Description

Remolexam is used for the short-term treatment of symptoms associated with flare-ups of osteoarthritis.

Composition

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.

Dosage

Always use this medicine exactly as your doctor or pharmacist has told you. If you have any questions, ask your doctor or pharmacist.

The tablet should be swallowed with water or other liquid during a meal.

• The recommended dose is one Remolexam 7.5 mg tablet.

Do not exceed the maximum dose of 7.5 mg per day.

If you do not feel better or if you feel worse after 7 days, contact your doctor.

• Elderly patients: The recommended dose is 7.5 mg daily.
• Patients with renal and hepatic impairment: The recommended dose is 7.5 mg daily.

Action

Remolexam contains the active substance meloxicam. Meloxicam belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Meloxicam is used to reduce inflammation and pain in the joints and muscles.

Indications

Remolexam is used for the short-term treatment of symptoms associated with flare-ups of degenerative joint disease such as rheumatoid arthritis or ankylosing spondylitis also known as Bechterew's disease (a type of arthritis that causes pain and stiffness in the spine area).

Contraindications

When not to use Remolexam :

• if you are allergic to meloxicam or any of the other ingredients of this medicine;
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), i.e. if you have ever had any of the following symptoms after taking these medicines:
• if you have had stomach or intestinal bleeding or perforation after previous NSAID therapy;
• if you currently have (or have had two or more episodes of) peptic ulcer (stomach or intestinal ulcer) or gastrointestinal bleeding;
• if you have severe liver problems;
• if you have severe kidney disease not requiring dialysis; if you have recently had bleeding in the brain; if you have had any other bleeding problems;
• if you have severe heart disease;
• in patients in the last three months of pregnancy;
• in children and adolescents under 16 years of age.

Side effects

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

• Very common side effects: occurring in more than 1 in 10 patients: indigestion, nausea, vomiting, abdominal pain, constipation, flatulence, loose stools.
• Common side effects: occurring in 1 to 10 out of 100 patients: headache.
• Uncommon side effects: affecting 1 to 70 in 1000 patients: dizziness (light-headedness), feeling of dizziness or spinning, drowsiness, anaemia (reduction in red blood cells which can make the skin pale, weak and tired), increase in blood pressure (hypertension), flushing (temporary redness of the face and neck), sodium and water retention, increased potassium levels (hyperkalaemia), gastritis, gastrointestinal bleeding, inflammation of the mouth, belching, immediate allergic reactions, itching, skin rash, swelling due to fluid retention including swelling of the ankles/legs, sudden swelling of the skin or mucosa, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema), abnormal kidney or liver function tests (e.g. increased liver enzymes, increased bilirubin, creatinine, urea).
• Not known: frequency cannot be estimated based on the 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 who are taking medicines that potentially have a depressing or destructive effect on the bone marrow (myelotoxic medicines).

Warnings and precautions

• Remolexam contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Store at room temperature.
Protect from light and moisture.
Store out of reach of small children.

Use of other medications

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

Remolexam may affect the way other medicines work. There are some medicines that should not be taken with Remolexam. In some cases, the dose of other medicines may need to be adjusted while you are taking Remolexam.

Please tell your doctor or pharmacist, especially if you are using or receiving any of the following medicines:

• acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); anticoagulants;
• medicines that dissolve blood clots (thrombolytics);
• drugs used to treat heart and kidney diseases; drugs used to treat high blood pressure;
• diuretics;
• corticosteroids

Taking the medicine with food and drink

The tablet should be swallowed with water or other liquid during a meal.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

If you become pregnant while taking Remolexam, tell your doctor. During the first 6 months of pregnancy, your doctor may continue to prescribe Remolexam if necessary. Do not use Remolexam during the last three months of pregnancy. This medicine can have serious effects on the unborn baby, even after a single dose.

Remolexam is not recommended for use in breastfeeding women.

Impact on fertility

Remolexam may make it more difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Use of the drug in children and adolescents

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

Driving and operating machinery

Visual disturbances, including blurred vision, dizziness, drowsiness, a sensation of spinning or unsteadiness, or other central nervous system disturbances may occur after taking this medicine. If these symptoms occur, do not drive or operate machinery.