Aspicam bio

Package leaflet: information for the patient

Aspicam Bio
7.5 mg, tablets
Meloxicam
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet, or as
directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 7 days, you should consult your doctor.

Table of contents

1. What Aspicam Bio is and what it is 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 pack and other information

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

Aspicam Bio contains the active substance meloxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic and antipyretic properties.
The anti-inflammatory mechanism of action of meloxicam is based on preferential inhibition of cyclooxygenase COX-2 over COX-1.
Indications for Aspicam Bio
As an anti-inflammatory and analgesic agent used in bone, joint and muscular pain associated with rheumatic and degenerative joint diseases.
Used for short-term treatment of flare-ups of symptoms in rheumatic diseases, such as:

• Rheumatoid arthritis,
• Juvenile rheumatoid arthritis,
• Ankylosing spondylitis.

If there is no improvement or if you feel worse after 7 days, you should consult your doctor.

2. Important information before using Aspicam Bio

When not to use Aspicam Bio

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• In pregnant women during the last three months of pregnancy.
• If the patient is under 15 years of age.
• If the patient has an allergy (hypersensitivity) to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has previously experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
  • Wheezing, tightness in the chest, shortness of breath (asthma),
  • Nasal congestion due to swelling of the nasal mucosa (nasal polyps),
  • Skin rash (urticaria),
  • Sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, which may possibly make breathing difficult (angioedema).
• If the patient has previously experienced:
  • Gastrointestinal bleeding,
  • Perforation of the stomach or intestines, during earlier treatment with NSAIDs.
• If the patient has an active peptic ulcer or gastrointestinal bleeding.
• If the patient has a history of peptic ulcer or gastrointestinal bleeding or bleeding (peptic ulcer disease or bleeding occurring at least twice).
• If the patient has severe liver function disorders.
• In non-dialysed patients with severe renal insufficiency.
• If the patient has recently experienced bleeding within the brain (cerebral haemorrhage).
• If the patient has any other bleeding disorders.
• 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, they should
contact a doctor or pharmacist.
Warnings and precautions
Before starting to use Aspicam Bio, discuss this with a doctor or pharmacist:

• If the patient has ever experienced a persistent rash (drug eruption) [circular or oval red and swollen patches on the skin, usually recurring in the same location(s), blisters, urticaria and itching] after taking meloxicam or other oxicams (e.g. piroxicam).

Taking medicines such as 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. Do not use higher doses or longer treatment duration than recommended (see section 3.
“How to use Aspicam Bio”).
If the patient has heart problems, has had a stroke, or suspects they are at risk of these
conditions, they should discuss treatment options with a doctor or pharmacist.
For example, if the patient:

• has high blood pressure (hypertension),
• has high blood sugar levels (diabetes),
• has high cholesterol levels in the blood (hypercholesterolemia),
• smokes tobacco.

If serious allergic reactions occur, discontinue use of Aspicam Bio immediately upon
the first signs of skin rash, soft tissue damage (mucosal damage), or any other allergic symptoms and contact
a doctor. Discontinue use of Aspicam Bio immediately if bleeding (causing tarry stools) or gastrointestinal ulceration
(causing abdominal pain) is observed.
Aspicam Bio is not recommended for the treatment of acute pain attacks.
Aspicam Bio may mask signs of infection (e.g. fever). If the patient suspects they have an infection, they should contact a doctor.
Consult a doctor or pharmacist before using Aspicam Bio if the patient:

• has previously had oesophagitis, gastritis or any other inflammatory condition of the gastrointestinal tract, e.g. ulcerative colitis, Crohn's disease,
• has high blood pressure (hypertension),
• is elderly,
• has heart, liver or kidney disease,
• has high blood sugar levels (diabetes),
• has reduced circulating blood volume (hypovolemia), for example due to significant blood loss or burns, surgery, or low fluid intake,
• has been diagnosed by a doctor with intolerance to certain sugars (related to the lactose content of the medicine),
• has previously diagnosed high potassium levels in the blood.

In the above cases, the doctor will monitor the patient's progress during treatment.
Children and adolescents
Aspicam Bio must not be used in children and adolescents under 15 years of age.
Aspicam Bio and other medicines
Since Aspicam Bio may affect other medicines, and other medicines may affect Aspicam Bio, tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines, always inform the doctor or pharmacist:

• other non-steroidal anti-inflammatory drugs (NSAIDs),
• anticoagulant medicines,
• medicines that dissolve blood clots (thrombolytic agents),
• medicines used for heart and kidney diseases,
• corticosteroids (e.g. used for inflammatory conditions or allergic reactions),
• cyclosporine – used after organ transplantation or in severe skin diseases, rheumatoid arthritis or nephrotic syndrome,
• diuretics; if the patient is taking such medicines, the doctor may monitor 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 cancers or severe uncontrolled skin disease and active rheumatoid arthritis,
• cholestyramine – used to reduce cholesterol levels,
• if the patient uses an intrauterine contraceptive device, commonly known as an IUD.

If in doubt about using Aspicam Bio, consult a doctor or pharmacist.
Taking Aspicam Bio with food and drink
Aspicam Bio should be taken with food, with water or another liquid.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Aspicam Bio during pregnancy.
Do not take Aspicam Bio if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Aspicam Bio may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, Aspicam Bio should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Aspicam Bio may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Aspicam Bio is not recommended for breastfeeding women.
Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely
affect fertility in women. This effect is reversible and resolves after stopping treatment.
If the patient plans to become pregnant or has difficulty becoming pregnant, she should inform the doctor about the use of Aspicam Bio.
Driving and operating machinery
Visual disturbances, drowsiness, dizziness or other central nervous system disorders
may occur after taking Aspicam Bio. If these symptoms occur, do not drive
or operate machinery.
Aspicam Bio contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult a doctor before taking this medicine.

3. How to use Aspicam Bio

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Before first use of the medicine, consult your doctor.
The recommended dose is 1 (one) tablet per day.
Aspicam Bio may be used as continuation of treatment following a prior visit to the doctor.
Do not use for longer than 7 days without consulting a doctor.
Aspicam Bio should be taken with food, with a glass of 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 must not be used in children and adolescents under 15 years of age.

If the patient feels that the effect of Aspicam Bio is too strong or too weak, or if no improvement is noticed after a few days, medical advice should be sought.

Overdose of Aspicam Bio
In case of taking more than the recommended dose of Aspicam Bio or suspected overdose, seek immediate medical advice from a 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 discontinuation of Aspicam Bio. Gastrointestinal bleeding (bleeding from the digestive tract) may occur.

Severe poisoning may lead to serious adverse effects:

• increased blood pressure (hypertension),
• acute kidney failure,
• liver function disorders,
• shallow or stopped breathing (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.

Missed dose of Aspicam Bio
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping Aspicam Bio
If you have any further questions about use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the reactions described below occur, discontinue use of the medicine
Aspicam Bio and consult a doctor or the nearest hospital.
Any allergic reactions (hypersensitivity) which may manifest as follows:

• skin reactions such as itching (pruritus), blistering and peeling of the skin, which may be severe (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes) or erythema multiforme; erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin; it may also occur on the lips, eyes and other moist parts of the body;
• swelling of the skin or mucous membranes, for example swelling around the eyes, face and lips, mouth or throat, which may make breathing difficult, swelling of the ankles and legs (peripheral oedema);
• shortness of breath or asthma attack;
• hepatitis, which may cause symptoms such as:
• yellowing of the skin and whites of the eyes (jaundice),
• abdominal pain,
• loss of appetite.

Any adverse gastrointestinal symptoms, and in particular:

• bleeding (causing black, tarry stools),
• gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding, ulceration or perforation may occasionally be severe and potentially fatal, especially in elderly patients.
If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, the patient should seek immediate medical advice, particularly if elderly. The doctor may monitor treatment progress concurrently.
If use of Aspicam Bio causes visual disturbances, do not drive or operate machinery.
General adverse reactions associated with the use of non-steroidal anti-inflammatory
drugs (NSAIDs)
The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke), especially following high-dose or long-term treatment.
Oedema, hypertension and heart failure have been reported during NSAID therapy.
The most commonly observed adverse reactions are gastrointestinal (stomach and intestinal disturbances):

• gastric and duodenal ulcer disease,
• intestinal perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse reactions have been reported with NSAID use:

• nausea and vomiting,
• loose stools (diarrhoea),
• flatulence,
• constipation,
• dyspepsia,
• abdominal pain,
• black stools due to gastrointestinal bleeding,
• vomiting blood,
• oral ulceration,
• exacerbation of colitis,
• exacerbation of gastrointestinal inflammation (exacerbation of Crohn's disease).

Gastritis has been observed less frequently.
Adverse reactions of meloxicam – the active substance in Aspicam Bio
Very common: occurring in more than 1 in 10 patients

• dyspepsia,
• nausea and vomiting,
• abdominal pain,
• constipation,
• flatulence,
• loose stools (diarrhoea).

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 sensation of spinning (of labyrinthine origin),
• somnolence (drowsiness),
• anaemia (reduced concentration of the red blood pigment – haemoglobin),
• increased blood pressure (hypertension),
• facial flushing (transient redness of the face and neck),
• sodium and water retention,
• increased potassium concentration (hyperkalaemia); this may lead to symptoms such as:
• cardiac arrhythmias,
• palpitations (when the patient feels heartbeat more than usual),
• muscle weakness;
• belching,
• gastritis,
• gastrointestinal bleeding,
• inflammation of the oral mucosa,
• immediate hypersensitivity reactions,
• pruritus,
• skin rash,
• fluid retention-related oedema, including swelling of ankles or legs (peripheral oedema),
• sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema),
• transient abnormalities in liver function tests (e.g. increased activity of liver enzymes – aminotransferases or increased concentration of bile pigment – bilirubin); the doctor may detect these changes via blood tests,
• abnormalities in laboratory tests of kidney function (e.g. increased creatinine or urea concentration).

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

• mood disturbances,
• nightmares,
• blood morphology disorders, including:
• abnormal blood smear,
• reduced white blood cell count (leukopenia),
• reduced platelet count (thrombocytopenia); these adverse reactions may lead to increased risk of infection and symptoms such as bruising or nosebleeds;
• tinnitus,
• palpitations,
• gastric or duodenal ulcer disease,
• oesophagitis,
• onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs),
• development of skin blisters or epidermal detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• urticaria,
• visual disturbances, including:
• blurred vision,
• conjunctivitis (inflammation of the eyeball or eyelids);
• colitis.

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

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

Frequency unknown: cannot be estimated from the available data

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic or anaphylactoid), skin rashes caused by exposure to sunlight (photosensitivity reactions),
• heart failure reported in association with NSAID therapy,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking meloxicam together with other medicines that may suppress or destroy bone marrow function (myelotoxic drugs). This may result in:
• sudden fever,
• sore throat,
• infections,
• pancreatitis,
• a characteristic allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-exposure to the drug and may appear as itchy, round or oval, red and swollen skin patches or blisters (urticaria).

Adverse reactions caused by non-steroidal anti-inflammatory drugs (NSAIDs), but
not yet reported after meloxicam use:

• acute renal failure due to structural changes in the kidneys:
• very rarely cases of kidney inflammation (interstitial nephritis),
• death of certain kidney cells (acute necrosis of glomeruli or renal papillae),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aspicam Bio

Keep the medicine at a temperature below 25°C.
Store in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aspicam Bio contains

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

What Aspicam Bio looks like and contents of the pack
Aspicam Bio is a yellow, round, biconvex tablet.
Aspicam Bio is available in PVC/Aluminium blisters packed in a cardboard box.
The pack contains: 10, 14, 20 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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