MELOX 10 mg. 1.5 ml. 5 ampoules

What MELOX and what it is used
MELOX contains an active substance called meloxicam. Meloxicam belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which are used to reduce inflammation, pain and temperature.
MELOX used in adults for the short-term treatment of inflammatory rheumatic diseases, rheumatoid arthritis and ankylosing spondylitis (ankylosing spondylitis), when the use of drugs by mouth or rectal is not possible.

2. What you should know before using MELOX
Do not use Melox:
if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
during the third trimester of pregnancy;
in children and adolescents under 18 years of age;
if you are allergic to aspirin or other anti-inflammatory drugs (NSAIDs);
if you had any of the following symptoms after taking aspirin or other NSAIDs:
asthma;
nasal congestion due to the small swelling of the nasal mucosa (nasal polyps);
hives;
swelling of the face, tongue or throat; difficulty breathing; difficulty swallowing (angioedema);
if you have ever had bleeding or perforation of the stomach or intestines after taking NSAIDs;
if have ulcers or bleeding in the stomach or intestines;
if you have a history of recurrent ulcers or bleeding in the stomach or intestine (ulcers or bleeding, which occurred at least twice);
if you have severely impaired liver function;
If you have severe renal impairment is not being treated by dialysis;
if you have recently had bleeding in the brain (cerebrovascular bleeding);
if you suffer from severe heart failure;
if you have bleeding disorders or are being treated with medicines used to prevent blood clotting.
Warnings and Precautions
MELOX is not intended for the treatment of acute pain.

Talk to your doctor or pharmacist before using MELOX:
If you have ever suffered from esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach) or other gastrointestinal disease, such as ulcerative colitis, Crohn's disease;
if you suffer from heart disease:
Medicines like MELOX associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely when using high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3 "How to use MELOX");
If you suffer from heart problems experienced you are stroke or think that you may be at risk of these conditions (for example, if you suffer from high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist;
if have skin problems:
The use of meloxicam reported potentially life-threatening skin rashes (Stevens-Johnson, toxic epidermal necrolysis), which initially appear as reddish spots that resemble targets or circular patches often with blisters. Additional symptoms that need to track are mouth ulcers, throat, nose, genitals and conjunctivitis (swelling and redness of the eyes). These potentially life-threatening skin rashes are often accompanied by symptoms that resemble the flu. The rash may progress to widespread peeling or flaking of skin. The risk of serious skin reactions was highest in the first weeks of treatment;
If during treatment with meloxicam have developed Stevens-Johnson and toxic epidermal necrolysis, you should not be subjected to treatment with meloxicam again;
If you get a rash or these skin symptoms, seek immediate medical advice and tell him that you are taking this medicine;
if you have impaired liver or kidney function;
if you are an elderly patient;
if you have low blood volume (hypovolemia), which can happen when serious blood loss or burns in operation or insufficient fluid intake;
if you have diabetes or are taking medications that increase potassium levels in the blood. Your doctor will monitor your improvement during treatment.
MELOX may mask symptoms of infection (such as fever). If you think you suffer from an infection, consult your doctor.

Other medicines and MELOX
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

The following medicines may affect or be affected by the action of MELOX:
other NSAIDs and aspirin;
corticosteroids (medicines used to reduce inflammation and allergic reactions);
anticoagulants such as warfarin or heparin (medicines used to prevent blood clotting);
thrombolytics (drugs that dissolve blood clots);
selective inhibitors of serotonin reuptake (SSRI, SSRIs) (used to treat depression);
diuretics. You may need your doctor to monitor your kidney function if you are taking diuretics;
drugs used to treat high blood pressure and heart diseases (e.g., ACE inhibitors, angiotensin-II antagonists, beta-blockers);
ciclosporin (used after organ transplantation in severe skin diseases, such as rheumatoid arthritis or nephrotic syndrome);
tacrolimus (used after organ transplantation);
contraceptive intrauterine devices (IUD);
lithium (used for the treatment of mood disorders);
methotrexate (used in the treatment of certain tumors and skin diseases and severe uncontrolled active rheumatoid arthritis);
cholestyramine (used to lower cholesterol).
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Taking this drug should be avoided during the first 6 months of pregnancy. This medicine will be prescribed only if your doctor deems it necessary.
You should never take MELOX in the last three months of pregnancy, as it can have serious consequences for your child, even if you take only one dose.

Breastfeeding
Meloxicam is excreted in human milk. MELOX therefore not recommended during lactation.

Fertility
MELOX can make conception more difficult. You should tell your doctor if you have problems conceiving.

Driving and using machines
The use of this product may occur visual disturbances, drowsiness, vertigo (dizziness). If this happens, do not drive or operate machinery.

3. How to use MELOX
Always use this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
MELOX is administered as an intramuscular injection. Injection should be made only by a health professional. This drug will be injected slowly into the buttock. If you make more than one injection, your doctor will inject alternating left and right sides of the seat.
If you have undergone surgery for hip replacement, your doctor will administer the injection of the opposite side. If you experience pain during the injection, your doctor should stop the injections.

Recommended dosage:
The dose is limited to a single injection once daily starting treatment. In special cases (when using the tablets and suppositories is not possible), the dose may be increased to 2 to 3 injections daily.
Do not exceed the maximum daily dose of 15 mg.

Elderly patients or patients at increased risk of adverse reactions
If you are an elderly patient or if you are exposed to an increased risk of adverse reactions, the recommended dose is 7.5 mg daily (half a vial of 15 mg).

Renal impairment
If you suffer from renal impairment, or are undergoing dialysis, the dose should not exceed 7.5 mg daily (half a vial of 15 mg).

If you take more dose MELOX
If you take too much meloxicam, contact your doctor immediately or go to the nearest hospital.

Symptoms that occur following acute NSAID overdose are usually limited to:
loss of vigor;
drowsiness;
nausea or vomiting;
stomachache.
These symptoms usually improve with discontinuation of MELOX. It is possible to display or gastrointestinal bleeding.

Severe poisoning can cause serious side effects:
high blood pressure;
acute renal failure;
hepatic impairment;
reduction or cessation of breathing;
loss of consciousness;
seizures;
lowering blood pressure;
cardiac arrest;
sudden allergic reactions including: seizures, difficulty breathing, skin reactions.

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

MELOX stop using and consult your doctor or visit the nearest hospital immediately if you notice:
allergic reactions, which may be expressed as:
severe skin reactions including blistering, red or purple spots or peeling of the skin. They can also affect the mouth, eyes and other mucous membranes (Stevens-Johnson, toxic epidermal necrolysis and erythema multiforme). These effects are very rare (may affect up to 1 in 10,000 people);
swelling of the skin or mucous membranes, such as swelling around the eyes, face and lips, mouth or throat that may cause difficulty in breathing (angioedema), and swelling of the ankles and legs (edema) (may affect up to 1 in 100 people);
shortness of breath or asthma attack (may affect up to 1 in 1000 people);
inflammation of the liver, which can cause: yellowing of the skin or whites of the eyes, abdominal pain, loss of appetite (may affect up to 1 in 10,000 people);
side effects of the digestive tract:
bleeding from the digestive tract (tarry stools), formation or perforation (causing abdominal pain) ulcers can sometimes be severe and potentially fatal, especially in elderly patients (may affect up to 1 in 1000 people).
Other side effects
Very common (may affect more than I of 10 people):
indigestion;
nausea and vomiting;
abdominal pain;
constipation;
flatulence (wind);
disorder (diarrhea).
Common (may affect up to 1 in 10 people):
headache;
occurrence of mass at the injection site, pain at the injection site.
Uncommon (may affect up to 1 in 100 people):
dizziness;
drowsiness;
anemia (decreased hemoglobin concentration);
high blood pressure;
redness;
retention of sodium and water;
Elevated potassium levels;
belching;
inflammation of the stomach or mouth;
rash;
deviations in studies of liver and kidney function. Your doctor can identify these anomalies through blood tests.
Rare (may affect up to 1 in 1000 people):
mood disorders;
nightmares;
abnormal blood count;
noise in the ears;
palpitations;
inflammation of the esophagus;
hives;
visual disturbances including blurred vision, inflammation of the whites of the eyes, eyelids;
inflammation of the colon.
Very rare (may affect up to 1 in 10,000 people):
acute renal failure, especially in patients with risk factors such as heart or kidney disease;
agranulocytosis (complete loss of certain white blood cells). It may cause:
sudden fever;
sore throat;
infections. If you get any of these symptoms, you should consult with a doctor to do a blood test to rule out a shortage of white blood cells.
Not known (frequency can not be established from the available data):
confusion;
disorientation;
serious allergic reactions with symptoms such as fever, swelling, sudden drop in blood pressure, shortness of breath and skin reactions;
skin rashes caused by sun exposure.

5. How to store MELOX
Keep out of reach of children.
This medicinal product does not require any special storage conditions. Store in the original container to protect from light. The solution is intended for single use. The unused portion should be discarded.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of that month.