Painket

Package leaflet: Information for the patient

PAINKET 40 mg granules

Ketoprofen Lysine Salt
Please read this leaflet carefully before taking this medicine because 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 you notice worsening of symptoms after a few days of treatment.

Contents of this leaflet:

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

1. What PAINKET is and what it is used for

PAINKET contains the active substance ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs"), used to treat pain and inflammation.
PAINKET is indicated in adults and adolescents over the age of 15 for the treatment of mild to moderate acute pain.

2. What you should know before taking PAINKET

Do not take PAINKET

• 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;
• if you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways);
• if you have severe heart failure (inability of the heart to pump adequate blood to meet the body's needs);
• if you have gastritis (inflammation of the stomach lining);
• 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 experienced recurrent peptic ulcer or bleeding (two or more distinct, confirmed episodes of bleeding or ulceration);
• if you have previously suffered from 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 Crohn’s disease (inflammation of the intestine) or ulcerative colitis (inflammation of the intestine with ulcers);
• if you have severe liver (reduced liver function due to cirrhosis or severe hepatitis) or kidney (reduced kidney function) insufficiency;
• if you suffer from leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you have haemorrhagic diathesis (predisposition to bleeding) or other coagulation disorders, or if you have haemostatic disorders (difficulty in stopping bleeding);
• if you are being treated with high doses of diuretics;
• if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if the person taking the medicine is a child or adolescent under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking PAINKET.
Warnings
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see “How to take PAINKET” and the sections below on gastrointestinal and cardiovascular risks).
Concomitant use of PAINKET with other anti-inflammatory drugs should be avoided.
During treatment with all NSAIDs, including PAINKET, gastrointestinal bleeding, ulceration, and perforation have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events, and may be fatal. Patients with a prior history of these conditions are at higher risk (see “Do not take PAINKET”).
Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the beginning of treatment.
Inform your doctor if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), anticoagulants (medicines that delay blood clotting), such as warfarin, selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents such as acetylsalicylic acid (see “Other medicines and PAINKET”).
Elderly patients are at increased risk of developing adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.
Immediately discontinue treatment with PAINKET at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions, some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with the use of NSAIDs (see “Possible side effects”). These reactions usually occur in the early stages of treatment. Discontinue use of PAINKET if a skin rash, mucosal lesions, or any other signs of hypersensitivity (allergic reaction) appear.
Precautions
Consult your doctor or pharmacist before taking PAINKET:

• If your kidneys do not function properly, as PAINKET should be used with caution in such cases. If you use PAINKET, kidney function should be monitored, especially if you are elderly or are taking diuretics (medicines that lower blood pressure).
• If you have liver problems, you should undergo periodic checks.
• If you have an infection – see the section «Infections» below.
• If you have liver disease or abnormal liver function tests, as transaminase levels (liver enzymes) should be periodically assessed, especially during long-term therapy.
• 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 cardiac pumping function), established ischemic heart disease (heart disease resulting from reduced blood flow due to narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the brain's arteries and vessels), as PAINKET should only be taken after careful evaluation by your doctor.
• If you have risk factors for these conditions, for example high blood pressure, diabetes (a disease caused by high blood glucose levels), hyperlipidemia (high levels of fats in the blood), or if you smoke.
• If you have a history of allergic reactions or previous allergies, as the medicine should be administered with caution.
• If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways), or have allergic diathesis (predisposition to develop allergies), chronic rhinitis (inflammation of the nasal mucosa), allergic rhinitis, chronic sinusitis, and/or nasal polyposis.
• If you have hematopoietic disorders (affecting the formation and maturation of blood cells), systemic lupus erythematosus (an immune system disease), or mixed connective tissue diseases, as PAINKET should be used with caution.
• If you have hepatic porphyria (a rare blood disorder characterized by altered activity of one of the liver enzymes), as the medicine could trigger an attack.

Some NSAIDs may be associated with an increased risk of arterial thrombotic events (e.g., heart attack or stroke). Currently, there are insufficient data to exclude a similar risk for PAINKET.
An increased risk of atrial fibrillation (a disturbance in the heart's rhythm) has been reported in association with the use of NSAIDs.
Hyperkalemia (increased potassium levels in the blood) may occur, particularly if you have diabetes, kidney failure, and/or are taking medicines that can cause hyperkalemia (see “Other medicines and PAINKET”). In such circumstances, potassium levels should be monitored periodically.
Infections
PAINKET may mask symptoms of infections such as fever and pain. Therefore, PAINKET 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 the symptoms of infection persist or worsen, consult your doctor immediately.
Consult your doctor if you experience visual disturbances, such as blurred vision, as treatment must be discontinued.
Avoid exposure to sunlight during treatment with this medicine, as the skin may become more sensitive.
Children and adolescents
PAINKET must not be administered to children and adolescents under 15 years of age.
Other medicines and PAINKET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of PAINKET is not recommended with:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase-2 inhibitors, and high doses of salicylates (more than 3 g per day);
• Medicines used to slow down blood clotting, such as heparin and warfarin, and medicines that prevent platelet aggregation, such as ticlopidine and clopidogrel;
• Lithium, a medicine used to treat manic-depressive psychosis;
• High-dose methotrexate (more than 15 mg per week), a medicine used in the treatment of certain autoimmune diseases and some cancers;
• Hydantoins (used to treat epilepsy) and sulfonamides (such as certain antibiotics used to treat bacterial infections).

Caution is required when using PAINKET concomitantly with:

• Potassium salts;
• Potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
• NSAIDs (anti-inflammatory drugs);
• Heparins (anticoagulants);
• Cyclosporine and tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Trimethoprim (an antibiotic used for bacterial infections);
• Tenofovir (a medicine used in the treatment of certain viral infections);
• Low-dose methotrexate, less than 15 mg per week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• Corticosteroids (medicines used to treat inflammatory conditions);
• Pentoxifylline (a medicine used to improve blood circulation in the limbs);
• Zidovudine (a medicine used for HIV treatment);
• Sulfonylureas (medicines used to treat diabetes);
• Cardiac glycosides (medicines acting on the heart).

Consider the concomitant use of PAINKET with:

• Beta-blockers, ACE inhibitors, diuretics (medicines used to lower blood pressure);
• Mifepristone (a medicine used for medical termination of pregnancy);
• Intrauterine contraceptive devices;
• Cyclosporine, tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Thrombolytics (medicines that help dissolve blood clots);
• Ticlopidine and clopidogrel (medicines that prevent platelet aggregation);
• Selective serotonin reuptake inhibitors (some antidepressants);
• Probenecid (a medicine used to treat gout);
• Quinolones and sulfamidics (antibiotics used to treat bacterial infections);
• Phenytoin (a medicine used to treat epilepsy);
• Gemeprost (a medicine used for uterine examinations and surgical procedures).

Consumption of alcoholic beverages is not recommended during treatment with PAINKET.
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 PAINKET 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.
You should not take PAINKET during the first 6 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 duration should be used. From week 20 of pregnancy, PAINKET may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause 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.
Do not take the medicine close to delivery, as it may cause disturbances in the newborn’s circulation and respiration.
Breastfeeding
Do not take PAINKET while breastfeeding.
Fertility
PAINKET may cause fertility problems in women. Therefore, if you plan to become pregnant, inform your doctor, as this medicine may reduce fertility.
Discontinue treatment if you have fertility problems and plan to conceive or if you are undergoing fertility investigations.
Driving and using machines
After taking PAINKET, drowsiness, dizziness, convulsions, and visual disturbances may occur. Therefore, it is recommended to avoid driving, operating machinery, or performing activities requiring special alertness (see “Possible side effects”).
PAINKET contains aspartame, benzyl alcohol and sodium
This medicine contains 10.56 mg of aspartame per dose (1 sachet), equivalent to 31.78 mg per maximum recommended daily dose (3 sachets).
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body’s inability to properly metabolize it.
This medicine contains lime flavor, lemon flavor, and frescofort flavor, which in turn contain 0.00032 mg of benzyl alcohol per dose (1 sachet), equivalent to 0.00096 mg per maximum recommended daily dose (3 sachets). Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take PAINKET

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Use in adults and adolescents over 15 years of age
The recommended dose is 40 mg once daily (corresponding to 1 sachet), or repeated 2–3 times daily in cases of more intense pain.

Use in elderly patients
If you are elderly, take the lowest possible daily dose (see section 2, “What you need to know before taking PAINKET – Warnings and precautions”).

Use in patients with mild or moderate liver problems
If you have mild or moderate liver impairment, take the lowest possible daily dose.
Do not take this medicine if you have severe liver disease (see section 2, “What you need to know before taking PAINKET – Do not take PAINKET”).

Use in patients with mild or moderate kidney problems
If you have mild or moderate kidney impairment, consult your doctor, who must monitor you during treatment with this medicine.
Do not take this medicine if you have severe kidney problems (see section 2, “What you need to know before taking PAINKET – Do not take PAINKET”).

Use in children
The safety and efficacy of PAINKET have not yet been established.

Duration of treatment
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not use for prolonged periods without medical advice and do not exceed the recommended doses.
Limit the duration of treatment to the resolution of the painful episode.
Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics.

Method of administration
Place the medicine directly on the tongue. It dissolves with saliva, allowing it to be used without water.
Take this medicine with a full stomach.
Always use the lowest effective dose for the shortest possible time needed to control symptoms, in order to reduce the risk of adverse effects.

If you take more PAINKET than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital Emergency Department.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms were limited to lethargy, confusion, loss of consciousness, drowsiness, headache, vertigo, dizziness, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, and diarrhoea.
Gastrointestinal bleeding, hypotension (low blood pressure), respiratory depression, and cyanosis (bluish discoloration of the skin and mucous membranes) may also occur.
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.
In cases of renal failure, haemodialysis (a blood purification technique using extracorporeal circulation) may help remove the circulating medicine.

If you forget to take PAINKET
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effects are gastrointestinal in nature.
The following adverse reactions have been observed with the use of ketoprofen in adults:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence (passing intestinal gas), gastritis (inflammation of the stomach lining)
• skin rash, itching, fatigue.

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 (numbness or tingling sensations)
• blurred vision (see "Warnings and precautions")
• tinnitus (persistent ringing or noise in the ears)
• asthma (inflammation of the bronchi and narrowing of the airways)
• stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion in the stomach or the first part of the intestine)
• hepatitis (inflammation of the liver), increased transaminases (elevated levels of certain enzymes indicating liver function), increased bilirubin (a substance indicating liver function)
• weight gain.

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

• facial oedema (swelling) and erythema (redness of the skin).

Frequency not known (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 caused by destruction of red blood cells), leucopenia (decrease in white blood cell count), neutropenia (decrease in a type of white blood cells), aplastic anaemia (reduction in haemoglobin in the blood caused by inadequate 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)
• jaundice (yellowing of the skin and whites of the eyes)
• depression, hallucination (perception of things not present in reality), confusion, mood changes, agitation, insomnia, convulsions (uncontrolled body movements), dizziness, dysgeusia (altered taste), tremor, dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital oedema (swelling around the eye), peripheral oedema
• chills, asthenia (weakness)
• 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), tachycardia (increased heart rate), hypertension (high blood pressure), hypotension (low blood pressure)
• vasodilation (dilation 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), dyspnoea (difficulty breathing), laryngeal oedema (swelling of the throat due to fluid accumulation), laryngospasm (narrowing of the larynx), acute respiratory failure (one fatal case has been reported in an asthmatic patient sensitive to acetylsalicylic acid)
• exacerbation of colitis (worsening of intestinal inflammation), exacerbation of Crohn's disease (worsening of intestinal inflammation), gastrointestinal haemorrhage (bleeding from the stomach or intestine), gastrointestinal perforation (sometimes fatal, especially in elderly patients; see "Warnings"), gastric ulcer (lesion in the stomach), oral ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, gastric pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melena (presence of digested blood in stools), haematemesis (vomiting blood), abdominal discomfort, colitis, 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), urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing), bullous eruptions including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (serious skin reactions), oedema (fluid retention), exanthema (skin rash), maculopapular exanthema (skin rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), generalised acute exanthematous pustulosis (skin eruption with pustule formation), dermatitis (skin irritation)
• acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritis and nephrotic syndrome (inflammation of the kidneys), nephrotic syndrome (kidney disorder causing loss of protein 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 (serious kidney damage), oliguria (reduced urine production), abnormal kidney function test, haematuria (presence of blood in urine)
• aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of the lymphatic vessels)
• hyperkalaemia (increased potassium levels in blood), hyponatraemia (decreased sodium levels in blood).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PAINKET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What PAINKET contains
The active substance is ketoprofen lysine salt.
Each sachet contains 40 mg of ketoprofen lysine salt (equivalent to 25 mg of ketoprofen).
The other components are: mannitol, xylitol, lime flavour, lemon flavour, frescofort flavour,
aspartame, talc, basic butyl methacrylate copolymer, magnesium stearate, colloidal hydrated silica,
hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of PAINKET and pack contents
PAINKET is an oral granulate, consisting of homogeneous granules of white to pale yellow colour.
This medicinal product is available in packs of 12 sachets, 24 sachets or 30 sachets.

Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto De’ Stampi - Rozzano (MI)