Adverse reactions caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet reported after use of Opokan fast:
Acute renal failure due to structural kidney changes;

• Very rare 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions 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 reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Opokan FAST

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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 of injection solution) contains 15 mg of meloxicam.
• Other ingredients are: meglumine, glycine, poloxamer 188, glycofurol, sodium chloride, sodium hydroxide (for pH adjustment), water for injections.

What Opokan fast looks like and contents of the packaging
Opokan fast is a clear, yellow or greenish-yellow liquid.
The packaging contains a blister with 3 or 5 ampoules made of colorless glass (type I), each containing 1.5 mL of injection solution, and a package leaflet, all packed in a cardboard box.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice,
tel. (42) 22-53-100
Importer:
Farmak International Sp. z o.o.
ul. Chełmżyńska 249,
04-458 Warsaw

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
PL: Opokan fast