POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31388/0004.
Meloxicam 15mg Orodispersible Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Meloxicam 15 mg Orodispersible Tablets
Meloxicam 15.0 mg
Read all of this leaflet carefully before you start taking this medicine.
IN THIS LEAFLET:
1. What Meloxicam orodispersible tablets are and what they are used for
2 . Before you take Meloxicam tablets
3. How to take Meloxicam tablets
4. Possible Side Effects
5. How to store Meloxicam tablets
6. Further Information
1. WHAT MELOXICAM ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Meloxicam tablets belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which can be used to reduce inflammation and pain in joints and muscles. (Orodispersible tablets are tablets which dissolve easily in the mouth).
Meloxicam tablets are used for:
2. BEFORE YOU TAKE MELOXICAM TABLETS
Do not take Meloxicam tablets and tell your doctor if you:
If you think any of these apply to you, do not start taking these Meloxicam tablets. Talk to your doctor first and follow the advice given to you.
Take special care with Meloxicam tablets
Tell your doctor or pharmacist before taking this medicine:
Tell your doctor if you think any of these apply to you.
Medicines such as these Meloxicam tablets may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Discuss your treatment with your doctor or pharmacist if you have heart problems, have previously had a stroke or you think you might be at risk of conditions such as high blood pressure, diabetes or high cholesterol, or if you are a smoker.
Taking other medicines
When you are taking Meloxicam tablets, do not take any other medicines – including medicines obtained without a prescription – without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking any of the following medicines:
Pregnancy and breast-feeding
Meloxicam tablets are not recommended for use by women who are pregnant or breast-feeding.
Tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before using any medicine.
Children (under 16 years old)
This medicine must not be given to children under 16 years old.
Driving and using machinery
Do not drive or operate machinery until you know how Meloxicam tablets affect you. If the tablets make you feel light-headed, dizzy or drowsy, or cause blurred vision, do not drive or operate machinery.
Important information about some of the ingredients of Meloxicam tablets
3. HOW TO TAKE MELOXICAM TABLETS
Always take Meloxicam tablets exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure. Read the label carefully.
Taking this medicine
The dose depends on the medical condition which is being treated. Your doctor will let you know how much you should take.
For the treatment of acute attacks of osteoarthritis:
The usual dose is 7.5 mg (half a tablet) a day. Your doctor may increase your dose to 15 mg (one tablet) a day, if necessary.
For the treatment of rheumatoid arthritis and ankylosing spondylitis:
The usual dose is 15 mg (one tablet) a day. Your doctor may reduce your dose to 7.5 mg (half a tablet) a day if necessary.
If you are aged 65 years and over, the recommended dose for the long term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (half a tablet) a day.
If you have any of the conditions listed in Section 2 under the heading “Take special care with Meloxicam tablets”, your doctor may restrict your dose to 7.5 mg (half a tablet) a day.
If you feel that the effect of these Meloxicam tablets is too strong or too weak, or after several days you do not feel any improvement in your condition, consult your doctor or pharmacist.
If you take more of this medicine than you should
Contact your doctor or pharmacist immediately or go immediately to the accident and emergency department of your nearest hospital, taking this leaflet or the tablets with you.
If you forget to take your tablet (or half tablet)
Never take two doses on the same day to make up for one you have missed.
Take your usual dose the next day.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meloxicam tablets can cause side effects, although not everybody gets them.
Clinical trials and scientific data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of blood clots in the arteries (which could, for example, lead to heart attack or stroke).
Contact your doctor immediately, or go immediately to the accident and emergency department of your nearest hospital, (taking this leaflet or the tablets with you), if you get the following serious side effects:
Contact your doctor if you get the following side effects:
Pancreatitis (inflammation of the pancreas)
Common side effects (affects 1 to 10 users in 100 ):
Uncommon side effects (affects 1 to 10 users in 1,000):
Rare side effects (affects 1 to 10 users in 10,000):
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MELOXICAM TABLETS
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 Meloxicam 15 mg orodispersible tablets contain
The active ingredient is Meloxicam.
Each tablet contains 15mg.
The other ingredients are mannitol (E421), aspartame (E951), sorbitol (E420), citric acid anhydrous (E330), yoghurt flavour, forest fruit flavour, povidone (E1201), talc (E553b), sodium lauryl sulfate and magnesium stearate (E572).
What Meloxicam tablets look like and contents of the pack
Meloxicam 15 mg tablets are round light yellow, flat, scored tablet embossed with AX5 on one side, which can be divided into equal halves. . The tablets are supplied in:
Marketing Authorisation Holder
Contact address: PO BOX 849, Bedford, MK45 9EG
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria & Poland: Trosicam
Czech Republic: Oramellox 15 mg
Greece & Republic of Cyprus: Meloxicam /Medical
Hungaria: Trosicam 15 mg szájban diszpergálódó tabletta
Romania: Trosicam 15 mg comprimate orodispersible
Slovakia: Oramellox 15 mg
UK: Meloxicam 15 mg Orodispersible Tablets
This leaflet was last approved in 29.06.2017.