Okitask

PACKAGE LEAFLET

Package leaflet: information for the user

Okitask 25 mg, coated tablets
Ketoprofenum
Please read the entire leaflet carefully before taking this 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 physician 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 any adverse reactions occur, including any 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 or 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 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 short-term discomfort by altering the body's response to pain, swelling, and high body temperature. Ketoprofen lysine salt is a salt form 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, pain associated with sore throat, toothache, menstrual pain, as well as fever in adults aged over 18 years.
If there is no improvement within 3 days in case of fever or 5 days in case of pain, or if the patient feels worse, consult a doctor.

2. Information before using 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 properly

• if the patient currently has or has previously had intestinal disorders, such as:

  • active peptic ulcer
  • gastric or intestinal ulcers
  • gastrointestinal bleeding
  • perforation of the stomach or intestine (gastrointestinal perforation)
  • painful or disturbed digestion, which may include nausea, vomiting, heartburn, bloating and gastric discomfort (chronic dyspepsia)
  • inflammation of the gastric mucosa (gastritis)

• if the patient has reduced blood cell counts (leukopenia or thrombocytopenia), active bleeding, or shows a tendency to bleed while being treated with anticoagulant drugs (blood thinners)

• if the patient has severe kidney or liver disease

Warnings and precautions

If the patient experiences symptoms such as rash, redness and pain in the skin or mucous membranes, or allergic reactions after taking ketoprofen with lysine, they should stop using the medicine immediately and contact 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 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 ketoprofen with lysine, they should stop taking the medicine and contact their doctor immediately.

Elderly patients may experience more adverse effects from NSAIDs, especially gastrointestinal effects, which can be fatal. Elderly patients should use this product with caution.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to relieve symptoms.

The use of anti-inflammatory/pain-relieving medicines such as ketoprofen may be associated with a small increased risk of heart attack or stroke, particularly when high doses are used over a prolonged period. Do not exceed the recommended doses or extend the duration of treatment.

Concomitant use of ketoprofen with lysine and other products containing NSAIDs (e.g. ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.

The patient should discontinue use of 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 them.

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 experienced fluid retention or has swelling (edema)
• 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 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 existing infection and symptoms persist or worsen, they should consult a doctor immediately.

Children and adolescents

Do not give ketoprofen with lysine to children under 18 years of age.

Okitask with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes over-the-counter medicines, including herbal preparations.

The patient should inform their doctor or pharmacist if they 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, or 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
• glucocorticoids (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 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

Okitask and alcohol

Alcohol may irritate the throat, stomach and intestines, thereby increasing the risk of bleeding and ulceration when NSAIDs are taken concomitantly 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. Ketoprofen should not be taken during the first six months of pregnancy unless absolutely necessary and only if prescribed by a doctor.

If treatment is necessary during this time or when 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 baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby'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 is planning 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 a high level of psychomotor performance (see section 4 "Possible side effects").

3. How to take Okitask

This medicine should always be taken exactly as described in this 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 duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
The recommended dose is 1 tablet up to 3 times daily, as needed.
Wait at least four hours before taking the next tablet.
Do not exceed the recommended dose.
Tablets should be swallowed whole with a glass of water.
The break line on the tablet is not intended for dividing the tablet.
Patients should consult their 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.

Route of administration
For oral use.

Overdose of Okitask
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.

Missed dose of 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 instead of the missed dose. Maintain a minimum interval of 4 hours between doses, and do not exceed the maximum of 3 tablets per day.

Stopping treatment with Okitask
Patients should stop taking this medicine as soon as they feel better. 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 not everyone will experience them. Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
Discontinue use of Okitask and seek immediate medical advice if, at any time during treatment with this medicine, the patient experiences:

• symptoms of gastrointestinal bleeding, such as: bright red stool (faeces), tarry black stools, vomiting blood or dark particles resembling coffee grounds
• symptoms of rash, severe skin reactions and blisters affecting the skin, mouth or eyes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
• symptoms of severe allergic reaction, such as:
  • difficulty breathing or unexplained wheezing,
  • dizziness or rapid heartbeat,
  • swelling of the 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 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 the 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 of the skin
• blurred vision
• ringing in the ears (tinnitus)
• asthma
• inflammation of the mucous membrane lining 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)
• disorders of adrenal gland function
• 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)
• difficulty breathing (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 reactions
If any adverse reactions occur, including any symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store the medicine Okitask

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture. There are no special
recommend游戏副本

6. Contents of the package and other information

What Okitask contains:

• The active substance is ketoprofen. Each tablet contains 25 mg of ketoprofen in the form of ketoprofen lysine salt.
• 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, aluminium lake (E104).

What Okitask looks like and contents of the pack
Ketoprofen lysine tablets are coated, round, blue tablets with a score 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 Authorisation Holder
Dompe Farmaceutici S.p.A
Via San Martino, 12
Milano
MI 20122
Italy

Manufacturer
Abiogen Pharma S.p.A.
Via Meucci, 36
56121 Ospedaletto
Pisa
Italy

This medicinal product is authorised in the EEA countries under the following names:
Bulgaria Okitask 25 mg film-coated tablets
Croatia Okitask 25 mg filmom obložene tablete
France Okitask 25 mg comprimé pelliculé
Finland Okitask 25 mg kalvopäällysteiset tabletit
Greece Okitask 25 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary Okitask 25 mg filmtabletta
Latvia Okitask 25 mg apvalkotās tabletes
Lithuania Okitask 25 mg Film-coated Tablets
Netherlands Okitask 25 mg filmomhulde tablet
Portugal Okiact 25 mg comprimidos revestidos
Romania Okitask 25 mg comprimate filmate
Slovenia Okitask 25 mg filmsko obložene tablete
Spain Okidol 25 mg comprimidos recubiertos