Flamexin

Leaflet accompanying the packaging: information for the user

Flamexin,

20 mg, tablets
Piroxicam

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Flamexin and what is it used for
• 2. Important information before taking Flamexin
• 3. How to take Flamexin
• 4. Possible side effects
• 5. How to store Flamexin
• 6. Contents of the packaging and other information

1. What is Flamexin and what is it used for

Flamexin contains the active substance piroxicam in combination with beta-cyclodextrin. Piroxicam belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs), which have analgesic, anti-inflammatory, and antipyretic properties. The special combination of piroxicam with beta-cyclodextrin allows for faster absorption of the medicine by the body and faster reduction of pain.
Before prescribing Flamexin, your doctor will assess the benefits that the medicine can provide to you, compared to the risk of side effects. Your doctor may order control tests and inform you how often control visits will be necessary in connection with taking Flamexin.
Your doctor may prescribe Flamexin only if other nonsteroidal anti-inflammatory drugs (NSAIDs) have not provided sufficient relief of symptoms.
Flamexin is used to relieve symptoms such as swelling, stiffness, and joint pain caused by:

• osteoarthritis;
• rheumatoid arthritis;
• ankylosing spondylitis (spinal rheumatism).

The medicine does not cure arthritis and only works while it is being taken.

2. Important information before taking Flamexin

When not to take Flamexin

• If you have ever had an allergic reaction to piroxicam, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of this medicine (listed in section 6). Symptoms of allergic reactions include difficulty breathing, runny nose, or severe skin reactions (see section 4).

if you have or have had stomach or duodenal ulcers, bleeding, or perforation in the gastrointestinal tract.

• If you have a history of gastrointestinal diseases (gastritis or colitis) that may lead to complications such as bleeding, including ulcerative colitis, Crohn's disease, gastrointestinal tumors, or diverticulitis (inflamed or infected pouches/pockets in the colon).
• If you are taking other NSAIDs, including selective COX-2 inhibitors, and acetylsalicylic acid (a substance found in many painkillers and antipyretics).
• If you are taking anticoagulant medications, such as acenocoumarol, to prevent blood clots.
• If you have had a severe allergic reaction to piroxicam, other NSAIDs, and other medications, especially with a history of severe skin reactions (regardless of severity), such as exfoliative dermatitis (intense redness of the skin with scaling), blistering reactions (Stevens-Johnson syndrome, a condition with redness of the skin and formation of blisters, erosions, bleeding, or scabs), and toxic epidermal necrolysis (Lyell's syndrome, a disease with blistering and peeling of the skin).
• If you have symptoms of asthma, rhinitis, nasal polyps, angioedema, or urticaria after taking acetylsalicylic acid or other NSAIDs.
• If you have moderate or severe heart failure.
• If you have hypertension.
• If you have severe liver failure.
• If you have severe kidney failure.
• If you have a tendency to frequent bleeding or coagulation disorders.
• If you are breastfeeding.
• If you are pregnant or suspect that you may be pregnant.
• If you are under 18 years of age.

Patient belonging to any of the above groups should not take piroxicam. You should immediately inform your doctor if any of the above circumstances apply to you.

Warnings and precautions

Before starting treatment with Flamexin, you should discuss it with your doctor.
Like all nonsteroidal anti-inflammatory drugs, Flamexin may cause serious gastrointestinal reactions, such as pain, bleeding, ulcers, and perforation.
If you experience stomach pain or any symptoms of gastrointestinal bleeding, such as dark stools, stools with blood, or bloody vomiting, you should stop taking piroxicam immediately and consult your doctor.
In case of any allergic reaction, such as skin rash, facial swelling, wheezing, or difficulty breathing, you should stop taking piroxicam immediately and inform your doctor about this reaction.
People with any diseases or allergies or people who are not sure if they can take piroxicam should consult their doctor before taking the medicine.
Potentially life-threatening severe skin reactions have been reported with the use of Flamexin: drug reaction with eosinophilia and systemic symptoms (DRESS, a syndrome with eosinophilia and systemic symptoms), Stevens-Johnson syndrome, and toxic epidermal necrolysis, which appear on the torso initially as red, round, or oval patches, often with blisters in the center.
Additionally, you should pay attention to the following symptoms: oral ulcers, pharyngitis, nasal or genital ulcers, and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may lead to the spread of blisters or peeling of the skin.
The greatest risk of severe skin reactions occurs within the first few weeks of treatment.
If you have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Flamexin, you should never take Flamexin again.
In case of a rash or any of the above skin symptoms, you should stop taking Flamexin, contact your doctor as soon as possible, and inform them about taking this medicine.
If you experience a rash or other skin symptoms, you should stop taking piroxicam immediately, seek medical attention, and tell your doctor about taking this medicine.
In patients over 70 years of age, your doctor may reduce the treatment period to a minimum and order more frequent control visits during treatment with piroxicam. In patients over 70 years of age or taking other medications, such as corticosteroids, certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid as a blood thinner, your doctor may prescribe a medicine to protect the stomach and intestines at the same time as Flamexin.
You should avoid giving the medicinal product to patients over 80 years of age.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss the treatment with your doctor.
Taking such medications as Flamexin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should not take higher doses or longer treatment than recommended.

Flamexin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Medicines can sometimes interact with each other. Your doctor may limit the use of piroxicam or other medicines or may prescribe another medicine.
It is especially important to inform your doctor:

• if you are taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs to reduce pain;
• if you are taking corticosteroids, which are medications used to treat, for example, allergies and endocrine disorders;
• if you are taking anticoagulant medications, such as warfarin, acenocoumarol, to prevent blood clots;
• if you are taking any medications, such as acetylsalicylic acid, to prevent blood clotting; or if you are taking certain antidepressants called selective serotonin reuptake inhibitors (SSRIs);
• if you are taking lithium for the treatment of depression;
• if you are taking antacids;
• if you are taking cardiac glycosides (e.g., digoxin and digitoxin);
• if you are taking cimetidine for the treatment of stomach ulcers;
• if you are taking medications to lower blood pressure, including diuretics, angiotensin-converting enzyme inhibitors, and angiotensin II receptor antagonists;
• if you are taking cyclosporine (an immunosuppressive medication used, among other things, in the treatment of transplant patients);
• if you are taking tacrolimus (an immunosuppressive medication used, among other things, in the treatment of atopic dermatitis);
• if you are taking medications containing potassium and potassium-sparing diuretics;
• if you are taking methotrexate (a medication used, among other things, in cancer and rheumatoid arthritis);
• if you are taking quinolone antibiotics, such as ciprofloxacin, for the treatment of bacterial infections;
• if you are using intrauterine contraceptive devices.

If any of the above statements apply to you, you should inform your doctor immediately.

Flamexin and alcohol

You should not consume alcohol while taking piroxicam. Alcohol increases the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
Taking piroxicam is contraindicated in case of confirmed pregnancy or suspected pregnancy, as well as during breastfeeding.
Fertility
Taking piroxicam may have a negative effect on fertility in women and is not recommended for women who plan to become pregnant.

Driving and using machines

If you experience headaches, vision disturbances, dizziness, or drowsiness after taking Flamexin, you should not drive or operate machinery.

Flamexin contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Flamexin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Flamexin

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. Your doctor will order regular control visits to ensure that you are taking the optimal dose of piroxicam. Your doctor will adjust the treatment to the smallest effective dose. If you feel that the medicine is not effective enough, you should always consult your doctor.

Dosage Adults and elderly

The maximum daily dose is 20 milligrams of piroxicam taken as a single daily dose.
This corresponds to 1 tablet containing 191.2 mg of piroxicam with beta-cyclodextrin.
In patients over 70 years of age, your doctor may recommend a lower daily dose and shorten the treatment period.
Your doctor may recommend taking half the dose. To divide the tablet into two equal doses (10 mg each), you should place the tablet on a flat surface with the dividing line facing up and gently press it with your thumb, breaking it into two equal parts.
The medicine should be taken orally during a meal.
Your doctor may recommend taking piroxicam with another medicine to protect the stomach and intestines from potential side effects.
In no caseshould you change the dose without consulting your doctor.

Do not increase the dose of the medicine.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

Taking a higher dose of Flamexin than recommended

In case of taking a higher dose of Flamexin than recommended, you should immediately contact your doctor or pharmacist. Remember to take the packaging of the medicine and all remaining tablets with you.

Missing a dose of Flamexin

You should take the medicine as soon as possible. However, if it is almost time for the next dose, do not take the missed dose, just take the next dose at the right time. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions have been reported with the use of piroxicam. You should immediatelycontact your doctor or the nearest hospital emergency department if you experience any of the following symptoms:

• chest pain, severe breathing difficulties, or anaphylactic reaction, which may be characterized by rapid heartbeat, excessive sweating, fever, and in severe cases, shock and collapse;
• skin rashes, including itching, urticaria, skin rash, severe reaction causing facial swelling or throat swelling, severe skin reactions, such as exfoliative dermatitis (intense redness of the skin with scaling), potentially life-threatening skin rashes associated with skin redness and formation of blisters, erosions, bleeding, or scabs (Stevens-Johnson syndrome), toxic epidermal necrolysis;
• separation of nails from the nail bed, nail splitting, and hair loss;
• angioedema, which may be associated with fever, rash, and joint pain.

In case of any of the following severe side effects, you should immediately stop takingFlamexin and contact your doctor:

• bloody stools or bloody diarrhea;
• bloody vomiting;
• perforation or ulceration of the stomach or small intestine;
• abdominal pain or stomach pain.

The following side effects are listed according to their frequency:

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 people)

• decrease in red blood cell count, which may cause paleness, weakness, or shortness of breath;
• decrease in platelet count, which may increase the risk of bleeding or bruising;
• significant decrease in white blood cell count, which may cause weakness, unusual bruising, or increased risk of infection; may also cause an increase in eosinophils (a type of white blood cell);
• loss of appetite, increased blood sugar levels;
• dizziness, headache, drowsiness, tinnitus;
• discomfort in the abdomen, stomach pain, constipation, diarrhea, abdominal pain or discomfort, bloating, nausea, vomiting, indigestion;
• skin rash, itching;
• swelling of the feet and ankles;
• weight gain, changes in laboratory test results (increased transaminase activity).

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 people):

• decrease in blood sugar levels, which may cause shakiness, sweating, and rapid heartbeat;
• blurred vision;
• palpitations;
• stomatitis.

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 people):

• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure.

Very rare side effects (occurring in less than 1 in 10,000 people):

• severe skin reactions, including skin rashes associated with skin redness and formation of blisters, erosions, bleeding, or scabs (Stevens-Johnson syndrome), toxic epidermal necrolysis.

Frequency of side effects not known (cannot be estimated from available data)

• aplastic anemia, hemolytic anemia;
• serum sickness, anaphylaxis;
• fluid retention;
• depression, sleep disturbances, hallucinations, insomnia, disorientation, mood changes, nervousness;
• aseptic meningitis, paresthesia (a feeling of tingling, pricking, or burning);
• eye irritation, eyelid edema;
• hearing loss;
• hypertension, vasculitis;
• bronchospasm, dyspnea, epistaxis;
• gastritis, gastrointestinal bleeding, perforation of the gastrointestinal tract, melena, bloody vomiting, peptic ulcer, pancreatitis, dry mouth;
• jaundice, hepatitis;
• alopecia, angioedema, exfoliative dermatitis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity, nail separation, urticaria, vesiculobullous reactions, purpura;
• persistent drug rash (may have the form of round or oval red patches and swelling on the skin), blisters (urticaria), itching;
• glomerulonephritis;
• malaise;
• weight loss, changes in laboratory test results (elevated alkaline phosphatase, positive antinuclear antibodies, decreased hemoglobin, decreased hematocrit).

In elderly patients or patients with heart disease, there is a possibility of congestive heart failure.
Taking some NSAIDs (especially in high doses and in chronic treatment) may be associated with a small increased risk of complications such as myocardial infarction or stroke.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Flamexin

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.
• There are no special precautions for storage.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Flamexin contains

The active substance of Flamexin is piroxicam in combination with beta-cyclodextrin.
One tablet contains: 191.2 mg of piroxicam with beta-cyclodextrin, which corresponds to 20 mg of piroxicam.
The other excipients are: lactose monohydrate, crospovidone, sodium carboxymethylcellulose, colloidal silica, gelatinized starch, magnesium stearate.

What Flamexin looks like and contents of the pack

Flamexin is a hexagonal tablet with a dividing line.
Flamexin is packaged in PVC/PVDC/Aluminum/PVDC blisters, placed in a cardboard box.
Flamexin is available in packs containing:
1 blister of 10 tablets
2 blisters of 10 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

Manufacturer:

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG), Italy
To obtain more detailed information, you should contact the representative of the marketing authorization holder in Poland:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
Phone: (22) 620 14 21
Fax: (22) 652 37 79
e-mail: info-pl@chiesi.com

Date of last revision of the leaflet:

[Chiesi logo]