Okitask

Package leaflet: Information for the user

Okitask, 25 mg, effervescent tablets
Ketoprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 unlisted side effects, 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, contact your doctor.

Leaflet contents

1. What Okitask is and what it is 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 Okitask is and what it is used for
The active substance in this medicine is ketoprofen lysine salt, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines relieve discomfort by altering the body's response to pain, swelling, and high body temperature. Ketoprofen lysine salt is a salt of ketoprofen that is rapidly and completely absorbed by the body. It is used for symptomatic treatment of mild to moderate pain, such as muscle and joint pain, headache, pain associated with sore throat, toothache, and menstrual pain, as well as fever in adults aged 18 years and above.
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, contact a doctor.

2. Important information before taking Okitask

When not to take Okitask:

• if the patient is allergic (hypersensitive) to ketoprofen or to any of the other ingredients of this medicine (listed in section 6)
• if the patient suffers from asthma or has previously experienced allergic reactions (hypersensitivity) to NSAIDs (e.g. acetylsalicylic acid, 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 in which the heart does not function as it should
• if the patient currently has or has previously had intestinal disorders, such as: active or recurrent peptic ulcer, gastric or intestinal ulcers, intestinal bleeding, perforation of the gastrointestinal tract (gastrointestinal perforation), any of the above conditions caused by treatment with NSAIDs, painful or disturbed digestion, which may include nausea, vomiting, heartburn, bloating and stomach discomfort (chronic dyspepsia), inflammation of the gastric mucosa
• if the patient has reduced blood cell count (leukopenia or thrombocytopenia), is bleeding or shows tendency to bleeding during treatment with anticoagulant drugs (blood thinners)
• if the patient has severe kidney or liver disease

Warnings and precautions
If the patient experiences symptoms of rash, redness and pain of the skin or mucous membranes, or allergic reactions after taking ketoprofen lysine salt, they should stop using the medicine and immediately inform their doctor.
If the patient notices symptoms of gastrointestinal bleeding (e.g. bright red, black, tarry stools, vomiting blood or dark particles resembling coffee grounds), they should stop taking the medicine and immediately contact their doctor.
If the patient notices symptoms of ulceration or perforation (symptoms may include severe abdominal pain, chills, nausea, vomiting, heartburn) after taking ketoprofen lysine salt, they should stop taking the medicine and immediately inform their doctor.
Elderly patients may experience more adverse effects from NSAIDs, especially affecting the stomach and intestines, which can be fatal. Elderly patients should use this product with caution.
Adverse effects can be minimized by taking the lowest effective dose for the shortest possible duration needed to relieve symptoms.
The use of anti-inflammatory or analgesic medicines, such as ketoprofen, may be associated with a small increased risk of heart attack or stroke, especially when large doses are used for prolonged periods. Do not use doses higher than recommended and do not extend the treatment period.
If the patient has high blood pressure, weakened heart function, arterial/vascular disease affecting the brain, or is in a group at increased risk of such diseases (for example, if the patient has diabetes, high cholesterol levels, or is a smoker), they should consult their doctor or pharmacist before using this medicine.
Consult your doctor if palpitations or irregular heartbeat occur.
Avoid using ketoprofen lysine salt together with other products containing NSAIDs (e.g. ibuprofen, acetylsalicylic acid, celecoxib).
The patient should discontinue use if any visual disturbances occur, such as blurred vision.
Since ketoprofen lysine salt is used to treat symptoms such as fever, it may mask more serious underlying diseases. If symptoms persist, inform your doctor.
Taking painkillers for too long may lead to worsening of headache symptoms.
Before starting treatment with Okitask, consult your 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 edema
• if the patient has blood disorders (e.g. anaemia)
• 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 hepatic porphyria (a rare blood disorder characterized by altered activity of one of the liver enzymes), as administration of the drug may trigger an attack
• if the patient has an infection – see below, section titled "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 ongoing infection and infection symptoms persist or worsen, they should immediately consult a doctor.
Children and adolescents
Do not give ketoprofen lysine salt to children under 18 years of age.
Okitask with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes over-the-counter medicines, including 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 (acetylsalicylic acid, warfarin, heparin, ticlopidine, dabigatran or clopidogrel), thrombolytic agents (reteplase, streptokinase), peripheral vasodilators (pentoxifylline), prasugrel, coumarin derivatives
• certain antibiotics (e.g. quinolones, sulfonamides)
• medicines used after organ transplantation to prevent organ rejection (e.g. cyclosporine, tacrolimus)
• medicines used in certain mental disorders and depression (e.g. lithium, venlafaxine and selective serotonin reuptake inhibitors (SSRIs))
• other NSAIDs (e.g. acetylsalicylic acid, 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 in the treatment of hypertension (e.g. ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxants, such as baclofen
• medicines used in the treatment of heart failure and to regulate heart rhythm (e.g. digoxin, digitoxin)
• medicines used in the treatment of diabetes (e.g. gliclazide)
• medicines used in the treatment of cancer (e.g. erlotinib, pemetrexed, methotrexate)
• medicines used in the treatment of gout (e.g. probenecid)
• phenytoin – an antiepileptic medicine
• penicillamine – a medicine used in the treatment of rheumatoid arthritis
• gemeprost (a medicine used for gynaecological problems)
• if the patient plans to use mifepristone for contraception.

Okitask and 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 tendency in both mother and child and may delay or prolong labour. Do not take ketoprofen during the first 6 months of pregnancy unless absolutely necessary and only if prescribed by a doctor. If treatment is necessary during this period or if the patient is trying to become pregnant, the lowest possible dose should be used for the shortest possible duration. 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, which may lead to reduced amniotic fluid volume surrounding the child (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, experiences dizziness, blurred vision or seizures, they should not drive, operate machinery or perform any other activities requiring high psycho-motor performance (see section 4 "Possible side effects").
Okitask contains sodium
The medicine contains 322 mg of sodium (the main component of table salt) in each tablet. This corresponds to 16% of the recommended maximum daily sodium intake for an adult.
Okitask contains sorbitol
The medicine contains 147 mg of sorbitol in each tablet.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance – a rare genetic disorder in which the patient's body cannot break down fructose – the patient should contact their doctor before taking this medicine.

3. How to take Okitask

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The recommended dose is 1 tablet up to 3 times daily, as needed.
Allow at least four hours to pass before taking the next tablet.
Do not exceed the recommended dose.
Before administration, dissolve the tablet in a glass of water.
The patient should consult a doctor or pharmacist if symptoms persist or worsen, or if new symptoms occur.

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

Use in elderly patients
Do not take more than 1 tablet of ketoprofen lysinate per day.

Taking more Okitask than recommended
If a larger than recommended dose of ketoprofen lysinate is accidentally taken, the patient may feel drowsy or experience nausea. Immediate medical advice should be sought, even if feeling well.

If you forget to take Okitask
Do not take a double dose to make up for a missed dose.
If a dose of ketoprofen lysinate is missed, take it as soon as possible. Do not take a double dose to replace the missed dose. Always maintain a minimum interval of 4 hours between doses, and do not exceed the maximum of 3 tablets per day.

Stopping treatment with Okitask
The patient should stop taking this medicine as soon as they feel better. If you have any further doubts 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 not everyone will experience them. Adverse reactions can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms.

Discontinue taking Okitask and seek immediate medical advice if at any time during treatment with this medicine the patient develops:

• 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, mouth or eyes
• symptoms of 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, fatigue
• indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or nausea, chest pain or rapid, irregular heartbeat
• liver and kidney disorders associated with swelling of hands and feet.

Adverse reactions 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
• blurred vision
• ringing in the ears (tinnitus)
• asthma
• inflammation of the mucous membrane of the mouth (stomatitis)
• gastric 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, nephritis, abnormal kidney function test results
• colitis
• worsening of gastrointestinal disorders
• dark or black stools
• vomiting blood
• nasal congestion and runny nose (rhinitis)
• throat swelling
• swelling of deep skin layers (e.g. face, hands) due to fluid accumulation (angioedema)
• breathing difficulties (dyspnoea)
• headaches
• respiratory failure due to airway constriction
• uncontrolled muscle contractions (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 reactions

If any adverse reactions occur, including any unlisted side effects, inform a doctor or pharmacist. Adverse reactions 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, Poland
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps increase knowledge about the safety of this medicine.

Adverse reactions may also be reported to the responsible entity.

5. How to store Okitask

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the cardboard box,
sachet, and tube after: Expiry date (EXP)
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. This will help
protect the environment.

6. Contents of the pack and other information

What Okitask contains:

• The active substance is ketoprofen. Each tablet contains 25 mg of ketoprofen in the form of ketoprofen lysine complex 40 mg.
• The other ingredients are: mannitol (E 421), sodium hydrogen carbonate (E 500), citric acid (E 330), orange flavour, sorbitol (E 420), sodium carbonate (E 500), leucine, sodium saccharin (E 954), polysorbate 20 (E 432), simeticone emulsion 30%, colloidal anhydrous silica (E 551).

What Okitask looks like and contents of the pack
Okitask effervescent tablets are white, round, flat tablets with an orange flavour. The tablets are
supplied in bottles or sachets containing 8, 10, 12, 15, 16 or 20 tablets per cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milan
Italy
Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina 2
38123 Trento
Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Okitask 25 mg bruistabletten
Poland Okitask
Finland Okitask 25 mg Poretabletti
Hungary Okitask 25 mg pezsgötabletta
Italy OKi dolore e febbre 25 mg Compresse Effervescenti
France Okitask 25 mg Comprimé Effervescent
Spain Ketoprofeno Dompe 25 mg Comprimido Efervescente
Portugal Okiact 25 mg Comprimido Efervescente