Okitask

PACKAGE LEAFLET

Package leaflet: Information for the user

Okitask 25 mg, coated granules
Ketoprofenum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms worsen or do not improve within 3 days in case of fever and within 5 days in case of pain, consult your doctor.

Table of contents

1. What Okitask is and what it is used for
2. Important information before using 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 Okitask is and what it is used for
The active substance in this medicine is ketoprofen, which belongs to a group of medicines known as "non-steroidal anti-inflammatory drugs" (NSAIDs). These medicines relieve short-term discomfort by altering the body's response to pain, swelling, and high body temperature. Ketoprofen with lysine is a salt of ketoprofen that is rapidly and completely absorbed by the body. It is used to treat mild to moderate pain, such as muscle and joint pain, headache, sore throat pain, toothache, menstrual pain, and fever in adults aged 18 years and older.
If there is no improvement after 3 days in case of fever or 5 days in case of pain, or if the patient feels worse, consult a doctor.

2. Important information before using 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 suffers from asthma or has previously experienced allergic reactions (hypersensitivity) to ketoprofen or any other NSAIDs (e.g. aspirin, ibuprofen)

• in women during the third trimester of pregnancy (from week 29 onwards). See section 2 "Pregnancy and breastfeeding"

• if the patient has severe heart disease where the heart does not function properly

• if the patient currently has or has previously had gastrointestinal disorders, such as:
  o active peptic ulcer
  o stomach or intestinal ulcers
  o gastrointestinal bleeding
  o perforation of the gastrointestinal tract (a hole in the stomach or intestine)
  o painful or disturbed digestion, which may include nausea, vomiting, heartburn, bloating, and gastric discomfort (chronic indigestion)
  o inflammation of the stomach lining (gastritis)

• if the patient has reduced blood cell counts (leukopenia or thrombocytopenia), active bleeding, or shows tendency to bleeding while on anticoagulant therapy (blood-thinning medicines)

• if the patient has severe kidney or liver disease

Warnings and precautions
If the patient experiences symptoms such as rash, redness, mucosal pain, or allergic reactions after taking Okitask, they should stop using the medicine and immediately inform their doctor.
If the patient notices symptoms of gastrointestinal bleeding (e.g. bright red or black, tarry stools, vomiting blood or dark particles resembling coffee grounds), they should stop taking the medicine and contact their doctor immediately.
If the patient experiences 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 contact their doctor immediately.
Elderly patients may experience more adverse effects from NSAIDs, particularly affecting the stomach and intestines, which can be life-threatening. Elderly patients should use this product cautiously.
Adverse effects can be minimized by taking the lowest effective dose for the shortest duration necessary to relieve symptoms.
The use of anti-inflammatory and pain-relieving medicines such as ketoprofen may be associated with a small increased risk of heart attack or stroke, especially when high doses are used over a prolonged period. Do not exceed the recommended doses or extend the treatment period.
Avoid using ketoprofen with lysine together with other products containing NSAIDs (e.g. ibuprofen, aspirin, celecoxib).
The patient should stop taking the medicine if any visual disturbances occur, such as blurred vision.
Since ketoprofen with lysine is used to treat symptoms such as fever, it may mask more serious underlying diseases. If symptoms persist, the patient should inform their doctor.
Prolonged use of painkillers for headaches may worsen the condition (medication-overuse headache).
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 retention or swelling
• if the patient has high blood pressure, weakened heart function, 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 suffers from chronic obstructive pulmonary disease (COPD)
• if the patient has hepatic porphyria (a rare blood disorder characterized by altered activity of a liver enzyme), as the medicine may trigger an attack
• if the patient has an infection – see below under the heading "Infections"

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

Children and adolescents
Do not give Okitask to children under 18 years of age.

Ketoprofen with lysine and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use, including over-the-counter medicines and herbal preparations.
You should inform your doctor or pharmacist if you are 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 transplantation to prevent rejection (e.g. cyclosporine, tacrolimus)
• medicines used in certain psychiatric 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
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone)
• antiretroviral medicines used in the treatment of HIV infection (e.g. ritonavir, zidovudine)
• medicines used to treat hypertension (e.g. ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxants, such as baclofen
• medicines used to treat heart failure and 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 irritate the throat, stomach, and intestines, thereby increasing the risk of bleeding and ulceration when NSAIDs are taken concurrently 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 bleeding tendencies in both mother and child and may delay or prolong labor. Ketoprofen should not be used during the first 6 months of pregnancy unless absolutely necessary and only if prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used.
If this medicine is taken for more than a few days starting from week 20 of pregnancy, ketoprofen may cause kidney problems in the unborn child, leading to reduced amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
If after taking Okitask the patient feels drowsy, dizzy, experiences blurred vision or seizures, they should not drive, operate machinery, or perform any other tasks requiring high levels of psychomotor performance (see section 4 "Possible side effects").

Okitask contains glucose and sucrose
If the doctor has informed the patient of an intolerance to certain sugars, consult the doctor before taking this medicine.

3. How to use Okitask

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be
sought immediately (see section 2).
The recommended dose is 1 sachet up to 3 times daily, according to need.
Allow at least four hours to elapse before taking the next sachet.
Do not exceed the recommended dose.
The contents of the sachet may be poured directly onto the tongue. Okitask may be taken with or
without water, as the granules will dissolve in saliva.
The patient should consult a doctor or pharmacist if symptoms persist, pain worsens, or new
symptoms occur.

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
For oral use.

Overdose of Okitask
If an overdose of Okitask is taken accidentally, the patient may feel drowsy or experience nausea.
Medical advice should be sought immediately, even if feeling well.

Missed dose of Okitask
Do not take a double dose to make up for a missed dose.
If a dose of Okitask is missed, take it as soon as possible. Do not take a double dose instead of the
missed dose. Maintain a minimum interval of 4 hours between doses, and do not exceed the
maximum of 3 sachets per day.

Stopping treatment with Okitask
The patient should stop taking this medicine as soon as they feel better. If there are any further
doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The use of Okitask must be discontinued and immediate medical advice sought if at any time during treatment with this medicine the patient experiences:

• symptoms of gastrointestinal bleeding, such as: bright red stool, tarry black stool, vomiting blood or dark particles resembling coffee grounds
• symptoms of rash, severe skin reactions and blisters on the skin, inside the mouth or eyes
• symptoms of a severe allergic reaction, such as:
  • difficulty breathing or unexplained wheezing,
  • dizziness or rapid heartbeat,
  • swelling of lips, face, throat or tongue
• worsening of Crohn's disease and ulcerative colitis (chronic inflammatory bowel disease with symptoms of abdominal pain, diarrhoea, fever and weight loss).

Inform the doctor if the patient experiences:

• fever, sore throat, mouth ulcers, headache, vomiting, unexplained bleeding and bruising, severe exhaustion
• indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence, chest pain or rapid, irregular heartbeat
• liver and kidney disorders associated with swelling of hands and feet.

Adverse effects associated with Okitask may include:
Common (may occur in up to 1 in 10 people)

• digestive disturbances (dyspepsia), nausea, abdominal pain, vomiting

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

• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence, inflammation of the stomach lining (gastritis)
• fluid retention causing oedema
• itching and rash
• fatigue

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

• iron deficiency (anaemia) due to bleeding
• numbness, tingling of the skin
• blurred vision
• ringing in the ears (tinnitus)
• asthma
• inflammation of the lining of the mouth (stomatitis)
• stomach ulcer
• hepatitis, increased liver enzyme activity, yellowing of the skin or whites of the eyes (jaundice)
• weight gain

Frequency not known (cannot be estimated from available data)

• changes in blood cell and platelet counts
• allergic reactions (anaphylaxis)
• adrenal gland dysfunction
• hypertension, hot flushes (vasodilation)
• heart failure
• kidney failure, kidney inflammation, abnormal kidney function test results
• colitis
• worsening of gastrointestinal disorders
• dark or black stool
• vomiting blood
• stuffy nose and runny nose (rhinitis)
• throat swelling
• swelling of deep skin layers (e.g. face, hands) due to fluid accumulation (angioedema)
• breathing difficulties (dyspnoea)
• headache
• respiratory failure due to airway constriction
• uncontrolled muscle spasms (seizures)
• photosensitivity (increased sensitivity to sunlight or UV lamps)
• taste disturbances
• mood changes
• behavioural changes
• hair loss
• itchy rash
• bleeding from the stomach and/or intestine; symptoms may include severe stomach pain, chills, nausea, vomiting blood or dark particles resembling coffee grounds, heartburn, bright red or black, tarry stools

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Okitask

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

6. Contents of the pack and other information

What Okitask contains

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

What Okitask looks like and contents of the pack
Ketoprofen lysine, coated granules, is white to ivory-coloured and is packed in sachets.
Pack sizes containing 8, 10, 15, 16 or 20 sachets are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Dompe Farmaceutici S.p.A
Via San Martino, 12
Milano
MI 20122
Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Okitask 25 mg granules
Croatia: Okitask 25 mg obložene granule u vrećici
France: Okitask 25 mg granules enrobes en sachet
Finland: Okitask 25 mg rakeet
Greece: Okitask 25 mg kόκκοι σε φακελάκι
Hungary: Okitask 25 mg granulátum
Latvia: Okitask 25 mg apvalkotās granulas paciņā
Lithuania: Okitask 25 mg Granules
Netherlands: Okitask 25 mg omhuld granulaat
Portugal: Okiact 25 mg granulado
Romania: Okitask 25 mg granule drajefiate în plic
Slovenia: Okitask 25 mg zrnca v vrečici
Spain: Okidol 25 mg Granulado