Okitask

LEAFLET INCLUDED IN THE PACKAGE

Leaflet included in the package: information for the user

Okitask, 25 mg, coated granules

Ketoprofen

You should carefully read the contents of the leaflet 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If the symptoms worsen or do not improve after 3 days in the case of fever and after 5 days in the case of pain, the patient should contact their 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 package and other information

1. What is Okitask and what is it used for

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

If after 3 days in the case of fever or 5 days in the case of pain, there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Okitask

When not to take Okitask:

• if the patient is allergic(hypersensitive) to any of the other ingredients of the medicine (listed in section 6)
• if the patient has asthmaor has had allergic reactions(hypersensitivity) to ketoprofen or any other NSAID (e.g., aspirin, 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 disorders, such as: active stomach ulcers or duodenal ulcers

gastrointestinal bleeding or perforation (hole in the stomach or intestine)
painful or disturbed digestion, which may include nausea, vomiting, heartburn, bloating, and stomach discomfort (chronic indigestion)
inflammation of the stomach lining (gastritis)

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

Warnings and precautions

If the patient notices symptoms of rash, redness, and mucosal irritation or allergic reactions after taking Okitask, they should stop taking the medicine and immediately consult their doctor.
If the patient notices symptoms of gastrointestinal 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 their doctor.
If the patient notices symptoms of ulceration or perforation (symptoms may include severe abdominal pain, chills, nausea, vomiting, heartburn) after taking Okitask, they should stop taking the medicine and immediately consult their doctor.
In elderly patients, more side effects may occur with 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 for the shortest possible time.
Taking anti-inflammatory and pain-relieving medicines like 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.

Avoid taking ketoprofen lysinate with other products containing NSAIDs (e.g., ibuprofen, aspirin, celecoxib).
The patient should stop taking the medicine if they experience any vision disturbances, such as blurred vision.
Since ketoprofen lysinate is used to treat symptoms such as fever, it may mask underlying conditions. If symptoms persist, the patient should inform their doctor.
Taking pain-relieving medicine for headaches for too long can make them worse.
Before taking Okitask, the patient should consult their 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 retention or swelling
• if the patient has high blood pressure, heart failure, arterial disease, 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 disorder characterized by a change in liver enzyme activity), 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 hide the objective symptoms of infection, such as fever and pain. Therefore, Okitask may delay the application of appropriate infection treatment, which can lead to 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 their doctor.

Children and adolescents

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

Ketoprofen lysinate and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those bought without a prescription, including herbal preparations.
The patient should inform their doctor or pharmacistabout taking any of the following medicines:

• medicines that improve blood flow, such as anticoagulants (aspirin, warfarin, heparin, ticlopidine, dabigatran, or clopidogrel), thrombolytics (reteplase, streptokinase), 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 health disorders and depression(e.g., lithium, venlafaxine, and selective serotonin reuptake inhibitors (SSRIs))
• other NSAIDs(e.g., aspirin, 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)
• phenytoin- an antiepileptic medicine
• pentoxifylline- a medicine used to treat muscle pain
• penicillamine- a medicine used to treat rheumatoid arthritis

Taking Okitask with alcohol

Alcohol may cause irritation of the throat, stomach, and intestines, which can increase the risk of bleeding and ulcers when NSAIDs are taken at the same time as alcohol.

Pregnancy and breastfeeding

This medicine should not be taken during the last three months of pregnancy, as it may harm the unborn child or affect the course of labor. It may cause kidney and heart problems in the unborn child. It may affect the tendency to bleeding in the mother and child and may cause labor to be delayed or prolonged. This medicine should not be taken during the first six months of pregnancy, unless it is absolutely necessary and the doctor recommends it. If treatment is necessary during this time or when the patient is trying to become pregnant, the smallest effective dose should be used for the shortest possible time.
In case of taking this medicine 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, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

Okitask contains glucose and sucrose

If the doctor has informed the patient that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

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, the patient should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest possible time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
The recommended dose is 1 sachet up to 3 times a day, as needed.
The patient should wait at least 4 hours before taking the next sachet.

Do not take a higher dose than recommended.

The contents of the sachet can be poured directly onto the tongue. Okitask can be taken with or without water, as the granules will dissolve in saliva.
The patient should consult their doctor or pharmacist if the symptoms persist, worsen, or new symptoms appear.

Use in children

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

Use in elderly patients

Do not take more than 1 sachet of Okitask per day.

Route of administration

Oral use.

Overdose of Okitask

In case of accidental overdose of Okitask, the patient may feel drowsy or experience nausea. The patient should immediately consult their doctor, even if they feel well.

Missed dose of Okitask

The patient should not take a double dose of the medicine to make up for a missed dose.
If the patient misses a dose of Okitask, they should take it as soon as possible. The patient should not take a double dose instead of the missed dose; they should always maintain an interval of at least 4 hours between doses and not exceed the maximum of 3 sachets per day.

Stopping Okitask

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

4. Possible side effects

Like all medicines, Okitask can cause side effects, although not everybody gets them.
The patient should stop taking Okitask and immediately consult their doctorif at any time during treatment with this medicine they experience:

• 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, mouth, and eyes
• 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 or ulcerative colitis(chronic inflammatory bowel disease with symptoms of abdominal pain, diarrhea, fever, and weight loss)

The patient should inform their doctor if they experience:

• 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

Okitask side effects may include:

Common(may occur in up to 1 in 10 people)

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

Uncommon(may occur in up to 1 in 100 people)

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

Rare(may occur in 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
• mouth inflammation
• 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
• gastrointestinal bleeding; symptoms may include severe stomach pain, chills, nausea, vomiting blood or dark particles that look like coffee grounds, heartburn, bright red, black, tarry stools

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the
Department of Monitoring of Adverse Reactions to Medicinal Products, 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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package and other information

What Okitask contains

• The active substance is ketoprofen in the form of ketoprofen lysinate. Each sachet contains 25 mg of ketoprofen in the form of ketoprofen lysinate.
• The other ingredients are: povidone K25, anhydrous colloidal silica, hypromellose, butyl methacrylate copolymer, sodium lauryl sulfate, stearic acid, magnesium stearate, mannitol (E 421), xylitol (E 967), talc, natural lemon flavor, natural orange flavor, natural mint flavor, maltodextrin, sucrose, glucose, corn starch, butylhydroxyanisole, arabic gum.

What Okitask looks like and contents of the package

Ketoprofen lysinate, coated granules, are white to ivory in color and are packaged in sachets.
Available in packs of 8, 10, 15, 16, or 20 sachets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Dompé Farmaceutici S.p.A.
Via Campo di Pile
67100 L'Aquila
Italy

Date of last revision of the leaflet: December 2024

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

Bulgaria
Okitask 25 mg granules
Croatia
Okitask 25 mg coated granules in sachets
France
Okitask 25 mg coated granules in sachets
Finland
Okitask 25 mg granules
Greece
Okitask 25 mg granules in sachets
Hungary
Okitask 25 mg granules
Latvia
Okitask 25 mg coated granules in sachets
Lithuania
Okitask 25 mg granules
Netherlands
Okitask 25 mg coated granules
Portugal
Okiact 25 mg granules
Romania
Okitask 25 mg granules in sachets
Slovenia
Okitask 25 mg granules in sachets
Spain
Okidol 25 mg granules