Kelis pain and inflammation: detailed information

Package leaflet: Information for the patient

KELIS PAIN AND INFLAMMATION 40 mg oral solution

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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after short periods of treatment.

Contents of this leaflet:

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

1. What KELIS PAIN AND INFLAMMATION is and what it is used for

KELIS PAIN AND INFLAMMATION 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 PAIN AND INFLAMMATION is indicated in adults for the treatment of pain of various origin and nature, and in particular: headache, toothache, neuralgia, menstrual pain, and musculoskeletal pain.

2. What you should know before taking KELIS PAIN AND INFLAMMATION

Do not take KELIS PAIN AND INFLAMMATION

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 or other non-steroidal anti-inflammatory drugs (NSAIDs) has previously caused you problems such as asthma (asthma attacks), breathing difficulties due to temporary narrowing of the bronchi (bronchospasm) or nasal polyps, acute rhinitis, allergic skin reactions such as urticaria, or swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and 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 problem (active or recurrent peptic ulcer), or digestive disorders;
if you currently suffer or have previously suffered from bleeding or perforation of the stomach or intestine, even after taking non-steroidal anti-inflammatory drugs (NSAIDs);
if you have severe heart problems (heart failure);
if you have severe liver or kidney problems (hepatic or renal insufficiency);
if you have a tendency to bleed (hemorrhagic diathesis) or a blood coagulation disorder, or if you are taking medications to improve blood fluidity (anticoagulants);
if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
if the person who is to take the medicine is a child or adolescent under 18 years of age. Simultaneous administration with other anti-inflammatory drugs and acetylsalicylic acid is also not recommended.

Warnings and precautions
Talk to your doctor or pharmacist before taking KELIS PAIN AND INFLAMMATION.
Be especially careful with KELIS PAIN AND INFLAMMATION if:

you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and KELIS PAIN AND INFLAMMATION”);
you are elderly, as this increases the risk of stomach or intestinal injury or bleeding, which may be life-threatening;
you currently suffer or have previously suffered from stomach and/or intestinal problems (e.g., peptic ulcers, perforation, or bleeding from the stomach or intestine). 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 block stomach acid production);
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, fluid retention, or have previously experienced any of these conditions. In such cases, your doctor should monitor you closely;
you have hepatic porphyria (a rare blood disorder characterized by impaired activity of a liver enzyme), as this medicine could trigger an attack;
you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
you are taking medications 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 PAIN AND INFLAMMATION”). In such cases, consult your doctor before taking KELIS PAIN AND INFLAMMATION, as you may need additional medication to protect your stomach (e.g., misoprostol or acid-reducing drugs);
you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with fertility;
you have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, previous 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 PAIN AND INFLAMMATION 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 duration of treatment;

you suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
you have an infection – see section “Infections” below.

Infections
KELIS PAIN AND INFLAMMATION may mask symptoms of infections such as fever and
pain. Therefore, KELIS PAIN AND INFLAMMATION may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
As with other anti-inflammatory drugs, ketoprofen may mask symptoms or signs of infection (such as fever) and may cause minor transient increases in some liver function tests and also elevations in transaminases. 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.
Take this medicine at the lowest effective dose and for the shortest possible duration to minimize the occurrence of side effects.
Stop taking 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 and adolescents
KELIS PAIN AND INFLAMMATION must not be administered to children and adolescents under 18 years of age.
Other medicines and KELIS PAIN AND INFLAMMATION
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking this medicine if you are taking :

other non-steroidal anti-inflammatory drugs (NSAIDs) or high-dose salicylates (over 3 g per day);
medicines used to slow blood clotting (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
lithium, used to treat depression or similar disorders;
high-dose methotrexate (over 15 mg per week), used to treat rheumatoid arthritis or cancer;
hydantoins, used for epilepsy;
sulfonamides, used for bacterial infections.

If you are taking any of the following medicines, inform your doctor, who will monitor you closely :

corticosteroids, used for inflammation;
ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
low-dose methotrexate (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
pentoxifylline, used to treat chronic venous ulcers;
zidovudine and tenofovir, used to treat AIDS;
sulfonylureas, used for diabetes;
thrombolytics, used for blood clotting disorders;
probenecid, used for gout;
certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders;
certain antibiotics, used for bacterial infections.

Your doctor should monitor you closely and may decide to reduce the dose of
KELIS PAIN AND INFLAMMATION.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take KELIS PAIN AND INFLAMMATION during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. 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 labor.
You should not take KELIS PAIN AND INFLAMMATION 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. From week 20 of pregnancy, KELIS PAIN AND INFLAMMATION may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels around the baby (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 PAIN AND INFLAMMATION while breastfeeding.
Fertility
KELIS PAIN AND INFLAMMATION 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 undergoing fertility testing.
Driving and using machines
This medicine may cause dizziness, drowsiness, or seizures. If this occurs, avoid driving or operating machinery.
KELIS PAIN AND INFLAMMATION contains sorbitol, methyl parahydroxybenzoate, and
sodium
This medicine contains 3.15 g of sorbitol per dose, equivalent to 9.45 g for the maximum recommended daily dose. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, consult your doctor before taking this medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially sodium-free.

3. How to take KELIS PAIN AND INFLAMMATION

Take this medicine exactly as described in this leaflet or 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. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in adults
The recommended dose is one stick, once only, 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 KELIS PAIN AND INFLAMMATION – Warnings and precautions”).

Use in patients with 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 KELIS PAIN AND INFLAMMATION – Do not take KELIS PAIN AND INFLAMMATION”).

Use in patients with kidney problems
If you have mild or moderate kidney impairment, consult your doctor, who will need to 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 PAIN AND INFLAMMATION – Do not take KELIS PAIN AND INFLAMMATION”).

Do not use this medicine for prolonged periods without medical advice and do not exceed the recommended doses.
Limit the duration of treatment to the time needed to overcome the painful episode.

Method of administration
For oral use.
Take this medicine with food.
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 KELIS PAIN AND INFLAMMATION than you should
The most common symptoms of overdose are: lethargy, drowsiness, nausea, vomiting, and stomach pain.
Other symptoms may include headache, dizziness, confusion, loss of consciousness, low blood pressure, respiratory depression, bluish discoloration of the skin and mucous membranes (cyanosis), kidney failure, seizures, and coma.
In case of accidental ingestion of an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they can identify which medicine has been taken.

If you forget to take KELIS PAIN AND INFLAMMATION
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 missed 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. Stomach or intestinal disorders may occur (peptic ulcers, perforation, or bleeding from the stomach or intestines, which can be life-threatening, especially in elderly patients). Inform your doctor immediately if you experience any side effects affecting the stomach and/or intestines (stomach pain, burning sensation, bleeding), particularly if you are an elderly patient.

Stop taking KELIS PAIN AND INFLAMMATION immediately and contact your doctor as soon as you notice a skin rash, any lesions inside the mouth or on the genitals, or any signs of an allergic reaction.

The side effects that may occur with KELIS PAIN AND INFLAMMATION are:

Common (may affect up to 1 in 10 people)
Nausea, vomiting, digestive disturbances (dyspepsia), abdominal pain/discomfort.

Uncommon (may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, diarrhoea, excessive gas production in the gastrointestinal tract (flatulence), constipation, inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to fluid retention (oedema), fatigue.

Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cell count due to bleeding (haemorrhagic anaemia), tingling and numbness in hands and feet (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), stomach or intestinal problems (peptic ulcer), liver problems (hepatitis, increased levels of transaminases and bilirubin in the blood), yellowing of the skin and whites of the eyes (jaundice), weight gain.

Frequency not known (frequency cannot be estimated from the available data)
Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), reduced platelet count (thrombocytopenia), reduced white blood cell count (agranulocytosis), increased white blood cell count (leucocytosis), reduced white blood cell count (leucopenia), reduced neutrophil count, a type of white blood cell (neutropenia), development of numerous bleeding spots on the skin due to reduced platelet count (thrombocytopenic purpura), reduced bone marrow activity (myelophthisis), destruction of red blood cells (haemolytic anaemia), reduced production of red blood cells (aplastic anaemia), sudden potentially fatal allergic reaction (including anaphylactic shock), depression, seeing and hearing things that are not real (hallucinations), mood changes, hyperexcitability, insomnia, transient loss of consciousness (syncope), seizures, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), dizziness, eye swelling due to fluid retention (periorbital oedema), heart problems (heart failure), awareness of your own heartbeat (palpitations), rapid heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of blood vessels (vasculitis), swelling of the larynx, breathing difficulties (bronchospasm), cold-like symptoms (rhinitis), shortness of breath (dyspnoea), breathing difficulties due to laryngeal contraction (laryngospasm), acute respiratory failure, skin rash (exanthema, maculopapular exanthema), skin inflammation (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in breathing and swallowing (angioedema), rare skin condition with blisters and bleeding of lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome), severe skin disease (Lyell’s syndrome, toxic epidermal necrolysis), worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), bleeding and perforation of the stomach and intestines, stomach or duodenal ulcer, heartburn, stomach pain, damage to the stomach lining without perforation leading to bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, passage of blood in stools (melena), vomiting blood (haematemesis), kidney problems such as blood in urine (haematuria), acute kidney failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, fluid retention, reduced urine output (oliguria), difficulty urinating (dysuria), chills, tiredness (asthenia), swelling of the extremities (peripheral oedema), facial swelling (facial oedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 PAIN AND INFLAMMATION

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 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. Package contents and other information

What KELIS PAIN AND INFLAMMATION contains
The active substance is ketoprofen lysine salt.
Each stick contains 40 mg of ketoprofen lysine salt.
The other components are: non-crystallizable liquid sorbitol, disodium hydrogen phosphate dihydrate,
methyl parahydroxybenzoate sodium, sodium saccharin, mint flavour, liquorice flavour, purified water.

Description of the appearance of KELIS PAIN AND INFLAMMATION and contents of the pack
KELIS PAIN AND INFLAMMATION is a clear, colourless to yellowish solution.
Each pack contains 10 or 20 PET/AL/PE sticks of 7 ml.

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

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo,
03012 Anagni (FR) – Italy