REUMAGIL 20 mg /1 Ml Roztwór Do Wstrzykiwań

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1. REUMAGIL 20 mg/1 ml injectable solution for intramuscular use
   1. WHAT IS REUMAGIL AND WHAT IT IS USED FOR
   2. BEFORE USING REUMAGIL
   3. HOW TO USE REUMAGIL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE REUMAGIL
   6. FURTHER INFORMATION

REUMAGIL 20 mg/1 ml injectable solution for intramuscular use

(Piroxicam)
Read this leaflet carefully before using the medicine.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What REUMAGIL is and what it is used for
• 2. Before using REUMAGIL
• 3. How to use REUMAGIL
• 4. Possible side effects
• 5. How to store REUMAGIL
• 6. Further information

1. WHAT IS REUMAGIL AND WHAT IT IS USED FOR

Before prescribing REUMAGIL, your doctor will assess the benefits of this medicine in relation to the risk of undesirable effects. The doctor may need to review you periodically and will tell you how often a check-up will be necessary during treatment with REUMAGIL.
REUMAGIL is an anti-inflammatory and analgesic medicine, which is used to relieve some symptoms caused by osteoarthritis (osteoarthritis: degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (spinal rheumatism), such as swelling, stiffness and joint pain. REUMAGIL does not cure arthritis and will only give you relief as long as you continue to take it.
The doctor will prescribe REUMAGIL only when other non-steroidal anti-inflammatory drugs (NSAIDs) will no longer be useful in relieving your symptoms.

2. BEFORE USING REUMAGIL

DO NOT TAKE REUMAGIL

• If you are allergic (hypersensitive) to Piroxicam or any of the excipients of REUMAGIL
• If you have had an ulcer or bleeding or perforation of the stomach or intestine in the past,
• If you have an ulcer or bleeding or perforation of the stomach or intestine
• If you have or have had previous gastrointestinal disorders (inflammation of the stomach or intestine) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancer, diverticulitis (inflamed or infected pouches/cavities in the colon).
• If you are taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid (present in many medicines used to relieve pain and reduce fever). Remember that many NSAIDs are also available over the counter.
• If you are taking anticoagulants, such as warfarin, to prevent blood clots from forming.
• If you have had a severe allergic reaction to piroxicam, other NSAIDs and other medicines in the past, in particular severe skin reactions (regardless of their intensity), such as erythema multiforme, exfoliative dermatitis (intense redness of the skin, with scaling in flakes or layers), vesiculobullous reactions: Stevens-Johnson syndrome, characterized by skin with red blisters, eroded, bleeding or covered with a crust, and necrolytic epidermal detachment, characterized by blisters and peeling of the superficial layer of the skin.
• If you have had symptoms of asthma, rhinitis, nasal polyps, angioedema or urticaria during treatment with acetylsalicylic acid or other NSAIDs
• If you are pregnant or suspect you may be pregnant.
• If you are breastfeeding.
• If you are under 18 years of age.
• If you suffer from severe liver disease.
• If you suffer from severe kidney disease.
• If you have moderate or severe heart failure.
• If you have severe hypertension.
• If you have severe blood disorders.
• If you have a bleeding diathesis (a predisposition to bleed frequently).

If any of these conditions are present, REUMAGIL should not be prescribed to you. Immediately inform your doctor.
SPECIAL CARE WITH REUMAGIL
Be careful with REUMAGIL and always inform your doctor before using
REUMAGIL; like all non-steroidal anti-inflammatory drugs, REUMAGIL can cause
serious reactions to the stomach and intestines such as pain, bleeding and ulcers.
You must immediately stop taking REUMAGIL and contact your doctor if you have
stomach pain or if you experience any signs of bleeding in the stomach or
intestine, such as passing black or tarry stools or if you vo-
mit blood.
You must immediately stop using REUMAGIL and contact your doctor in case of
an allergic reaction such as skin rash, facial swelling, wheezing or difficulty in
breathing.
If you are over 70 years of age, your doctor may want to minimize the duration of treatment
and visit you more often when you are being treated with REUMAGIL.
If you are over 70 years of age or are taking other medicines such as corticosteroids or certain medi-
cines for treating depression called selective serotonin reuptake inhibitors
(SSRIs), or acetylsalicylic acid to prevent blood clots from forming, your
doctor may prescribe you a medicine together with REUMAGIL to protect your stomach
and intestines.
You should not take this medicine if you are over 80 years of age.
If you have or have had any clinical problem or any form of allergy or if you are not sure
you can take REUMAGIL, inform your doctor before taking this medi-
cine.
Tell your doctor if you are taking any other medicines, including those available without a prescription.
Medicines such as REUMAGIL may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and
prolonged treatments. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, or a history of stroke or think you may be at risk for these
conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke)
you should discuss your therapy with your doctor or pharmacist.
REUMAGIL, like other non-steroidal anti-inflammatory drugs, decreases platelet aggregation
and prolongs coagulation time; this possibility should be remembered when performing
hematological tests and requires vigilance when undergoing concomitant treatment
with drugs that inhibit platelet aggregation.
Caution is advised if you have a history of hypertension and/or heart failure, as fluid retention and edema have been reported in association
with NSAID therapy.
Particular caution is required if you have heart failure, arterial hypertension,
reduced liver or kidney function, renal hypoperfusion, current or previous blood disorders, and if you are on diuretic therapy.
If you are asthmatic, due to the interaction of the drug with arachidonic acid metabolism,
bronchospasm and possibly shock and other allergic phenomena may occur.
Since ocular alterations have been observed during therapy with NSAIDs, periodic ophthalmological checks are recommended in case of
prolonged treatments.
As with other substances with similar action, increases in azotemia (levels of
nitrogen in the blood) have been observed which do not progress, with prolonged administration, beyond a certain
level. They return to normal values once therapy is discontinued.
If you are diabetic, it is advisable to have frequent blood tests.
Serious allergic reactions (particularly severe skin reactions) have been reported very
rarely in association with the use of NSAIDs (see “Undesirable Effects”).
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrosis) have been reported with the use of REUMAGIL, these initially appear as
red, round spots or circular patches often accompanied by blisters on the trunk.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress with the development of widespread blisters or exfoliation
of the skin.
The highest risk of developing severe skin reactions occurs within the first weeks of
treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrosis while using
REUMAGIL, the medicine should no longer be reused.
If you develop a skin rash or these skin symptoms, stop taking
REUMAGIL, urgently consult a doctor and inform them that you are taking this
drug.
If you are planning a pregnancy, if you have fertility problems or if you are undergoing
fertility investigations,you should discuss your therapy with your doctor.

USE OF REUMAGIL WITH OTHER MEDICINES
Tell your doctor about any other medicines you are taking or have recently
taken (within the last week) - even those purchased without a prescription. Medicines can sometimes interfere with each other. Your doctor may limit the use of
REUMAGIL or other medicines, or you may need to take a
different medicine. It is particularly important to report the following cases:

• if you are taking aspirin or other non-steroidal anti-inflammatory medicines to relieve pain
• if you are taking corticosteroids, medicines used to treat a variety of conditions such as allergies and hormonal imbalances
• if you are taking anticoagulants such as warfarin to prevent blood clots from forming
• if you are taking some medicines for depression called selective serotonin reuptake inhibitors (SSRIs)
• if you are taking any medicine, such as aspirin, to prevent blood clots from forming
• if you are taking diuretics, ACE inhibitors and angiotensin II antagonists - used for high blood pressure and heart conditions
• if you are taking lithium - used to treat depression
• if you are taking quinolone antibacterial agents, used to treat bacterial infections
• if you are using intrauterine devices

If any of these conditions are present, inform your doctor immediately.

USE OF REUMAGIL WITH FOODS AND DRINKS
It is advisable not to drink alcohol during treatment with REUMAGIL.

PREGNANCY AND BREASTFEEDING
Ask your doctor or pharmacist for advice before taking any medicine.

• If you are pregnant or suspect you may be pregnant, inform your doctor as REUMAGIL is not indicated for you. If you are planning a pregnancy, if you have fertility problems or ifyou are undergoing fertility investigations, inform your doctor anyway, as REUMA-GIL may not be indicated for you.
• If you are breastfeeding, you should not take REUMAGIL. Ask your doctor: it may be better to stop breastfeeding.

DRIVING AND OPERATING MACHINERY
If you experience dizziness or unusual fatigue, be particularly careful when driving or
operating machinery.

IMPORTANT INFORMATION ABOUT SOME EXCIPIENTS OF REUMAGIL
1 vial of REUMAGIL 20 mg injectable solution contains 0.1 g of 95% ethyl alcohol and
0.02 g of benzyl alcohol: it is dangerous for subjects with liver disorders, alcoholism, epilepsy,
brain disorders or damage, pregnant women, breastfeeding women and children. It may alter
the effects of other medicines.

3. HOW TO USE REUMAGIL

Always take REUMAGIL exactly as your doctor has instructed. If you have any doubts, you should
consult your doctor or pharmacist.
Your doctor will check you regularly to ensure that you are taking the optimal dose of
REUMAGIL. Your doctor will adjust the treatment to the minimum dose that best controls your
symptoms. Under no circumstances should you change the dose without first informing your doctor.
Adults and the elderly:
The maximum daily dose of REUMAGIL is 20 milligrams to be taken as a single daily
dose. If you are over 70 years of age, your doctor may prescribe a lower daily dose
and reduce the duration of treatment.
Your doctor may prescribe REUMAGIL together with another medicine to protect the sto-
mach and intestines from possible undesirable effects.
Do not increase the dose:
If you feel that the medicine is not very effective, always talk to your doctor.

If you forget to take REUMAGIL
Take the medicine as soon as you remember. If it is almost time to take the next dose, do not
take the dose you forgot, but take the next dose at the correct time. Do not
take a double dose.
If you take more REUMAGIL than you have been prescribed:
Symptoms: The most indicative symptoms of an overdose are headache, vomiting,
drowsiness, dizziness and syncope.
In case of accidental intake of an excessive dose of REUMAGIL, immediately inform
your doctor or go to the nearest hospital.
If you have any further questions about the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, REUMAGIL can cause side effects, although not everybody gets them.

Stop taking REUMAGIL immediately and contact your doctor:

• if you develop blisters, redness or peeling skin (skin rash), an ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of an allergic reaction such as skin rash, swelling of the face, lips or tongue that can cause difficulty breathing or wheezing
• if the skin or whites of the eyes turn yellow (jaundice)
• if you experience signs of bleeding in the stomach or intestines, such as passing black or blood-stained stools or if you vomit blood

Below are listed all the side effects associated with REUMAGIL.

More common side effects

• Ulcers of the digestive tract and gastrointestinal bleeding
• Nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, ulcerative stomatitis, inflammatory bowel diseases (colitis and Crohn’s disease)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure
• Heart failure (difficulty breathing and fatigue)

Less common side effects

• Heart attack (myocardial infarction)
• Stroke
• Anorexia
• Fatigue
• Anaemia
• Blisters, redness or peeling skin (skin rash) or ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of allergic reactions such as rash, swelling of the face, lips, tongue, wheezing
• Yellowing of the skin and eyes (jaundice)
• Increased normal liver function values
• Pancreatitis
• Acute renal failure, blood in the urine, difficulty urinating
• Increased non-protein nitrogen in the blood (increased azotaemia)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure (hypertension)
• Nosebleeds
• Headache
• Drowsiness
• Hearing loss or ringing in the ears
• Dizziness
• Vision disturbances
• Feeling unwell
• Alterations of the blood and lymphatic system
• Gastritis

Rare side effects

• Appearance of bruises
• Changes in blood sugar levels (hypo- and hyperglycemia)
• Sweating
• Changes in body weight
• Insomnia
• Depression
• Swelling, blisters or peeling of the skin
• Skin photosensitivity
• Dry mouth
• Agitation
• Alterations in bladder function
• Shock
• Alopecia
• Nail growth alterations
• Fatal hepatitis

Very rare side effects
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2)
If any of these side effects get worse, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE REUMAGIL

Keep REUMAGIL out of the reach and sight of children.
Do not use REUMAGIL after the expiry date indicated on the outer packaging and
on the inner label. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. FURTHER INFORMATION

What REUMAGIL contains

• The active ingredient is piroxicam. Each 1 ml vial contains Piroxicam 20 mg. The excipients are: Monosodium phosphate monohydrate, nicotinamide, macrogol, ethyl alcohol 95%, benzyl alcohol, sodium hydroxide, concentrated hydrochloric acid, water for injectable preparations.

Description of the appearance of REUMAGIL and contents of the pack
The pack contains n° 6 glass vials containing injectable solution for intramuscular
use

Marketing Authorisation Holder
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Roma

Manufacturer
ESSETI FARMACEUTICI S.r.l. via Campobello n°15 – Pomezia (Roma)