Remolexam

Patient Information Leaflet

Remolexam, 7.5 mg, tablets
Meloxicam
Please read this leaflet carefully 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 directed by
the doctor or pharmacist.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Leaflet Contents:

1. What Remolexam is and what it is used for
2. What you need to know before taking Remolexam
3. How to take Remolexam
4. Possible side effects
5. How to store Remolexam
6. Contents of the pack and other information

1. What Remolexam is and what it is used for

Remolexam contains the active substance meloxicam. Meloxicam belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam is used to reduce inflammation and
pain in joints and muscles.
Remolexam is used for the short-term treatment of symptoms associated with an exacerbation of
osteoarticular diseases, such as rheumatoid arthritis or ankylosing spondylitis, also known as
Bechterew's disease (a type of arthritis causing pain and stiffness in the spine).

2. Information before using Remolexam

When not to use Remolexam:

• 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 acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), meaning if the patient has ever experienced any of the following symptoms after taking these medicines:
  • wheezing, tightness in the chest, shortness of breath (asthma),
  • nasal congestion due to swelling of the nasal mucosa (nasal polyps),
  • skin rash or 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 gastrointestinal bleeding or perforation of the stomach or intestines while on NSAID therapy;
• if the patient currently has (or has had two or more episodes of) peptic ulcer disease (stomach or intestinal ulcer) or gastrointestinal bleeding;
• if the patient has severe liver function disorders;
• if the patient has severe kidney disease not requiring dialysis;
• if the patient has recently experienced bleeding within the brain;
• if the patient has any other bleeding disorders;
• if the patient has severe heart disease;
• in women during the last three months of pregnancy;
• in children and adolescents under 16 years of age.

If the patient is unsure whether any of the above points apply, they should contact their doctor.

Warnings and precautions

Before starting treatment with Remolexam, discuss this with a doctor or pharmacist if:

• the patient has ever had oesophagitis, gastritis, or any other gastrointestinal disorder (e.g. Crohn's disease or ulcerative colitis);
• the patient has high blood pressure (hypertension);
• the patient is elderly; there is an increased risk of adverse effects in elderly patients, therefore the doctor may reduce the dose and closely monitor heart, liver, and kidney function during treatment;
• the patient has heart, liver, or kidney disease;
• the patient has reduced circulating blood volume (hypovolemia), which may occur following significant blood loss or burns, after surgery, or due to low fluid intake;
• the patient has elevated potassium levels in the blood;
• the patient has previously developed a persistent drug eruption (rash) after taking meloxicam or other oxicams (e.g. piroxicam) [circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria, and itching].

To minimize the risk of adverse effects, the lowest effective dose should be taken for the shortest duration necessary to relieve symptoms.

Remolexam is not recommended for immediate pain relief.

Remolexam may mask symptoms of infection such as fever, pain, swelling, and redness. The patient may mistakenly believe they feel better or that the infection is not serious. If the patient suspects an infection, they should contact their doctor.

Skin reactions

Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with meloxicam use. These initially appear as red spots or round patches on the trunk, often with central blisters.

Additional symptoms may include mouth, throat, nose, or genital ulcers, and conjunctivitis (red, swollen eyes).

These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or detachment of the epidermis.

The highest risk of severe skin reactions occurs during the first weeks of treatment.

Remolexam must not be restarted in patients who previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam.

If a rash or any skin symptoms develop, the patient should seek immediate medical advice and inform the doctor about taking this medicine.

Cardiovascular reactions

Taking medicines such as Remolexam 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.

Doses higher than recommended or longer treatment durations than advised should not be used.

If the patient has heart problems, a history of stroke, or suspects they may be at risk of such conditions, they should discuss treatment options 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 (hypercholesterolemia);
• the patient smokes tobacco.

Children and adolescents

Remolexam must not be given to children and adolescents under 16 years of age.

Remolexam and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Remolexam may affect the action of other medicines. There are several medicines that should not be taken together with Remolexam. In some cases, the dose of other medicines may need to be adjusted during treatment with Remolexam.

Inform the doctor or pharmacist especially if the patient is taking or receiving any of the following medicines:

• acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• anticoagulants;
• medicines that dissolve blood clots (thrombolytics);
• medicines used for heart and kidney diseases;
• medicines used to treat hypertension;
• diuretics;
• corticosteroids (used to treat inflammatory or allergic conditions);
• certain antidepressants: selective serotonin reuptake inhibitors (SSRIs) or lithium;
• methotrexate (used to treat certain cancers, severe uncontrolled skin disorders, and active rheumatoid arthritis);
• pemetrexed (used to treat certain cancers);
• deferasirox (used to treat chronic iron overload due to multiple blood transfusions);
• cyclosporine (used after organ transplantation or to treat autoimmune diseases, such as severe cases of certain skin disorders, rheumatoid arthritis, or a kidney disease called nephrotic syndrome);
• tacrolimus (used after organ transplantation);
• cholestyramine (used to lower cholesterol levels);
• if the patient uses an intrauterine contraceptive device, commonly known as an IUD.

If in doubt about using these medicines, consult a 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 baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

If the patient becomes pregnant while taking Remolexam, she should inform her doctor.

Remolexam must not be taken during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may also affect bleeding tendencies in both mother and child and may result in delayed or prolonged labour.

Remolexam should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment during this period or while trying to conceive is necessary, the lowest possible dose should be used for the shortest possible time. Remolexam taken for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, which 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 longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding

Remolexam is not recommended for use in breastfeeding women.

Fertility

Remolexam may impair fertility. The patient should inform the doctor if she is planning to become pregnant or has difficulty becoming pregnant.

Driving and operating machinery

Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo, or loss of balance, or other central nervous system effects may occur after taking this medicine. If these symptoms occur, the patient should not drive or operate machinery.

Remolexam contains lactose and sodium

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

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

3. How to use Remolexam

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The tablet should be swallowed with water or another liquid during a meal.
The recommended dose is one 7.5 mg Remolexam tablet.
Do not exceed the maximum dose of 7.5 mg per day.
If there is no improvement after 7 days, or if the patient feels worse, contact your doctor.

Elderly patients
The recommended dose is 7.5 mg per day.

Patients with renal or hepatic impairment
The recommended dose is 7.5 mg per day.

Use in children and adolescents
Remolexam is not recommended for children and adolescents under 16 years of age.

Taking more Remolexam than recommended
If you take more Remolexam than recommended, seek immediate medical advice from a doctor or go to the nearest hospital.
Symptoms of overdose may include: weakness (feeling of lack of energy), drowsiness, nausea and vomiting, abdominal pain, gastrointestinal bleeding.
In cases of severe poisoning, the following symptoms may occur: high blood pressure, acute kidney failure, liver function disorders, slow or weak breathing, loss of consciousness (coma), seizures, circulatory failure, sudden cessation of effective blood circulation, immediate allergic reactions including fainting, shortness of breath, and skin reactions.

Missed dose of Remolexam
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you have any further questions about the 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.
You must stop taking Remolexam and consult a doctor or the nearest hospital immediately if any of the following occur:

• Any allergic reactions, which may manifest as:
• skin reactions such as itching, blisters, or peeling skin, which may be potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue damage (lesions of mucous membranes), or erythema multiforme; see section "Warnings and precautions";
• swelling of the skin or mucous membranes, such as swelling around the eyes, face and lips, inside the mouth or throat, which may make breathing difficult, swelling of the ankles or legs;
• shortness of breath or asthma attack.
• Any symptoms of liver inflammation, particularly:
• yellowing of the skin or whites of the eyes (jaundice);
• abdominal pain;
• loss of appetite.
• Any gastrointestinal adverse effects, particularly:
• bleeding (causing black, tarry stools or vomiting blood);
• gastrointestinal ulceration (causing abdominal pain). Gastrointestinal bleeding, ulcers, or perforation may sometimes be severe and potentially fatal, especially in elderly patients.

Very common adverse reactions: occurring in more than 1 in 10 patients

• indigestion,
• nausea, vomiting,
• abdominal pain,
• constipation,
• bloating,
• loose stools.

Common adverse reactions: occurring in 1 to 10 in 100 patients

• headache.

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

• dizziness (feeling of emptiness in the head),
• sensation of dizziness or spinning,
• drowsiness,
• anaemia (reduced number of red blood cells, which may cause pale skin, weakness and fatigue),
• increased blood pressure (hypertension),
• flushing (temporary redness of the face and neck),
• sodium and water retention,
• increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
• heart rhythm disorders (arrhythmias),
• palpitations (when the patient feels heartbeat more than usual),
• muscle weakness,
• gastritis,
• gastrointestinal bleeding,
• stomatitis,
• belching,
• immediate allergic reactions,
• itching,
• skin rash,
• fluid retention causing swelling, including swelling of ankles/legs,
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema),
• abnormal kidney or liver function test results (e.g. increased liver enzyme activity, increased bilirubin, creatinine or urea levels).

Rare adverse reactions: 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 reactions may lead to increased risk of infection, bruising or nosebleeds,
• ringing in the ears (tinnitus),
• sensation of heart palpitations,
• peptic ulcer disease (stomach or duodenal ulcer),
• oesophagitis,
• onset of asthma attacks (in patients allergic to aspirin or other NSAIDs),
• severe blistering of the skin or peeling of the epidermis (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• urticaria,
• visual disturbances, including: blurred vision, inflammation of the eyeball or eyelids (conjunctivitis),
• colitis.

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

• blistering 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,
• acute renal failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease,
• intestinal perforation.

Frequency unknown: frequency cannot be estimated from available data

• confusion,
• disorientation,
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions),
• rashes caused by exposure to sunlight (photosensitivity reactions),
• heart failure,
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking medicines which potentially have bone marrow suppressing or destructive effects (myelotoxic drugs). This may cause:
• sudden fever,
• sore throat,
• infections.
• pancreatitis
• 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 patches on the skin, blisters (urticaria).

The use of medicines such as Remolexam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when used at high doses and for long-term treatment (see section "Warnings and precautions").
Adverse reactions caused by other similar medicines (NSAIDs), but not yet reported after meloxicam administration:

• kidney inflammation (interstitial nephritis)
• death of certain kidney cells (acute necrosis of glomeruli or renal papillae)
• presence of protein in urine (nephrotic syndrome with proteinuria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Remolexam

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after
"Expiry date (EXP):". The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.
Do not use this medicine if visible signs of degradation are observed.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Remolexam contains

• The active substance is meloxicam. Each tablet contains 7.5 mg of meloxicam corresponding to 100% anhydrous substance.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K-17, sodium citrate, crospovidone (type B), colloidal anhydrous silica, magnesium stearate.

What Remolexam looks like and contents of the pack
Remolexam 7.5 mg tablets are yellow, round, flat tablets with bevelled edges and a division line,
with a diameter of (6.0 ± 0.2) mm and a height of (2.4 ± 0.4) mm. Mottling of the surface is acceptable.
The tablet can be divided into equal doses.
Remolexam tablets are packed in blisters made of PVC/PVdC/Aluminium.
Remolexam is available in pack sizes containing 10, 20 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Importer:
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
This medicinal product is authorised in the European Economic Area under the following names:
PL: Remolexam