PATIENT LEAFLET: Information for the patient

KELIS 80 mg powder for oral solution

Ketoprofen Lysine Salt
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What KELIS is and what it is used for
What you need to know before taking KELIS
How to take KELIS
Possible side effects
How to store KELIS
Contents of the pack and other information

1. What KELIS is and what it is used for

KELIS 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.
KELIS is indicated:

in adults , for the symptomatic treatment of pain associated with:
- inflammatory joint disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, painful osteoarthritis, extra-articular rheumatism);
- inflammatory conditions due to trauma and painful inflammations affecting the mouth, teeth, ears, larynx, urinary tract, and respiratory tract.
in children , for the short-term symptomatic treatment of pain, even with fever, caused by:
- inflammation affecting joints and bones;
- ear inflammation (otitis);
- surgical procedures.

2. What you should know before taking KELIS

Do not take KELIS

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 taking medicines such as acetylsalicylic acid, ketoprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) has previously caused you problems such as asthma, difficulty breathing (bronchospasm), nasal polyps, acute rhinitis, or allergic skin reactions such as urticaria or swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). In such cases, a sudden allergic reaction may occur, which could be life-threatening;
if you currently suffer or have previously suffered from a stomach or intestinal disorder (active or recurrent peptic ulcer, two or more distinct episodes confirmed by bleeding or ulceration);
if you have previously experienced gastrointestinal bleeding, ulceration, or perforation, or chronic dyspepsia;
if you currently suffer or have previously suffered from bleeding or perforation of the stomach or intestines, even following the use of non-steroidal anti-inflammatory drugs (NSAIDs);
if you have leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets in the blood);
if you suffer from an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis;
if you suffer from gastritis;
if you currently suffer or have previously suffered from asthma (bronchial asthma);
if you have severe heart problems (heart failure);
if you have severe liver or kidney problems (hepatic insufficiency, liver cirrhosis, severe hepatitis, or renal insufficiency);
if you have a tendency to bleed (haemorrhagic diathesis) or a disorder due to a blood clotting defect (haemostatic disorders);
if you are currently undergoing intensive diuretic therapy;
if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
if the person to take the medicine is a child under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking KELIS.
Take this medicine at the lowest effective dose and for the shortest possible duration to reduce the risk of adverse effects.
Be especially cautious with KELIS and inform your doctor if:

you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid (aspirin), even at low doses (see section “Other medicines and KELIS”);
you are elderly. In this case, adverse effects, especially gastrointestinal bleeding and/or perforation, are more likely and may be life-threatening;
you currently suffer or have previously suffered from stomach and/or intestinal problems (e.g. peptic ulcers, perforation, or gastrointestinal bleeding). In such cases, your doctor may decide to monitor you closely and prescribe additional medication to protect your stomach (e.g. misoprostol or drugs that inhibit gastric acid production);
you suffer from a blood cell formation disorder (haematopoietic disorders);
you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
you have allergies or have previously experienced allergic reactions;
you have kidney, liver, or heart problems, or fluid retention, or have previously suffered from any of these conditions. In such cases, your doctor should monitor you closely;
you are taking diuretics or medicines used to reduce blood volume;
you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
you are taking medicines that may increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin (see section “Other medicines and KELIS”). In such cases, consult your doctor before taking KELIS, as you may need additional medication to protect your stomach (e.g. misoprostol or acid-suppressing drugs);
you are a woman with fertility problems planning a pregnancy, as this medicine may interfere with fertility;
you have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, or a history of stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels, or are a smoker). KELIS may be associated with a slight increase in the risk of heart attack and stroke. This risk is higher at high doses and with prolonged use. Do not exceed the recommended dose or treatment duration;
you suffer from asthma associated with chronic rhinitis and/or nasal polyps;
you have an infection – see section “Infections” below.

Infections
KELIS may mask symptoms of infections such as fever and pain. Therefore, KELIS 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.
As with other NSAIDs, ketoprofen may increase certain laboratory test values such as blood urea nitrogen and creatinine, and may cause slight transient increases in liver function tests, including transaminases (GPT/ALT and GOT/AST). If significant increases occur, discontinue treatment and consult your doctor.
Avoid exposure to sunlight during treatment with this medicine, as your skin may become more sensitive.
An increased risk of atrial fibrillation (a heart rhythm disorder) has been reported with NSAID use.
Hyperkalaemia may occur, especially if you have diabetes, renal insufficiency, or are taking agents that promote hyperkalaemia (see subsection “Other medicines and KELIS”). In such cases, potassium levels should be monitored.
Stop treatment with this medicine and contact your doctor immediately if

you develop skin rashes, mucosal lesions, or any other signs of hypersensitivity;
you experience a severe, potentially life-threatening skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis);
you experience eye problems (such as blurred vision);
you have stomach burning, bleeding, or pain.

Children
KELIS should be administered with caution, under strict medical supervision, and only if necessary in children over 6 years of age, as it may cause gastrointestinal bleeding and ulcers, which can be severe.

Other medicines and KELIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking the following medicines together with KELIS:

other non-steroidal anti-inflammatory drugs (NSAIDs) and high-dose salicylates (more than 3 g per day);
medicines used to prevent blood clots (anticoagulants such as heparin and warfarin, antiplatelet agents such as ticlopidine and clopidogrel);
lithium, used to treat depression or similar disorders;
high-dose methotrexate (more than 15 mg per week), used to treat rheumatoid arthritis or cancer. At least 12 hours should elapse between the administration of ketoprofen and methotrexate;
hydantoins, used for epilepsy;
sulfonamides, used for bacterial infections.

The combination of KELIS with any of the following medicines requires certain precautions:

medicines that may promote hyperkalaemia, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim;
tenofovir (a medicine used to treat certain viral infections) due to increased risk of renal failure;
low-dose methotrexate (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
corticosteroids, used for inflammatory conditions;
pentoxifylline, used to treat chronic venous ulcers;
zidovudine, used to treat AIDS;
sulfonylureas, used for diabetes;
cardiac glycosides (e.g. digoxin), used to treat heart problems.

Combinations to consider

ACE inhibitors, diuretics, and beta-blockers, used for high blood pressure and heart problems: NSAIDs may reduce the effectiveness of antihypertensive medicines;
mifepristone (a medicine used for medical termination of pregnancy): the effectiveness of contraceptive methods may theoretically be reduced due to the properties of NSAIDs;
intrauterine contraceptive devices: the effectiveness of the device may be reduced, leading to unintended pregnancy;
cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders: increased risk of additional kidney toxicity, especially in the elderly;
thrombolytics, used for blood clotting disorders;
antiplatelet agents, used to prevent blood clot formation;
certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs);
probenecid, used for gout; concomitant administration may increase ketoprofen blood levels, requiring dose adjustment;
certain antibiotics such as quinolones, used for bacterial infections: possible increased risk of seizures;
phenytoin, a medicine used to treat epilepsy: dosage reduction may be necessary;
sulfamides, medicines used for bacterial infections: dosage reduction may be necessary;
gemeprost, a medicine used in obstetrics: reduced effectiveness.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take KELIS during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour.
You should not take KELIS during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, KELIS may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take KELIS while breastfeeding.
Fertility
KELIS may cause fertility problems in women. Therefore, if you are planning a pregnancy, inform your doctor, as this medicine may reduce fertility.
Discontinue treatment if you have fertility problems and are planning a pregnancy, or if you are undergoing fertility testing.

KELIS and alcohol
Avoid consuming alcoholic beverages while taking this medicine.

Driving and using machines
This medicine may cause dizziness, drowsiness, or seizures. If you experience any of these, avoid driving or operating machinery.

KELIS contains sorbitol and sodium
This medicine contains approximately 1.7 g of sorbitol per dose, equivalent to about 5.1 g per maximum recommended daily dose (3 sachets). Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor before taking this medicine.
This medicine contains less than 23 mg (1 mmol) of sodium per dose, i.e. essentially "sodium-free".

3. How to take KELIS

Always take this medicine exactly as instructed 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. If you have
an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Use in adults
The recommended dose is one sachet of 80 mg (full dose) three times daily, taken during meals.
The maximum daily dose must not exceed 320 mg. Higher doses are not recommended (see subsection “Warnings and precautions”).
Take this medicine using the lowest effective dose and for the shortest possible duration.
Use in children aged 6 to 14 years
The recommended dose is half a sachet of 40 mg (half dose) three times daily, taken during meals.
Use in elderly
If you are elderly, your doctor will determine the appropriate dose (see section 2 “What you need to know before taking Kelis – Warnings and precautions”).
Use in patients with liver problems
If you have liver problems such as hepatic insufficiency, take the lowest possible daily dose.
Do not take this medicine if you have severe liver problems (see section 2 “What you need to know before taking Kelis – Do not take Kelis”).
Use in patients with mild to moderate kidney problems
If you have mild or moderate kidney problems, your doctor should 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 Kelis – Do not take Kelis”).
Take this medicine for the shortest possible duration necessary to control symptoms, in order to reduce the occurrence of adverse effects.
Method of administration
Open the sachet along the line marked "half dose" to obtain a 40 mg dose. To obtain an 80 mg dose, open the sachet along the line marked "full dose".
Pour the contents of one sachet or half a sachet into half a glass of water and stir.
If you take more KELIS than you should
If you (or someone else) have taken too much KELIS, or if you suspect that a child has taken an overdose, contact a doctor immediately or go to the nearest hospital Emergency Department.
The most common symptoms of overdose are: lethargy, drowsiness, nausea, vomiting, stomach pain and abdominal pain, dizziness and diarrhoea.
Other symptoms may include headache, vertigo, confusion, and loss of consciousness. In cases of severe overdose, low blood pressure, respiratory depression, gastrointestinal bleeding, and cyanosis (bluish discoloration of the skin and mucous membranes) have been observed.
Bring this leaflet, any remaining medicine, and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to take KELIS
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 a 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 of gastrointestinal 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, vomiting.

Uncommon (may affect up to 1 in 100 people)

headache, dizziness, vertigo, drowsiness
constipation, diarrhoea, flatulence (gas in the intestine), gastritis, abdominal discomfort
rash, pruritus (itching)
oedema (fluid retention causing swelling), fatigue, peripheral oedema (swelling in extremities), chills.

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

haemorrhagic anaemia (anaemia due to blood loss)
paraesthesia (abnormal skin sensation, tingling and numbness of hands and feet)
blurred vision (see section “Warnings and precautions”)
tinnitus (ringing in the ears)
asthma
stomatitis (mouth ulcers), peptic ulcer (stomach or intestinal ulcer), colitis
hepatitis, increased transaminases (liver enzymes), increased blood bilirubin (elevated serum bilirubin levels due to liver disorders), jaundice
weight gain.

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

dyskinesia (movement disorder), syncope (transient loss of consciousness)
hypotension (low blood pressure)
oedema (swelling) of the larynx
haematuria (blood in urine)
asthenia (physical weakness), facial oedema (facial swelling).

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

thrombocytopenia (reduced number of platelets in the blood), agranulocytosis (severe reduction in white blood cells), bone marrow failure (reduced production of blood cells), haemolytic anaemia (anaemia due to abnormal destruction of red blood cells), neutropenia (decrease in neutrophil white blood cells), aplastic anaemia (anaemia due to insufficient production of blood cells in the bone marrow), leukocytosis (increased number of white blood cells), thrombocytopenic purpura, leukopenia (reduced number of white blood cells)
sudden potentially life-threatening allergic reaction (including anaphylactic shock), hypersensitivity
depression, hallucinations, confusion, mood alterations, excitability, insomnia. In a paediatric patient who received a double dose compared to that recommended in the SmPC, anxiety and behavioural disturbances were also observed
convulsions
dysgeusia (altered taste)
tremor, hyperkinesia (movement disorders)
heart failure, atrial fibrillation (irregular heart rhythm), palpitations, tachycardia (increased heart rate)
hypertension (increased blood pressure), vasodilation, vasculitis (inflammation of blood or lymphatic vessels), including leukocytoclastic vasculitis
bronchospasm (difficulty breathing), rhinitis, dyspnoea (shortness of breath), breathing difficulty due to laryngeal spasm (laryngospasm), acute respiratory failure
gastralgia (stomach pain), gastrointestinal haemorrhage, worsening of colitis and Crohn’s disease, gastric pyrosis (heartburn), stomach and intestinal disorders (perforation or bleeding from the stomach or intestine, which may be life-threatening), gastric ulcer, duodenal ulcer, oedema (swelling) of the mouth and tongue, inflammation of the pancreas (pancreatitis), erosive gastritis, haematemesis (vomiting blood) or melena (passage of digested blood in stools), hyperchlorhydria (excess hydrochloric acid in gastric juice), stomach pain
photosensitivity (excessive sensitivity to light), alopecia (hair loss), urticaria, angioedema (swelling of face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing), blistering rashes including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (serious skin reactions), erythema (redness of the skin), exanthema (skin rash), maculopapular exanthema, purpura, acute generalized exanthematous pustulosis (skin eruption with pustule formation), dermatitis
acute renal failure, tubulo-interstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerular nephritis, fluid/sodium retention with possible oedema, acute tubular necrosis (damage to kidney tubular cells), renal papillary necrosis (damage to kidney papillae), oliguria (reduced urine output), abnormal kidney function test
periorbital oedema (swelling around the eyes)
aseptic meningitis (inflammation of the membranes covering the brain not caused by bacteria)
lymphangitis (inflammation of lymphatic vessels)
hyperkalaemia (increased potassium levels in blood), hyponatraemia (decreased sodium levels in blood).

Immediately inform your doctor if you notice any gastrointestinal side effects (stomach pain, heartburn, bleeding), especially if you are an elderly patient.
Immediately stop taking KELIS and contact your doctor if you notice a skin rash, any lesions inside the mouth or on the genitals, or any signs of an allergic reaction.
Medicines such as KELIS may be associated with a slight increased risk of heart attack (myocardial infarction) and stroke.
Reporting of side effects
If you experience any side effects, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KELIS

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

6. Package contents and other information

What KELIS contains
The active substance is ketoprofen lysine salt.
Each sachet contains 80 mg of ketoprofen lysine salt (equivalent to 50 mg of ketoprofen).
The other components are: sorbitol (Neosorb P60), sorbitol (Neosorb P30/P60), povidone, anhydrous colloidal silica, sodium chloride, sodium saccharin, ammonium glycyrrhizinate, peppermint flavour.

Description of the appearance of KELIS and contents of the pack
KELIS is a powder for oral solution. Homogeneous powder, white to pale yellow in colour.
This medicinal product is available in packs of 30 double-chambered sachets.

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

Manufacturers
Special Product’s Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)