ORUDIS 50 mg Hard Capsules

Зміст інструкції

1. ORUDIS 50 mg hard capsules
   1. What ORUDIS is and what it is used for
   2. What you need to know before taking ORUDIS
   3. How to take ORUDIS
   4. Possible side effects
   5. How to store ORUDIS
   6. Contents of the pack and other information
2. ORUDIS 200 mg prolonged-release hard capsules
   1. What ORUDIS is and what it is used for
   2. What you need to know before taking ORUDIS
   3. How to take ORUDIS
   4. Possible side effects
   5. How to store ORUDIS
   6. Contents of the pack and other information
3. ORUDIS 100 mg / 2 ml injectable solution for intramuscular use
   1. What is ORUDIS and what is it used for?
   2. What you need to know before using ORUDIS
   3. How to use ORUDIS
   4. Possible side effects
   5. How to store ORUDIS
   6. Contents of the pack and other information
4. ORUDIS 100 mg suppositories
   1. What ORUDIS is and what it is used for
   2. Cosa deve sapere prima di usare ORUDIS
   3. How to use ORUDIS
   4. Possible side effects
   5. How to store ORUDIS
   6. Contents of the pack and other information
5. ORUDIS 5% gel
   1. What is ORUDIS and what is it used for
   2. What you need to know before using ORUDIS
   3. How to use ORUDIS
   4. Possible side effects
   5. How to store ORUDIS
   6. Contents of the pack and other information

ORUDIS 50 mg hard capsules

Ketoprofen

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ORUDIS is and what it is used for

ORUDIS contains the active ingredient ketoprofen which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
ORUDIS is indicated for the treatment of painful symptoms due to inflammation of bones, muscles and
joints such as: rheumatoid arthritis, ankylosing spondylitis, acute gout; osteoarthritis with variable
location; sciatica, radiculitis, myalgia; bursitis, tendinitis, tenosynovitis, synovitis, capsulitis; contusions,
sprains, dislocations, muscle tears; phlebitis, superficial thrombophlebitis, lymphangitis.
This medicine is also indicated for the treatment of painful symptoms due to inflammation of the
mouth, teeth, ears, throat, urinary tract and respiratory tract.

2. What you need to know before taking ORUDIS

Do not take ORUDIS

• 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 had an allergic reaction (e.g. narrowing of the airways, asthma, hay fever, hives) after taking other non-steroidal anti-inflammatory medicines such as acetylsalicylic acid;
• if you have severe kidney problems (severe renal failure), liver problems (severe hepatic failure, cirrhosis of the liver, severe hepatitis) and heart problems (severe heart failure);
• if you suffer from or have suffered from ulcers in the stomach or intestines (active peptic ulcer), bleeding or perforation of the stomach and intestines;
• if you are taking large doses of medicines that promote urine excretion (diuretics) (see the sections “Warnings and precautions” and “Other medicines and ORUDIS”);
• if you suffer from blood problems such as leucopenia and thrombocytopenia, if you have bleeding (loss of blood), if you are predisposed to bleeding (haemorrhagic diathesis) or if you have bleeding disorders (haemostatic disorders);
• if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if the person who needs to take the medicine is a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORUDIS.

Pay particular attention with ORUDIS:

• if you suffer from asthma associated with chronic hay fever, sinusitis and/or nasal polyps or if you are predisposed to problems with narrowing of the airways or other allergic reactions;
• if you are taking other anti-inflammatory non-steroidal medicines (NSAIDs) (see section “Other medicines and ORUDIS”);
• if you suffer from high blood pressure that is not adequately treated, or heart problems (e.g. congestive heart failure, confirmed ischemic heart disease, peripheral arteriopathy and/or cerebrovascular disease);
• if you have an irregular heartbeat (atrial fibrillation);
• if you have high potassium levels, especially if you suffer from diabetes, kidney problems or are being treated with other medicines that cause increased potassium levels. In this case, your doctor will need to monitor these values;
• if you have suffered from problems with your stomach and intestines (bleeding, perforations, ulcers, Crohn's disease, ulcerative colitis) or if you are taking medicines that can increase the risk of injury to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as aspirin or nicorandil) (see sections “Do not take ORUDIS” and “Other medicines and ORUDIS”);
• if you have an infection - see paragraph “Infections” below;
• if you suffer from liver problems or have suffered from liver problems, because ORUDIS may worsen your condition. In these cases, your doctor will need to subject you to frequent checks during treatment, especially for prolonged treatments;
• if you suffer from diabetes (diabetes mellitus) or if you have high levels of fats in your blood (hyperlipidemia) or if you smoke;
• if you have kidney problems, if you are taking diuretic medicines that increase urine excretion (see sections “Do not take ORUDIS” and “Other medicines and ORUDIS”). Your doctor will need to monitor your kidneys during treatment with this medicine;
• if you have ever developed a fixed drug eruption (round or oval patches of redness and swelling of the skin that usually reappear at the same site(s), blisters, hives and itching) with ketoprofen.

Infections
Orudis can mask the symptoms of infections such as fever and pain. It is therefore possible that Orudis may
delay adequate treatment of the infection, which could increase the risk of complications. This has been
observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take
this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your
doctor immediately.

This medicine can cause:

• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments or if used to treat pain in the period before or after coronary artery bypass surgery;
• serious problems with the stomach and intestines (bleeding, ulcers, perforations), especially at high doses. Your doctor may advise you to take medicines to protect the ulcer (misoprostol or proton pump inhibitors);
• skin and mucous membrane diseases, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes. This can occur especially in 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 consult your doctor immediately.
You can reduce the risk of experiencing side effects by taking ORUDIS at the lowest effective dose and for
the shortest possible duration (See section “How to take ORUDIS”).

Children
This medicine is contraindicated in children.

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

Other medicines and ORUDIS
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 ORUDIS:

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

Take ORUDIS 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 excretion, especially if you are an elderly patient who is particularly dehydrated (see sections “Do not take ORUDIS” and “Warnings and precautions”);
• medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are poorly hydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for blood circulation problems;
• tenofovir, a medicine used to treat some viral infections;
• nicorandil, a medicine used to prevent or relieve chest pain due to heart problems;
• cardiac glycosides, medicines used to treat heart failure.

Your doctor will need to monitor you and may possibly 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 anti-aggregating agents, such as tirofiban, eptifibatide, abciximab and iloprost, used for blood coagulation problems;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in operations of the female genital apparatus;
• intrauterine devices (IUDs), the effectiveness of the device may be reduced with resulting pregnancy.
• mifepristone: a medicine used for medical abortion;
• cyclosporine and tacrolimus, medicines used after an organ transplant or for the treatment of immune system disorders;
• some medicines used to treat infections (quinolone antibiotics).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ORUDIS in the last 3 months of pregnancy as it may harm the fetus or cause problems during
delivery. This medicine can cause kidney and heart problems in the fetus. In addition, it may affect your and
your baby's tendency to bleed and delay or prolong labour more than expected. You should not take ORUDIS in
the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If treatment is
needed during this period or during attempts to conceive, the minimum dose should be used for the shortest
possible time. From the 20th week of pregnancy, ORUDIS can cause kidney problems in the fetus if taken for
more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or 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
The use of ORUDIS during breastfeeding is not recommended.
Fertility
ORUDIS can 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 these may be
altered.

Driving and using machines
ORUDIS can cause dizziness, vertigo, drowsiness, seizures or visual disturbances. If this happens to you, do not
drive vehicles or use machines.

ORUDIS contains lactose
This medicine contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars,
contact your doctor before taking this medicine.

3. How to take ORUDIS

Take this medicine following exactly the instructions of 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 between meals.
Take the capsule with a little water. Your doctor will indicate the appropriate dose depending on the severity of
your symptoms.
The lowest effective dose for the shortest period necessary to relieve symptoms should be used. If you have
an infection, consult your doctor immediately if symptoms (such as fever and pain) persist
or worsen (see paragraph 2).

Use in the elderly and people with kidney problems
If you are elderly or if you have kidney problems, your doctor will determine the dose.

Use in people with liver problems
In this case, your doctor will determine the appropriate dose (see paragraph 2 “Do not take ORUDIS” and “Warnings and
precautions”).

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

If you take more ORUDIS than you should
In case of accidental intake/ingestion of an excessive dose of this medicine, inform
your doctor immediately or go to the nearest hospital emergency room.
The disorders of an overdose with doses up to 2.5 g of ketoprofen are as follows: lethargy, drowsiness,
stomach pain, nausea and vomiting. If this occurs, consult your doctor who will establish an appropriate
therapy for the disorders. Headache, dizziness and diarrhea may also occur.
In case of severe overdose, low blood pressure, breathing problems (respiratory depression) and bleeding of the stomach or intestine may also occur.

If you forget to take ORUDIS
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take
the next dose. Do not take a double dose to make up for the missed dose.
If you have any doubts 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 gets them.
The side effects that may occur with ORUDIS 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, giddiness, drowsiness, constipation, diarrhoea, flatulence, inflammation of the stomach
(gastritis), skin irritation (rash) and itching, swelling due to fluid retention (edema),
fatigue.

Rare(may affect up to 1 in 1,000 people)
Decrease in red blood cells due to bleeding (hemorrhagic anemia), decrease in the number of white blood
cells (leukopenia), altered sensitivity of the limbs (paresthesia), blurred vision, ringing in the ear
(tinnitus), asthma, inflammation of the mouth (stomatitis), ulcer (peptic ulcer), colitis, liver problems
(hepatitis, increased values of some blood tests, such as transaminases, bilirubin due to liver disorders, jaundice), increased body weight.

Frequency not known(the frequency of which cannot be estimated based on available data)
Blood problems (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood
cells (hemolytic anemia), depression, hallucinations, confusion, altered mood, convulsions, alterations
of taste (dysgeusia), inflammation of the membranes lining the brain not caused by bacteria
(aseptic meningitis), heart problems (heart failure), altered heartbeat (palpitations,
tachycardia, atrial fibrillation), increased blood pressure, dilation of blood vessels, widespread redness due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis),
constriction of the bronchi (bronchospasm), runny nose (rhinitis), difficulty breathing (dyspnea), problems with the
stomach and intestines (worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation
, blood in the stool and vomit, inflammation of the pancreas (pancreatitis), excessive
sensitivity to light (photosensitivity), hair loss (alopecia), skin diseases, even very serious
(skin rash, urticaria, erythema, blistering eruptions, Stevens-Johnson syndrome and toxic epidermal
necrolysis), widespread red and infected lesions (acute generalized exanthematous pustulosis), swelling of the skin,
mucous membranes and submucosal tissues (angioedema), symptoms of an allergic reaction distinctive of the skin
known as fixed drug eruption which usually reappears at the same site(s) upon re-exposure to the
drug and may appear as round or oval patches of redness and swelling of the skin, blister formation (urticaria), itching; kidney problems (acute renal failure, tubular-interstitial nephritis,
nephrotic syndrome, abnormalities in kidney function tests), allergic reactions (anaphylactic), even serious,
with shock, decreased amount of sodium in the blood (hyponatremia), increased amount of potassium
in the blood (hyperpotassemia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 ORUDIS

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ORUDIS contains
The active ingredient is ketoprofen. Each capsule contains 50 mg of ketoprofen.
The other ingredients are: magnesium stearate, lactose.
Capsule shell components: yellow iron oxide (E172), gelatin, titanium dioxide (E171).

Description of the appearance of ORUDIS and contents of the pack
Pack of 30 hard capsules in blisters.

Marketing Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan

Manufacturer
FAMAR Health Care Services Madrid S.A.U. – Avda Leganés 62 – Alcorcon, 28923 Madrid (Spain)

ORUDIS 200 mg prolonged-release hard capsules

Ketoprofen

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ORUDIS is and what it is used for

ORUDIS contains the active ingredient ketoprofen which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
ORUDIS 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 (strains, lumbago, sciatica, fibrositis), musculoskeletal pain syndromes and
dysmenorrhea.

2. What you need to know before taking ORUDIS

Do not take ORUDIS

• 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 had an allergic reaction (e.g. narrowing of the airways, asthma, hay fever, hives) after taking other non-steroidal anti-inflammatory medicines such as acetylsalicylic acid;
• if you have severe kidney problems (severe renal failure), liver problems (severe hepatic failure, hepatic cirrhosis, severe hepatitis) and heart problems (severe heart failure);
• if you suffer from or have suffered from ulcers in the stomach or intestines (active peptic ulcer), bleeding or perforation of the stomach and intestines;
• if you are taking intensively medicines that promote urine excretion (diuretics) (see sections “Warnings and precautions” and “Other medicines and ORUDIS”);
• if you suffer from blood problems such as leukopenia and thrombocytopenia, if you have a hemorrhage (blood loss), if you are predisposed to bleeding (bleeding diathesis) or if you have bleeding problems (hemostatic disorders);
• if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if the person who needs to take the medicine is a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORUDIS.

Pay particular attention with ORUDIS:

• if you suffer from asthma associated with chronic hay fever, sinusitis and/or nasal polyps or if you are predisposed to airway constriction or other allergic reactions;
• if you are taking other non-steroidal anti-inflammatory medicines (NSAIDs) (see section “Other medicines and ORUDIS”);
• if you suffer from high blood pressure, not adequately treated, or heart problems (e.g. congestive heart failure, confirmed ischemic heart disease, peripheral arteriopathy and/or cerebrovascular disease);
• if you have an irregular heartbeat (atrial fibrillation);
• if you have high potassium levels, especially if you suffer from diabetes, kidney problems or are being treated with other medicines that cause increased potassium levels. In this case, the doctor will need to monitor these values;
• if you have suffered from problems with the stomach and intestines (bleeding, perforations, ulcers, Crohn's disease, ulcerative colitis) or if you take medicines that can increase the risk of injury to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as aspirin or nicorandil) (see sections “Do not take ORUDIS” and “Other medicines and ORUDIS”);
• if you have an infection - see paragraph “Infections” below;
• if you suffer from liver problems or if you have suffered from liver problems, because ORUDIS may worsen your condition. In these cases, the doctor will need to subject you to frequent checks during treatment, especially for prolonged periods;
• if you suffer from diabetes (diabetes mellitus) or if you have high levels of fats in the blood (hyperlipidemia) or if you smoke;
• if you have kidney problems, if you are taking diuretic medicines, which increase urine excretion (see sections “Do not take ORUDIS” and “Other medicines and ORUDIS”). The doctor will need to monitor your kidneys during treatment with this medicine;
• if you have ever developed a fixed drug eruption (round or oval patches of redness and swelling of the skin that usually reappear at the same site(s), blisters, hives and itching) with ketoprofen.

Infections
Orudis can mask the symptoms of infections such as fever and pain. Therefore, Orudis may
delay adequate treatment of the infection, which could increase the risk of complications. This
has been observed in pneumonia caused by bacteria and bacterial skin infections related to
varicella. If you take this medicine while you have an infection and the symptoms of the infection persist or
worsen, contact your doctor immediately.

This medicine can cause:

• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments or if used to treat pain in the period before or after coronary artery bypass surgery;
• serious problems with the stomach and intestines (bleeding, ulcers, perforations), especially at high doses. The doctor may advise you to take medicines to protect the ulcer (misoprostol or proton pump inhibitors);
• skin and mucous membrane diseases, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes. This can 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 immediately and contact your doctor immediately.
You can reduce the risk of experiencing side effects by taking ORUDIS at the lowest effective dose and for
the shortest possible duration (see section “How to take ORUDIS”).

Children
This medicine is contraindicated in children.

Elderly
If you are elderly, take this medicine with caution as you are more prone to bleeding and
perforation of the stomach and intestines, which can be fatal, and other side effects such as
reduced kidney, heart and liver function (see section “Possible side effects”). The
doctor will indicate the dose to be taken and whether it is necessary to take medicines that protect against ulcers
(misoprostol or proton pump inhibitors). The doctor will need to monitor you during
treatment with ketoprofen.

Other medicines and ORUDIS
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 ORUDIS:

• other non-steroidal anti-inflammatory medicines (NSAIDs) and high doses of salicylates (see section “Warnings and precautions”);
• medicines to make the blood more fluid (anticoagulants, e.g. heparin, warfarin, dabigatran, apixaban, rivaroxaban, edoxaban and antiplatelet agents such as ticlopidine and clopidogrel) (see sections “Do not take ORUDIS” and “Warnings and precautions”);
• lithium, used for the treatment of depression or similar disorders;
• methotrexate (medicine used for the treatment of rheumatoid arthritis and cancer) used at high doses (15 mg per week).

Take ORUDIS 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 excretion, especially if you are an elderly patient who is particularly dehydrated (see sections “Do not take ORUDIS” and “Warnings and precautions”);
• medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are poorly hydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for problems with blood circulation;
• tenofovir, a medicine used in the treatment of some viral infections;
• nicorandil, a medicine used to prevent or relieve chest pain due to heart problems;
• cardiac glycosides, medicines used to treat the heart's inability to provide the body with an adequate supply of blood.

The doctor will need to monitor you and may possibly reduce the dosage of ketoprofen
if you are taking any of the following medicines:

• medicines used for the treatment of high blood pressure such as beta-blockers, angiotensin-converting enzyme inhibitors;
• thrombolytics and anti-aggregating agents, such as tirofiban, eptifibatide, abciximab and iloprost, used for blood coagulation problems;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in operations on the female genital apparatus;
• intrauterine devices (IUDs), the effectiveness of the device may be reduced with consequent pregnancy;
• mifepristone, a medicine used for termination of pregnancy;
• cyclosporine and tacrolimus, medicines used after an organ transplant or for the treatment of immune system disorders;
• some medicines used for the treatment of infections (quinolone antibiotics).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ORUDIS in the last 3 months of pregnancy as it may harm the fetus or cause
problems during childbirth. This medicine can cause problems with the kidneys and heart of the fetus. In addition,
it may affect your and the baby's tendency to bleed and delay or prolong labor more than expected. You should not
take ORUDIS in the first 6 months of pregnancy unless absolutely
necessary and under the advice of a doctor. If treatment is needed during this period or during attempts
to conceive, the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy, ORUDIS can cause kidney problems in the fetus if taken for more than a few days, reducing
the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing a blood vessel
(ductus arteriosus) in the baby's heart. If treatment is needed for more than a few
days, the doctor may recommend additional monitoring.
Breastfeeding
The use of ORUDIS during breastfeeding is not recommended.
Fertility
ORUDIS can 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 need to have fertility tests, as these may be altered.

Driving and using machines
ORUDIS can cause dizziness, vertigo, drowsiness, convulsions or visual disturbances. If this happens to you, avoid
driving vehicles or using machinery.

ORUDIS contains sucrose
This medicine contains sucrose, a type of sugar. If you have been diagnosed with an intolerance
to some sugars, contact your doctor before taking this medicine.

3. How to take ORUDIS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is 200 mg once a day, to be taken by mouth after a meal.
The doctor will indicate the appropriate dose according to your 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 should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if the symptoms (for example fever and pain) persist
or worsen (see paragraph 2).

Use in the elderly and people with kidney problems
If you are elderly or if you have kidney problems, your doctor will determine the dose.

Use in people with liver problems
In this case, the doctor will determine the appropriate dose (see paragraph 2 “Do not take ORUDIS” and “Warnings and
precautions”).

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

If you take more ORUDIS than you should
In case of accidental intake/ingestion of an excessive dose of this medicine, inform
your doctor immediately or go to the Emergency Room of the nearest hospital.
The disturbances of an overdose with doses up to 2.5 g of ketoprofen are as follows: lethargy, drowsiness,
stomach pain, nausea and vomiting. If this occurs, consult your doctor who will establish an appropriate
therapy for the symptoms. Headache, dizziness and diarrhea may also occur.
In case of severe overdose, low blood pressure, breathing problems (respiratory depression) and bleeding of the stomach or intestines may also occur.

If you forget to take ORUDIS
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take
the next dose. Do not take a double dose to make up for the missed dose.
If you have any doubts 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 gets them.
The side effects that may occur with ORUDIS 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, giddiness, drowsiness, constipation, diarrhea, flatulence, inflammation of the stomach
(gastritis), skin irritation (rash) and itching, swelling due to fluid retention (edema),
fatigue.

Rare(may affect up to 1 in 1,000 people)
Decrease in red blood cells due to bleeding (hemorrhagic anemia), decrease in the number of white blood cells
(leukopenia), altered sensitivity of the limbs (paresthesia), blurred vision, ringing in the ear
(tinnitus), asthma, inflammation of the mouth (stomatitis), ulcer (peptic ulcer), colitis, liver problems
(hepatitis, increased values of some blood tests, such as transaminases, bilirubin due to liver disorders, jaundice), increased body weight.

Frequency not known(the frequency of which cannot be estimated based on available data)
Blood problems (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood cells
(hemolytic anemia), depression, hallucinations, confusion, mood alteration, convulsions, alterations
of taste (dysgeusia), inflammation of the membranes lining the brain not caused by bacteria
(aseptic meningitis), heart problems (heart failure), altered heartbeat (palpitations,
tachycardia, atrial fibrillation), increased blood pressure, dilation of blood vessels, generalized flushing due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis),
constriction of the bronchi (bronchospasm), common cold (rhinitis), difficulty breathing (dyspnea), problems with the
stomach and intestines (worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation
, blood in the stool and vomit, inflammation of the pancreas (pancreatitis), excessive
sensitivity to light (photosensitivity), hair loss (alopecia), skin diseases, even very serious
(skin rash, urticaria, erythema, blistering eruptions, Stevens-Johnson syndrome and toxic epidermal
necrosis), widespread red and infected lesions (acute generalized exanthematous pustulosis), swelling of the skin,
mucous membranes and submucosal tissues (angioedema), symptoms of an allergic reaction distinctive of the skin
known as fixed drug eruption which usually recurs in the same site(s) upon re-exposure to the
drug and may appear as round or oval patches of redness and swelling of the skin, formation
of blisters (urticaria), itching; kidney problems (acute renal failure, tubular-interstitial nephritis,
nephrotic syndrome, abnormalities in kidney function tests), allergic reactions (anaphylactic), even serious,
with shock, decreased sodium levels in the blood (hyponatremia), increased potassium levels
in the blood (hyperpotassemia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 ORUDIS

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ORUDIS 200 mg prolonged-release hard capsules contain
The active ingredient is ketoprofen. Each capsule contains 200 mg of ketoprofen.
The other ingredients are: sugar spheres (sucrose, corn starch), colloidal silicon dioxide, shellac,
ethylcellulose, talc.
Capsule shell components: erythrosine (E127), titanium dioxide (E171), gelatin.

Description of the appearance of ORUDIS and contents of the pack
Pack of 30 capsules in blisters.

Marketing Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan

Manufacturers
Famar Health Care Services Madrid, S.A.U Avenida de Leganés n. 62
28925 Alcorcon (Madrid) Spain

or
Sanofi Winthrop Industrie
1, rue de la Vierge Ambarés est Lagrave
33565 Carbon Blanc Cedex - France

ORUDIS 100 mg / 2 ml injectable solution for intramuscular use

Ketoprofen

Read this leaflet carefully before using 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ORUDIS and what is it used for?

ORUDIS contains the active ingredient ketoprofen which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
ORUDIS is indicated for the treatment of acute painful episodes due to inflammation of bones, muscles and
joints.

2. What you need to know before using ORUDIS

Do not use ORUDIS

• 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 had an allergic reaction in the past (e.g. constriction of the bronchi, asthma, cold, urticaria) after taking other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid, as severe (anaphylactic) allergic reactions, in rare cases fatal, may occur;
• if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if the person who needs to use the medicine is a child;
• if you are taking medicines that promote urine excretion (diuretics) intensively (see section “Other medicines and ORUDIS);
• if you suffer from or have suffered from an ulcer in the stomach or intestine (active peptic ulcer), bleeding or perforation of the stomach and intestine (see section “Other medicines and ORUDIS);
• if you have severe kidney problems (severe renal failure), liver (severe hepatic failure, hepatic cirrhosis, severe hepatitis) and heart (severe heart failure);
• if you suffer from blood problems such as leukopenia and thrombocytopenia, if you have bleeding (blood loss) or if you are predisposed to bleeding (bleeding diathesis);
• if you have bleeding problems (hemostatic disorders)
• if you are taking medicines that make the blood more fluid (anticoagulants) (see section “Other medicines and ORUDIS);
• if you have bleeding affecting the blood vessels in the brain.

Warnings and precautions
Talk to your doctor or pharmacist before using ORUDIS.

Pay particular attention with ORUDIS:

• if you suffer from or have suffered from allergies, if you suffer from asthma associated with chronic cold, chronic sinusitis and nasal polyps;
• if you suffer from heart failure, cirrhosis, nephrosis, chronic renal failure or take diuretics (medicines that increase urine excretion), especially if you are elderly, the doctor will subject you to checks, as the administration of ketoprofen may worsen kidney function;
• if you suffer from high blood pressure and/or heart problems such as mild or moderate congestive heart failure because fluid retention and swelling due to fluid accumulation (edema) may occur;
• if you have an irregular heartbeat (atrial fibrillation);
• if you suffer from uncontrolled high blood pressure, heart problems and circulation (congestive heart failure, confirmed ischemic heart disease, and peripheral arterial disease and/or cerebrovascular disease), diabetes, if you have high levels of fats in the blood (hyperlipidemia) or if you smoke. In these cases, the doctor will determine if you can use this medicine;
• if you have suffered from problems with the stomach and intestines (ulcers, Crohn's disease, ulcerative colitis) or if you are taking medicines that can increase the risk of injury to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as aspirin or nicorandil) (see section “Other medicines and ORUDIS);
• if you have high potassium levels due to diabetes or medicines called potassium-sparing agents;
• if you have an infection - see paragraph “Infections” below;
• if you suffer from liver problems or have suffered from liver problems, because ORUDIS may worsen your condition. In these cases, the doctor will have to subject you to frequent checks during treatment, especially for prolonged treatments;
• if you suffer from an ulcer, especially 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; the doctor may prescribe medicines to protect the stomach, such as misoprostol or proton pump inhibitors;
• if you have ever developed a fixed drug eruption (round or oval red and swollen skin patches that usually reappear at the same site(s), blisters, urticaria and itching) with ketoprofen.

Infections
Orudis can mask the symptoms of infections such as fever and pain. It is therefore possible that Orudis may
delay adequate treatment of the infection, which could increase the risk of complications. This has been
observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this
medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor
immediately.

This medicine can cause:

• problems with the stomach and intestines that can be even fatal (bleeding, ulcers, perforations), especially at high doses and if your body weight is low;
• severe, even very rare, irritation of the skin and mucous membranes, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes. This can occur especially in the first month of treatment;
• serious problems with the heart and blood circulation (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments or if used to treat pain in the period before or after coronary artery bypass surgery (see section “Possible side effects”);
• problems with the liver or kidneys (see section “Possible side effects”);
• visual disturbances (blurred vision).

During therapy, especially if long-term, the doctor will have to keep you under control.
If you experience any of these effects, stop treatment immediately and consult your doctor immediately.
You can reduce the risk of developing side effects by taking ORUDIS at the lowest effective dose and for
the shortest possible duration.
Avoid taking other non-steroidal anti-inflammatory drugs during treatment with ORUDIS.
Use this medicine always under strict medical supervision because it is not a simple pain reliever.
Use ORUDIS only for the treatment of acute pain and when the pain is relieved, switch to the use of
other medicines based on ketoprofen to be used by routes other than parenteral (injection through the
muscles and into the vein).

This medicine can be administered for prolonged periods for intramuscular use only in
hospitals and nursing homes.
Solutions for intramuscular use can only be injected into the muscles and not
directly into the vein.
Children
This medicine is contraindicated in children.

Elderly
If you are elderly, use this medicine with caution as you are more prone to bleeding and
perforation of the stomach and intestines, which can be even fatal, and to other side effects such as
reduced function of the kidneys, heart and liver (see section “Possible side effects”). The
doctor will indicate the dose to be taken and whether it is necessary to use medicines that protect against
ulcers (misoprostol or proton pump inhibitors). The doctor will have to keep you under control during
treatment with ketoprofen.

Other medicines and ORUDIS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Avoid using the following medicines together with ORUDIS:

• lithium, used to treat depression or similar disorders;
• other non-steroidal anti-inflammatory drugs (NSAIDs) and high doses of salicylates (see section “Warnings and precautions”);
• methotrexate (medicine used to treat rheumatoid arthritis and cancer) used at high doses (15 mg per week);
• medicines to make the blood more fluid (anticoagulants, e.g. heparin, warfarin, dabigatran, apixaban, rivaroxaban, edoxaban and antiplatelet agents such as ticlopidine and clopidogrel) (see section “Warnings and precautions”).

Use ORUDIS 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 excretion, especially if you are an elderly patient who is particularly dehydrated (see section “Do not use ORUDIS” and “Warnings and precautions”);
• medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists), especially if you are elderly and drink little water (are poorly hydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids, medicines used for inflammation;
• pentoxifylline, a medicine used for blood circulation problems;
• tenofovir, a medicine used in the treatment of some viral infections;
• nicorandil, a medicine used to prevent or alleviate chest pain due to heart problems;
• cardiac glycosides, medicines used to treat the heart's inability to provide blood to the body in adequate quantities.

The doctor will have to keep you under control and may eventually reduce the dosage of ketoprofen
if you are taking any of the following medicines:

• medicines used for the treatment of high blood pressure such as beta-blockers, ACE inhibitors, diuretics;
• thrombolytics and anti-aggregating agents such as tirofiban, eptifibatide, abciximab and iloprost, used for blood coagulation problems;
• selective serotonin reuptake inhibitors (SSRIs);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in operations of the female genital apparatus;
• intrauterine devices (IUDs), the effectiveness of the device may be reduced with consequent pregnancy;
• mifepristone: medicine used for termination of pregnancy;
• cyclosporine and tacrolimus (medicines used after an organ transplant or for the treatment of immune system disorders);
• some medicines used for the treatment of infections (quinolone antibiotics).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not take ORUDIS in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. This medicine can cause problems with the kidneys and heart of the fetus. In
addition, it may affect your and your baby's tendency to bleed and delay or prolong labor longer than
expected. You should not take ORUDIS in the first 6 months of pregnancy unless absolutely
necessary and under the advice of a doctor. If treatment is needed in this period or during attempts
to conceive, the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy, ORUDIS can cause kidney problems in the fetus if taken for more than a few days, reducing
the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing a blood vessel
(ductus arteriosus) in the baby's heart. If treatment is needed for more than a few
days, the doctor may recommend additional monitoring.
Breastfeeding
The use of ORUDIS during breastfeeding is not recommended.
Fertility
ORUDIS can 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 need to undergo fertility tests, as these may
be altered.

Driving and using machines
ORUDIS can cause dizziness, drowsiness, vertigo, convulsions or visual disturbances. If
this happens, avoid driving vehicles or using machines.

ORUDIS contains benzyl alcohol
This medicine contains 50 mg of benzyl alcohol per 2 ml vial.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems (respiratory distress syndrome) in young children.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts
of benzyl alcohol can accumulate in the body and cause side effects (such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney condition. This is because large
amounts of benzyl alcohol can accumulate in the body and cause side effects (such as metabolic
acidosis).

3. How to use ORUDIS

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose is 50 - 100 mg, 1 or 2 times a day. The maximum dose is 200 mg of ketoprofen per
day and higher doses are not recommended.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist
or worsen (see paragraph 2)..
This medicine can be administered for prolonged periods for intramuscular use only in
hospitals and nursing homes.
Solutions for intramuscular use can only be injected into the muscles and not directly into
vein.
The solution must be used immediately and the injection must be performed according to strict
sterilization, asepsis, and antisepsis rules.

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

Use in people with liver problems
If you suffer from liver problems, your doctor will need to monitor you during treatment and must use
the minimum effective daily dose (see the paragraph “Do not use ORUDIS” and “Warnings and precautions”).

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

If you take more ORUDIS than you should
If you (or someone else) have ingested an excessive dose of ORUDIS, or if you think a child has ingested
an excessive dose, consult a doctor immediately or go to the Emergency Room of the nearest
hospital.
The disorders of an overdose are as follows: headache, dizziness, drowsiness, abdominal pain, nausea,
vomiting and diarrhea. Low blood pressure, breathing problems (respiratory depression) and bleeding of the stomach or intestines can also occur. If this happens
consult your doctor who will establish an appropriate therapy for the disorders.

If you forget to use ORUDIS
If you forget to use a dose, take it as soon as you remember, unless it is almost time to use the next
dose. Do not take a double dose to compensate for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

The side effects that may occur with ORUDIS are:

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

Uncommon(may affect up to 1 in 100 people)
Headache, dizziness, giddiness, drowsiness, constipation, diarrhoea, flatulence, inflammation of the stomach
(gastritis), skin irritation (rash) and itching, swelling due to fluid retention (edema).

Rare(may affect up to 1 in 1,000 people)
Decrease in red blood cells due to bleeding and decrease in white blood cells (haemorrhagic anaemia,
leukopenia), blurred vision, ringing in the ear (tinnitus), asthma, inflammation of the mouth (stomatitis),
ulcer (peptic ulcer), colitis, liver problems (hepatitis, increase in the values of some blood tests,
such as transaminases and bilirubin due to liver disorders, jaundice), disorders of sensitivity of legs and arms or
other parts of the body (paresthesia), increase in body weight.

Frequency not known(the frequency of which cannot be estimated on the basis of the available data)
Blood problems (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood cells
(hemolytic anaemia), depression, hallucinations, confusion, mood alteration, convulsions, alterations
of taste (dysgeusia), inflammation of the membranes lining the brain not caused by bacteria
(aseptic meningitis), heart problems (heart failure), alteration of the heartbeat (palpitations,
tachycardia, atrial fibrillation), increase in blood pressure, dilation of blood vessels, generalized flushing due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis),
constriction of the bronchi (bronchospasm), runny nose (rhinitis), difficulty breathing (dyspnea), problems in the
stomach and intestines (worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation
), blood in the stool and vomit, inflammation of the pancreas (pancreatitis), excessive
sensitivity to light (photosensitivity), hair loss (alopecia), skin diseases even very serious
(skin rash, urticaria, erythema, blistering eruptions, Stevens-Johnson syndrome and toxic epidermal
necrolysis), widespread red and infected lesions (acute generalized exanthematous pustulosis), swelling of the skin,
mucous membranes and submucosal tissues (angioedema), symptoms of an allergic reaction distinctive of the skin
known as fixed drug eruption which usually recurs in the same site(s) upon re-exposure to the
drug and may appear as round or oval patches of redness and swelling of the skin, blister formation (urticaria), itching; kidney problems (acute renal failure, tubular-interstitial nephritis,
nephrotic syndrome, abnormalities in kidney function tests), allergic reactions (anaphylactic), even serious,
with shock, decrease in the amount of sodium in the blood (hyponatremia), increase in the amount of potassium
in the blood (hyperkalemia), reactions at the injection site such as pain, burning, redness and spots
(including Nicolau syndrome).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 ORUDIS

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 pack after “Scad.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light.
Use the contents of the vial immediately once opened.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains ORUDIS 100 mg / 2 ml injectable solution for intramuscular use
The active ingredient is ketoprofen. Each vial contains 100 mg of ketoprofen.
The other ingredients are: arginine, benzyl alcohol, citric acid monohydrate, water for injections.

Description of the appearance of ORUDIS and contents of the pack
Pack of 6 vials of 2 ml.

Marketing Authorisation Holder
Manufacturers
Famar Health Care Services Madrid, S.A.U - Avenida de Leganes 62 - Alcorcon, Madrid - Spain
Delpharm Dijon - 6, boulevard de l’Europe - 21800 Quétigny - France

ORUDIS 100 mg suppositories

Ketoprofen

Read this leaflet carefully before using 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ORUDIS is and what it is used for

ORUDIS contains the active ingredient ketoprofen which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
ORUDIS is indicated for the treatment of painful symptoms due to inflammation of bones, muscles and
joints such as: rheumatoid arthritis, ankylosing spondylitis, acute gout; osteoarthritis with varying
location; sciatica, radiculitis, myalgia; bursitis, tendinitis, tenosynovitis, synovitis, capsulitis; contusions,
sprains, dislocations, muscle tears; phlebitis, superficial thrombophlebitis, lymphangitis.
This medicine is also indicated for the treatment of painful symptoms due to inflammation of the
mouth, teeth, ears, throat, urinary tract and respiratory tract.

2. Cosa deve sapere prima di usare ORUDIS

Non usi ORUDIS

• se è allergico al ketoprofene, to medicinali simili (FANS) o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• se ha avuto in passato una reazione allergica (ad es. costrizione dei bronchi, asma, raffreddore, orticaria) dopo l’assunzione di altri medicinali antinfiammatori non steroidei come acido acetilsalicilico;
• se sta assumendo in modo intensivo medicinali che favoriscono l’eliminazione dell’urina (diuretici) (vedere i paragrafi “Avvertenze e precauzioni” e “Altri medicinali e ORUDIS”);
• se ha gravi problemi ai reni (grave insufficienza renale), al fegato (grave insufficienza epatica, cirrosi epatica, epatiti gravi) e al cuore (grave insufficienza cardiaca);
• se soffre di problemi del sangue come leucopenia e piastrinopenia, se ha un’emorragia (perdita di sangue), se è predisposto alle perdite di sangue (diatesi emorragica) o se ha problemi di sanguinamento (disordini emostatici);
• se ha avuto in passato perforazione o sanguinamento dello stomaco o dell’intestino causati dall’assunzione di medicinali antinfiammatori non steroidei (FANS);
• se soffre o ha sofferto di ulcera allo stomaco o all’intestino (ulcera peptica attiva), di sanguinamento o di perforazione dello stomaco e dell’intestino;
• se è nel terzo trimestre di gravidanza (vedere il paragrafo “Gravidanza e allattamento”);
• se la persona che deve usare il medicinale è un bambino;
• se soffre di una malattia infiammatoria o di emorragia del retto (proctite, proctorragia);
• se soffre o se ha sofferto di recente di problemi delle vene del retto o dell’ano (disturbi emorroidali) o di altre lesioni nella stessa zona.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di usare ORUDIS.

Faccia particolare attenzione con ORUDIS:

• se soffre di asma associata a raffreddore cronico, sinusite e/o polipi al naso o se è predisposto a problemi di costrizione ai bronchi o ad altre reazioni allergiche;
• se sta assumendo altri medicinali antiinfiammatori non steroidei (FANS) (vedere il paragrafo “Altri medicinali e ORUDIS”);
• se soffre di pressione alta del sangue, non adeguatamente trattata, o di problemi al cuore (ad es. insufficienza cardiaca congestizia, cardiopatia ischemica conclamata, arteriopatia periferica e/o malattia cerebrovascolare);
• se ha un’alterazione del ritmo cardiaco (fibrillazione atriale);
• se ha livelli di potassio alti, soprattutto se soffre di diabete, problemi ai reni o è in trattamento con altri medicinali che provocano l’aumento dei livelli di potassio. In questo caso il medico dovrà tenere sotto controllo tali valori;
• se ha sofferto di problemi a stomaco e intestino (emorragie, perforazioni, ulcere, morbo di Crohn, colite ulcerosa) o se assume medicinali che possono aumentare il rischio di lesioni a questi organi (corticosteroidi orali, anticoagulanti come warfarin, inibitori selettivi del reuptake della serotonina, agenti antiaggreganti come l'aspirina o il nicorandil) (vedere i paragrafi “Non usi ORUDIS” e “Altri medicinali e ORUDIS”);
• se ha un’infezione - vedere paragrafo “Infezioni” di seguito;
• se soffre di problemi al fegato o se ha sofferto di problemi al fegato, perché ORUDIS può peggiorare le sue condizioni. In questi casi il medico la dovrà sottoporre a frequenti controlli, durante il trattamento, soprattutto per trattamenti per periodi prolungati;
• se soffre di diabete (diabete mellito) o se ha i livelli di grassi nel sangue alti (iperlipidemia) o se fuma;
• se ha problemi ai reni, se sta assumendo medicinali diuretici, che aumentano l’eliminazione dell’urina (vedere i paragrafi “Non usi ORUDIS” e “Altri medicinali e ORUDIS”). Il medico dovrà tenere sotto controllo i suoi reni durante il trattamento con questo medicinale;
• se ha mai sviluppato un’eruzione fissa da farmaco (chiazze rotonde o ovali di arrossamento e gonfiore della pelle che solitamente si ripresentano nello stesso sito(i), vesciche, orticaria e prurito) con ketoprofene.

Infezioni
Orudis può nascondere i sintomi di infezioni quali febbre e dolore. È pertanto possibile che Orudis possa
ritardare un trattamento adeguato dell’infezione, cosa che potrebbe aumentare il rischio di complicanze. Ciò
è stato osservato nella polmonite causata da batteri e nelle infezioni cutanee batteriche correlate alla
varicella. Se prende questo medicinale mentre ha un’infezione e i sintomi dell’infezione persistono o
peggiorano, si rivolga immediatamente al medico.

Questo medicinale può causare:

• gravi problemi al cuore e nella circolazione del sangue (eventi trombotici arteriosi, infarto del cuore o ictus), soprattutto ad alte dosi e per trattamenti per periodi prolungati o se utilizzato per trattare il dolore nel periodo precedente o successivo ad un intervento chirurgico di bypass aorto-coronarico;
• gravi problemi allo stomaco e all’intestino (emorragie, ulcere, perforazioni), soprattutto ad alte dosi. Il medico potrà indicarle di assumere medicinali per proteggere l’ulcera (misoprostolo o inibitori della pompa protonica);
• malattie della pelle e delle mucose anche mortali, come dermatite esfoliativa, sindrome di Stevens- Johnson e necrolisi epidermica tossica che si possono manifestare con lesioni della pelle e delle mucose. Questo si può verificare soprattutto nel primo mese di trattamento;
• problemi alla vista come vista offuscata (Vedere il paragrafo “Possibili effetti indesiderati”).

Se manifesta uno di questi effetti, interrompa immediatamente il trattamento e si rivolga subito al medico.
Può ridurre il rischio di manifestare effetti indesiderati usando ORUDIS alla dose minima efficace e per la
durata più breve possibile (Vedere il paragrafo “Come usare ORUDIS”).

Bambini
Questo medicinale è controindicato nei bambini.

Anziani
Se è anziano, usi questo medicinale con cautela in quanto è più predisposto alle perdite di sangue e alla
perforazione di stomaco ed intestino, che possono essere anche mortali, e agli altri effetti indesiderati come
riduzione della funzionalità di reni, cuore e fegato (vedere il paragrafo “Possibili effetti indesiderati”). Il
medico le indicherà la dose da assumere e se è necessario prendere medicinali che proteggono dall’ulcera
(misoprostolo o inibitori della pompa protonica). Il medico la dovrà tenere sotto controllo durante il
trattamento con ketoprofene.

Altri medicinali e ORUDIS
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi
altro medicinale.

Eviti di prendere i seguenti medicinali insieme a ORUDIS:

• altri antiinfiammatori non steroidei (FANS) e alte dosi di salicilati (vedere il paragrafo “Avvertenze e precauzioni”);
• medicinali per rendere più fluido il sangue (anticoagulanti, per es. eparina, warfarin, dabigatran, apixaban, rivaroxaban, edoxaban e antiaggreganti piastrinici come ticlopidina e clopidogrel (vedere i paragrafi “Non usi ORUDIS” e “Avvertenze e precauzioni”);
• litio, usato per il trattamento della depressione o di disturbi simili;
• metotrexato (medicinale usato per il trattamento delle artriti reumatoidi e del cancro) usato ad alte dosi (15 mg alla settimana).

Usi con cautela ORUDIS se sta assumendo uno dei seguenti medicinali:

• medicinali che aumentano i livelli di potassio nel sangue come sali di potassio, diuretici risparmiatori di potassio, ACE inibitori, antagonisti del recettore dell’angiotensina II, FANS, eparina (a basso peso molecolare o non frazionata), ciclosporina, tacrolimus e trimetoprim;
• medicinali diuretici utilizzati per favorire l’eliminazione dell’urina, soprattutto se è un paziente anziano particolarmente disidratato (vedere il paragrafo “Non usi ORUDIS”e“Avvertenze e precauzioni”);
• medicinali per il trattamento della pressione del sangue alta (ACE inibitori e antagonisti dell’angiotensina II), soprattutto se è anziano e beve poca acqua (è poco idratato);
• metotrexato a dosi basse (inferiori a 15 mg alla settimana);
• corticosteroidi (medicinali utilizzati per le infiammazioni);
• pentossifillina, medicinale utilizzato per problemi di circolazione;
• tenofovir, medicinale utilizzato nel trattamento di alcune infezioni provocate da virus;
• nicorandil, medicinale utilizzato per prevenire o attenuare il dolore toracico dovuto a problemi al cuore;
• glicosidi cardioattivi, medicinali usati per trattare l’incapacità del cuore di fornire il sangue al corpo in quantità adeguata.

Il medico la dovrà tenere sotto controllo ed eventualmente potrebbe ridurre il dosaggio di ketoprofene
se sta assumendo uno dei seguenti medicinali:

• medicinali utilizzati per il trattamento della pressione del sangue alta come beta-bloccanti, inibitori dell’enzima di conversione dell’angiotensina;
• trombolitici e agenti anti-aggreganti, come tirofiban, eptifibarid, abciximab e iloprost, utilizzati per problemi della coagulazione del sangue;
• inibitori selettivi del reuptake della serotonina (SSRIs) (vedere il paragrafo “Avvertenze e precauzioni”);
• probenecid, un medicinale utilizzato per la gotta;
• gemeprost, un medicinale usato nelle operazioni dell’apparato genitale femminile;
• dispositivi anticoncezionali intrauterini (IUDs), l’efficacia del dispositivo può risultare ridotta con conseguente gravidanza
• mifepristone: medicinale utilizzato per l’interruzione della gravidanza;
• ciclosporina e tacrolimus, medicinali usati dopo un trapianto di organo o per il trattamento di disturbi del sistema immunitario;
• alcuni medicinali usati per il trattamento delle infezioni (antibiotici chinolonici).

Gravidanza, allattamento e fertilità
Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con latte
materno chieda consiglio al medico o al farmacista prima di usare questo medicinale.
Gravidanza
Non prenda ORUDIS negli ultimi 3 mesi di gravidanza, in quanto potrebbe nuocere al feto o causare
problemi durante il parto. Questo medicinale può causare problemi ai reni e al cuore del feto. Inoltre,
potrebbe influire sulla tendenza sua e del bambino al sanguinamento e ritardare o prolungare più del previsto
il travaglio. Non dovrebbe assumere ORUDIS nei primi 6 mesi di gravidanza, se non assolutamente
necessario e sotto consiglio del medico. Laddove necessiti del trattamento in tale periodo o durante i tentativi
di concepimento, dovrebbe essere utilizzata la dose minima per il minor tempo possibile. Dalla 20 settimana
di gravidanza, ORUDIS può causare problemi renali al feto, se assunto per più di qualche giorno, riducendo
così i livelli del liquido amniotico che circonda il bambino (oligoidramnios) o restringimento di un vaso
sanguigno (dotto arterioso) nel cuore del bambino. Laddove necessiti del trattamento per più di qualche
giorno, il medico potrebbe consigliare un monitoraggio aggiuntivo.
Allattamento
L’uso di ORUDIS durante l’allattamento con latte materno non è raccomandato.
Fertilità
ORUDIS può causare problemi di fertilità nella donna. Deve informare il medico se prevede di iniziare una
gravidanza, perché questo medicinale potrebbe ridurre la fertilità, e se deve effettuare esami sulla fertilità,
perché questi possono risultare alterati.

Guida di veicoli e utilizzo di macchinari
ORUDIS può causare capogiri, vertigini, sonnolenza, convulsioni o disturbi visivi. Se questo le accade, eviti
di guidare veicoli o di usare macchinari.

3. How to use ORUDIS

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 2 suppositories (200 mg) per day.
The maximum dose is 200 mg per day and higher doses are not recommended.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if the symptoms (for example fever and pain) persist
or worsen (see paragraph 2).

Use in the elderly and people with kidney problems
If you are elderly or if you have kidney problems, your doctor will determine the dose.

Use in people with liver problems
In this case, the doctor will determine the minimum effective dose (see the paragraph “Do not use ORUDIS” and
“Warnings and precautions”).

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

If you use more ORUDIS than you should
In case of accidental use/ingestion of an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital emergency room.
The disorders of an overdose with doses up to 2.5 g of ketoprofen are as follows: lethargy, drowsiness,
stomach pain, nausea and vomiting. If this occurs, consult your doctor who will establish an appropriate
therapy for the disorders. Headache, dizziness and diarrhea may also occur.
In case of severe overdose, low blood pressure, breathing problems (respiratory depression) and bleeding of the stomach or intestines may also occur.

If you forget to use ORUDIS
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take
the next dose. Do not use a double dose to make up for a missed dose.
If you have any doubts 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 gets them.
The side effects that may occur with ORUDIS 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, giddiness, drowsiness, constipation, diarrhoea, flatulence, inflammation of the stomach
(gastritis), skin irritation (rash) and itching, swelling due to fluid retention (edema),
fatigue.

Rare(may affect up to 1 in 1,000 people)
Decrease in red blood cells due to bleeding (hemorrhagic anemia), decrease in the number of white blood cells
(leukopenia), altered sensitivity of the limbs (paresthesia), blurred vision, ringing in the ear
(tinnitus), asthma, inflammation of the mouth (stomatitis), ulcer (peptic ulcer), colitis, liver problems
(hepatitis, increased values of some blood tests, such as transaminases, bilirubin due to liver disorders, jaundice), increased body weight.

Frequency not known(the frequency of which cannot be estimated based on the available data)
Blood problems (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood cells
(hemolytic anemia), depression, hallucinations, confusion, mood alteration, convulsions, alterations
of taste (dysgeusia), inflammation of the membranes lining the brain not caused by bacteria
(aseptic meningitis), heart problems (heart failure), altered heartbeat (palpitations,
tachycardia, atrial fibrillation), increased blood pressure, dilation of blood vessels, generalized flushing due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis),
constriction of the bronchi (bronchospasm), runny nose (rhinitis), difficulty breathing (dyspnea), problems with the
stomach and intestines (worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation
), blood in the stool and vomit, inflammation of the pancreas (pancreatitis), excessive
sensitivity to light (photosensitivity), hair loss (alopecia), skin diseases, even very serious
(skin rash, urticaria, erythema, blistering eruptions, Stevens-Johnson syndrome and toxic epidermal necrolysis), widespread red and infected lesions (acute generalized exanthematous pustulosis), swelling of the skin,
mucous membranes and submucosal tissues (angioedema), symptoms of an allergic reaction distinctive of the skin
known as fixed drug eruption which usually reappears at the same site(s) upon re-exposure to the
drug and may appear as round or oval patches of redness and swelling of the skin, blister formation (urticaria), itching; kidney problems (acute renal failure, tubular – interstitial nephritis,
nephrotic syndrome, abnormalities in renal function tests), allergic reactions (anaphylactic), even serious,
with shock, decreased sodium levels in the blood (hyponatremia), increased potassium levels
in the blood (hyperpotassemia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 ORUDIS

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ORUDIS contains
The active ingredient is ketoprofen. Each suppository contains 100 mg of ketoprofen.
The other ingredients are: lidocaine hydrochloride, semi-synthetic glycerides.

Description of the appearance of ORUDIS and contents of the pack
Pack containing 10 suppositories.

Marketing Authorisation Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B - Milan

Manufacturer
UNITHER LIQUID MANUFACTURING -– 1-3 Allée de la Neste, - Z.I. d’en Sigal, - 31770 Colomiers
(France)

ORUDIS 5% gel

Ketoprofen

Read this leaflet carefully before using 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ORUDIS and what is it used for

ORUDIS contains the active ingredient ketoprofen which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
ORUDIS is indicated for the local treatment of pain due to rheumatism or trauma of the joints, muscles, tendons and ligaments (for example, sports injuries).

2. What you need to know before using ORUDIS

Do not use ORUDIS

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

Immediately stop using ORUDIS if skin reactions occur, including those
that develop following the concomitant use of products containing octocrylene (octocrylene is an
excipient present in various cosmetic and personal hygiene products such as shampoos, aftershaves, shower gels and baths, skin creams, lipsticks, anti-aging creams, make-up removers, hair sprays,
used to prevent their photodegradation).
During treatment with ORUDIS and for two weeks after its discontinuation, do not expose
yourself to sunlight (even when cloudy), to UV light from solariums (See sections “Warnings and
precautions” and “Possible side effects”).

Warnings and precautions
Talk to your doctor or pharmacist before using ORUDIS.

• Use this medicine with caution if you suffer from 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 bandages that do not allow the skin to breathe (occlusive).
• Exposure to sunlight (even when cloudy) or to UVA lamps of areas treated with ORUDIS may induce skin reactions potentially serious (photosensitivity) (see section “Do not use Orudis”). Therefore it is necessary to:
• protect the treated parts from the sun with clothing for the entire duration of treatment and for two weeks after its discontinuation in order to avoid any risk of photosensitivity.
• wash your hands thoroughly after each application of ORUDIS.
• Immediately stop treatment and contact your doctor if you experience any skin reaction following the application of ORUDIS (See section “Possible side effects”).
• Do not use this medicine for periods beyond 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 problems such as asthma associated with chronic hay fever, chronic sinusitis (a disease of the nasal mucosa that typically causes headaches) and/or polyps in the nose, you are at a higher risk of allergy to aspirin and/or non-steroidal anti-inflammatory drugs.
• if you have ever developed a fixed drug eruption (round or oval patches of redness and swelling of the skin that usually reappear at the same site(s), blisters, hives and itching) with ketoprofen.

Children
This medicine is not recommended for children.

Other medicines and ORUDIS
Tell 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, tell your doctor if you are taking in particular
coumarin medicines, used for problems with blood coagulation.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use ORUDIS in the last 3 months of pregnancy. You should not use ORUDIS in the first 6 months
of pregnancy unless strictly necessary and under the advice of your doctor. If treatment is necessary
during this period, the minimum dose should be used for the shortest possible time.
Oral formulations (e.g. tablets) of ORUDIS can cause adverse effects on the fetus. It is
not known whether ORUDIS carries the same risk when used on the skin.

Breastfeeding
The use of ORUDIS during breastfeeding is not recommended.

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

ORUDIS contains methyl-parahydroxybenzoate, propylene glycol and ethanol
ORUDIS contains methyl-parahydroxybenzoate which may cause allergic reactions (including delayed ones).
ORUDIS contains propylene glycol which may cause skin irritation.
ORUDIS contains 100 mg of alcohol (ethanol) per gram of product. It may cause a burning sensation on damaged skin.

3. How to use ORUDIS

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply the gel to the painful or inflamed area of the skin 2 or 3 times a day.
The amount of gel should be sufficient to cover the painful area with a thin layer of gel. Massage
lightly for a few minutes to promote absorption. Do not apply it 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 ORUDIS than you should
It is unlikely that an overdose will occur when using the medicine on the skin. However, if you accidentally ingest
this medicine, you may experience reactions of the undesirable effects, the severity of which depends
on the amount ingested. In case of accidental intake/ingestion of an excessive dose of this
medicine, immediately inform your doctor or go to the Emergency Room of the nearest hospital.

If you forget to use ORUDIS
Do not use a double dose to make up for a missed dose.
If you have any doubts 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 gets them.
Stop using ORUDIS and contact your doctor immediately if:

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

Other side effects that may occur with ORUDIS are:

Uncommon(may affect up to 1 in 100 people)
Allergic skin reactions (erythema, eczema, itching and burning sensation).

Rare(may affect up to 1 in 1,000)
Skin irritation with itching (urticaria).
Severe skin reactions following exposure to sunlight (photosensitisation).
More serious adverse reactions, such as eczema with blisters or vesicles (bullous or blistering eczema), which may
spread beyond the application area to the whole body.

Very rare(may affect up to 1 in 10,000)
Worsening of pre-existing kidney problems.
Isolated cases of adverse reactions affecting the whole body (systemic) have also been reported
such as kidney disorders.

Frequency not known(the frequency cannot be estimated from the available data)
Allergic reactions (anaphylactic shock, hypersensitivity reaction).
Skin irritation with blisters (bullous dermatitis).
Symptoms of a distinctive allergic skin reaction known as fixed drug eruption which usually
reappears at the same site(s) on re-exposure to the drug and may appear as round or oval
patches of redness and swelling of the skin, blister formation (urticaria), itching.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 ORUDIS

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 pack after “Exp.”. The expiry date refers to the last day of that month.
Close the tube tightly after use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ORUDIS contains
The active ingredient is ketoprofen.
100 g of gel contains 5 g of ketoprofen.
The other ingredients are: sodium hydroxide, propylene glycol, ethyl alcohol 95°, hydroxyethylcellulose, methyl-
parahydroxybenzoate, fragrance, diethylene glycol monoethyl ether, polyethylene glycol glyceryl stearate, citric
acid anhydrous, purified water.

Description of the appearance of ORUDIS and contents of the pack
Gel in a tube of 30 g or 50 g.

Marketing Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan - Italy.

Manufacturer
Sanofi Winthrop Industrie - 196, rue du Marechal Juin - Amilly - France.