OKIDOL

PACKAGE LEAFLET

Package leaflet: information for the user

Okidol 80 mg coated granules in sachet

Lysine ketoprofen
Please 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days in adolescents and after 5 days in adults.

Contents of this leaflet:

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

1. What Okidol is and what it is used for

The active substance of this medicine is ketoprofene (as ketoprofene lysine salt), 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 and swelling. Ketoprofene lysine salt is a salt of ketoprofene that is rapidly and completely absorbed by the body.
Okidol is recommended for the short-term symptomatic treatment of mild to moderate acute pain such as headache, toothache, menstrual pain, and pain due to minor sprains and strains.
Okidol is indicated for use in adults and adolescents aged 16 years and older.
If symptoms persist for more than 5 days in adults or 3 days in adolescents, or if symptoms worsen, a doctor should be consulted.

2. What you need to know before taking Okidol

Do not take Okidol

• if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have a history of hypersensitivity reactions (allergy) triggered by the use of ketoprofen or substances with a similar mechanism of action, for example acetylsalicylic acid or other NSAIDs (other anti-inflammatory medicines), such as asthma (bronchial inflammation and narrowing of the airways), bronchospasm (constriction of the bronchi), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes), or other allergic-type reactions. Severe anaphylactic reactions, rarely fatal, have been observed in these patients (see section 4 “Possible side effects”);
• if you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways);
• if you have a severe heart disease causing the heart to function poorly;
• if you currently have a peptic ulcer (a lesion in the stomach or the first part of the intestine) or gastrointestinal bleeding, or if you have previously suffered from recurrent peptic ulcer or bleeding (two or more distinct, documented episodes of bleeding or ulceration);
• if you have previously experienced gastrointestinal bleeding, ulceration, perforation, or chronic dyspepsia (indigestion);
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs;
• if you suffer from leukopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you suffer from Crohn’s disease (inflammation of the intestine) or ulcerative colitis (inflammation of the intestine with ulcers);
• if you suffer from gastritis (inflammation of the stomach lining);
• if you have severe liver (reduced liver function due to cirrhosis, severe hepatitis) or kidney (reduced kidney function) failure;
• if you suffer from hemorrhagic diathesis (predisposition to bleeding) or other coagulation disorders, or if you have hemostatic disorders (difficulty in stopping bleeding);
• if you are undergoing treatment with high-dose diuretics;
• if you are in the third trimester of pregnancy (see section 2 “Pregnancy, breastfeeding and fertility”);
• if you are under 16 years of age.

Warnings and precautions
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 3 “How to take Okidol” and the sections below regarding gastrointestinal and cardiovascular risks).
If you notice signs of skin rash, red and painful skin around body orifices (mucous membranes), or allergic reactions after taking Okidol, stop taking this medicine and inform your doctor immediately.
If you notice signs of stomach or intestinal bleeding (for example, bright red stools, black tarry stools, vomit containing blood or dark particles resembling coffee grounds), stop taking this medicine and inform your doctor immediately.
If you notice signs of ulceration or perforation (symptoms may include severe stomach pain, chills, nausea, vomiting, heartburn) after taking Okidol, stop taking this medicine and inform your doctor immediately.
Elderly patients may experience more side effects when taking NSAIDs, particularly affecting the stomach and intestine, which can be fatal (see section 3 “How to take Okidol”). Elderly patients should use this medicine with caution.
Anti-inflammatory/pain-relieving medicines such as ketoprofen may be associated with a small increased risk of heart attack or stroke, especially when taken at high doses and for long periods. Do not exceed the recommended treatment duration or dosage.
The use of Okidol together with other medicines containing NSAIDs (e.g., ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.
Skin reactions:
Severe skin reactions, some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with NSAID use (see section 4 “Possible side effects”). Patients appear to be at higher risk during the initial stages of therapy: the reaction usually occurs within the first month of treatment. Discontinue use of Okidol at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Stop taking this medicine if you experience vision problems, such as blurred vision.
Long-term use of painkillers to relieve headache may worsen headache.
Consult your doctor or pharmacist before taking Okidol:

• If you are pregnant, planning a pregnancy, or breastfeeding (see section 2 “Pregnancy and breastfeeding”)
• If you experience fluid retention and swelling
• If you have high blood pressure, heart weakness, arterial disease, and/or problems with blood vessels supplying the brain.
• If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pump function), confirmed ischemic heart disease (heart condition resulting from reduced blood flow due to narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the brain arteries and vessels), as Okidol should only be taken after careful evaluation by your doctor.
• If you have hematopoietic disorders (affecting the formation and maturation of blood cells), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as Okidol should be used with caution.
• If you have a condition called phenylketonuria, in which your body cannot properly metabolize a substance called phenylalanine
• If you have liver disease
• If you have kidney disease
• If you have allergies (e.g., hay fever)
• If you suffer from chronic obstructive pulmonary disease (COPD)
• If you have hepatic porphyria (a rare blood disorder characterized by impaired activity of one of the liver enzymes), as the medicine may trigger an attack
• If you have an infection – see the next section “Infections”.

Infections
Okidol may mask symptoms of infections such as fever and pain. Therefore, Okidol could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and varicella-related bacterial skin infections. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Children and adolescents
Do not administer Okidol to children under 16 years of age.
Other medicines and Okidol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription or herbal remedies.
The use of Okidol in combination with the following is not recommended:

• Other anti-inflammatory medicines, such as NSAIDs, selective cyclooxygenase-2 inhibitors, and high doses of salicylates (over 3 g/day);
• Medicines that delay blood coagulation (such as heparin and warfarin);
• Medicines that prevent platelet aggregation (such as ticlopidine and clopidogrel);
• Lithium (a medicine used to treat certain mental disorders and depression);
• Methotrexate at doses exceeding 15 mg/week (a medicine used in the treatment of cancers and certain autoimmune diseases);
• Medicines used to treat epilepsy (such as hydantoins);
• Certain antibiotics used to treat bacterial infections (such as sulfonamides).

Particular caution is required when using Okidol in combination with:

• Medicines that may increase blood potassium levels (e.g., potassium chloride and other potassium salts, heparin, cyclosporine, tacrolimus, and trimethoprim);
• Antiretroviral medicines used to treat HIV (such as tenofovir, zidovudine);
• Diuretics, as their effect may be reduced;
• Medicines used to treat hypertension (such as ACE inhibitors, angiotensin II receptor blockers, beta-blockers);
• Methotrexate at doses below 15 mg/week (a medicine used in the treatment of cancers and certain autoimmune diseases);
• Medicines used to treat inflammatory conditions (such as corticosteroids);
• Pentoxifylline (a medicine used to treat muscle pain);
• Medicines used to treat diabetes (such as sulfonylureas);
• Medicines used to treat heart failure and to control heart rate (such as cardiac glycosides).

The combination of Okidol with the following should be considered:

• Medicines used to lower blood pressure (such as beta-blockers, ACE inhibitors, diuretics);
• Medicines used for medical termination of pregnancy (such as mifepristone and gemeprost), or if you use intrauterine contraceptive devices, as their effectiveness may be reduced;
• Medicines that prevent organ transplant rejection (such as cyclosporine, tacrolimus);
• Medicines to improve blood circulation such as anticoagulants (e.g., aspirin, warfarin, heparin, ticlopidine or clopidogrel, thrombolytics);
• Probenecid (a medicine used to treat gout);
• Certain antibiotics (such as quinolones);
• Medicines used to treat epilepsy (such as diphenylhydantoin).

Okidol and alcohol
Avoid consuming alcohol during treatment with ketoprofen lysine salt.
Alcohol may cause irritation of the throat, stomach, and intestine; therefore, drinking alcohol together with NSAIDs may increase the risk of gastrointestinal bleeding and ulceration.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Okidol during the last three months 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 and your baby’s tendency to bleed and may delay or prolong labor more than expected. You should not take Okidol during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Okidol may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Use of this medicine close to delivery may cause circulatory and respiratory disturbances in the newborn.
Therefore, DO NOT use Okidol during the third trimester of pregnancy (see “Do not take Okidol”).
Breastfeeding
There is no available information on the excretion of ketoprofen in breast milk.
Ketoprofen is not recommended during breastfeeding.
Fertility
The use of NSAIDs, including Okidol, may reduce female fertility; therefore, it is not recommended for women attempting to conceive. Discontinue Okidol if you experience fertility problems or are undergoing fertility investigations.
Driving and use of machinery
If you experience drowsiness, dizziness, blurred vision, or seizures after taking Okidol, you should not drive, operate machinery, or perform tasks requiring special vigilance (see “Possible side effects”).
Okidol contains aspartame
This medicine contains 0.70 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot eliminate it properly.
Okidol contains sucrose (contained in the lemon flavor) and glucose (contained in the lime flavor)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Okidol contains sodium (also present in lime flavor, lemon flavor, and frescofort flavor)
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially 'sodium-free'.

3. How to take Okidol

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
The recommended dose is 1 sachet up to 2 times a day, as needed.
The interval between doses must not be less than 8 hours.
Do not exceed the recommended dose.
Duration of treatment
Adults: Consult your doctor if you do not notice improvement or if symptoms worsen
after 5 days.
Adolescents: Consult your doctor if you do not notice improvement or if symptoms worsen
after 3 days.
Use in children
Okidol must not be used in children under 16 years of age.
Use in the elderly
Okidol must be used with caution in the elderly. Your doctor will reduce the dose to use the lowest possible dose.
Reduced liver or kidney function
If you have mild to moderate reduced liver or kidney function, your doctor will reduce the dose to use the lowest effective dose.
Do not take Okidol if you have severe impairment of liver or kidney function.
Method of administration
Okidol is for oral use.
The contents of the sachet can be placed directly on the tongue. It dissolves with saliva and can therefore be taken without water.
If you take more Okidol than you should
If you accidentally take more Okidol than you should, you may experience drowsiness or nausea. In this case, inform your doctor immediately, even if you feel well.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
If you forget to take Okidol
If you forget to take Okidol, take it as soon as possible.
Do not take a double dose to make up for the missed dose. Wait at least 8 hours between doses and do not take more than 2 sachets per day.
If you stop taking Okidol
Stop taking the medicine as soon as you feel better.
If you have any questions about the use of this medicine, consult your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most commonly observed adverse events are gastrointestinal in nature.
Stop taking Okidol and consult a doctor immediately if, at any time during treatment with Okidol, you develop:

• signs of intestinal bleeding, such as bright red stools (faeces), black tarry stools, vomiting blood or dark particles resembling coffee grounds
• signs of skin rashes [including maculopapular exanthema (skin rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), acute generalized exanthematous pustulosis (skin rash with pustule formation), dermatitis (skin irritation)], severe skin reactions (including Stevens-Johnson syndrome, Lyell syndrome and toxic epidermal necrolysis) and blistering of the skin, mouth and eyes
• signs of a severe allergic reaction, such as:
  • difficulty breathing or unexplained wheezing
  • dizziness or rapid heartbeat
  • swelling of the lips, face, throat or tongue (which may cause difficulty breathing and swallowing)
• worsening of Crohn’s disease and colitis (a chronic inflammatory bowel disease characterized by symptoms such as abdominal pain, diarrhoea, fever and weight loss)

Other side effects associated with Okidol may include:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence (presence of gas in the intestine), gastritis (inflammation of the stomach lining), abdominal discomfort
• oedema and peripheral oedema (swelling due to fluid accumulation), chills, fatigue
• itching and skin rash

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

• haemorrhagic anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen in the blood, caused by bleeding)
• paraesthesia
• blurred vision
• tinnitus (ringing in the ears)
• asthma (bronchial inflammation and narrowing of the airways)
• stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion of the stomach or the first part of the intestine), colitis (inflammation of the inner lining of the colon)
• hepatitis (liver inflammation), increased transaminases (elevated levels of certain enzymes indicating liver function), increased blood bilirubin (a substance indicating liver function), jaundice (yellowing of the skin and whites of the eyes)
• weight gain

Very rare (may affect up to 1 in 10,000 people)

• facial oedema (swelling), asthenia (physical weakness)
• dyskinesia (involuntary movements), syncope (fainting)
• hypotension (low blood pressure)
• laryngeal oedema (swelling of the throat due to fluid accumulation)
• haematuria (presence of blood in the urine)

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

• thrombocytopenia (reduced platelet count), agranulocytosis (severe reduction in a type of white blood cells), bone marrow failure (reduced production of blood cells by the bone marrow), haemolytic anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen, caused by destruction of red blood cells), leucopenia (decreased white blood cell count), neutropenia (reduced number of a type of white blood cells), aplastic anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen, caused by insufficient production of blood cells by the bone marrow), leucocytosis (increased white blood cell count), thrombocytopenic purpura (skin spots due to reduced platelet count)
• anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy)
• depression, hallucination (perception of non-existent things), confusion, mood changes, agitation, insomnia
• seizures (uncontrolled body movements), dysgeusia (altered taste), tremor, hyperkinesia (involuntary and uncoordinated movements)
• periorbital oedema (swelling around the eye)
• heart failure (inability of the heart to pump sufficient blood to meet the body's needs), atrial fibrillation (irregular heart rhythm), palpitations (awareness of heartbeat)
• hypertension (high blood pressure), vasodilation (widening of blood vessels), vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels)
• bronchospasm (constriction of the bronchi), especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), laryngospasm (narrowing of the larynx), acute respiratory failure (one fatal case has been reported in an asthmatic patient sensitive to acetylsalicylic acid)
• gastrointestinal bleeding (bleeding from the stomach or intestine), gastrointestinal perforation (sometimes fatal, particularly in the elderly), gastric ulcer (lesion of the stomach), duodenal ulcer (lesion of the first part of the intestine), pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), hyperchlorhydria (excess acid in the stomach), gastric pain (stomach ache), erosive gastritis (severe inflammation of the stomach lining), oedema of the tongue (swelling of the tongue)
• photosensitivity reactions (sensitivity to sunlight or UV lamps), alopecia (loss of hair and body hair), urticaria, erythema and skin rash
• acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritis and nephritic syndrome (kidney inflammations), nephrotic syndrome (kidney disorder causing protein loss in urine), glomerulonephritis (inflammatory kidney disease), fluid/sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (reduced urine production), abnormal kidney function tests
• aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of lymphatic vessels)
• hyperkalaemia (increased potassium levels in the blood), hyponatraemia (decreased sodium levels in the blood)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 Okidol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Okidol contains

• The active substance is ketoprofen lysine salt. Each sachet contains 80 mg ketoprofen lysine salt.
• The other components are Povidone (E1201), Anhydrous colloidal silica (E551), Hypromellose, Butyl methacrylate copolymer base, Sodium lauryl sulfate, Stearic acid (E570), Magnesium stearate (E572), Aspartame (E951), Mannitol (E421), Xylitol (E967), Talc (E553B), Lime flavour (contains maltodextrins, modified starch E1450, glucose, butylated hydroxyanisole E320, bergamot oil, sodium), Lemon flavour (contains sucrose, maltodextrins, modified starch E1450, sodium), Freshfort flavour (contains gum arabic, sodium)

Description of the appearance of Okidol and contents of the pack
Okidol is presented as a white-ivory granulate filled in sachets.
Each pack contains 10 sachets.

Marketing Authorisation Holder and Manufacturer
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milano
Italy

Manufacturer
Dompé farmaceutici S.p.A.
Via Campo di Pile
67100 L’Aquila
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Ketoprofen Dompé 50 mg oбвити гранули в саше
Croatia Ketoprofen Dompé 50 mg obložene granule u vrećici
Italy Okidol
Poland Ketoprofen Dompé
Romania Ketoprofen Dompé 50 mg granule drajefiate în plic