OKIDOL 25 mg GRANULES

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 serious heart problems where your heart does not work as well as it should
• if you have or have a history of intestinal problems, such as:

active peptic ulcer

ulcers in the stomach or intestines

intestinal bleeding

holes in the stomach or gastrointestinal tube (gastrointestinal perforation)

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

inflammation of the stomach lining (gastritis)

• If you have a low blood cell count (leukopenia or thrombocytopenia), active bleeding, or a tendency to bleed with treatment with medications that help prevent blood clots (anticoagulants)
• If you have serious 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 sign of bleeding in the stomach or intestines (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 sign 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 time necessary 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 vision problems, such as blurred vision.

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

Taking a pain reliever 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 have 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 liver disease.
• If you have 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 disorder 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 mask the signs of an infection, such as fever and pain. Consequently, Okidol may delay 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 medications without a prescription 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 used 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 greater 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 prolong or delay 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 time or while you plan to become pregnant, you need treatment, the lowest dose should be used for the shortest possible time. If you take ketoprofen for a few 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 fetal 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 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 exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest time necessary 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 sachet of Okidol 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 sachets 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 your 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:
• difficulty breathing or unexplained 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

The side effects of 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), inflammation of the stomach lining
• 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
• inflammation of the liver (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)
• impairment of the glands located above the kidneys (adrenal gland)
• 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 difficulties caused by narrowing of the airways
• uncontrolled muscle contractions (seizures)
• sensitivity to sunlight or UV lamps
• alterations in taste
• mood changes
• behavior changes
• hair loss
• itchy skin rash
• bleeding in the stomach and/or intestines, symptoms may include severe stomach pain, chills, nausea, vomiting, blood or dark particles that look like coffee grounds, heartburn, black tarry stools or bright red 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 Pharmacovigilance System for Human Use Medications: 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.

Do not use this medication after the expiration date stated on the packaging. 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 packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Okidol

• The active ingredient is ketoprofen. Each sachet contains 25 mg of ketoprofen (as ketoprofen lysine salt).
• The other components are: povidone (E1201), anhydrous colloidal silica (E551), hypromellose (E464), basic butyl methacrylate copolymer, sodium lauryl sulfate (E487), stearic acid (E570), magnesium stearate (E572), mannitol (E421), xylitol (E967), talc (E553B), natural lime flavor, natural lemon flavor, natural peppermint flavor, maltodextrin, sucrose, glucose, corn starch, butylated hydroxyanisole, arabic gum.

Appearance of the Product and Packaging Content

The Okidol granules are white to ivory in color and are packaged in sachets.

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

Marketing Authorization Holder

Dompe farmaceutici S.P.A.

Via San Martino, 12

20122 – Milan

Italy

Manufacturer

Dompé farmaceutici S.p.A.

Via Campo di Pile

67100 L'Aquila

Italy

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

Bulgaria Okitask 25 mg granules

Croatia Okitask 25 mg coated granules in sachet

France Okitask 25 mg coated granules in sachet

Finland Okitask 25 mg granules

Greece Okitask 25 mg κόνις

Hungary Okitask 25 mg granulate

Latvia Okitask 25 mg coated granules in sachet

Lithuania Okitask 25 mg coated granules in sachet

Netherlands Okitask 25 mg coated granulate

Poland Okitask 25 mg coated granulate

Portugal Okiact 25 mg coated granulate in sachet

Romania Okitask 25 mg coated granules in sachet

Slovenia Okitask 25mg granules in sachet

Spain Okidol 25 mg granulate

Date of the last revision of this prospectus: February 2025