Meloxicam apteo med

Package leaflet: information for the patient

Meloxicam APTEO MED, 7.5 mg, tablets
Meloxicamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.

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

Contents of the leaflet

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

1. What Meloxicam APTEO MED is and what it is used for

Meloxicam APTEO MED contains the active substance meloxicam. Meloxicam belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce
inflammation and pain in the joints and muscles.
Meloxicam APTEO MED is used:

• for the short-term symptomatic treatment of flare-ups of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis (also known as Bechterew's disease).

2. Important information before using Meloxicam APTEO MED

When not to use Meloxicam APTEO MED:

• In pregnant women during the last three months of pregnancy
• In children and adolescents under 16 years of age
• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• If the patient is allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• If the patient has 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 obstruction due to swelling of the nasal mucosa (nasal polyps)
• Skin rash (urticaria)
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may possibly make breathing difficult (angioedema)
• If the patient has previously experienced the following during treatment with NSAIDs:
• Bleeding from the stomach or intestines
• Perforation of the stomach or intestines
• If the patient currently has a peptic ulcer or bleeding from the stomach or intestines
• If the patient has previously suffered from peptic ulcers of the stomach or intestines or gastrointestinal bleeding (peptic ulcer or bleeding occurring at least twice)
• If the patient has severe liver function disorders
• In non-dialysed patients with severe renal failure
• If the patient has recently experienced bleeding within the brain (cerebral haemorrhage)
• If the patient has experienced any other bleeding
• If the patient has severe heart failure
• In case of intolerance to certain sugars – the product contains lactose (see also Meloxicam APTEO MED contains monohydrate lactose)

If the patient is unsure whether any of the above points apply, they should
contact their doctor.
Warnings and precautions
Warnings
Taking medicines such as Meloxicam APTEO MED may be associated with a small
increase in the 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).
If the patient has heart problems, has had a stroke, or suspects that they are at risk of such
conditions, they should discuss the treatment approach with their doctor or pharmacist.
For example, when:

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

The use of Meloxicam APTEO MED should be discontinued immediately upon noticing
bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain).
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam APTEO MED, initially appearing as red spots or round patches on the trunk, often with central blisters. Additional symptoms that may be observed include ulcers in the mouth, throat, nose, genitals and inflammation of the conjunctiva (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to generalized blisters or separation of the epidermis. The highest risk of severe skin reactions occurs during the first weeks of treatment.
Patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Meloxicam APTEO MED must not resume treatment with meloxicam.
If a skin rash or any of the above symptoms occur, the use of Meloxicam APTEO MED should be stopped and immediate medical advice should be sought, informing the doctor about the use of this medicine.
Meloxicam APTEO MED is not recommended for the treatment of acute pain attacks.
Meloxicam APTEO MED may mask symptoms of infection (e.g. fever). If the patient suspects an infection, they should contact their doctor.
Precautions for use
Due to the need for treatment adjustments, consult a doctor before starting Meloxicam APTEO MED in the following cases:

• If there has been a history of oesophagitis, gastritis or any other gastrointestinal disorder, e.g. Crohn's disease or ulcerative colitis,
• High blood pressure (hypertension),
• Use in elderly patients,
• Heart, liver or kidney disease,
• High blood glucose (sugar) levels (diabetes),
• Reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgical procedures or low fluid intake,
• Diagnosed intolerance to certain sugars, as the medicine contains lactose,
• High potassium levels in the blood, previously diagnosed by a doctor. In the above cases, the doctor will monitor treatment outcomes.

Before starting Meloxicam APTEO MED, discuss this with your doctor,
pharmacist or nurse.
Meloxicam APTEO MED and other medicines
Meloxicam APTEO MED may affect the action of other medicines being taken, and other medicines may also affect the action of Meloxicam APTEO MED.
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if any of the following medicines are being used:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)
• Potassium salts – used to treat low potassium levels in the blood
• Tacrolimus – used after organ transplantation
• Anticoagulants
• Medicines that dissolve blood clots (thrombolytic agents)
• Medicines used for heart and kidney diseases
• Corticosteroids (e.g. used for anti-inflammatory purposes or to treat allergic reactions)
• Cyclosporine – used after organ transplantation or in severe skin diseases, rheumatoid arthritis or nephrotic syndrome
• Deferasirox – used to treat iron overload after frequent blood transfusions
• Diuretics – the doctor may monitor kidney function when diuretics are used
• Medicines used to treat high blood pressure (e.g. beta-blockers, ACE inhibitors, angiotensin II receptor antagonists)
• Lithium – used to treat psychiatric disorders
• Selective serotonin reuptake inhibitors (SSRIs) – used to treat depression
• Methotrexate – used to treat cancers or severe uncontrolled skin diseases and active rheumatoid arthritis
• Pemetrexed – used to treat cancers
• Cholestyramine – used to reduce cholesterol levels
• Trimethoprim – used to treat urinary tract infections
• Oral antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for the occurrence of hypoglycaemia.

If in doubt about using Meloxicam APTEO MED, consult your doctor or pharmacist.
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 her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Meloxicam APTEO MED if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Meloxicam APTEO MED may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour.
During the first 6 months of pregnancy, Meloxicam APTEO MED 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, Meloxicam APTEO MED may cause kidney problems 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 the blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Meloxicam APTEO MED is not recommended for breastfeeding women.
Fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. If the patient plans to become pregnant or has difficulty becoming pregnant, she should inform her doctor about the use of Meloxicam APTEO MED.
Driving and operating machinery
Visual disturbances, including blurred vision, drowsiness, dizziness or other central nervous system disorders may occur after using Meloxicam APTEO MED. If these symptoms occur, do not drive or operate machinery.
Meloxicam APTEO MED contains monohydrate lactose
If intolerance to certain sugars has been previously diagnosed in the patient, the patient should contact their doctor before taking the medicine.
Meloxicam APTEO MED contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Meloxicam APTEO MED

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 tablet per day. The dose should not exceed 7.5 mg per day.
Without consulting a doctor, the patient must not use the medicine for longer than 7 days.
Use in children and adolescents
Meloxicam APTEO MED must not be used in children and adolescents under 16 years of age.
If the patient feels that the effect of Meloxicam APTEO MED is too strong or too weak, or if no improvement is felt after a few days, consult a doctor or pharmacist.
This medicine is for oral use.
The total daily dose should be taken at once, with water or another liquid, during a meal.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.

Taking more Meloxicam APTEO MED than recommended
If a larger than recommended dose of Meloxicam APTEO MED has been taken or if overdose is suspected, seek immediate medical advice or go to the nearest hospital emergency department.
Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy)
• drowsiness
• nausea and vomiting
• stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Meloxicam APTEO MED. Gastrointestinal bleeding (bleeding from the gastrointestinal tract) may occur in the patient.

Severe poisoning may lead to serious adverse drug reactions (see also section 4):

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

Missing a dose of Meloxicam APTEO MED
Do not take a double dose to make up for a missed dose.
Take the next dose at the scheduled time.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking Meloxicam APTEO MED and consult a doctor or the nearest hospital immediately if any of the following occur:
Any allergic (hypersensitivity) reactions, which may manifest as:

• Skin reactions such as itching (pruritus), blistering and peeling of the skin, which may potentially be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), damage to soft tissues (lesions of mucous membranes) or erythema multiforme (see section 2). 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 areas of the body.
• Swelling of the skin or mucous membranes, such as 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. This may cause symptoms such as:
  • Yellowing of the skin and whites of the eyes (jaundice)
  • Abdominal pain
  • Loss of appetite

Any adverse gastrointestinal symptoms, particularly:

• Bleeding (resulting in 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 a 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 the progress of treatment.

General adverse effects 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), particularly when used at high doses and for prolonged periods.
Oedema, hypertension and heart failure have been reported during NSAID therapy.

The most commonly observed adverse effects are gastrointestinal (stomach and intestinal disturbances):

• Peptic ulcer disease of the stomach and duodenum
• Perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse effects have been reported with NSAID use:

• Nausea and vomiting
• Loose stools (diarrhoea)
• Bloating with gas
• Constipation
• Indigestion (dyspepsia)
• Abdominal pain
• Tarry stools due to gastrointestinal bleeding
• Vomiting blood
• Ulcerative stomatitis
• Exacerbation of gastrointestinal inflammation (e.g. flare-up of colitis or Crohn's disease)

Gastritis has been observed less frequently.

Adverse effects of meloxicam – the active substance in Meloxicam APTEO MED

Very common: occurring in more than 1 in 10 patients

• Gastrointestinal disorders such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, bloating, loose stools (diarrhoea)

Common: occurring in 1 to 10 in 100 patients

• Headache

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

• Dizziness
• Dizziness or vertigo (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 levels (hyperkalaemia). This may lead to symptoms such as:
  • Cardiac arrhythmias
  • Palpitations (when the patient feels the heartbeat more than usual)
  • Muscle weakness
  • Regurgitation (reflux of stomach contents into the oesophagus)
• Gastritis
• Gastrointestinal bleeding
• Inflammation of the oral mucosa
• Immediate hypersensitivity reactions (hypersensitivity)
• Itching (pruritus)
• Skin rash
• Fluid retention-related oedema, including ankle/leg swelling (peripheral oedema)
• Sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may impair breathing (angioedema)
• Transient abnormalities in liver function tests (e.g. increased liver enzyme activity, such as aminotransferases, or increased levels of the bile pigment – bilirubin). These changes may be detected by the doctor through blood tests.
• Abnormalities in laboratory kidney function tests (e.g. increased creatinine or urea levels)

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

• Mood disturbances
• Nightmares
• Blood morphology disorders, including:
  • Abnormal blood smear
  • Decreased white blood cell count (leukopenia)
  • Decreased platelet count (thrombocytopenia)
    These adverse effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• Tinnitus (ringing in the ears)
• Palpitations (awareness of heartbeat)
• Peptic ulcer disease of the stomach or duodenum
• Oesophagitis
• Asthma attacks (in patients hypersensitive to aspirin or other NSAIDs)
• Skin blistering or epidermal detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Urticaria (hives)
• Visual disturbances, including:
  • Blurred vision
    If treatment with Meloxicam APTEO MED causes visual disturbances, patients should not drive or operate machinery.
• Conjunctivitis (inflammation of the eye or eyelids)
• Colitis (inflammation of the large intestine)

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

• Bullous skin reactions and 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 areas of the body.
• Hepatitis. This 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 not known: frequency cannot be estimated from the available data

• Confusion
• Disorientation
• Dyspnoea and skin reactions (anaphylactic and/or anaphylactoid), 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), particularly in patients taking Meloxicam APTEO MED together with other medicines that potentially have myelosuppressive or myelotoxic effects. This may cause:
  • Sudden fever
  • Sore throat
  • Infections
• Pancreatitis
• Infertility in women, delayed ovulation

Adverse effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet reported with Meloxicam APTEO MED:

Acute renal failure due to structural changes in the kidneys:

• Very rare 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 effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Meloxicam APTEO MED

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging following EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Meloxicam APTEO MED contains

• The active substance is meloxicam. One tablet contains 7.5 mg of meloxicam.
• The other ingredients are: maize starch, pregelatinized maize starch 1500, colloidal anhydrous silica, sodium citrate, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

What Meloxicam APTEO MED looks like and contents of the pack
Meloxicam APTEO MED 7.5 mg tablets are yellow, round, flat, biconvex, uncoated tablets with a central break line on one side and an embossment "7.5" on the other side.
The break line on the tablet is intended only to facilitate breaking for ease of swallowing and does not guarantee an equal division into two doses.
Meloxicam APTEO MED is available in PVC/PVDC/Al blisters packed in a cardboard box.
Meloxicam APTEO MED 7.5 mg tablets are available in packs containing 10 and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240
Importer:
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz