Aspicam

Leaflet attached to the packaging: information for the user

Aspicam, 15 mg, tablets

Meloxicam

You should carefully read the contents of the leaflet before using 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aspicam and what is it used for

Aspicam contains the active substance meloxicam.
This medicine belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory and analgesic effects.

Indications

• Short-term symptomatic treatment of exacerbations of osteoarthritis.
• Long-term symptomatic treatment of rheumatoid arthritis.
• Long-term symptomatic treatment of ankylosing spondylitis.

2. Important information before taking Aspicam

When not to take Aspicam

• if the patient is allergic to meloxicam, other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms of allergy such as rhinitis, urticaria, angioedema or bronchial asthma related to the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if the patient has active or recurrent gastric or duodenal ulcers;
• if the patient has had perforations or gastrointestinal bleeding related to the use of other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had other gastrointestinal bleeding, cerebral bleeding, or other bleeding;
• if the patient has severe liver failure;
• if the patient has severe kidney failure and is not undergoing dialysis;
• if the patient has severe heart failure;
• during pregnancy or breastfeeding, or if the patient plans to become pregnant.

Warnings and precautions

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

• if the patient has had esophageal, gastric, or duodenal ulcers (these conditions require complete healing before starting treatment with meloxicam);
• if the patient has gastrointestinal disorders or gastrointestinal disease (e.g., ulcerative colitis, Crohn's disease), due to the risk of worsening their condition;
• if the patient is elderly, as the risk of side effects is increased (especially gastrointestinal bleeding or perforation, which can be very dangerous for the patient);
• if the patient has had toxicity caused by non-steroidal anti-inflammatory drugs (any unusual symptoms related to the abdominal cavity, especially at the start of treatment, should be reported to the doctor);
• if the patient is taking other medicines that may increase the risk of gastrointestinal ulcers or bleeding (such as oral corticosteroids), anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as acetylsalicylic acid);
• as patients are most susceptible to severe skin reactions at the start of treatment, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (sometimes life-threatening). If a skin rash, mucosal damage, or any symptoms of hypersensitivity to the medicine occur, treatment with meloxicam should be discontinued;
• if the patient has liver or kidney function disorders;
• if the patient has reduced blood flow to the kidneys and reduced blood volume, as this may lead to the manifestation of latent kidney failure. However, after discontinuing treatment with Aspicam, kidney function returns to its pre-treatment state. This risk occurs in all elderly patients, patients with circulatory failure, liver cirrhosis, nephrotic syndrome, or kidney function disorders, as well as patients taking diuretics or undergoing extensive surgical procedures leading to hypovolemia (reduced blood volume);
• if the patient has heart disorders, hypertension, peripheral artery disease, or cerebrovascular disease:
• if the patient has ever experienced a persistent rash (erythema) 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, urticaria, and itching.

Meloxicam should be avoided in combination with other non-steroidal anti-inflammatory drugs.
To minimize the risk of side effects, the doctor will use the smallest effective dose of meloxicam for the shortest possible time.
Taking such medicines as Aspicam may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of meloxicam in high doses. Do not take higher doses or longer treatment than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should consult their doctor or pharmacist.
In patients with gastric or duodenal ulcers, elderly patients, and patients requiring concurrent use of low-dose acetylsalicylic acid or other medicines that increase the risk of gastrointestinal damage, the doctor will start treatment with the smallest effective dose of the medicine, due to the risk of gastrointestinal bleeding, ulcers, or perforation. The doctor may recommend concurrent use of medicines that protect the gastric mucosa.
Treatment should be discontinued in case of gastrointestinal bleeding (often manifested by bloody vomiting or black stools).
Like other non-steroidal anti-inflammatory drugs, meloxicam may mask the symptoms of an existing infectious disease.
Rarely, non-steroidal anti-inflammatory drugs may cause interstitial nephritis, nephrotic syndrome, renal papillary necrosis, or nephrotic syndrome.

Using Aspicam in patients with kidney function disorders

During treatment with Aspicam in patients with kidney function disorders, the doctor will order appropriate tests to assess kidney function.

Using Aspicam in patients with liver function disorders

During treatment with Aspicam in patients with liver function disorders, the doctor may order appropriate tests to assess liver function.

Using Aspicam in elderly patients

Elderly or weakened patients often tolerate the adverse effects of the medicine poorly and require careful medical supervision. Particular caution is required in elderly patients, who often have kidney, liver, and heart function disorders. Treatment should be started with the smallest effective dose.

Children and adolescents

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

Aspicam and other medicines

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.
In particular, the patient should mention the following medicines:

• anticoagulants such as acenocoumarol, heparin, ticlopidine;
• other anti-inflammatory medicines, including acetylsalicylic acid;
• lithium;
• methotrexate;
• cyclosporine;
• diuretics;
• medicines that lower blood pressure, including beta-blockers (e.g., atenolol, propranolol), angiotensin II receptor antagonists (e.g., ibesartan), ACE inhibitors (e.g., enalapril, perindopril);
• thrombolytic agents (medicines that cause the dissolution of blood clots in blood vessels, e.g., streptokinase, urokinase);
• antidepressant medicines belonging to the group of selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline);
• corticosteroids;
• cholestyramine.

Aspicam with food and drink

The medicine should be taken during a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking Aspicam is contraindicated in pregnant women.
The patient should not take Aspicam if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Aspicam may cause kidney and heart function disorders in the unborn child. It may also increase the risk of bleeding in the patient and child, as well as prolong or delay labor.
During the first 6 months of pregnancy, Aspicam should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Aspicam may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Aspicam should not be taken during breastfeeding.
Aspicam may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Aspicam may cause dizziness, headaches, ringing in the ears, drowsiness, and rarely, vision disturbances, including blurred vision.
In such cases, the patient should not drive or operate machinery.

Aspicam contains lactose

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

3. How to take Aspicam

This medicine should always be taken according to the doctor's recommendations. If the patient has any doubts, they should consult their doctor or pharmacist.
The daily dose of Aspicam should be taken in a single dose, during a meal, with a glass of water.

DO NOT EXCEED THE DAILY DOSE OF 15 mg.

For adolescents over 15 years of age and adults, the following is usually used:

• Short-term treatment of exacerbations of osteoarthritis: 7.5 mg per day. If the therapeutic effect is not achieved, the doctor may increase the dose to 15 mg per day.
• Long-term symptomatic treatment of rheumatoid arthritis: 15 mg per day. In elderly patients with rheumatoid arthritis, the dose of meloxicam is 7.5 mg per day. In patients with an increased risk of side effects, treatment should be started with a dose of 7.5 mg per day.
• Long-term symptomatic treatment of ankylosing spondylitis: 15 mg per day. In patients undergoing dialysis, with severe kidney failure, the daily dose should not exceed 7.5 mg.

Using Aspicam in children and adolescents

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

Taking a higher dose of Aspicam than recommended

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

Missing a dose of Aspicam

In case of missing a dose, the patient should take the next dose at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Aspicam

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, the patient should stop taking the medicine, consult their doctor, or go to the nearest hospital:

• gastrointestinal bleeding;
• shortness of breath;
• facial swelling;
• swelling of the mouth and (or) throat, manifested by difficulty swallowing or breathing.

The side effects of Aspicam are listed below by frequency of occurrence:
Common (occurring in 1 to 10 out of 100 patients):

• anemia;
• dizziness;
• headache;
• nausea, vomiting, abdominal pain, constipation, bloating, diarrhea;
• itching, rash;
• edema, including edema of the lower limbs.

Uncommon (occurring in 1 to 10 out of 1,000 patients):

• blood disorders: leukopenia (decreased white blood cell count), thrombocytopenia (decreased platelet count), agranulocytosis (absence of granulocytes in the blood);
• dizziness;
• ringing in the ears;
• drowsiness;
• palpitations, heart failure;
• increased blood pressure;
• sudden flushing of the face;
• gastrointestinal bleeding, gastric ulcers, esophagitis, oral mucositis (including ulcerative);
• transient disorders of liver function tests (e.g., increased transaminase activity or bilirubin levels);
• urticaria;
• disorders of kidney function tests (e.g., increased creatinine or urea levels).

Rare (occurring in 1 to 10 out of 10,000 patients):

• anaphylactic or anaphylactoid reactions;
• mood disorders;
• insomnia and nightmares;
• disorientation;
• vision disturbances (including blurred vision);
• asthma attacks in some patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• perforation of the gastrointestinal tract, gastric mucositis, colitis (perforation or gastrointestinal bleeding may have a severe course, especially in elderly patients), black stools, bloody vomiting, or exacerbation of Crohn's disease;
• hepatitis;
• Stevens-Johnson syndrome and toxic epidermal necrolysis;
• angioedema;
• bullous symptoms such as erythema multiforme;
• photosensitivity (blisters may form during sun exposure, resembling severe burns);
• kidney failure.

Frequency not known (cannot be estimated from available data):

• 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 (urticaria).

Taking such medicines as Aspicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Non-steroidal anti-inflammatory drugs (NSAIDs) have been reported to cause edema, hypertension, and heart failure.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell 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
Aleje 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aspicam

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine 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 contains

• The active substance of the medicine is meloxicam. One tablet contains 15 mg of meloxicam.
• The other ingredients are: lactose monohydrate, povidone, crospovidone, magnesium stearate.

What Aspicam looks like and what the packaging contains

Round, biconvex tablets, light yellow in color
The tablets are packaged in PVC/PVDC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
The packaging contains: 10, 20, 30, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: +48 61 66 51 500
Fax: +48 61 66 51 505
Date of last revision of the leaflet:12.06.2023