Aspicam Bio

Leaflet attached to the packaging: patient information

Aspicam Bio

7.5 mg, tablets

Meloxicam

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Aspicam Bio and what is it used for

Aspicam Bio contains the active substance meloxicam, which belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic, and antipyretic properties. The anti-inflammatory mechanism of meloxicam involves the preferential inhibition of cyclooxygenase-2 (COX-2) over cyclooxygenase-1 (COX-1).

Indications for use of Aspicam Bio

Aspicam Bio is used as an anti-inflammatory and analgesic in musculoskeletal and joint disorders in the course of rheumatoid and degenerative joint diseases. It is used for short-term treatment of exacerbations of symptoms of rheumatoid diseases, such as:

• rheumatoid arthritis,
• juvenile rheumatoid arthritis,
• ankylosing spondylitis.

If there is no improvement or the patient feels worse after 7 days, they should consult their doctor.

2. Important information before taking Aspicam Bio

When not to take Aspicam Bio

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• In the last three months of pregnancy.
• If the patient is under 15 years of age.
• If the patient has an allergy (hypersensitivity) to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If the patient has experienced any of the following symptoms after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs):
• wheezing, feeling of chest tightness, shortness of breath (asthma),
• nasal congestion due to swelling of the nasal mucosa (nasal polyps),
• skin rash (hives),
• sudden swelling of the skin or mucous membranes, e.g., swelling around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema).
• If the patient has experienced:
• gastrointestinal bleeding or perforation after taking NSAIDs.
• If the patient has a history of gastrointestinal ulcers or bleeding.
• If the patient has had gastrointestinal ulcers or bleeding (ulcers or bleeding that have occurred at least twice).
• If the patient has severe liver dysfunction.
• In patients with severe renal impairment who are not on dialysis.
• If the patient has recently experienced cerebral bleeding (cerebral hemorrhage).
• If the patient has experienced any other bleeding.
• If the patient has severe heart failure.
• If the patient has previously been diagnosed with intolerance to certain sugars, as the medicine contains lactose (see also "Aspicam Bio contains lactose").

If the patient is unsure whether any of the above points apply to them, they should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with Aspicam Bio, the patient should discuss it with their doctor or pharmacist;

• If the patient has ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g., piroxicam), characterized by round or oval, red, and swollen patches on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.

Taking medicines like Aspicam Bio 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. The patient should not take higher doses or use the medicine for longer than recommended (see section 3, "How to take Aspicam Bio"). In case of heart problems, a history of stroke, or suspected risk of these disorders, the patient should discuss their treatment with their doctor or pharmacist. For example, if the patient:

• has high blood pressure (hypertension),
• has high blood sugar (diabetes),
• has high cholesterol (hypercholesterolemia),
• smokes.

In the event of severe allergic reactions, the patient should stop taking Aspicam Bio after the first symptoms of skin rash, soft tissue damage (mucosal lesions), or any other signs of allergy and consult their doctor. The patient should stop taking Aspicam Bio immediately if they notice bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain). Aspicam Bio is not recommended for the treatment of acute pain attacks. Aspicam Bio may mask the symptoms of infection (e.g., fever). If the patient suspects they have an infection, they should consult their doctor. The patient should consult their doctor or pharmacist for advice before taking Aspicam Bio if they:

• have a history of esophagitis, gastritis, or any other inflammatory condition of the gastrointestinal tract, e.g., ulcerative colitis, Crohn's disease,
• have high blood pressure (hypertension),
• are elderly,
• have heart, liver, or kidney disease,
• have high blood sugar (diabetes),
• have decreased blood volume (hypovolemia), e.g., due to significant blood loss or burns, surgery, or low fluid intake,
• have intolerance to certain sugars, diagnosed by a doctor (related to the lactose content in the medicine),
• have high potassium levels in the blood, previously diagnosed by a doctor.

In these cases, the doctor will monitor the patient's progress.

Children and adolescents

Aspicam Bio should not be used in children and adolescents under 15 years of age.

Aspicam Bio and other medicines

Since Aspicam Bio may interact with other medicines, and other medicines may affect Aspicam Bio, the patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. If the patient is taking any of the following medicines, they should always inform their doctor or pharmacist:

• other nonsteroidal anti-inflammatory drugs (NSAIDs),
• anticoagulants,
• medicines that dissolve blood clots (thrombolytic agents),
• medicines used to treat heart and kidney diseases,
• corticosteroids (e.g., used in inflammatory conditions or to treat allergic reactions),
• cyclosporin - used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome,
• diuretics; if the patient is taking these medicines, their doctor may monitor their kidney function,
• medicines used to treat high blood pressure (e.g., beta-blockers),
• lithium - used to treat mood disorders,
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression,
• methotrexate - used to treat cancer or severe uncontrolled skin disease and active rheumatoid arthritis,
• cholestyramine - used to reduce cholesterol levels,

In case of doubts about taking Aspicam Bio, the patient should consult their doctor or pharmacist.

Taking Aspicam Bio with food and drink

Aspicam Bio should be taken with food, washed down with water or another liquid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy Aspicam Bio should not be used during pregnancy. The patient should not take Aspicam Bio if they are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Aspicam Bio may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and prolong or delay labor. During the first 6 months of pregnancy, Aspicam Bio should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Aspicam Bio may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring. Breastfeeding Aspicam Bio is not recommended for breastfeeding women. Fertility This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the end of treatment. If the patient plans to become pregnant or is having trouble conceiving, they should inform their doctor about taking Aspicam Bio.

Driving and using machines

Visual disturbances, drowsiness, dizziness, or other central nervous system disorders may occur after taking Aspicam Bio. If these symptoms occur, the patient should not drive or operate machinery.

Aspicam Bio contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Aspicam Bio

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The medicine should be taken orally. Before the first use of the medicine, the patient should consult their doctor. The recommended dose is 1 (one) tablet per day. Aspicam Bio may be used as a continuation of treatment after a previous doctor's visit. Without consulting a doctor, the patient should not take the medicine for more than 7 days. Aspicam Bio should be taken with food, washed down with water or another liquid. Patients with kidney or liver disease: see section 2, "Important information before taking Aspicam Bio".

Use in children and adolescents

Aspicam Bio should not be used in children and adolescents under 15 years of age.

If the patient thinks that the effect of Aspicam Bio is too strong or too weak, or if they do not feel any improvement after a few days, they should consult their doctor.

Taking a higher dose of Aspicam Bio than recommended

In case of taking a higher dose of Aspicam Bio than recommended or suspected overdose, the patient should immediately consult their doctor or go to the nearest hospital.

Symptoms of NSAID overdose are usually limited to:

• weakness (lethargy),
• drowsiness,
• nausea and vomiting,
• stomach pain. These symptoms usually resolve after stopping the use of Aspicam Bio. The patient may experience gastrointestinal bleeding (gastrointestinal bleeding).

Severe poisoning may lead to serious side effects:

• increased blood pressure (hypertension),
• acute kidney failure,
• liver dysfunction,
• shallow breathing or respiratory arrest (respiratory depression),
• loss of consciousness (coma),
• seizures (convulsions),
• circulatory collapse (cardiovascular collapse),
• cardiac arrest,
• immediate allergic reactions (hypersensitivity), including:
• fainting,
• shortness of breath,
• skin reactions.

Missing a dose of Aspicam Bio

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the scheduled time.

Stopping treatment with Aspicam Bio

In case of further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following reactions occur, the patient should stop taking Aspicam Bio and consult their doctor or the nearest hospital.

Any allergic reactions (hypersensitivity), which may manifest as:

• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (mucosal lesions), or a rash (erythema multiforme); erythema multiforme is a severe allergic skin reaction that causes patches, red or purple stripes, or blisters on the skin and can also occur on the lips, eyes, and other moist body parts;
• swelling of the skin or mucous membranes, e.g., swelling around the eyes, face, and lips, mouth, or throat, which may cause difficulty breathing, swelling of the ankles and feet (peripheral edema);
• shortness of breath or asthma attacks;
• liver inflammation, which may cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite.

Any gastrointestinal side effects, in particular:

• bleeding (causing black stools),
• ulcers in the gastrointestinal tract (causing abdominal pain).

Gastrointestinal bleeding or ulcers may sometimes have a severe course and potentially be life-threatening, especially in elderly patients. If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor their progress simultaneously. If taking Aspicam Bio causes visual disturbances, the patient should not drive or operate machinery.

General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke), especially when the medicine is used in high doses and for long-term treatment. NSAID treatment has been reported to cause edema, hypertension, and heart failure. The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• gastric or duodenal ulcer,
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting,
• diarrhea (diarrhea),
• flatulence with gas release,
• constipation,
• indigestion (dyspepsia),
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• bloody vomiting,
• mouth ulcers,
• worsening of ulcerative colitis,
• worsening of Crohn's disease.

Side effects of meloxicam - the active substance of Aspicam Bio

Very common: occurring in more than 1 in 10 patients

• indigestion (dyspepsia),
• nausea (nausea) and vomiting,
• abdominal pain,
• constipation,
• bloating,
• diarrhea (diarrhea).

Common: occurring in 1 to 10 in 100 patients

• headache.

Uncommon: occurring in 1 to 10 in 1,000 patients

• dizziness (feeling of emptiness in the head),
• vertigo or a feeling of spinning (of labyrinthine origin),
• drowsiness (somnolence),
• anemia (reduced hemoglobin levels),
• increased blood pressure (hypertension),
• flushing (temporary flushing of the face and neck),
• retention of sodium and water,
• increased potassium levels (hyperkalemia); this may lead to symptoms such as:
• arrhythmias,
• palpitations (feeling of heartbeat more than usual),
• muscle weakness;
• bloating,
• gastritis,
• gastrointestinal bleeding,
• mouth ulcers,
• immediate allergic reactions (hypersensitivity),
• itching,
• skin rash,
• edema caused by fluid retention, including ankle or foot swelling (peripheral edema),
• sudden swelling of the skin or mucous membranes, e.g., swelling around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema),
• temporary changes in liver function test results (e.g., increased liver enzyme activity - transaminases or increased bilirubin levels); the doctor may detect these changes with a blood test,
• changes in kidney function test results (e.g., increased creatinine or urea levels).

Rare: occurring in 1 to 10 in 10,000 patients

• mood disorders,
• nightmares,
• blood disorders, including:
• abnormal blood smear,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia); these side effects may increase the risk of infection and cause symptoms such as:
• sudden fever,
• sore throat,
• infections
• pancreatitis,
• a characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same place (in the same places) after re-administration of the medicine and may appear as itchy, round or oval, red, and swollen patches on the skin, blisters (hives).

Very rare: occurring in less than 1 in 10,000 patients

• blistering skin reactions and erythema multiforme,
• liver inflammation, which may cause symptoms such as:
• yellowing of the skin and eyes (jaundice),
• abdominal pain,
• loss of appetite;
• acute kidney failure, particularly in patients with risk factors such as heart disease, diabetes, or kidney disease,
• perforation of the intestinal wall.

Frequency not known: cannot be estimated from the available data

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic or anaphylactoid), sun-induced skin reactions (photosensitivity reactions),
• heart failure reported in association with NSAID treatment,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam with other medicines that may suppress bone marrow activity or damage it (myelotoxic agents). This may cause:
• sudden fever,
• sore throat,
• infections
• pancreatitis,
• a characteristic skin allergic reaction known as fixed drug eruption.

Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) but not yet reported with meloxicam:

• acute kidney failure due to changes in kidney structure:
• very rare cases of kidney inflammation (interstitial nephritis),
• necrosis of some kidney cells (acute tubular necrosis or renal papillary necrosis),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Aspicam Bio

The medicine should be stored at a temperature below 25°C. It should be kept out of sight and reach of children. The medicine should not be used after the expiration date stated on the packaging and blister. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Aspicam Bio contains

• The active substance of Aspicam Bio is meloxicam. One tablet contains 7.5 mg of meloxicam.
• The other ingredients are: lactose monohydrate, povidone, crospovidone, magnesium stearate.

What Aspicam Bio looks like and what the pack contains

Aspicam Bio is a round, biconvex, light yellow tablet. Aspicam Bio is available in PVC/Aluminum blisters, placed in a cardboard box. The packaging contains: 10, 14, 20, or 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań tel.: +48 61 66 51 500 fax: +48 61 66 51 505 Date of last revision of the leaflet:04.03.2024