KETOPROFEN EG

Patient Information Leaflet

KETOPROFENE EG 50 mg Hard Capsules

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ketoprofene EG is and what it is used for

Ketoprofene EG 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.
Ketoprofene EG is indicated for the treatment of painful symptoms caused by inflammation of bones, muscles, and joints, such as: rheumatoid arthritis, ankylosing spondylitis, acute gout; osteoarthritis at various sites; sciatica, radiculitis, myalgia; bursitis, tendinitis, tenosynovitis, synovitis, capsulitis; bruises, sprains, dislocations, muscle tears; phlebitis, superficial thrombophlebitis, lymphangitis.
This medicine is also indicated for the treatment of painful symptoms caused by inflammation of the mouth, teeth, ears, throat, urinary tract, and respiratory tract.

2. What you should know before taking Ketoprofene EG

Do not take Ketoprofene EG

• if you are allergic to ketoprofen, to similar medicines (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced an allergic reaction (e.g. bronchospasm, asthma, rhinitis, urticaria) after taking other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid;
• if you are pregnant (especially during the third trimester) or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if you have severe kidney problems (severe renal insufficiency), liver problems (severe hepatic insufficiency, liver cirrhosis, severe hepatitis), or heart problems (severe heart failure);
• if you currently suffer or have previously suffered from stomach or intestinal ulcers (active peptic ulcer), gastrointestinal bleeding, or perforation of the stomach or intestines;
• if you are taking diuretic medicines (diuretics) intensively (see sections “Warnings and precautions” and “Other medicines and Ketoprofene EG”);
• if you have blood disorders such as leukopenia or thrombocytopenia, if you are experiencing bleeding (blood loss), or if you are prone to bleeding. Ketoprofene EG must not be given to children.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketoprofene EG.
Talk to your pharmacist or nurse if:

• you suffer from asthma associated with chronic rhinitis, sinusitis, and/or nasal polyps, or if you are prone to bronchospasm or other allergic reactions;
• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and Ketoprofene EG”);
• you have high blood pressure that is not adequately controlled, or heart problems (e.g. congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease);
• you have an irregular heart rhythm (atrial fibrillation);
• you have high potassium levels, especially if you have diabetes, kidney problems, or are being treated with other medicines that increase potassium levels. In this case, your doctor should monitor these values;
• you have previously experienced stomach or intestinal problems (bleeding, perforations, ulcers, Crohn’s disease, ulcerative colitis), or if you are taking medicines that may increase the risk of damage to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin) (see sections “Do not take Ketoprofene EG” and “Other medicines and Ketoprofene EG”);
• you have an infection – see section «Infections» below;
• you have liver problems or have previously had liver problems, as Ketoprofene EG may worsen your condition. In such cases, your doctor should perform regular check-ups during treatment, especially if treatment is prolonged;
• you have diabetes (diabetes mellitus), high blood lipid levels (hyperlipidemia), or if you smoke;
• you have kidney problems, or if you are taking diuretic medicines that increase urine elimination (see sections “Do not take Ketoprofene EG” and “Other medicines and Ketoprofene EG”). Your doctor should monitor your kidney function during treatment with this medicine.

Infections
Ketoprofene EG may mask symptoms of infections such as fever and pain. Therefore, Ketoprofene EG could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or worsen, contact your doctor immediately.

This medicine may cause:

• serious heart and circulatory problems (arterial thrombotic events, heart attack, or stroke), especially at high doses and during prolonged treatment;
• serious stomach and intestinal problems (bleeding, ulcers, perforations), especially at high doses. Your doctor may prescribe medicines to protect against ulcers (misoprostol or proton pump inhibitors);
• serious skin and mucous membrane disorders, even fatal ones, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may present with skin and mucous membrane lesions. These may occur especially during the first month of treatment;
• vision problems such as blurred vision (see section “Possible side effects”). If you experience any of these effects, stop treatment and contact your doctor immediately. You can reduce the risk of side effects by taking Ketoprofene EG at the lowest effective dose and for the shortest possible duration (see section “How to take Ketoprofene EG”).

Children
This medicine is contraindicated in children.
Elderly
If you are elderly, take this medicine with caution, as you are more prone to gastrointestinal bleeding and perforation, which may be fatal, and to other side effects such as reduced kidney, heart, and liver function (see section “Possible side effects”). Your doctor will determine the appropriate dose and whether you need to take medicines to protect against ulcers (misoprostol or proton pump inhibitors). Your doctor should monitor you during treatment with ketoprofen.
Other medicines and Ketoprofene EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking the following medicines together with Ketoprofene EG:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
• medicines that make the blood thinner (anticoagulants, e.g. heparin, warfarin, antiplatelet agents such as ticlopidine and clopidogrel, or other salicylates) (see sections “Do not take Ketoprofene EG” and “Warnings and precautions”);
• lithium, used to treat depression or similar disorders;
• methotrexate (a medicine used to treat rheumatoid arthritis and cancer) at high doses (15 mg per week).

Take Ketoprofene EG with caution if you are taking any of the following medicines:

• medicines that increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim;
• diuretic medicines used to increase urine elimination (see sections “Do not take Ketoprofene EG” and “Warnings and precautions”);
• medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are dehydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for circulatory problems;
• tenofovir, a medicine used to treat certain viral infections.

Your doctor should monitor you and may reduce the dose of ketoprofen if you are taking any of the following medicines:

• medicines used to treat high blood pressure such as beta-blockers, angiotensin-converting enzyme inhibitors;
• thrombolytics and antiplatelet agents, used for blood clotting disorders;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in gynecological procedures;
• intrauterine contraceptive devices (IUDs), as their effectiveness may be reduced, potentially leading to pregnancy.

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 KETOPROFENE EG 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 beyond normal duration.
You should not take KETOPROFENE EG 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, KETOPROFENE EG may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the amount of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing 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 Ketoprofene EG while breastfeeding.
Fertility
Ketoprofene EG may cause fertility problems in women. You should inform your doctor if you are planning a pregnancy, as this medicine may reduce fertility, and if you are undergoing fertility tests, as results may be affected.
Driving and using machines
Ketoprofene EG may cause dizziness, drowsiness, or seizures. If this happens, avoid driving or operating machinery.
Ketoprofene EG contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Ketoprofene EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 150–200 mg (3–4 capsules) per day, divided with meals. Take the capsule with
a glass of water. Your doctor will determine the appropriate dose depending on the severity of your symptoms.
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).
Undesirable effects can be minimized by using the shortest possible duration of treatment needed to control symptoms (see "Warnings and precautions").
Use in elderly patients and patients with kidney problems
If you are elderly or have kidney problems, your doctor will determine the appropriate dose.
Use in patients with liver problems
In this case, your doctor will determine the appropriate dose.
Use in children
Safety and efficacy have not been studied in children.
If you take more Ketoprofene EG than you should
Symptoms of overdose with doses up to 2.5 g of ketoprofen include: lethargy, drowsiness,
stomach pain, nausea and vomiting. If this occurs, contact your doctor, who will initiate appropriate treatment for the symptoms.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
If you forget to take Ketoprofene EG
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 will experience them.
The side effects that may occur with Ketoprofen EG are:
Common (may affect up to 1 in 10 people)
Nausea, digestive problems (dyspepsia), abdominal pain, vomiting.
Uncommon (may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, constipation, diarrhoea, flatulence, inflammation of the stomach (gastritis), skin irritation (rash) and itching, swelling due to fluid retention (oedema), fatigue.
Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cells due to bleeding (haemorrhagic anaemia), altered sensation in limbs (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (stomatitis), ulcer (peptic ulcer), liver problems (hepatitis, increased blood test values such as transaminases and bilirubin due to liver disorders), weight gain.
Frequency not known (frequency cannot be estimated from the available data)
Blood disorders (thrombocytopenia, agranulocytosis, bone marrow failure), decreased number of white blood cells (leucopenia), decreased red blood cells (haemolytic anaemia), depression, hallucinations, confusion, mood alterations, seizures, taste disturbances (dysgeusia), inflammation of the membranes covering the brain not caused by bacteria (aseptic meningitis), heart problems (heart failure), changes in heart rhythm (atrial fibrillation), increased blood pressure, dilation of blood vessels, generalized redness due to blood vessel disorders (vasculitis, including leukocytoclastic vasculitis), bronchial constriction (bronchospasm), cold-like symptoms (rhinitis), stomach and intestinal problems (colitis and Crohn's disease, gastrointestinal bleeding and perforation), blood in stools and vomit, inflammation of the pancreas (pancreatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), skin diseases, even very severe ones (urticaria, bullous eruptions, Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis), widespread red and infected lesions (generalized exanthematous pustulosis), swelling of the skin, mucous membranes and submucosal tissues (angioedema), kidney problems (acute renal failure, tubulo-interstitial nephritis, nephrotic syndrome, abnormalities in kidney function tests), allergic reactions (anaphylactic), even severe ones, with shock, decreased sodium levels in the blood (hyponatraemia), increased potassium levels in the blood (hyperkalaemia).
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 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 Ketoprofen EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
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 Ketoprofene EG contains
The active substance is ketoprofen. Each capsule contains 50 mg of ketoprofen.
The other components are: magnesium stearate, lactose, gelatin, titanium dioxide.
Description of the appearance of Ketoprofene EG and contents of the pack
Box containing 30 capsules in blisters.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – Quinto Dè Stampi – Rozzano (MI) – Italy.

Package leaflet: information for the patient

KETOPROFENE EG 200 mg prolonged-release hard capsules

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ketoprofene EG is and what it is used for

Ketoprofene EG contains the active substance ketoprofene, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs ("NSAIDs"), used to treat pain and inflammation.
Ketoprofene EG is indicated for the treatment of painful symptoms due to inflammation of bones, muscles and
joints, such as: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular manifestations (bursitis, capsulitis, synovitis, tendinitis); cervical spondylitis, low back pain (muscle strains, lumbago, sciatica, fibrositis), musculoskeletal pain syndromes and dysmenorrhoea.

2. What you should know before taking Ketoprofene EG

Do not take Ketoprofene EG

• if you are allergic to ketoprofen, to similar medicines (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced an allergic reaction (e.g. bronchospasm, asthma, rhinitis, urticaria) after taking other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid;
• if you are pregnant (especially during the third trimester) or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if you have severe kidney problems (severe renal failure), liver problems (severe hepatic insufficiency, liver cirrhosis, severe hepatitis), or heart problems (severe heart failure);
• if you suffer or have suffered from stomach or intestinal ulcers (active peptic ulcer), gastrointestinal bleeding, or perforation of the stomach or intestine;
• if you are intensively taking medicines that promote urine elimination (diuretics) (see sections “Warnings and precautions” and “Other medicines and Ketoprofene EG”);
• if you suffer from blood disorders such as leukopenia or thrombocytopenia, if you have bleeding (blood loss), or if you are prone to bleeding. Ketoprofene EG must not be given to children.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketoprofene EG.
Contact your pharmacist or nurse if:

• you suffer from asthma associated with chronic rhinitis, sinusitis, and/or nasal polyps, or if you are prone to bronchospasm or other allergic reactions;
• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and Ketoprofene EG”);
• you have untreated high blood pressure or heart problems (e.g. congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease);
• you have a heart rhythm disorder (atrial fibrillation);
• you have high potassium levels, especially if you have diabetes, kidney problems, or are being treated with other medicines that increase potassium levels. In this case, your doctor should monitor these values;
• you have had stomach or intestinal problems (bleeding, perforations, ulcers, Crohn’s disease, ulcerative colitis), or if you are taking medicines that may increase the risk of damage to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin) (see sections “Do not take Ketoprofene EG” and “Other medicines and Ketoprofene EG”);
• you have an infection – see section “Infections” below;
• you have liver problems or have previously had liver problems, because Ketoprofene EG may worsen your condition. In such cases, your doctor should perform frequent check-ups during treatment, especially if treatment is prolonged;
• you have diabetes (diabetes mellitus), high blood lipid levels (hyperlipidemia), or if you smoke;
• you have kidney problems, or if you are taking diuretic medicines that increase urine elimination (see sections “Do not take Ketoprofene EG” and “Other medicines and Ketoprofene EG”). Your doctor should monitor your kidney function during treatment with this medicine.

Infections
Ketoprofene EG may mask symptoms of infections such as fever and pain. Therefore, Ketoprofene EG could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or worsen, contact your doctor immediately.

This medicine may cause:

• serious heart and circulatory problems (arterial thrombotic events, heart attack, or stroke), especially at high doses and during prolonged treatment;
• serious stomach and intestinal problems (bleeding, ulcers, perforations), especially at high doses. Your doctor may prescribe medicines to protect against ulcers (misoprostol or proton pump inhibitors);
• serious skin and mucous membrane disorders, even fatal ones, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may present as skin and mucous membrane lesions. These reactions are most likely to occur during the first month of treatment;
• vision problems such as blurred vision (see section “Possible side effects”).

If you experience any of these effects, stop treatment immediately and contact your doctor. You can reduce the risk of side effects by taking Ketoprofene EG at the lowest effective dose and for the shortest possible duration (see section “How to take Ketoprofene EG”).

Children
This medicine is contraindicated in children.

Elderly
If you are elderly, take this medicine with caution, as you are more prone to gastrointestinal bleeding and perforation, which can be fatal, and to other side effects such as reduced function of the kidneys, heart, and liver (see section “Possible side effects”). Your doctor will determine the appropriate dose and whether you need to take medicines to protect against ulcers (misoprostol or proton pump inhibitors). Your doctor should monitor you during treatment with ketoprofen.

Other medicines and Ketoprofene EG
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 Ketoprofene EG:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
• medicines that thin the blood (anticoagulants, e.g. heparin, warfarin, antiplatelet agents such as ticlopidine and clopidogrel, or other salicylates) (see sections “Do not take Ketoprofene EG” and “Warnings and precautions”);
• lithium, used to treat depression or similar disorders;
• methotrexate (a medicine used to treat rheumatoid arthritis and cancer) at high doses (15 mg per week).

Take Ketoprofene EG with caution if you are taking any of the following medicines:

• medicines that increase potassium levels in the blood, such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim;
• diuretic medicines used to promote urine elimination (see sections “Do not take Ketoprofene EG” and “Warnings and precautions”);
• medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists), especially if you are elderly and drink little water (are dehydrated);
• low-dose methotrexate (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for circulatory problems;
• tenofovir, a medicine used to treat certain viral infections.

Your doctor should monitor you and may need to reduce the dose of ketoprofen if you are taking any of the following medicines:

• medicines used to treat high blood pressure such as beta-blockers, angiotensin-converting enzyme inhibitors;
• thrombolytics and antiplatelet agents, used for blood clotting disorders;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in gynecological procedures;
• intrauterine contraceptive devices (IUDs); the effectiveness of the device may be reduced, leading to pregnancy.

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 KETOPROFENE EG during the last 3 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 beyond the expected duration.
You should not take KETOPROFENE EG 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 time should be used. From week 20 of pregnancy, KETOPROFENE EG may cause kidney problems in the fetus if taken for more than a few days, leading to reduced amniotic fluid levels (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Do not take Ketoprofene EG if you are breastfeeding.

Fertility
Ketoprofene EG may cause fertility problems in women. You should inform your doctor if you are planning to become pregnant, as this medicine may reduce fertility, and if you are undergoing fertility tests, as results may be altered.

Driving and using machines
Ketoprofene EG may cause dizziness, drowsiness, or seizures. If this occurs, avoid driving or operating machinery.

Ketoprofene EG contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Ketoprofene EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 200 mg once daily, taken orally after a meal.
Your doctor will determine the appropriate dose according to your body weight and the severity of your symptoms.
The maximum dose is 200 mg per day, and higher doses are not recommended.
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 (for example, fever and pain) persist or worsen (see section 2).
Undesirable effects can be minimized by using the shortest treatment duration possible needed to control symptoms (see "Warnings and precautions").
Use in elderly patients and patients with kidney problems
If you are elderly or have kidney problems, your doctor will determine the appropriate dose.
Use in patients with liver problems
In this case, your doctor will determine the appropriate dose.
Use in children
Safety and efficacy have not been established in children.
If you take more Ketoprofene EG than you should
Symptoms of an overdose with doses up to 2.5 g of ketoprofene include: lethargy, drowsiness,
stomach pain, nausea and vomiting. If this occurs, contact your doctor, who will determine appropriate
treatment for the symptoms.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
If you forget to take Ketoprofene EG
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects that may occur with Ketoprofen EG are:
Common (may affect up to 1 in 10 people)
Nausea, digestive problems (dyspepsia), abdominal pain, vomiting.
Uncommon (may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, constipation, diarrhoea, flatulence, inflammation of the stomach (gastritis), skin irritation (rash) and itching, swelling due to fluid retention (oedema), fatigue.
Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cells due to bleeding (haemorrhagic anaemia), altered sensation in limbs (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (stomatitis), ulcer (peptic ulcer), liver problems (hepatitis, increased blood test values such as transaminases, bilirubin due to liver disorders), weight gain.
Frequency not known (frequency cannot be estimated from the available data)
Blood disorders (thrombocytopenia, agranulocytosis, bone marrow failure), decreased number of white blood cells (leucopenia), decreased number of red blood cells (haemolytic anaemia), depression, hallucinations, confusion, mood changes, convulsions, taste disturbances (dysgeusia), inflammation of the membranes covering the brain not caused by bacteria (aseptic meningitis), heart problems (heart failure), irregular heartbeat (atrial fibrillation), increased blood pressure, dilation of blood vessels, generalized redness due to blood vessel disorders (vasculitis, including leukocytoclastic vasculitis), narrowing of the airways (bronchospasm), runny nose (rhinitis), stomach and intestinal problems (colitis and Crohn's disease, gastrointestinal bleeding and perforation), blood in faeces and vomit, inflammation of the pancreas (pancreatitis), increased sensitivity to light (photosensitivity), hair loss (alopecia), skin disorders including very severe ones (urticaria, bullous eruptions, Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis), widespread red and infected lesions (generalized exanthematous pustulosis), swelling of the skin, mucous membranes and submucosal tissues (angioedema), kidney problems (acute renal failure, tubulo-interstitial nephritis, nephrotic syndrome, abnormalities in kidney function tests), allergic (anaphylactic) reactions, even severe, with shock, decreased sodium levels in the blood (hyponatraemia), increased potassium levels in the blood (hyperkalaemia).
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 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 Ketoprofene EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store below 25°C and keep in the original packaging to protect the medicine from moisture.
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 Ketoprofene EG contains
The active substance is ketoprofen.
Each capsule contains 200 mg of ketoprofen.
The other components are:

• Internal components: sucrose and starch microgranules, povidone K30, ammonium methacrylate copolymer (Eudragit RS 100), talc.
• Capsule components: gelatin, titanium dioxide (E171).

Description of the appearance of Ketoprofene EG and package contents
Box containing 28 capsules in blister packs.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – Quinto De' Stampi – Rozzano (MI) – Italy.