OKI 25 mg Effervescent Tablet

Зміст інструкції

1. OKi pain and fever 25 mg effervescent tablets
   1. What is OKi pain and fever and what is it used for
   2. What you need to know before taking OKi pain and fever
   3. How to take OKi dolore e febbre
   4. Possible side effects
   5. How to store OKi dolore e febbre
   6. Contents of the pack and other information

OKi pain and fever 25 mg effervescent tablets

Ketoprofen

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of fever and 5 days of pain.

Contents of this leaflet

• 1. What OKi pain and fever is and what it is used for
• 2. What you need to know before you take OKi pain and fever
• 3. How to take OKi pain and fever
• 4. Possible side effects
• 5. How to store OKi pain and fever
• 6. Contents of the pack and other information

1. What is OKi pain and fever and what is it used for

The active ingredient of this medicine is lysine ketoprofen, which belongs to a group of
medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs). These medicines provide
short-term relief by modifying the body's response to pain, swelling and high
temperature. Lysine ketoprofen is a salt of ketoprofen that is rapidly and completely absorbed
by the body. It is used to relieve mild to
moderate pain, such as muscle and joint pain, headache, pain associated with sore throat, toothache
and menstrual pain, and fever in adults aged 18 years and over.

Consult your doctor if you do not feel better or if you feel worse after 3 days in case of fever and 5
days in case of pain.

2. What you need to know before taking OKi pain and fever

Do not take OKi pain and fever:

• if you are allergic(hypersensitive) to ketoprofen or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from asthmaor have previously experienced allergic(hypersensitivity) reactions to NSAIDs (such as acetylsalicylic acid, ibuprofen)
• in the third trimester of pregnancy(from the 29th week onwards). See section 2 “Pregnancy and breastfeeding”
• if you suffer from a serious heart conditionthat causes heart malfunction
• if you suffer from or have had in the past intestinal problemssuch as: o active or recurrent peptic ulcer o ulcers in the stomach or intestine

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or intestinal bleeding
or perforation in the stomach or esophagus (gastrointestinal perforation)
or any of the above conditions caused by treatment with an NSAID
or pain or discomfort during digestion, which may include nausea, vomiting,
heartburn, bloating and stomach discomfort (chronic dyspepsia)
or inflammation of the lining of the stomach (gastritis)

• if you have a low number of blood cells(leukopenia or thrombocytopenia), ongoing bleedingor a tendency tobleedingwhile being treated with medicines to prevent blood clots (anticoagulants)
• if you suffer from severe kidneyor liverproblems

Warnings and precautions
If you notice signs of skin rash, red and painful skin around the body openings
(mucous membranes) or allergic reactions after taking OKi pain and fever, stop taking
this medicine and immediately inform your doctor.
If you notice signs of bleeding in the stomach or intestine (e.g. bright red stools, black tarry stools, vomiting containing blood or dark particles similar to coffee grounds), stop taking this medicine and immediately inform your doctor.
If you notice signs of ulceration or perforation (whose symptoms may include severe stomach pain, chills, nausea, vomiting, heartburn) after taking OKi pain and fever,
stop taking this medicine and immediately inform your doctor.
Elderly patients may experience more side effects with the use of NSAIDs, in
particular affecting the stomach and intestines, which can be fatal. Elderly patients should
use this medicine with caution.
Side effects can be minimized by taking the lowest dose for the shortest time possible needed to relieve symptoms.
Anti-inflammatory/pain relieving medicines such as ketoprofen may be associated with a slight
increased risk of heart attack or stroke, especially if taken in high doses and for long
periods of time. Do not exceed the duration of treatment or the recommended dose.
Inform your doctor or pharmacist before taking this medicine if you have high blood pressure, a weakened heart, an arterial disease and/or problems with blood vessels supplying
the brain or if you are at increased risk of developing such diseases (e.g. if you suffer from
diabetes, have high cholesterol levels or are a smoker).
Inform your doctor if you experience palpitations, i.e. sensations of rapid, uncomfortable and irregular
heartbeat.
The use of OKi pain and fever with other medicines containing NSAIDs (e.g. ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.
Stop taking this medicine if you experience vision problems, such as blurred vision.
Being intended for the treatment of symptoms such as fever, OKi pain and fever may mask
underlying more serious conditions. If symptoms persist, inform your doctor.
Long-term use of pain relievers to relieve headaches can worsen headaches.
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Consult your doctor or pharmacist before taking OKi pain and fever:

• if you are pregnant, trying to become pregnantor breastfeeding(see section 2 “Pregnancy and breastfeeding”)
• if you have fluid retentionand swelling
• if you suffer from a blood disease(e.g. anemia)
• if you suffer from a liver disease
• if you suffer from a kidney disease
• if you suffer from allergies (e.g. hay fever)
• if you suffer from hepatic porphyria(a rare blood disease characterized by altered activity of one of the liver enzymes) because the medicine may trigger an attack.

Children and adolescents
Do not administer ketoprofen lysine to children under 18 years of age.

Other medicines and OKi pain and fever
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription or herbal medicines.

Tell your doctor or pharmacistif you are taking/using any of the following medicines:

• medicines to improve blood flow, such as anticoagulants (acetylsalicylic acid, warfarin, heparin, ticlopidine, dabigatran or clopidogrel), thrombolytics (reteplase, streptokinase), peripheral vasodilators (pentoxifylline), prasugrel, coumarins
• some antibiotics(e.g. quinolones, sulfonamides)
• medicines used after an organ transplantto prevent rejection (e.g. cyclosporine, tacrolimus)
• medicines used for some types of mental illnessand depression(e.g. lithium, venlafaxine and selective serotonin reuptake inhibitors (SSRIs))
• otherNSAIDs(e.g. acetylsalicylic acid, ibuprofen) or paracetamol
• diuretics(medicines that increase urine production) such as bendroflumethiazide
• glucocorticosteroids(steroid hormones, such as hydrocortisone or prednisolone)
• antiretroviral medicines used to treat HIVinfections (e.g. ritonavir, zidovudine)
• medicines for the treatment of high blood pressure(e.g. ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxantssuch as baclofen
• medicines used to treat heart failureand control heart rhythm(e.g. digoxin, digitoxin)
• medicines for the treatment of diabetes(e.g. gliclazide)
• medicines used to treat tumors(e.g. erlotinib, pemetrexed, methotrexate)
• medicines for the treatment of gout(e.g. probenecid)
• phenytoin- an antiepileptic medicine
• penicillamine- a medicine used to treat rheumatoid arthritis
• gemeprost(a medicine used to treat gynecological problems)
• if you plan to use mifepristoneas a contraceptive method

OKi pain and fever with alcohol
Alcohol can cause irritation of the throat, stomach and intestines, so concomitant consumption with NSAIDs may increase the risk of bleeding and ulceration.

Pregnancy and breastfeeding
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Do not take this medicine in the 3rd trimester of pregnancy. As a precaution, it is advisable
to avoid taking this medicine in the 1st or 2nd trimester of pregnancy.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast milk
ask your doctor or pharmacist before taking this medicine.

Driving and operating machinery
If you experience drowsiness, dizziness, blurred vision
or convulsions after taking OKi pain and fever, do not drive vehicles, operate machinery and do not perform activities that require a
high level of vigilance (see section 4 “Possible side effects”).

OKi pain and fever contains sodium
This medicine contains 322 mg of sodium (the main component of table salt) per
effervescent tablet. This is equivalent to 16% of the recommended maximum daily intake
with the diet of an adult.

OKi pain and fever contains sorbitol
This medicine contains 147 mg of sorbitol per effervescent tablet.

3. How to take OKi dolore e febbre

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet up to 3 times a day, as needed.
Wait at least four hours between one tablet and the next.

Do not exceed the recommended dose.
Dissolve 1 tablet in a glass of water before administration.
If symptoms persist or worsen or if new symptoms appear, consult your doctor or pharmacist.

Use in children
Ketoprofene lysine salt should not be taken by children under 18 years of age.

Use in elderly patients
Do not take more than 1 tablet of OKi dolore e febbre in 24 hours.

If you take more OKi dolore e febbre than you should
If you have accidentally taken more OKi dolore e febbre than you should, you may experience drowsiness
or nausea. Consult a doctor immediately, even if you feel well.

If you forget to take OKi dolore e febbre
Do not take a double dose to make up for a missed dose.
If you forget to take OKi dolore e febbre, take it as soon as possible. Do not take a double dose
to make up for the missed dose, make sure to wait at least 4 hours between doses and do not exceed
the maximum limit of 3 tablets per day.

If you stop taking OKi dolore e febbre
You should stop taking this medicine as soon as you feel better. If you have any
doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms.

Stop taking OKi dolore e febbre and consult a doctor immediatelyif, at any time during treatment with OKi dolore e febbre, you develop:

• signs of intestinal bleedingsuch as bright red stools (faeces), black tarry stools, vomiting blood or vomit that looks like coffee grounds
• signs of skin rashes, severe skin reactions and blistering of the skin, mouth and eyes
• signs of a severe allergic reaction, such as:
• difficulty breathing or unexplained wheezing
• dizziness or a racing heartbeat
• swelling of the lips, face, throat or tongue
• worsening of Crohn's diseaseand colitis(a chronic inflammatory bowel disease characterised by symptoms such as abdominal pain, diarrhoea, fever and weight loss)

Tell your doctor if you experience:

• fever, sore throat, mouth ulcers, headache, vomiting, unexplained bleeding and bruising, severe fatigue
• indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or feeling unwell, chest pain or a fast and irregular heartbeat
• liver and kidney problems associated with swelling of the arms and legs.

Side effects associated with OKi dolore e febbre may include:
Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence, inflammation of the stomach lining
• swelling due to fluid retention
• itching and skin rashes, irritations
• fatigue

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

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

Not known(frequency cannot be estimated from the available data)

• alteration of blood cell and platelet counts
• allergic reactions (anaphylaxis)
• impaired function of the glands above the kidneys (adrenal glands)
• high blood pressure, flushing (vasodilation)

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• heart failure
• kidney failure, inflammation in the kidneys, abnormalities in kidney function tests
• colitis
• worsening of gastrointestinal conditions
• dark or black stools
• blood in vomit
• blocked or runny nose (rhinitis)
• swelling of the throat
• swelling of the deep layers of the skin, caused by excess fluid (for example on the face or hands)
• difficulty breathing (dyspnoea)
• headache
• difficulty breathing caused by narrowing of the airways
• uncontrolled muscle contractions (convulsions)
• sensitivity to sunlight or UV lamps
• changes in taste
• changes in behaviour
• hair loss
• itchy rash
• bleeding from the stomach and/or intestine, the symptoms of which may include severe stomach pain, chills, nausea, vomiting, vomiting containing blood or particles resembling coffee grounds, heartburn, bright red or black tarry stools

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store OKi dolore e febbre

Keep this medicine out of the sight and reach of children.
Store it in the original packaging (sachet or tube) to protect it from light and moisture.
Do not use this medicine after the expiry date which is stated on the carton, on the sachet and on the
tube after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OKi pain and fever contains

• The active ingredient is ketoprofen. Each tablet contains 25 mg of ketoprofen, as ketoprofen lysine salt 40 mg.
• The other ingredients are: mannitol (E421), sodium bicarbonate (E500), citric acid (E330), orange flavour, sorbitol (E420), sodium carbonate (E500), leucine, sodium saccharin (E954), polysorbate 20 (E432), simethicone, colloidal anhydrous silica (E551). Description of the appearance of OKi pain and fever and contents of the pack

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The effervescent tablets of OKi pain and fever are white, round, flat tablets with an orange flavour. The tablets are supplied in tubes or sachets of 8, 10, 12, 15, 16, 20, 24.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milano
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 with the
following denominations:
Netherlands Sprintafen 25 mg Bruistablet
Poland Sprintafen 25 mg Tabletka musująca
Finland Sprintafen 25 mg Poretabletti
Hungary Sprintafen 25 mg Pezsgötabletta
Italy OKi dolore e febbre
France Ketoprofene Dompé 25 mg Comprimé Effervescent
Spain Sprintafen 25 mg Comprimido Efervescente
Portugal Sprintafen 25 mg Comprimido Efervescente
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