MOVALIS 15MG TABLETS

Active substance: MELOXICAM

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Movalis 15mg Tablets
Mobic 15mg Tablets
Meloxicam 15mg Tablets
(meloxicam)
This product is available using any of the above names but will be referred to
as Mobic throughout the following:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1) What Mobic is and what it is used for
2) Before you take Mobic
3) How to take Mobic
4) Possible side effects
5) How to store Mobic
6) Further information

1) What Mobic is and what it is used for
Mobic contains the active substance meloxicam. Meloxicam belongs to a
group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs)
which are used to reduce inflammation and pain in joints and muscles.
Mobic is used for the:
 short-term treatment of flare-ups of osteoarthritis
 long-term treatment of
 rheumatoid arthritis
 ankylosing spondylitis (also known as Bechterew's Disease)

2) Before you take Mobic
Do not take Mobic if any of the following apply:
 during the last three months of pregnancy
 children and adolescents under 16 years of age
 allergy (hypersensitivity) to meloxicam
 allergy (hypersensitivity) to aspirin or other anti-inflammatory medicines
(NSAlDs)
 allergy (hypersensitivity) to any of the other ingredients of Mobic. (See
section 6 "Further information" for a list of other ingredients)
 any of the following signs after taking aspirin or other NSAlDs:
 wheezing, chest tightness, breathlessness (asthma)
 nasal blockage due to swellings in the lining in your nose (nasal polyps)
 skin rashes/nettle rash (urticaria)
 sudden skin or mucosal swelling, such as swelling around the eyes,
face, lips, mouth or throat, possibly making breathing difficult
(angioneurotic oedema)
 after previous therapy with NSAIDs and history of
 bleeding in your stomach or intestines
 holes (perforations) in your stomach or intestines
 ulcers or a bleeding in your stomach or intestines
 recent or history of stomach or peptic ulcers or bleeding (ulceration or
bleeding occurring at least twice)
 serious liver disease
 serious kidney disease and not undergoing dialysis
 recent bleeding in the brain (cerebrovascular bleeding)
 any kind of bleeding disorders
 severe heart failure
 intolerance to some sugars as this product contains lactose (see also
"Important information about some of the ingredients of Mobic")
If you are unsure whether any of the above apply to you, please contact your
doctor.
Take special care with Mobic
Warnings
Medicines such as Mobic may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke (apoplexy). Any risk is more
likely with high doses and prolonged treatment. Do not take more than the
recommended dose. Do not take Mobic for longer than it is prescribed for you
(see section 3 "How to take Mobic").
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. For example if you:
 have high blood pressure (hypertension)
 have high levels of sugar in the blood (diabetes mellitus)
 have high levels of cholesterol in the blood (hypercholesterolemia)
 are a smoker
If you develop severe allergic reactions, you should discontinue Mobic at first
appearance of skin rash, lesions of soft tissues (mucosal lesions), or any
other sign of allergy, and contact your doctor.
Stop your treatment with Mobic immediately as soon as you notice bleeding
(causing tar-coloured stools) or ulceration of your digestive tract (causing
abdominal pain).







high blood pressure (hypertension)
older age
heart, liver or kidney disease
high levels of sugar in the blood (diabetes mellitus)
reduced blood volume (hypovolaemia) which may occur if you have a
serious blood loss or bum, surgery or low fluid intake
 intolerance to some sugars diagnosed by your doctor as this product
contains lactose
 high potassium levels in the blood previously diagnosed by your doctor
Your doctor will need to monitor your progress whilst on treatment.
Taking other medicines
As Mobic may affect or be affected by other medicines, please tell your doctor
or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
In particular please tell your doctor or pharmacist if you are taking/have taken,
or are using any of the following:
 other NSAIDs
 medicines which prevent blood clotting (e.g. warfarin, heparin)
 medicines which break down blood clots (thrombolytics)
 medicines to treat heart and kidney diseases
 corticosteroids (e.g. used against inflammation or allergic reactions)
 cyclosporin - used after organ transplants, or for severe skin conditions,
rheumatoid arthritis or nephrotic syndrome
 tacrolimus - used after organ transplants or for severe skin conditions
 any diuretic medicine ("water tablets")
Your doctor may monitor your kidney function if you are taking diuretics.
 medicine to treat high blood pressure (e.g. Beta-blockers)
 lithium - used to treat mood disorders
 selective Serotonin re-uptake inhibitors (SSRls) - used in the treatment of
depression
 methotrexate - used to treat tumours or severe uncontrolled skin conditions
and active rheumatoid arthritis
 cholestyramine - used to lower cholesterol levels
 if you are a woman who uses an intrauterine contraceptive device (IUD),
usually known as a coil
If in doubt, ask your doctor or pharmacist.
Fertility
Mobic may make it more difficult to become pregnant. You should inform your
doctor if you are planning to become pregnant or if you have problems to
become pregnant.
Pregnancy
If you become pregnant whilst using Mobic, you should tell your doctor.
During the first 6 months of pregnancy only, your doctor may prescribe you
this medical product if necessary.
During the last three months of pregnancy do not use this product, because
Mobic can have serious effects on your unborn child, in particular heart, lung
and kidney effects, even with only one dose.
Breast-feeding
The active ingredient of this medicine is known to pass into breast-milk. This
product is not recommended during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or
other central nervous system disturbances may occur with this product. If
affected do not drive or operate machinery.
Important information about some of the ingredients of Mobic
This product contains milk sugar (lactose). If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

3) How to take Mobic
Always take Mobic exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The usual dose is:
Flare-ups of osteoarthritis:
7.5 mg (half a tablet) once a day. This may be increased to 15 mg (one tablet)
once a day.
Rheumatoid arthritis:
15 mg (one tablet) once a day. This may be reduced to 7.5 mg (half a tablet)
once a day.
Ankylosing spondylitis:
15 mg (one tablet) once a day. This may be reduced to 7.5 mg (half a tablet)
once a day.
The tablets should be swallowed with water, or another drink, during a meal.

Mobic is not appropriate, if you require immediate relief from acute pain.

Do not exceed the recommended maximum dose of 15 mg a day.

Mobic may hide the symptoms of infection (e.g. fever). If you think you may
have an infection you should see your doctor.

If any of the statements listed under the heading "Take special care with
Mobic" apply to you, your doctor may restrict your dose to 7.5 mg (half a
tablet) once a day.

Precautions for use
As it will be necessary to adjust the treatment, it is important to ask your
doctor's advice before you take Mobic in case of:
 history of inflammation of the gullet (oesophagitis), inflammation of the
stomach (gastritis) or a history of any other disease of the digestive tract,
e.g. Crohn's Disease or Ulcerative Colitis

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

If you feel that the effect of Mobic is too strong or too weak, or if after several
days you do not feel any improvement in your condition, talk to your doctor or
pharmacist.
If you take more Mobic than you should
Whether you have taken too many tablets or suspect an overdose,
contact your doctor or go to your nearest hospital immediately
Symptoms following acute NSAID overdose are usually limited to:
 lack of energy (lethargy)
 drowsiness
 feeling sick (nausea) and being sick (vomiting)
 pain in the area of the stomach (epigastric pain)
These symptoms generally get better when you stop taking Mobic. You may
suffer from bleeding of the stomach or intestines (gastrointestinal bleeding).
Severe poisoning may result in serious drug reaction (see section 4.):
 high blood pressure (hypertension)
 acute kidney (renal) failure
 liver (hepatic) dysfunction
 reduction flattening or stopping of breathing (respiratory depression)
 loss of consciousness (coma)
 seizures (convulsions)
 collapse of the blood circulation (cardiovascular collapse)
 stopping of the heart (cardiac arrest)
 immediate allergic (hypersensitivity) reactions, including:
 fainting
 shortness of breath
 skin reactions
If you forget to take Mobic
Do not take a double dose to make up for a forgotten dose. Just take the next
dose at the usual time.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, Mobic can cause side effects, although not everybody gets
them.
Stop taking Mobic and consult a doctor or your nearest hospital
immediately if you notice:
Any allergic (hypersensitivity) reactions, which may appear in the form of:
 skin reactions, such as itching (pruritus), blistering or peeling of the skin,
which can be severe (Stevens-Johnson Syndrome and toxic epidermal
necrolysis), lesions of soft tissues (mucosal lesions) or erythema
multiforme.
Erythema multiforme is a serious allergic skin reaction causing spots, red
welts or purple or blistered areas. It can also affect the mouth, eyes and
other moist body surfaces.
 swelling of skin or mucosa, such as swelling around the eyes, face and lips,
mouth or throat, possibly making breathing difficult, swollen ankles or legs
(oedema 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 the eyeballs (jaundice)
 pain in the abdomen
 loss of appetite
Any side effects of the digestive tract, especially:
 bleeding (causing tar-coloured stools)
 ulceration of your digestive tract (causing abdominal pain)
Bleeding of the digestive tract (gastrointestinal bleeding), formation of ulcers
or formation of a hole in the digestive tract (perforation) may sometimes be
severe and potentially fatal, especially in elderly.
If you have previously suffered from any symptoms of the digestive tract due
to long term use of NSAIDs, seek medical advice immediately, especially if
you are elderly. Your doctor may monitor your progress whilst on treatment.
If affected by visual disturbances do not drive or operate machinery.
Side effects of meloxicam - the active substance of Mobic
Very common: affects more than 1 in 10 patients receiving the medicine
 indigestion (dyspepsia)
 feeling sick (nausea) and being sick (vomiting)
 abdominal pain
 constipation
 flatulence
 loose stools (diarrhoea)
Common: affects less than 1 in 10 patients receiving the medicine
 headache
Uncommon: affects less than 1 in 100 patients receiving the medicine
 dizziness (light-headedness)
 a feeling of dizziness or spinning (vertigo)
 somnolence ( drowsiness)
 anaemia (reduction of the concentration of the red blood pigment
haemoglobin)
 increase in blood pressure (hypertension)
 flushing (temporary redness of the face and neck)
 sodium and water retention
 increased potassium levels (hyperkalaemia). This can lead to symptoms
such as:
 changes to your heartbeat (arrhythmias)
 palpitations (when you feel your heartbeat more than usual)
 muscle weakness
 belching







inflammation of the stomach (gastritis)
inflammation of the mouth (stomatitis)
skin rash
swelling caused by fluid retention (oedema)
momentary disturbance of liver function tests (e.g. raised liver enzymes like
transaminases or an increase of the bile pigment bilirubin). Your doctor can
detect these using a blood test.
 disturbance of laboratory tests investigating kidney (renal) function (e.g.
raised creatinine or urea)
Rare: affects less than 1 in 1,000 patients receiving the medicine
 mood disorders
 nightmares
 abnormal blood count, including:
 abnormal differential blood count
 decreased number of white blood cells (leucocytopenia) which may lead
to increased risk of infection
 decreased number of blood platelets (thrombocytopenia) which may lead
to increased risk of bleeding or bruising
 ringing in the ear (tinnitus)
 feeling your heartbeat (palpitations)
 inflammation ofthe gullet (oesophagitis)
 nettle rash (urticaria)
 visual disturbances including:
 blurred vision
 conjunctivitis (inflammation of the eyeball or eyelids)
 inflammation of the large bowel (colitis)
Very rare: affects less than 1 in 10,000 patients receiving the medicine
 acute failure of the kidneys (renal failure) in particular in patients with risk
factors such as heart disease, diabetes or kidney disease.
Other side effects (frequency not known)
 confusion
 disorientation
 shortness of breath and skin reactions (anaphylactic/anaphylactoid
reactions) rashes caused by exposure to sunlight (photosensitivity
reactions)
 heart failure (cardiac failure) has been reported in association with NSAID
treatment
 complete loss of specific types of white blood cells (agranulocytosis),
especially in patients who take Mobic together with other drugs that are
potentially inhibitory, depressant or destructive to a component of the bone
marrow (myelotoxic drugs). This can cause:
 sudden fever
 sore throat
 infections
General side effects of non-steroidal anti-inflammatory medicines
(NSAIDs)
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be
associated with a small increased risk of heart attack (myocardial infarction)
or stroke (apoplexy), particularly at high doses and in long term treatment.
The following side effects have been reported after NSAID administration:
 vomiting of blood (haematemesis)
 worsening of inflammation of the digestive tract (e.g. exacerbation of colitis
or Crohn's disease)
Side effects caused by non-steroidal anti-inflammatory medicines
(NSAIDs), but not yet seen after taking Mobic
Changes to the kidney structure resulting in acute kidney failure:
 very rare cases of kidney inflammation (interstitial nephritis)
 death of some of the cells within the kidney (acute tubular or papillary
necrosis)
 protein in the urine (nephrotic syndrome with proteinuria)
If any of the side effects gets serious, or if you notice any side effect not listed
in this leaflet, please tell your doctor or pharmacist.

5) How to store Mobic





Keep all medicines out of the sight and reach of children.
Do not use after the expiry date printed on the carton, label or blister strip.
Mobic should be stored below 25°C in a dry place.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment

6) Further information
What Mobic contains
Each tablet contains 15mg meloxicam as the active ingredient.
Mobic also contain the following inactive ingredients: sodium citrate dihydrate,
lactose monohydrate, microcrystalline cellulose, povidone, anhydrous
colloidal silica, crospovidone and magnesium stearate.
What Mobic looks like and contents of the pack
The 15mg tablets are pale yellow, round and coded '77C breakline 77C' on
one side with the Boehringer logo on the reverse.
Mobic tablets are available as blister packs of 20 tablets.
PL 10383/0908

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Boehringer Ingelheim Pharma KG,
Birkendorfer Strasse 65, 88397 Biberach an der Riss, Germany. Procured
from within the EU and repackaged by the Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 04.12.2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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