Ketoprofen Eg Stada

Italy
Brand name Ketoprofen Eg Stada
Form solution for injection
Active substance / Dosage
KETOPROFEN
Prescription type Prescription only
ATC code
M01AE03
Registration number 036468
Manufacturer EG S.P.A.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

KETOPROFENE EG STADA 5% gel

Generic medicinal product

Prohibition symbol with red circle and diagonal bar overlapping a yellow sun with stylized rays on a white background

Please read this leaflet carefully before using 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 they have the same symptoms as you, 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:

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

1. What KETOPROFENE EG STADA is and what it is used for

KETOPROFENE EG STADA 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 STADA is indicated for the local treatment of pain due to rheumatic conditions or trauma affecting joints, muscles, tendons, and ligaments (e.g. sports injuries).

2. What you need to know before using KETOPROFENE EG STADA

Do not use KETOPROFENE EG STADA

  • 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, such as bronchospasm, asthma, rhinitis, or a skin reaction after taking other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid or tiaprofenic acid, or to other medicines such as fenofibrate, used to lower cholesterol levels;
  • if you have had a skin allergic reaction caused by sunscreens (UV filters) or perfumes;
  • on areas of skin affected by eczema, acne, infections or open wounds;
  • if you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”);
  • if you have previously suffered from skin disorders caused by exposure to light (photosensitivity).

During treatment with KETOPROFENE EG STADA and for two weeks after stopping it, do not expose treated areas to sunlight (even when the sky is overcast) or to UV lamps in sunbeds (see sections “Warnings and precautions” and “Possible side effects”).

Warnings and precautions
Talk to your doctor or pharmacist before using KETOPROFENE EG STADA.
Stop using KETOPROFENE EG STADA immediately if skin reactions occur, including those that develop following concomitant use of products containing octocrylene (octocrylene is an excipient found in various cosmetic and personal hygiene products such as shampoos, aftershaves, shower gels and bath products, skin creams, lipsticks, anti-aging creams, makeup removers, hair sprays, used to prevent their photodegradation).

  • Use this medicine with caution if you have heart, liver or kidney problems.
  • Do not apply the gel to the eyes or mucous membranes (e.g. mouth and oral cavity, nostrils).
  • Avoid using occlusive dressings (non-breathable bandages).
  • Exposure to sunlight (even when the sky is overcast) or to UVA lamps on areas treated with KETOPROFENE EG STADA may cause potentially severe skin reactions (photosensitivity) (see section “Do not use KETOPROFENE EG STADA”). Therefore, it is necessary to:
  • Wash your hands thoroughly after each application of KETOPROFENE EG STADA.
  • Protect treated areas from sunlight by wearing clothing throughout the duration of treatment and for two weeks after stopping it, in order to avoid any risk of photosensitivity.
  • Do not use this medicine for periods longer than the maximum recommended duration, to reduce the risk of skin irritation (contact dermatitis and increased photosensitivity reactions) (see section “Possible side effects”).
  • If you suffer from respiratory disorders such as asthma associated with chronic rhinitis, chronic sinusitis (a disease of the nasal mucosa that usually causes headache) and/or nasal polyps, you have an increased risk of allergy to aspirin and/or non-steroidal anti-inflammatory drugs.
  • Stop treatment immediately and contact your doctor if you experience any skin reaction after applying KETOPROFENE EG STADA (see section “Possible side effects”).

Children
This medicine is not recommended for use in children.

Other medicines and KETOPROFENE EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known; however, inform your doctor if you are taking, in particular, coumarin derivatives, used for blood clotting disorders.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use KETOPROFENE EG STADA during the last 3 months of pregnancy. You should not use KETOPROFENE EG STADA during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral formulations (e.g. tablets) of ketoprofen may cause adverse effects on the fetus. It is not known whether ketoprofen poses the same risk when applied to the skin.

Breastfeeding
The use of KETOPROFENE EG STADA during breastfeeding is not recommended.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

KETOPROFENE EG STADA contains parahydroxybenzoates
May cause allergic reactions (including delayed reactions).

KETOPROFENE EG STADA contains alcohol
This medicine contains 0.31 mg of alcohol (ethanol) in each gram of gel. It may cause a burning sensation on damaged skin.

3. How to use KETOPROFENE EG STADA

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the gel to the painful or inflamed area of skin 2 or 3 times a day.
The amount of gel should be sufficient to cover the affected area with a thin layer (3–5 cm).
Gently massage for a few minutes to promote absorption. Do not apply the gel for more than 1 week.
Wash your hands thoroughly and for a prolonged period after application.
Do not exceed the recommended doses.

If you use more KETOPROFENE EG STADA than you should
Overdose is unlikely when using the medicine on the skin. However, if you accidentally ingest the medicine, you may experience adverse effects, the severity of which depends on the amount ingested. In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to use KETOPROFENE EG STADA
Do not use 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 everyone gets them.
Stop using KETOPROFENE EG STADA and contact your doctor immediately if:

  • you experience symptoms of angioedema (frequency not known), such as: swollen face, tongue or throat; difficulty swallowing or breathing; or hives.
  • you experience symptoms of serious skin problems (frequency not known), such as: blisters, peeling or bleeding on any part of the skin with or without a rash (including lips, eyes, mouth, nose, genitals, hands or feet); you may also simultaneously have flu-like symptoms, such as fever, chills or muscle pain.

Other side effects that may occur with KETOPROFENE EG STADA are:
Uncommon (may affect up to 1 in 100 people)
Skin allergic reactions (erythema, eczema, dermatitis, itching and burning sensation).
Rare (may affect up to 1 in 1,000 people)
Skin reactions (dermatological reactions), severe skin reactions following exposure to sunlight (photosensitization), and skin irritation with itching (urticaria); more serious adverse reactions, such as blistering or vesicular eczema (bullous or vesicular eczema), which may extend beyond the application site to the entire body.
Very rare (may affect up to 1 in 10,000 people)
Worsening of pre-existing kidney problems.
Isolated cases of systemic adverse reactions, such as kidney disorders, have also been reported.
Frequency not known (cannot be estimated from the available data)
Allergic reactions (anaphylactic shock, hypersensitivity reaction). Skin irritation with blisters (bullous dermatitis).

As with other topical medicines, skin-related side effects may occur, which can be severe and widespread.
You can reduce the likelihood and severity of such effects by avoiding exposure to sunlight and sunbeds during treatment and for two weeks afterwards.

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOPROFENE EG STADA

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What KETOPROFENE EG STADA contains
The active substance is ketoprofen.
5 g of ketoprofen are contained in 100 g of gel.
The other components are: carbopol, ethyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, neroli essence, lavender essence, diethanolamine, purified water.

Description of the appearance of KETOPROFENE EG STADA and contents of the pack
Carton pack containing one tube of 50 g of gel.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan (Italy)

Manufacturer
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A., Via di Fossignano 2 - 04011 Aprilia (LT) (Italy)
Vamfarma S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO) (Italy)

Patient Information Leaflet: Information for the User

KETOPROFENE EG STADA 100 mg/2.5 ml injectable solution for intramuscular use

Generic medicine
Please read this leaflet carefully before using 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, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KETOPROFENE EG STADA is and what it is used for

KETOPROFENE EG STADA 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 STADA is indicated for the treatment of acute painful episodes caused by
inflammation of bones, muscles and joints.

2. What you should know before using KETOPROFENE EG STADA

Do not use KETOPROFENE EG STADA

  • 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, as severe allergic (anaphylactic) reactions, rarely fatal, may occur;
  • if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
  • if the person using the medicine is a child;
  • if you are taking diuretics (medicines that promote urine elimination) intensively (see section “Other medicines and KETOPROFENE EG STADA”);
  • if you suffer or have suffered from stomach or intestinal ulcer (active peptic ulcer), bleeding or perforation of the stomach or intestine due to previous treatments with other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and KETOPROFENE EG STADA”);
  • if you have severe kidney problems (severe renal insufficiency), liver problems (severe hepatic insufficiency, cirrhosis, severe hepatitis) or heart problems (severe heart failure);
  • if you suffer from blood disorders such as leukopenia and thrombocytopenia, if you have bleeding (blood loss) or are predisposed to blood loss (hemorrhagic diathesis);
  • if you have bleeding disorders (hemostatic disorders);
  • if you are taking anticoagulant medicines (blood thinners) (see section “Other medicines and KETOPROFENE EG STADA”);
  • if you have bleeding affecting blood vessels in the brain.

Warnings and precautions
Talk to your doctor or pharmacist before using KETOPROFENE EG STADA.
Talk to your pharmacist or nurse if:

  • you suffer or have suffered from allergies, or if you have asthma associated with chronic rhinitis, chronic sinusitis and nasal polyps;
  • you suffer from heart failure, cirrhosis, nephrosis, chronic renal insufficiency or are taking diuretic medicines (medicines that increase urine elimination), particularly if you are elderly; your doctor will monitor you, as ketoprofen administration may worsen kidney function;
  • you suffer from high blood pressure and/or heart problems such as mild or moderate congestive heart failure, as fluid retention and swelling due to fluid accumulation (edema) may occur;
  • you have a heart rhythm disorder (atrial fibrillation);
  • you suffer from uncontrolled high blood pressure, heart or circulation problems (congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease), diabetes, high blood lipid levels (hyperlipidemia) or if you smoke. In these cases, your doctor will determine whether you can use this medicine;
  • you have suffered from stomach or intestinal problems (ulcers, Crohn’s disease, ulcerative colitis) or if you are taking medicines that may increase the risk of injury to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin or nicorandil) (see section “Other medicines and KETOPROFENE EG STADA”);
  • you have high potassium levels (hyperkalemia) due to diabetes or medicines known as potassium-sparing agents;
  • you have an infection – see section «Infections» below;
  • you suffer from liver problems or have previously suffered from liver problems, because KETOPROFENE EG STADA may worsen your condition. In such cases, your doctor should monitor you frequently during treatment, especially for prolonged treatment periods;
  • you suffer from ulcers, particularly if complicated by bleeding or perforation; the risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses: start treatment with the lowest available dose; your doctor may prescribe medicines to protect the stomach, such as misoprostol or proton pump inhibitors;
  • you are a woman with fertility problems. Since KETOPROFENE EG STADA may interfere with your fertility, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations.

This medicine may cause:

  • stomach and intestinal problems, which may even be fatal (bleeding, ulcers, perforations), particularly at high doses and if your body weight is low;
  • severe, although very rare, skin and mucous membrane irritations, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which may present as skin and mucous membrane lesions. This may occur especially during the first month of treatment;
  • serious heart and circulatory problems (arterial thrombotic events, heart attack or stroke), particularly at high doses, for prolonged treatment periods, or when used to treat pain before or after coronary artery bypass surgery (see section “Possible side effects”);
  • liver or kidney problems (see section “Possible side effects”);
  • visual disturbances (blurred vision). During treatment, especially long-term, your doctor should monitor you closely.

If you experience any of these effects, stop treatment immediately and consult your doctor without delay.
You can reduce the risk of side effects by taking KETOPROFENE EG STADA at the lowest effective dose and for the shortest duration possible.
Avoid taking other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, during treatment with KETOPROFENE EG STADA.
Infections
KETOPROFENE EG STADA may mask symptoms of infections such as fever and pain. Therefore, KETOPROFENE EG STADA may 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 varicella. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Use this medicine only under strict medical supervision because it is not a simple painkiller.
Use KETOPROFENE EG STADA only for the treatment of acute pain; when pain subsides, switch to other ketoprofen-based medicines administered by non-parenteral routes (intramuscular or intravenous injection). This medicine may be administered for prolonged periods by intramuscular injection only in hospitals and care facilities. Intramuscular solutions must be injected only into the muscle and not directly into the vein.
Injections must be performed in strict adherence to hygiene standards.
Children
This medicine is contraindicated in children.
Elderly
If you are elderly, use this medicine with caution, as you are more prone to gastrointestinal bleeding and perforation, which may even be fatal, and to other side effects such as reduced kidney, heart and liver function (see section “Possible side effects”). Your doctor will advise you on the appropriate dose and whether you need to take ulcer-protective medicines (misoprostol or proton pump inhibitors). Your doctor should monitor you during treatment with ketoprofen.
Other medicines and KETOPROFENE EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid using the following medicines together with KETOPROFENE EG STADA:

  • lithium, used to treat depression or similar disorders;
  • other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
  • methotrexate (a medicine used to treat rheumatoid arthritis and cancer) at high doses (over 15 mg per week);
  • anticoagulant medicines (blood thinners, e.g. heparin, warfarin, dabigatran, apixaban, rivaroxaban, edoxaban) and antiplatelet agents such as ticlopidine and clopidogrel, or other salicylates (see section “Warnings and precautions”).
    Use KETOPROFENE EG STADA 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, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim;
  • diuretic medicines used to promote urine elimination, especially if you are an elderly patient who is particularly dehydrated (see section “Do not use KETOPROFENE EG STADA” 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 poorly hydrated);
  • corticosteroids, medicines used for inflammation;
  • methotrexate at low doses (less than 15 mg per week);
  • pentoxifylline, a medicine used for blood circulation problems;
  • tenofovir, a medicine used to treat certain viral infections;
  • nicorandil, a medicine used to prevent or relieve chest pain due to heart problems;
  • cardiac glycosides, medicines used to treat heart failure (inability of the heart to adequately supply blood to the body).

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, diuretics;
  • thrombolytics and antiplatelet agents such as tirofiban, eptifibatide, abciximab and iloprost, used for blood coagulation disorders;
  • selective serotonin reuptake inhibitors (SSRIs);
  • probenecid, a medicine used for gout;
  • gemeprost, a medicine used in gynecological procedures;
  • mifepristone, a medicine used for termination of pregnancy;
  • intrauterine contraceptive devices (IUDs); the effectiveness of the device may be reduced, leading to pregnancy;
  • cyclosporine and tacrolimus (medicines used after organ transplantation or to treat immune system disorders);
  • certain antibiotics (quinolone antibiotics).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take KETOPROFENE EG STADA 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 delay or prolong labour beyond the expected duration.
You should not take KETOPROFENE EG STADA 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 STADA may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing 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.
Breastfeeding
The use of KETOPROFENE EG STADA during breastfeeding is not recommended.
Fertility
KETOPROFENE EG STADA may cause fertility problems in women. You should inform your doctor if you plan 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 STADA may cause dizziness, vertigo, blurred vision, somnolence, seizures or visual disturbances. If you experience any of these, avoid driving or operating machinery.
KETOPROFENE EG STADA contains benzyl alcohol
This medicine contains 75 mg of benzyl alcohol per vial. 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 unwanted effects (such as metabolic acidosis).
KETOPROFENE EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How to use KETOPROFENE EG STADA

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 50–100 mg once or twice daily. The maximum dose is 200 mg of ketoprofen per day; doses higher than this are not recommended.
However, your doctor will assess the risk/benefit ratio before starting 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).
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
This medicine may be administered for prolonged periods by intramuscular use only in hospitals and nursing homes. Intramuscular solutions must be injected into muscle only and not directly into a vein. The solution must be used immediately and the injection must be performed according to strict sterilization, aseptic, and antiseptic procedures.

Use in elderly patients and patients with kidney problems
If you are elderly or have kidney problems, your doctor will determine the appropriate dose, possibly reducing the recommended dosage.

Use in patients with liver problems
If you have liver problems, your doctor must monitor you during treatment and should use the lowest effective daily dose (see section "Do not use KETOPROFENE EG STADA" and "Warnings and precautions").

Use in children
Safety and efficacy have not been studied in children.

If you take more KETOPROFENE EG STADA than you should
If you (or someone else) have taken an excessive dose of this medicine, contact a doctor immediately or go to the nearest hospital emergency department.
Symptoms of overdose include: headache, dizziness, drowsiness, abdominal pain, nausea, vomiting, and diarrhoea. Low blood pressure, breathing problems (respiratory depression), and gastrointestinal bleeding may also occur. If this happens, consult a doctor who will determine appropriate treatment for these conditions.

If you forget to use KETOPROFENE EG STADA
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 everyone experiences them.
The side effects that may occur with KETOPROFENE EG STADA are:
Common (may affect up to 1 in 10 people)
Nausea, vomiting, digestive problems (dyspepsia), abdominal pain and stomach pain.
Uncommon (may affect up to 1 in 100 people)
Headache (cephalalgia), dizziness, vertigo, somnolence, constipation, diarrhoea, flatulence, inflammation of the stomach (gastritis), skin irritation (rash) and pruritus, swelling due to fluid retention (oedema).
Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cells due to bleeding (haemorrhagic anaemia) and reduction in white blood cells (leucopenia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (stomatitis), stomach or intestinal ulcer (peptic ulcer), colitis, liver problems (hepatitis, jaundice, increased levels in certain blood tests such as transaminases and bilirubin due to liver disorders), disturbances in sensation in the legs, arms or other parts of the body (paraesthesiae), weight gain.
Frequency not known (frequency cannot be estimated from the available data)
Blood disorders (thrombocytopenia, agranulocytosis, bone marrow failure), reduction in red blood cells (haemolytic anaemia), seizures, depression, hallucinations, confusion, mood changes, inflammation of the membranes covering the brain not caused by bacteria (aseptic meningitis), taste disturbances (dysgeusia), heart problems (heart failure), changes in heart rhythm (palpitations, tachycardia, atrial fibrillation), increased blood pressure, blood vessel dilation, generalized redness due to blood vessel disorders (vasculitis, including leukocytoclastic vasculitis), bronchial constriction (bronchospasm), breathing difficulties (dyspnoea), cold-like symptoms (rhinitis), stomach and intestinal problems (worsening of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation), inflammation of the pancreas (pancreatitis), dark stools, blood in stools and vomit, increased sensitivity to light (photosensitivity), hair loss (alopecia), skin disorders, even very severe ones (skin rash, urticaria, erythema, bullous eruptions, Stevens-Johnson syndrome and toxic epidermal necrolysis), widespread red, infected lesions (generalized exanthematous pustulosis), worsening of chronic urticaria, swelling of the skin, mucous membranes and submucosal tissues (e.g. face, lips, mouth, tongue or throat) which may cause breathing or swallowing difficulties (angioedema), kidney problems (acute renal failure, tubulo-interstitial nephritis, nephrotic syndrome, acute tubular necrosis and renal papillary necrosis, abnormalities in kidney function tests), allergic (anaphylactic) reactions, even severe ones with shock, water and sodium retention possibly leading to oedema, decreased sodium levels in the blood (hyponatraemia), increased potassium levels in the blood (hyperkalaemia), injection site reactions such as pain, burning, redness and spots (including Nicolau syndrome).

Immediately inform your doctor if you notice any gastrointestinal side effects (gastrointestinal bleeding), especially if you are elderly or have previously suffered gastrointestinal disorders related to non-steroidal anti-inflammatory drugs (NSAIDs).
Immediately stop taking ketoprofen and contact your doctor if you develop a skin rash, any lesions inside the mouth or on the genitals, or any signs of an allergic reaction.

The use of non-steroidal anti-inflammatory drugs (NSAIDs) at high doses and for prolonged periods may be associated with a slight increase in the 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, consult your doctor or pharmacist. You may 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 KETOPROFENE EG STADA

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 25°C.
Keep in the original container to protect the medicine from light.
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 KETOPROFENE EG STADA contains
The active substance is ketoprofen.
Each vial contains 100 mg of ketoprofen.
The other ingredients are: sodium hydrate, citric acid, glycine, benzyl alcohol, water for injectable preparations.
Description of the appearance of KETOPROFENE EG STADC and packaging contents
Carton pack containing 6 glass vials.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan (Italy)
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello, 15 – 00071 Pomezia (RM)