MOVALIS 7.5 mg. 20 tablets

BOEHRINGER
MOVALIS 7.5 mg. 20 tablets
€ 15.00
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What is Movalis and what it is used
Movalis contains the active substance meloxicam. Meloxicam belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.

Movalis be used for:
short-term treatment of osteoarthritis aggravated;
long-term treatment of:
rheumatoid arthritis;
ankylosing spondylitis (known as ankylosing spondylitis).

2. Before you take Movalis:
Do not take Movalis in the following cases:
during the last three months of pregnancy;
children and adolescents under 16 years;
allergy (hypersensitivity) to meloxicam;
allergy (hypersensitivity) to aspirin or other anti-inflammatory drugs (NSAIDs);
allergy (hypersensitivity) to any of the other ingredients of Movalis. (See section 6 "Further information" for a list of other ingredients);
any of the following signs after taking aspirin or NSAIDs:
wheezing, chest tightness, shortness of breath (asthma);
nasal congestion due to swelling of the mucosa of the nasal cavity (nasal polyps);
skin rash / hives (urticaria);
sudden swelling of skin or mucous membrane, such as swelling around the eyes, face, lips, mouth or throat, difficulty in breathing (angioedema);
after previous treatment with NSAIDs and information on:
bleeding in the stomach or intestines;
perforations in the stomach or intestines;
ulcers or bleeding in the stomach or intestines;
recent or undergone stomach ulcer or intestine (ulcer or bleeding that occurred at least twice);
severely impaired liver function;
undialysed severe renal insufficiency;
recent bleeding in the brain (cerebrovascular bleeding);
any violations related to bleeding;
severe heart failure;
intolerance to some sugars as this product contains lactose (see also "Important information about some of the ingredients of Movalis").
If you are not sure if any of the above applies to you, please consult your doctor.

Take special care with MOVALIS:
Warnings:
Drugs such as Movalis may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment (see section 3 "How to take Movalis").

If you have heart problems, previous stroke or think that you might be at risk of these conditions, you should discuss your treatment with your doctor or pharmacist. Examples include:
have high blood pressure (hypertension);
you have high blood sugar levels (diabetes);
have high levels of blood cholesterol (hypercholesterolemia);
You are a smoker.
If you develop severe allergic reactions should stop using Movalis at first appearance of skin rash, lesions of the mucous membranes (mucosal lesion) or any other sign of hypersensitivity and consult your doctor.
Stop treatment Movalis at a time in which you find bleeding (causing black discoloration of feces) or ulceration of the digestive system (causing abdominal pain).
Movalis is not suitable if you need immediate relief of acute pain.
Movalis can mask the symptoms of inflammation (eg. Temperature).
If you think you may have an infection, you should consult with your doctor.
Movalis can complicate pregnancy. You should tell your doctor if you are planning to become pregnant or have difficulty getting pregnant.

Precautions for use
In these cases it is important to consult your doctor or pharmacist before taking Movalis as it will require adjustment of therapy:
history of inflammation of the esophagus (esophagitis), inflammation of the stomach (gastric) or any other disease of the digestive tract, e. ulcerating colitis, Crohn's disease;
high blood pressure (hypertension);
Elderly;
diseases of the heart, liver or kidney;
high levels of blood sugar (diabetes);
low blood volume (hypovolemia), which can occur in significant blood loss or burn, surgery or inadequate fluid intake;
intolerance to some sugars as determined by your doctor because this medicinal product contains lactose;
high levels of potassium in the blood, diagnosed earlier than your doctor.
Will be necessary for your doctor to monitor the course of treatment.

Taking other medicines
Since the action of Movalis can affect or be affected by other medicines, tell your doctor and pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, please inform your doctor or pharmacist if you are taking or you use one of the following:
other NSAIDs;
anti-clotting drugs;
drugs that destroy blood clots (thrombolytic);
drugs for treatment of heart and kidney disease;
corticosteroids (eg. used against inflammation or allergic reactions);
cyclosporin - used after organ transplants, or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome;
any diuretic drugs ("water"). Your doctor may monitor your kidney function if you are taking diuretics;
drugs for the treatment of high blood pressure (e. beta-blockers);
Lithium - used to treat mood swings;
selective inhibitors of serotonin reuptake inhibitors - used in the treatment of depression;
methotrexate used to treat tumors or severe uncontrolled skin conditions or acute rheumatoid arthritis;
cholestyramine - used to lower cholesterol levels;
if you are a woman who used intrauterine contraceptive devices known as spirals.
If in doubt, ask your doctor or pharmacist.

Pregnancy
If pregnancy is established during use of Movalis, then the doctor should be notified.
During the first 6 months of your pregnancy, your doctor may prescribe this medicine, if necessary.
During the last three months of pregnancy, do not take this medicine because Movalis, even with a dose can have serious effects on your child, in particular cardiopulmonary and kidney effects.

Breastfeeding
This medicine is not recommended during lactation.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
The use of this medicine may occur visual disturbances, drowsiness, lightheadedness (dizziness) or other disorders of the central nervous system. Do not drive or operate machinery if they occur to you.

Important information about some of the ingredients of Movalis
This product contains milk sugar (lactose). Tell your doctor before taking this medicine if you have been told you have an intolerance to some sugars.

3. How to take Movalis
Always take Movalis exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.

The usual dose is:
Worsening of osteoarthritis:
7,5 mg (one tablet) once daily. The dose may be increased to 15 mg (two tablets) once daily.

Rheumatoid arthritis:
15 mg (two tablets) once daily. The dose may be reduced to 7,5 mg (one tablet) once daily.

Ankylosing spindilit:
15 mg (two tablets) once daily. The dose may be reduced to 7,5 mg (one tablet) once daily.

The tablets should be swallowed with water or another liquid with food.
Do not exceed the recommended maximum dose of 15 mg daily.
If any of the allegations listed in the section "Take special care with this medicine" refers to you, your doctor may reduce your dose to 7,5 mg (one tablet) once daily.

Movalis should not be given to children and adolescents under 16 years
If you think the effect of Movalis is too strong or too weak, or do not feel any improvement in your condition after a few days, ask your doctor or pharmacist.

If you take a higher dose than you need
If you take too many tablets or suspect an overdose, consult your doctor immediately or go to the nearest hospital.

Symptoms following acute NSAID overdose are usually limited to:
lack of energy (lethargy);
drowsiness;
nausea and vomiting;
pain in the stomach (epigastric pain).
In most cases these symptoms improve after stopping the use of Movalis. May occur bleeding in the stomach or intestines (gastrointestinal bleeding).

Severe poisoning can cause serious effects (see section 4):
high blood pressure (hypertension);
acute renal failure;
functional disorders of the liver;
reduction / suppression or cessation of breathing (respiratory depression);
loss of consciousness (coma);
seizures (convulsions);
circulatory collapse (cardiovascular collapse);
cardiac arrest (cardiac arrest);
allergic immediate reactions (hypersensitivity) reactions, including:
tiredness;
shortness of breath;
skin reactions.
If you forget to take Movalis
Do not take a double dose to make up the missed dose. Take your next dose as usual.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Movalis can cause side effects, although not everybody gets them.
Stop using Movalis and consult your doctor or visit the nearest hospital if you:

Any allergic (hypersensitivity) reactions which can occur in the form of:
skin reactions such as itching (pruritus), communication blistering of the skin, which may be severe (Stevens-Johnson and toxic epidermal necrolysis), soft tissue lesions (lesions of the mucous membranes) or erythema multiforme.
Erythema multiforme is a serious, skin, allergic reaction, which leads to the formation of buds, red or purple edges or areas with blisters. Can affect the mouth, eyes and other moist body surfaces.
swelling of the skin or mucous membrane, such as swelling around the eyes, face and lips, mouth or throat that may cause difficulty in breathing, swelling of your ankles or feet (edema of the lower limbs);
shortness of breath or asthma attack;
inflammation of the liver (hepatitis). This can cause symptoms such as:
yellowing of the skin or eyeballs (jaundice);
abdominal pain;
loss of appetite.
Any side effects of the digestive system, particularly:
bleeding (causing black colored stools);
ulceration of the digestive system (causing abdominal pain).
Bleeding in the digestive tract (gastrointestinal bleeding), ulceration or perforations in the formation of the digestive system, can sometimes be severe and potentially fatal, especially in elderly patients.
If you have previously suffered from any of the symptoms of the digestive system due to prolonged use of NSAIDs, seek immediate medical advice, especially if you are elderly. If you have visual disturbances do not drive or operate machinery.

Common side effects of nonsteroidal antiinflammatory drugs (NSAIDs).
The use of nonsteroidal anti-inflammatory drugs (NSAIDs), especially at high doses and for prolonged periods of time may be associated with a small increased risk of clogging of the arteries (arterial thrombotic events) and heart attack (myocardial infarction) or stroke ( apoplexy).
Fluid retention (edema), high blood imposing (hypertension) and heart failure have been reported in association with NSAID therapy.

The most common adverse reactions are those of the digestive system (gastrointestinal events):
ulcers of the stomach and the upper small intestine (peptic / gastroduodenal ulcers);
hole in the wall of the intestine (perforation) or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).
The following adverse reactions have been reported following administration of NSAIDs:
nausea, vomiting;
diarrhea;
flatulence;
constipation;
indigestion (dyspepsia);
abdominal pain;
black colored stools due to blood in the digestive system (Melena);
vomiting blood (haematemesis);
inflammation with ulceration in the mouth (ulcerative stomatitis);
worsening inflammation of the colon (exacerbated colitis);
worsening inflammation of the digestive tract (Crohn's disease, acute).
With less frequently observed inflammation of the stomach (gastritis).

Side effects of meloxicam - the active substance of Movalis:
Very common: affects more than 1 patient in 10:
indigestion (dyspepsia);
nausea, vomiting;
abdominal pain;
constipation;
flatulence;
diarrhea.
Common: affects 1 to 10 patients in 100:
headache.
Uncommon: affects 1 to 10 patients in 1000:
dizziness;
feeling dizzy or spinning sensation (vertigo);
drowsiness;
anemia (a decrease in the concentration of red blood pigment hemoglobin);
high blood pressure (hypertension);
flushing (temporary redness of the face and neck);
retention of sodium and water;
Elevated potassium levels (hyperkalemia). This can cause symptoms such as:
abnormal heart rhythm (arrhythmia);
palpitations (awareness of heart beat);
muscle weakness.
belching;
inflammation of the stomach (gastritis);
bleeding of digestive tract;
inflammation of the mouth (stomatitis);
allergic reactions (hypersensitivity) immediate-type;
itching (pruritus);
skin rash;
swelling caused by fluid retention (edema), including swollen ankles, legs (edema of the lower limbs);
sudden swelling of the face or throat, such as swelling around the eyes, face, lips, mouth or throat that may cause difficulty in breathing (angioedema);
brief failure in liver function tests (eg. elevated liver enzymes, elevated transaminases or bile pigment - bilirubin). Your doctor can determine this by blood tests;
breach in laboratory tests of renal function (increased creatinine or urea).
Rare: affects 1 to 10 patients in 10,000:
change in mood;
dreaming of nightmares;
changes in the number of blood cells, including:
changes in the differential count of blood cells;
low white blood cells (leukopenia);
Decreased platelet counts (thrombocytopenia);
These side effects can lead to increased risk of infections and symptoms such as bruising or bleeding from the nose.
ringing in the ears;
palpitations;
ulcers of the stomach or upper intestine (peptic / gastroduodenal ulcers);
inflammation of the esophagus (esophagitis);
asthma attack (observed in individuals allergic to aspirin or other NSAIDs);
blistering or peeling skin on her that may be severe (Stevens-Johnson and toxic epidermal necrolysis);
hives (urticaria);
visual disturbances including:
blurred vision;
conjunctivitis (inflammation of the eyeball or eyelids);
inflammatory bowel disease (colitis).
Very rare: satiate less than 1 in 10 000 patients:
blistering of the skin (bullous reactions) and erythema multiforme.
Erythema multiforme is a serious, skin, allergic reaction, which leads to the formation of buds, red edges, or purple or blistered areas. Can affect the mouth, eyes and other moist body surfaces.

yellowing of the skin or eyeballs (jaundice);
abdominal pain;
loss of appetite.
acute renal failure, especially in patients with risk factors such as heart disease, diabetes or kidney disease;
hole in the wall of the intestine (perforation).

Not known: frequency can not be estimated from available data:
confusion;
sense of disorientation;
difficulty in breathing and skin reactions (anaphylaxis / anaphylactoid) reactions, rashes caused by exposure to sunlight (photosensitivity reaction);
Heart failure has been reported in connection with the use of NSAIDs;
complete loss of specific types of white blood cells (agranulocytosis), especially in patients who receive Movalis concomitantly with other drugs that are potent inhibitors, depressants, or harmful to the components of the bone marrow (myelotoxic drugs). This can cause:
sudden fever;
sore throat;
infections.
Side effects caused by NSAIDs, but not observed after using Movalis:
Changes to the structure of the kidney, leading to acute renal failure:
Very rare cases of kidney inflammation (interstitial nephritis);
death of some kidney cells (acute tubular or papillary necrosis);
protein in the urine (proteinuria in nephrotic syndrome).
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Movalis
Keep out of the reach and sight of children.
Do not use Movalis after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. FURTHER INFORMATION
What Movalis:
The active substance is:
meloxicam;
one tablet contains 7,5 mg of meloxicam.
Other ingredients are:
sodium citrate;
lactose monohydrate;
microcrystalline cellulose;
povidone;
anhydrous, colloidal silicon dioxide;
crospovidone;
magnesium stearate
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