Reumagil

PACKAGE LEAFLET: INFORMATION FOR THE USER

REUMAGIL 20 mg/1 ml solution for injection for intramuscular use

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 REUMAGIL IS AND WHAT IT IS USED FOR

Before prescribing REUMAGIL, your doctor will evaluate the benefits of this medicine against the risk of adverse effects. Your doctor may need to review your condition periodically and will inform you how often monitoring is required during treatment with REUMAGIL.
REUMAGIL is an anti-inflammatory and analgesic medicine used to relieve certain symptoms caused by osteoarthritis (osteoarthritis: a degenerative joint disease), rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine), such as joint swelling, stiffness, and pain. REUMAGIL does not cure arthritis and will provide relief only as long as you continue taking it.
Your doctor will prescribe REUMAGIL only when other non-steroidal anti-inflammatory drugs (NSAIDs) are no longer effective in relieving your symptoms.

2. BEFORE USING REUMAGIL

DO NOT TAKE REUMAGIL

• If you are allergic (hypersensitive) to piroxicam or to any of the excipients of REUMAGIL
• If you have previously had a stomach or intestinal ulcer, bleeding, or perforation
• If you currently have a stomach or intestinal ulcer, bleeding, or perforation
• If you have or have had gastrointestinal disorders (inflammation of the stomach or intestine) that predispose to hemorrhagic conditions, such as ulcerative colitis, Crohn's disease, gastrointestinal cancer, or diverticulitis (inflamed or infected pouches/cavities in the colon)
• If you are taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid (found in many medicines used to relieve pain and reduce fever). Remember that many NSAIDs are available without a prescription.
• If you are taking anticoagulants, such as warfarin, to prevent blood clots
• If you have previously experienced a severe allergic reaction to piroxicam, other NSAIDs, or other medicines, particularly severe skin reactions (regardless of severity), such as erythema multiforme, exfoliative dermatitis (intense skin redness with flaking or peeling), or vesiculobullous reactions: Stevens-Johnson syndrome, characterized by red, eroded, bloody skin or crust formation, and toxic epidermal necrolysis, characterized by blisters and shedding of the superficial layer of skin
• If you have experienced symptoms of asthma, rhinitis, nasal polyps, angioedema, or urticaria during treatment with acetylsalicylic acid or other NSAIDs
• If you are pregnant or suspect you might 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 serious blood disorders
• If you have a hemorrhagic diathesis (a tendency to bleed frequently)

If any of these conditions apply to you, REUMAGIL must not be prescribed. Contact your doctor immediately.

EXERCISE SPECIAL CAUTION WITH REUMAGIL

Be cautious when using REUMAGIL and always inform your doctor before starting treatment. Like all non-steroidal anti-inflammatory drugs (NSAIDs), REUMAGIL may cause serious stomach and intestinal side effects such as pain, bleeding, and ulcers.

Stop taking REUMAGIL immediately and contact your doctor if you experience stomach pain or any signs of gastrointestinal bleeding, such as passing black or blood-stained stools, or if you vomit blood.

Stop using REUMAGIL immediately and contact your doctor if you develop an allergic reaction such as skin rash, facial swelling, wheezing, or difficulty breathing.

If you are over 70 years old, your doctor may wish to minimize the duration of treatment and monitor you more frequently during REUMAGIL therapy.

If you are over 70 years old or are taking other medications such as corticosteroids or certain antidepressants known as selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clots, your doctor may prescribe a protective medicine for your stomach and intestines alongside REUMAGIL.

You must not take this medicine if you are over 80 years old.

If you have or have had any medical conditions or allergies, or if you are unsure whether you can take REUMAGIL, inform your doctor before taking this medicine.

Inform your doctor if you are taking any other medicines, including those obtained without a prescription.

Medicines such as REUMAGIL may be associated with an increased risk of heart attack ("myocardial infarction") or stroke. The risk is higher with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking), discuss your treatment with your doctor or pharmacist.

REUMAGIL, like other non-steroidal anti-inflammatory drugs, reduces platelet aggregation and prolongs clotting time; this should be considered when performing hematological tests and requires vigilance when used concomitantly with drugs that inhibit platelet aggregation.

Caution is required if you have a history of hypertension and/or heart failure, as fluid retention and edema have been reported during NSAID therapy.

Particular caution is necessary if you have cardiovascular insufficiency, arterial hypertension, impaired liver or kidney function, renal hypoperfusion, existing or previous blood disorders, or are undergoing diuretic therapy.

If you are asthmatic, bronchospasm attacks, and possibly shock or other allergic phenomena, may occur due to the interaction of the drug with arachidonic acid metabolism.

Since ocular changes have been observed during NSAID therapy, periodic ophthalmological examinations are recommended during prolonged treatment.

As with other substances with similar action, increases in blood urea nitrogen (azotemia) have been observed, which do not progress beyond a certain level even with prolonged administration. These return to normal once treatment is discontinued.

If you are diabetic, frequent blood tests are advisable.

Severe allergic reactions (particularly severe skin reactions) have been reported very rarely in association with NSAID use (see "Undesired Effects").

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with REUMAGIL use. These initially appear as round red spots or circular patches, often accompanied by blisters, typically on the trunk.

Additional symptoms to watch for include mouth, throat, nose, or genital ulcers, and conjunctivitis (red, swollen eyes).

These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

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 necrolysis while using REUMAGIL, the medicine must not be used again.

If you develop a skin rash or any of these skin symptoms, stop taking REUMAGIL immediately, consult a doctor urgently, and inform them that you are taking this medicine.

If you are planning a pregnancy, if you have fertility problems, or if you are undergoing fertility investigations, discuss your treatment with your doctor.

USING REUMAGIL WITH OTHER MEDICINES

Inform your doctor about any other medicines you are currently taking or have taken recently (within the last week), including those purchased without a prescription. Medicines can sometimes interact 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:

• If you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief
• If you are taking corticosteroids, medicines used to treat various conditions such as allergies and hormonal imbalances
• If you are taking anticoagulants such as warfarin to prevent blood clots
• If you are taking certain antidepressants called selective serotonin reuptake inhibitors (SSRIs)
• If you are taking any medicine, such as aspirin, to prevent blood clots
• If you are taking diuretics, ACE inhibitors, or 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 antibiotics, used to treat bacterial infections
• If you use intrauterine devices

If any of these conditions apply, inform your doctor immediately.

USING REUMAGIL WITH FOOD AND DRINK

It is advisable not to consume alcohol during treatment with REUMAGIL.

PREGNANCY AND BREASTFEEDING

Consult your doctor or pharmacist 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, have fertility problems, or are undergoing fertility investigations, inform your doctor, as REUMAGIL may not be suitable for you.
• If you are breastfeeding, you must not take REUMAGIL. Consult your doctor: it may be better to stop breastfeeding.

DRIVING AND USING MACHINES

If you experience dizziness or unusual tiredness, exercise particular caution when driving or operating machinery.

IMPORTANT INFORMATION ON SOME EXCIPIENTS IN REUMAGIL

One vial of REUMAGIL 20 mg injectable solution contains 0.1 g of 95% ethyl alcohol and 0.02 g of benzyl alcohol: this is potentially dangerous for individuals 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 directed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
Your doctor will monitor you regularly to ensure you are taking the optimal dose of REUMAGIL. Your doctor will adjust the treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change the dose without first informing your doctor.

Adults and elderly patients:
The maximum daily dose of REUMAGIL is 20 milligrams, taken as a single daily dose. If you are over 70 years old, 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 your stomach and intestines from possible side effects.

Do not increase the dose:
If you feel that the medicine is not very effective, always discuss this with your doctor.

If you forget to take REUMAGIL
Take the medicine as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but take the next dose at the correct time. Do not take a double dose.

If you take more REUMAGIL than prescribed:
Symptoms: The most indicative symptoms of overdose are headache, vomiting, drowsiness, dizziness, and fainting.
In case of accidental ingestion of an excessive dose of REUMAGIL, contact your doctor immediately or go to the nearest hospital.

If you have any further questions about the use of this product, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, REUMAGIL can cause adverse reactions, although not everyone experiences them.
Stop taking REUMAGIL immediately and contact your doctor if:

• you develop blisters, redness or peeling of the skin (skin rash), ulceration in any part of the body (e.g. skin, mouth, eyes, lips or tongue), or any other sign of allergic reaction such as skin rash, swelling of the face, lips or tongue, which may cause breathing difficulties or wheezing
• your skin or the whites of your eyes turn yellow (jaundice)
• you experience signs of stomach or intestinal bleeding, such as passing black stools or stools with blood, or if you vomit blood

Below is a list of all adverse reactions associated with REUMAGIL.
More common adverse reactions

• Ulcers in the digestive tract and gastrointestinal bleeding
• Nausea, vomiting, diarrhoea, flatulence, constipation, gastric acidity, 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 (breathing difficulties and fatigue)

Less common adverse reactions

• Heart attack (myocardial infarction)
• Stroke
• Anorexia
• Fatigue
• Anaemia
• Blisters, redness or peeling of the skin (skin rash), or ulceration in any part of the body (e.g. skin, mouth, eyes, lips or tongue), or any other sign of allergic reaction such as skin rash, swelling of the face, lips, tongue, wheezing
• Yellowing of the skin and eyes (jaundice)
• Increase in normal liver function values
• Pancreatitis
• Acute kidney failure, blood in urine, difficulty urinating
• Increased blood non-protein nitrogen (increased azotemia)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure (hypertension)
• Nosebleeds
• Headache
• Drowsiness
• Deafness or ringing in the ears
• Dizziness
• Visual disturbances
• Malaise
• Blood and lymphatic system disorders
• Gastritis

Rare adverse reactions

• Appearance of bruises
• Changes in blood sugar levels (hypoglycaemia and hyperglycaemia)
• Sweating
• Weight changes
• Insomnia
• Depression
• Swelling, blisters or peeling of the skin
• Skin photosensitivity
• Dry mouth
• Irritability
• Bladder function disorders
• Shock
• Alopecia
• Nail growth abnormalities
• Fatal hepatitis

Very rare adverse reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform 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 stated 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. OTHER INFORMATION

What REUMAGIL contains

• The active substance is piroxicam. Each 1 ml vial contains Piroxicam 20 mg.
  The other ingredients (excipients) are: Monosodium phosphate monohydrate, nicotinamide, macrogol, 95% ethyl alcohol, 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 6 glass vials with injectable solution for intramuscular use.

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

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

This patient information leaflet was last approved on