Remolexam

Patient Information Leaflet

Remolexam, 15 mg, tablets
Meloxicamum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Remolexam is and what it is used for
2. Important information 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:

• short-term treatment of symptoms associated with flare-ups of osteoarthritis,
• long-term treatment of symptoms associated with rheumatoid arthritis or ankylosing spondylitis, also known as Bechterew's disease (a type of arthritis causing pain and stiffness in the spine).

2. Important 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 hives,
• 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 during treatment with NSAIDs;
• 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, consult a doctor.
Warnings and precautions
Before starting treatment with Remolexam, discuss this with your doctor or pharmacist in case of:

• if the patient has ever had oesophagitis, gastritis or any other gastrointestinal disorder, e.g. Crohn's disease or ulcerative colitis;
• if the patient has high blood pressure (hypertension);
• if the patient is elderly; there is an increased risk of adverse effects in elderly patients, therefore the doctor may reduce the dose and will closely monitor heart, liver and kidney function during treatment;
• if the patient has heart, liver or kidney disease;
• if the patient has reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or low fluid intake;
• if the patient has elevated potassium levels in the blood;
• if the patient has ever developed a persistent drug rash (erythema multiforme) 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, hives and itching].

Remolexam is not recommended for immediate relief of pain.
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, contact a doctor.
Skin reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with meloxicam use, initially appearing as red spots or circular 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 generalized blisters or skin detachment.
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 must not restart meloxicam treatment.
If a rash or skin symptoms occur, seek immediate medical advice and inform the doctor that this medicine is being taken.
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.
Do not use higher doses or longer treatment duration than recommended.
If the patient has heart problems, a history of stroke, or suspects a risk of these conditions, discuss the treatment approach with a 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.

Remolexam and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient 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, dose adjustments of other medicines may be necessary during Remolexam treatment.
Inform your doctor or pharmacist especially if using 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 in the treatment of certain cancers, severe uncontrolled skin diseases and active rheumatoid arthritis);
• pemetrexed (used in the treatment of certain cancers);
• deferasirox (used to treat chronic iron overload due to multiple blood transfusions);
• cyclosporine (used after organ transplant or in the treatment of autoimmune diseases, i.e. severe cases of certain skin diseases, rheumatoid arthritis or a kidney disease called nephrotic syndrome);
• tacrolimus (used after organ transplant);
• cholestyramine (used to reduce 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 a doctor or pharmacist before using this medicine.
Pregnancy
If the patient becomes pregnant while taking Remolexam, inform the doctor immediately.
Do not take Remolexam 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 affect bleeding tendency in both mother and child and may result in delayed or prolonged labour.
Do not take Remolexam 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, use the lowest effective dose for the shortest possible time. Remolexam taken for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer treatment is required, the doctor may recommend additional monitoring.
Breastfeeding
Remolexam is not recommended for use in breastfeeding women.
Fertility
Remolexam may impair fertility. Inform the doctor if the patient is planning to conceive 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 disorders may occur after taking this medicine. If these symptoms occur, do not drive or operate machinery.
Remolexam contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Remolexam

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The total daily amount of Remolexam tablets (see dosing recommendations below)
should be swallowed as a single dose with water or other liquids during a meal.
The recommended dose is:

• Osteoarthritis: 7.5 mg (half a tablet of Remolexam 15 mg) per day. If necessary, the physician may increase the dose to 15 mg per day (one tablet of Remolexam 15 mg).
• Rheumatoid arthritis or ankylosing spondylitis: 15 mg (one tablet of Remolexam 15 mg) per day. After assessing the response to treatment, the physician may reduce the dose to 7.5 mg.

Do not exceed the maximum dose of 15 mg per day.
Elderly patients
The recommended dose for long-term treatment of rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day.
Patients with impaired kidney or liver function
If the patient has severe kidney disease and is undergoing dialysis, the dose should not exceed 7.5 mg per day.
If the patient has mild to moderate kidney or liver disease, the patient may receive the standard adult dose.
Use in children and adolescents
Remolexam is not recommended for children and adolescents under 16 years of age.
Taking more Remolexam than recommended
If more Remolexam than recommended has been taken, seek immediate medical advice from a physician 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.
Missing a dose of Remolexam
If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
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, blistering, or peeling of the 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, 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 symptoms, particularly:
• Bleeding (resulting in black, tarry stools or vomiting blood);
• Gastrointestinal ulceration (causing abdominal pain). Gastrointestinal bleeding, ulceration, 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

• Dyspepsia,
• Nausea, vomiting,
• Abdominal pain,
• Constipation,
• Flatulence,
• Diarrhea.

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,
• Somnolence,
• Anaemia (reduced number of red blood cells, which may cause paleness of the skin, weakness and fatigue),
• Increased blood pressure (hypertension),
• Flushing (temporary redness of the face and neck),
• Sodium and water retention,
• Increased potassium levels (hyperkalemia). This may lead to symptoms such as:
• Heart rhythm disturbances (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-related swelling, including swelling of the ankles or legs,
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may impair breathing (angioedema),
• Abnormal kidney or liver function tests (e.g. increased liver enzyme activity, increased bilirubin, creatinine, 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 number of white blood cells (leukopenia), decreased number of platelets (thrombocytopenia); these adverse reactions may lead to increased risk of infection, bruising or nosebleeds;
• Ringing in the ears (tinnitus),
• Sensation of heart palpitations,
• Gastric or duodenal ulcer disease,
• Esophagitis,
• Onset of asthma attacks (in patients allergic to aspirin or other NSAIDs),
• Severe blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis),
• Urticaria,
• Vision 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

• 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,
• Acute kidney failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease,
• Perforation (punching through) of the intestinal wall.

Frequency not known: frequency cannot be estimated from the available data

• Confusion,
• Disorientation,
• Shortness of breath and skin reactions (anaphylactic or anaphylactoid reactions),
• Skin 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 that potentially have bone marrow suppressing or destructive effects (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, which may appear as itchy, round or oval, red and swollen patches on the skin, blisters (urticaria).

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 use:

• 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 effects occur, including any adverse effects 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, 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 authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

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 box 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 wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Remolexam contains

• The active substance is meloxicam. Each tablet contains 15 mg of meloxicam.
• The other ingredients are: monohydrate lactose, 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 15 mg tablets are yellow, round, flat tablets with bevelled edges and a score line.
Marbled surface appearance is acceptable. The tablet can be divided into equal doses.
Remolexam tablets are packed in PVC/PVdC/Aluminium blisters.
Remolexam is available in packs containing 10 or 20 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 countries under the following names:
PL: Remolexam