OKIDOL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient.

Okidol25 mgfilm-coated tablets

ketoprofen

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days of fever and after 5 days of pain.

Contents of the Package Leaflet

1. What is Okidol and what is it used for
2. What you need to know before taking Okidol
3. How to take Okidol
4. Possible side effects
5. Storage of Okidol
6. Contents of the pack and further information

1. What is Okidol and what is it used for

The active substance of this medication is ketoprofen lysine salt, which belongs to a group of medications called "Non-steroidal anti-inflammatory drugs" (NSAIDs). These medications provide short-term relief by changing the body's response to pain, inflammation, and fever. Ketoprofen lysine salt is a salt of ketoprofen that the body absorbs quickly and completely.

Okidol is indicated in adults 18 years and older, for the symptomatic relief of occasional mild to moderate pain, such as muscle and joint pain, headache, pain associated with throat irritation, toothache, and menstrual pain, as well as in febrile states

You should consult a doctor if your condition worsens or does not improve after 3 days of fever and after 5 days of pain.

2. What you need to know before taking Okidol

Do not take Okidol:

• if you are allergic (hypersensitive) to any of the other components of this medication (listed in section 6)
• if you have asthma or have a history of allergic reactions (hypersensitivity) to ketoprofen or any other NSAID (e.g., acetylsalicylic acid, ibuprofen)
• during the third trimester of pregnancy (from week 29 onwards). See section 2 "Pregnancy and lactation".
• if you have severe heart problems where your heart does not work as well as it should
• if you suffer from or have a history of intestinal problems, such as:

o active peptic ulcer

o stomach or intestinal ulcers

o intestinal bleeding

o holes in the stomach or gastrointestinal tube (gastrointestinal perforation)

o painful or altered digestion, which may include nausea, vomiting, stomach acid, abdominal distension, and stomach discomfort (chronic dyspepsia)

o stomach lining inflammation (gastritis)

• If you have a low blood cell count (leukopenia or thrombocytopenia), active bleeding, or a tendency to bleed with blood clot prevention medication (anticoagulants)
• If you have severe kidney or liver problems.

Warnings and precautions

If you notice signs of skin rash, red and painful skin around body openings (mucous membranes), or allergic reactions after taking Okidol, stop taking this medication and inform your doctor immediately.

If you notice any signs of stomach or intestinal bleeding (e.g., bright red stools, black tarry stools, vomiting blood or dark particles that look like coffee grounds), stop taking this medication and inform your doctor immediately.

If you notice any signs of ulcers or perforation (symptoms may include: severe stomach pain, chills, nausea, vomiting, heartburn) after taking Okidol, stop taking this medication and inform your doctor immediately.

Elderly people may experience more side effects with NSAIDs, especially stomach and intestinal side effects, which can be fatal. If you are an elderly patient, the product should be used with caution.

Side effects can be minimized by taking lower doses for the shortest necessary time to relieve symptoms.

Anti-inflammatory/analgesic medications, such as ketoprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

The use of Okidol with other products containing NSAIDs (e.g., ibuprofen, aspirin, celecoxib) should be avoided.

Stop taking this medication if you experience any visual problems, such as blurred vision.

Since Okidol is used to treat symptoms such as fever, it may mask an underlying more serious condition. If your symptoms persist, inform your doctor.

Taking an analgesic to relieve headaches for a long time can worsen them.

Consult your doctor or pharmacist before starting to take Okidol:

• If you are pregnant, trying to become pregnant, or breastfeeding (see section 2 "Pregnancy and lactation")
• If you suffer from fluid retention and swelling.
• If you have high blood pressure, your heart is weakened, you have arterial disease, and/or problems with the blood vessels that supply the brain
• If you have a condition called phenylketonuria, in which your body cannot break down a substance called phenylalanine
• If you have liver disease.
• If you suffer from kidney disease.
• If you have allergies (e.g., hay fever)
• If you have chronic obstructive pulmonary disease (COPD)
• If you have hepatic porphyria (a rare blood disease characterized by altered activity of one of the liver enzymes) because the medication could trigger an attack.
• If you have an infection; see the "Infections" heading below.

Infections

Okidol may hide the signs of an infection, such as fever and pain. Consequently, Okidol may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Children and adolescents

Okidol should not be administered to children under 18 years of age.

Taking Okidol with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes over-the-counter medications or herbal remedies.

You must inform your doctor or pharmacistif you are taking any of the following medications:

• Medications to improve blood flow, such as anticoagulants (aspirin, warfarin, heparin, policosanol, dabigatran, or clopidogrel), thrombolytics (reteplase, streptokinase), pentoxifylline, prasugrel, coumarins.
• certain antibiotics (e.g., quinolones, sulfonamides)
• medications used after organ transplantation to help prevent rejection (e.g., cyclosporine, tacrolimus)
• medications used for certain types of mental illness 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 medications used to treat HIV infections (e.g., ritonavir, zidovudine)
• medications to treat high blood pressure (e.g., ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxants such as baclofen
• medications used to treat heart failure and to control heart rate (e.g., digoxin, digitoxin)
• medications to treat diabetes (e.g., gliclazide)
• medications used to treat cancer (e.g., erlotinib, pemetrexed, methotrexate)
• medications to treat gout (e.g., probenecid)
• diphenylhydantoin - an antiepileptic medication
• pentoxifylline: a medication used to treat muscle pain
• penicillamine: a medication used to treat rheumatoid arthritis

Taking Okidol with alcohol

Alcohol can cause irritation of the throat, stomach, and intestines, so there is a higher risk of bleeding and ulcers, and this risk increases when NSAIDs are taken at the same time.

Pregnancy and lactation

Do not take this medication if you are in the third trimester of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your or your child's predisposition to suffer from bleeding and delay or prolong delivery longer than expected. Ketoprofen should not be used during the first six months of pregnancy unless the clinical situation of the woman requires treatment with ketoprofen. If during this period or while you plan to become pregnant, you need treatment, the lowest dose should be used for the shortest possible time. If ketoprofen is taken for some days from week 20 of pregnancy onwards, it may cause kidney problems in the fetus, which may lead to a reduction in the volume of amniotic fluid surrounding it (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) of the fetus's heart. If you need treatment for more than a few days, your doctor will recommend closer monitoring.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

If after taking Okidol you feel drowsy, dizzy, have blurred vision, or have convulsions, do not drive, use machinery, or perform activities that require a high level of alertness (see section 4 "Possible side effects").

Okidol contains aspartame (E951)

This medication contains 0.35 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

Okidol contains glucose and sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Okidol

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The effective lowest dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is 1 sachet up to 3 times a day, as needed.

Wait at least 4 hours before taking another sachet.

Do not exceed the recommended dose.

If the symptoms persist or the pain worsens, or if new symptoms appear, consult your doctor or pharmacist.

Use in children

Okidol should not be taken by children under 18 years of age.

Use in elderly patients

Do not take more than 1 Okidol sachet in 24 hours.

Method of administration

Okidol is for oral use.

The contents of the sachet can be placed directly on the tongue. You can take Okidol with or without water, as the granules will dissolve in your saliva.

If you take more Okidol than you should

If you accidentally take more Okidol than recommended, you may feel drowsy or nauseous. You should seek medical attention immediately, even if you feel well.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Okidol

Do not take a double dose to make up for forgotten doses.

If you forget to take Okidol, take it as soon as possible. Do not take a double dose to make up for the forgotten dose, and make sure to leave a minimum of 4 hours between doses and do not exceed the maximum of 3 tablets per day.

If you stop taking Okidol

You should stop taking this medication as soon as you feel better.

If you have any other doubts about the use of this medication, ask a doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Okidol and seek medical attention immediatelyif at any time during treatment with Okidol you develop:

• signs of intestinal bleeding such as: bright red stools, black tarry stools, vomiting blood or dark particles that look like coffee grounds
• signs of skin rash, severe skin reactions, and blisters on the skin, mouth, and eyes
• signs of a severe allergic reaction, such as:
• unexplained difficulty breathing or wheezing
• dizziness or faster heartbeats
• swelling of your lips, face, throat, or tongue
• worsening of Crohn's disease and colitis (a chronic inflammatory disease of the intestine with symptoms of abdominal pain, diarrhea, fever, and weight loss)

Inform your doctor if you experience:

• fever, sore throat, mouth ulcers, headache, vomiting, unexplained bleeding, and severe fatigue
• indigestion, stomach pain or abdominal pain, constipation, diarrhea, flatulence, or if you feel sick, chest pain, or irregular rapid heartbeats
• kidney and liver problems associated with swelling in the arms and legs.

Side effects with Okidol may include:

Common(may affect up to 1 in 10 people)

• indigestion (dyspepsia), nausea, abdominal pain, vomiting

Uncommon(may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhea, flatulence (gas), stomach lining inflammation
• swelling due to fluid accumulation
• itching and rashes
• fatigue

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

• iron deficiency (anemia) caused by bleeding
• tingling, numbness
• blurred vision
• ringing in the ear (tinnitus)
• asthma
• inflammation of the mouth lining
• stomach ulcer
• liver inflammation (hepatitis), increased liver enzymes, yellowing of the skin or the white part of the eyes (jaundice)
• weight gain

Frequency not known(frequency cannot be estimated from available data)

• change in blood cell count and platelets
• allergic reactions (anaphylaxis)
• adrenal gland damage
• high blood pressure, hot flashes (vasodilation)
• heart failure
• kidney failure, kidney inflammation, abnormal kidney test results
• colitis
• worsening of gastrointestinal condition
• dark or black stools
• vomiting blood
• stuffy and runny nose (rhinitis)
• swelling of the throat
• swelling of the deep layers of the skin, caused by excess fluid (e.g., face, hands)
• difficulty breathing (dyspnea)
• headache
• breathing difficulty caused by narrowing of the airways
• uncontrolled muscle contractions (convulsions)
• sensitivity to sunlight or UV lamps
• taste disturbances
• mood changes
• behavior changes
• hair loss
• itchy skin rash
• stomach and/or intestinal bleeding, symptoms may include severe stomach pain, chills, nausea, vomiting, blood or dark particles that look like coffee grounds, heartburn, black tarry stools

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Okidol

Keep this medication out of sight and reach of children.

Keep it in the original package to protect it from light and moisture. This medication does not require any special storage temperature.

Do not use this medication after the expiration date shown on the package. The expiration date refers to the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Okidol Composition

• The active ingredient is ketoprofen. Each tablet contains 25 mg of ketoprofen (as ketoprofen lysine salt).
• The other components are: mannitol (E421), crospovidone, sodium lauryl sulfate, anhydrous colloidal silica (E551), sodium stearyl fumarate (E485), polyvinyl alcohol (E1203), macrogol 4000 (E1521), titanium dioxide (E171), talc (E553B), brilliant blue (E133), Quinoline Yellow aluminum lacquer (E104).

Product Appearance and Packaging Content

The Okidol film-coated tablets are round, blue, with a score line on one side.

The packages are available in 8, 10, 15, 16, or 20 tablets. Only some package sizes may be marketed.

Marketing Authorization Holder

Dompe farmaceutici S.P.A.

Via San Martino, 12

20122 – Milan

Italy

Manufacturer

Abiogen Pharma S.p.A.

Via Meucci, 36

56121 Ospedaletto

Pisa

Italy

This medicinal product is authorized in the EEA Member States under the following names:

Bulgaria Okitask 25 mg film-coated tablets

Croatia Okitask 25 mg film-coated tablets

France Okitask 25 mg film-coated tablets

Finland Okitask 25 mg film-coated tablets

Greece Okitask 25 mg film-coated tablets

Hungary Okitask 25 mg film-coated tablets

Latvia Okitask 25 mg film-coated tablets

Lithuania Okitask 25 mg film-coated tablets

Netherlands Okitask 25 mg film-coated tablets

Poland Okitask, 25 mg, film-coated tablets

Portugal Okiact 25 mg film-coated tablets

Romania Okitask 25 mg film-coated tablets

Slovenia Okitask 25 mg film-coated tablets

Spain Okidol 25 mg film-coated tablets

Date of the last revision of this leaflet: June 2023