OKITASK 25 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING
2. Leaflet included in the packaging: information for the user
3. Okitask, 25 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Okitask and what is it used for
   1. If after 3 days for fever or 5 days for pain there is no improvement or the patient feels worse, consult a doctor.
5. Important information before taking Okitask
   1. When not to take Okitask:
   2. Warnings and precautions
   3. Infections
   4. Children and adolescents
   5. Okitask and other medicines
   6. Okitask with alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
6. How to take Okitask
   1. Do not take a higher dose than recommended.
   2. Use in children
   3. Use in elderly patients
   4. Route of administration
   5. Overdose of Okitask
   6. Missing a dose of Okitask
   7. Do not take a double dose of the medicine to make up for a missed dose.
   8. Stopping Okitask
7. Possible side effects
   1. Tell the doctor if the patient experiences:
   2. The following are side effects of Okitask:
   3. Reporting side effects
8. How to store Okitask
9. Contents of the pack and other information
   1. What Okitask contains:
   2. What Okitask looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product has been authorized in the EEA Member States under the following names:

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: information for the user

Okitask, 25 mg, coated tablets

Ketoprofen

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If symptoms worsen or do not improve after 3 days for fever or 5 days for pain, consult a doctor.

Table of contents of the leaflet

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

1. What is Okitask and what is it used for

The active substance of this medicine is ketoprofen lysine, which belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). These medicines relieve short-term discomforts by changing the body's response to pain, swelling, and high body temperature. Ketoprofen lysine is a salt of ketoprofen, which is rapidly and completely absorbed by the body. It is used to treat mild to moderate pain, such as muscle and joint pain, headaches, throat pain, toothache, and menstrual pain, as well as fever in adults over 18 years of age.

If after 3 days for fever or 5 days for pain there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Okitask

When not to take Okitask:

• if the patient is allergic(hypersensitive) to ketoprofen or any of the other ingredients of this medicine (listed in section 6)
• if the patient has asthmaor has had allergic reactions(hypersensitivity) to NSAIDs (e.g., acetylsalicylic acid, ibuprofen)
• in women in the third trimester of pregnancy(from the 29th week onwards). See section 2 "Pregnancy and breastfeeding"
• if the patient has severe heart disease, in which the heart does not work as well as it should
• if the patient has had or has gastrointestinal disorderssuch as: active peptic ulcer, stomach or intestinal ulcers, gastrointestinal bleeding, perforation of the gastrointestinal tract

about painful or disturbed digestion, which may include nausea, vomiting, heartburn, bloating, and stomach discomfort (chronic indigestion)
about inflammation of the lining of the stomach (gastritis)

• if the patient has reduced blood cell count(leukopenia or thrombocytopenia), active bleeding, or shows a tendency to bleedingwhile taking anticoagulant medications
• if the patient has severe kidney or liver disease

Warnings and precautions

If the patient notices symptoms of rash, redness, and skin pain, mucous membranes, or allergic reactions after taking ketoprofen lysine, they should stop taking the medicine and immediately consult a doctor.
If the patient notices symptoms of stomach or intestinal bleeding (e.g., bright red, black, tarry stools, vomiting blood or dark particles that look like coffee grounds), they should stop taking the medicine and immediately consult a doctor.
If the patient notices symptoms of ulcers or perforation (symptoms may include severe abdominal pain, chills, nausea, vomiting, heartburn) after taking ketoprofen lysine, they should stop taking the medicine and immediately consult a doctor.
In elderly patients, there may be more side effects of NSAIDs, especially from the stomach and intestines, which can be fatal. Elderly patients should use the product with caution.
Side effects can be minimized by taking the smallest effective dose of the medicine for the shortest possible time necessary to relieve symptoms.
Taking anti-inflammatory/pain-relieving medications, such as ketoprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses for a long time. Do not take higher doses than recommended and do not prolong treatment.
Taking ketoprofen lysine with other products containing NSAIDs (e.g., ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.
The patient should stop taking the medicine if they experience any vision disturbances, such as blurred vision.
Since ketoprofen lysine is used to treat symptoms such as fever, it may mask underlying serious conditions. If symptoms persist, consult a doctor.
Taking pain-relieving medication for headaches for too long can make them worse.
Before taking Okitask, consult a doctor or pharmacist:

• if the patient is pregnant, trying to become pregnant, or breastfeeding(see section 2 "Pregnancy and breastfeeding")
• if the patient has fluid retentionor edema
• if the patient has high blood pressure, weakened heart, arterial disease, and/or cerebrovascular disease
• if the patient has liver disease
• if the patient has kidney disease
• if the patient has allergies(e.g., hay fever)
• if the patient has chronic obstructive pulmonary disease (COPD)
• if the patient has porphyria(a rare blood disease characterized by a change in the activity of one of the liver enzymes), as taking the medicine may trigger an attack of the disease
• if the patient has an infection- see below, section titled "Infections".

Infections

Okitask may mask the objective symptoms of infection, such as fever and pain. Therefore, Okitask may delay the application of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Children and adolescents

Ketoprofen lysine should not be given to children under 18 years of age.

Okitask and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those bought without a prescription, including herbal preparations.
Tell the doctor or pharmacistabout taking any of the following medicines:

• medicines that improve blood flow, such as anticoagulants (acetylsalicylic acid, warfarin, heparin, ticlopidine, dabigatran, or clopidogrel), thrombolytics (reteplase, streptokinase), vasodilators (pentoxifylline), prasugrel, coumarin derivatives
• certain antibiotics(e.g., quinolones, sulfonamides)
• medicines used after organ transplantationto prevent rejection (e.g., cyclosporine, tacrolimus)
• medicines used in certain mental disorders, depression(e.g., lithium, venlafaxine, and selective serotonin reuptake inhibitors (SSRIs))
• other NSAIDs(e.g., acetylsalicylic acid, ibuprofen) or paracetamol
• diuretics, such as bendroflumethiazide
• corticosteroids(steroid hormones, such as hydrocortisone or prednisolone)
• antiretroviral medicines used to treat HIV infection(e.g., ritonavir, zidovudine)
• medicines used to treat high blood pressure(e.g., ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxants, such as baclofen
• medicines used to treat heart failure to regulate heart rhythm(e.g., digoxin, digitoxin)
• medicines used to treat diabetes(e.g., gliclazide)
• medicines used to treat cancer(e.g., erlotinib, pemetrexed, methotrexate)
• medicines used to treat gout(e.g., probenecid)
• diphenylhydantoin- an antiepileptic medicine
• penicillamine- a medicine used to treat rheumatoid arthritis

Okitask with alcohol

Alcohol may cause irritation of the throat, stomach, and intestines, resulting in an increased risk of bleeding and ulcers when NSAIDs are taken with alcohol.

Pregnancy and breastfeeding

Do not take this medicine during 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 affect the tendency to bleeding in the mother and child and cause delayed or prolonged delivery. Do not take ketoprofen during the first six months of pregnancy, unless absolutely necessary and as directed by a doctor.
If treatment is necessary during this time or when the patient is trying to become pregnant, use the smallest effective dose for the shortest possible time. If this medicine is taken for more than a few days from the 20th week of pregnancy onwards, ketoprofen may cause kidney problems in the unborn child, which can lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

If after taking Okitask the patient feels drowsy, dizzy, has blurred vision, or experiences convulsions, they should not drive vehicles, operate machinery, or perform other activities that require a high level of physical and mental fitness (see section 4 "Possible side effects").

3. How to take Okitask

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Use the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose is 1 tablet up to 3 times a day, as needed.
Wait at least 4 hours before taking the next tablet.

Do not take a higher dose than recommended.

Swallow the tablets whole with a glass of water.
The dividing line on the tablet is not intended for dividing the tablet.
The patient should consult a doctor or pharmacist if symptoms persist or worsen or if new symptoms appear.

Use in children

Ketoprofen lysine should not be used in children under 18 years of age.

Use in elderly patients

Do not take more than 1 tablet of ketoprofen lysine per day.

Route of administration

The medicine is for oral use.

Overdose of Okitask

In case of accidental overdose of ketoprofen lysine, the patient may feel drowsy or experience nausea. Consult a doctor immediately, even if feeling well.

Missing a dose of Okitask

Do not take a double dose of the medicine to make up for a missed dose.

In case of a missed dose of ketoprofen lysine, take it as soon as possible. Do not take a double dose instead of a missed dose; always maintain an interval of at least 4 hours between doses and do not exceed the maximum number of 3 tablets per day.

Stopping Okitask

The patient should stop taking this medicine as soon as they feel better. If they have any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can be minimized by taking the smallest effective dose of the medicine for the shortest possible time necessary to relieve symptoms.
Stop taking Okitask and consult a doctor immediatelyif at any time during treatment with this medicine the patient experiences:

• symptoms of gastrointestinal bleeding, such as: bright red stools, black, tarry stools, vomiting blood or dark particles that look like coffee grounds
• symptoms of rash, severe skin reactions, and blisters on the skin, mucous membranes, and eyes(e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
• symptoms of severe allergic reactions, such as:
• difficulty breathing or unexplained wheezing
• dizziness or rapid heartbeat
• swelling of the lips, face, throat, or tongue
• worsening of Crohn's disease, ulcerative colitis(chronic inflammatory bowel disease with symptoms of abdominal pain, diarrhea, fever, and weight loss)

Tell the doctor if the patient experiences:

• fever, sore throat, mouth ulcers, headaches, vomiting, unexplained bleeding, and severe fatigue
• indigestion, stomach pain or abdominal pain, constipation, diarrhea, gas, or nausea, chest pain or rapid, irregular heartbeat
• liver and kidney disorders with swelling in the hands and feet.

The following are side effects of Okitask:

Common(may affect up to 1 in 10 people)

• digestive disorders (indigestion), nausea, abdominal pain, vomiting

Uncommon(may affect up to 1 in 100 people)

• headaches, dizziness, drowsiness
• constipation, diarrhea, gas, inflammation of the stomach lining
• edema due to fluid retention in the body
• itching and rash
• fatigue

Rare(may affect up to 1 in 1,000 people)

• iron deficiency (anemia) caused by bleeding
• numbness, tingling of the skin
• blurred vision
• ringing in the ears (tinnitus)
• asthma
• inflammation of the mouth lining
• stomach ulcers
• liver inflammation, increased liver enzyme activity, yellowing of the skin or whites of the eyes (jaundice)
• weight gain

Frequency not known(cannot be estimated from the available data)

• changes in blood cell and platelet count
• allergic reactions (anaphylaxis)
• disorders of the adrenal glands
• high blood pressure, hot flashes (vasodilation)
• heart failure
• kidney failure, kidney inflammation, abnormal kidney function test results
• ulcerative colitis
• worsening of gastrointestinal diseases
• dark or black stools
• vomiting blood
• stuffy nose and cold (rhinitis)
• throat swelling
• swelling of the deep layers of the skin (e.g., face, hands), caused by excess fluid
• breathing difficulties (dyspnea)
• headaches
• respiratory failure caused by bronchial constriction
• uncontrolled muscle contractions (seizures)
• sensitivity to sunlight or UV lamps
• taste disorders
• mood changes
• behavior changes
• hair loss
• itchy rash
• bleeding from the stomach and/or intestines; symptoms may include severe abdominal pain, chills, nausea, vomiting blood or dark particles that look like coffee grounds, heartburn, bright red or black, tarry stools

Reporting side effects

If side effects occur, including any not listed in the leaflet, tell the 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Okitask

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture. There are no special storage temperature recommendations.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Okitask contains:

• The active substance of the medicine is ketoprofen. Each tablet contains 25 mg of ketoprofen in the form of ketoprofen lysine.
• The other ingredients are: mannitol (E421), crospovidone, sodium lauryl sulfate, colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, macrogol 4000 (E1521), titanium dioxide (E171), talc, brilliant blue (E133), quinoline yellow, aluminum lake (E104).

What Okitask looks like and contents of the pack

Okitask tablets are coated, round, blue tablets with a dividing line on one side. The tablets are supplied in blisters containing 8, 10, 15, 16, or 20 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Dompe Farmaceutici S.p.A
Via San Martino, 12
Milan
MI 20122
Italy

Manufacturer

Abiogen Pharma S.p.A.
Via Meucci, 36
56121 Ospedaletto
Pisa
Italy
Date of last revision of the leaflet:June 2023

This medicinal product has been authorized in the EEA Member States under the following names:

Bulgaria
Okitask 25 mg film-coated tablets
Croatia
Okitask 25 mg film-coated tablets
France
Okitask 25 mg coated tablets
Finland
Okitask 25 mg film-coated tablets
Greece
Okitask 25 mg film-coated tablets
Hungary
Okitask 25 mg film-coated tablets
Latvia
Okitask 25 mg film-coated tablets
Lithuania
Okitask 25 mg film-coated tablets
Netherlands
Okitask 25 mg film-coated tablets
Portugal
Okiact 25 mg coated tablets
Romania
Okitask 25 mg film-coated tablets
Slovenia
Okitask 25 mg film-coated tablets
Spain
Okidol 25 mg coated tablets