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XEFO RAPID 8MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Xefo Rapid 8 mg film-coated tablets
Lornoxicam
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 or pharmacist.
In this leaflet:
1.
What Xefo Rapid is and what it is used for
2.
Before you take Xefo Rapid
3.
How to take Xefo Rapid
4.
Possible side effects
5.
How to store Xefo Rapid
6.
Further information

1.

WHAT XEFO RAPID IS AND WHAT IT IS USED FOR

Xefo Rapid is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the
oxicam class. It is intended for short term treatment of acute mild to moderate pain

2.

BEFORE YOU TAKE XEFO RAPID

Do not take xefo Rapid
if you are allergic (hypersensitive) to Xefo or any of the other ingredients of Xefo 8 mg
film-coated tablets.
if you suffer from thrombocytopenia
if you are hypersensitive to other NSAIDs including acetylsalicylic acid
if you suffer from severe heart failure.
if you suffer from gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding
disorders
if you have a history of gastrointestinal bleeding or perforation, related to previous
NSAIDs therapy
if you suffer from an active or have a history of recurrent peptic ulcer
if you suffer from severe liver impairment
if you suffer from severe renal impairment
if you are in the last three months of your pregnancy.
Take special care with Xefo Rapid
if you have impaired renal function
if you have a history of hypertension and or heart failure as fluid retention and oedema
if you suffer from ulcerative colitis or Crohn’s disease
if you have a history of bleeding tendency

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if you have a history of asthma
if you suffer from SLE (lupus erythematosus)

If you suffer from blood coagulation disorder, impaired liver function, are elderly or you will be
treated with Xefo Rapid for more than 3 months, your doctor may monitor you by laboratory test
on a frequent basis.
If you are going to be treated with heparin or tacrolimus concomitantly with Xefo Rapid, please
inform your doctor about your current medicine.
Xefo Rapid should not be used concomitantly with other NSAIDs such as acetylsalicylic acid,
ibuprofen and COX-2 inhibitors. Ask your doctor or pharmacist if you ar uncertain.
If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions
such as skin rash, mucosal lesions or other signs of hypersensitivity, you should stop taking Xefo
Rapid and contact you doctor immediately.
Medicines such as Xefo 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 of duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of theese conditions
(for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
During varicella it is advisable to avoid use of Xefo
Taking 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.
Xefo Rapid may interfere with other medicines.
Particular care should be taken if you are receiving any of the following substances:
Cimetidine
Anticoagulantia as heparin, phenprocoumon
Corticosteroids
Methotrexate
Lithium
Immunosuppressive agents as ciclosporine, tacrolimus
Heart medicine as digoxin, ACE-inhibitors, beta-adrenergic blockers
Diuretics
Beta blocker
Quinolone antibiotics
Anti-platelet agents
NSAIDs as ibuprofen, acetylsalicylic acids
SSRI
Sulphonylureas (e.g) glibenclamide
Inducer and inhibitors of CYP2C9-isoenzymes
Angiotensin II receptor blocker
Pemetrexed
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Taking Xefo Rapid with food and drink
Xefo Rapid film-coated tablets are supplied for oral use and should be taken with a glass quantity
of liquid.
Concomitant intake of food may reduce the uptake of the medicinal product.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Xefo Rapid should not be taken during the first six months of pregnancy and by breast-feeding
women. You must not take Xefo during the last three months of your pregnancy.
The use of Xefo may impair fertility and is not recommended in women attempting to conceive.
In women who have difficulties conceiving, or who are undergoing investigation of infertility,
withdrawal of Xefo should be considered.
Driving and using machines
Xefo Rapid has no or negligible influence on the ability to drive or use machinery.

3.

HOW TO TAKE XEFO RAPID

Always take Xefo Rapid exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Adults: The usual dose is 8-16 mg divided in doses of 8 mg twice daily. An initial dose of 16 mg
followed by 8 mg 12 hours later can be given on the first treatment day. After the first treatment
day the maximum recommended daily dose is 16 mg.
Xefo Rapid tablets must be swallowed with sufficient fluid. Do not take Xefo Rapid with a meal,
as food can reduce the effectiveness of Xefo Rapid.
Xefo Rapid is not recommended for use in children and adolescents below age 18 due to lack of
data
If you take more Xefo Rapid than you should
Please contact your doctor or the pharmacist if you have taken more Xefo Rapid than prescribed.
In case of an overdose the following symptoms may be expected: Nausea, vomiting, cerebral
symptoms (dizziness, disturbances in vision).
If you forget to take Xefo Rapid
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Xefo Rapid can cause side effects, although not everybody gets them.
Medicines such as xefo may be associated with a small increased risk of heart attack or stroke.

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If you get any of the following side effects, stop taking this medicine and tell your doctor
immediately, or contact the casualty department at your nearest hospital:
.

shortness of breath, chest pains, or ankle swelling appear or if they get worse
severe or continual stomach pain or your stools become black

yellowing of the skin and eyes (jaundice) – these are signs of liver problems
an allergic reaction- which can include skin problems such as ulcers or blistering,
or swelling of the face, lips, tongue, or throat which may cause difficulty in
breathing.
Fever, blistering eruption or inflammation especially on hands and feet or in the mouth
area (Stevens- Johnsons syndrome).
Exceptionally, serious infections of the skin in case of varicella.
Known side effects include:
Common: affects 1 to 10 users in 100
Mild and transient headache, dizziness, nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Uncommon : affects 1 to 10 users in 1,000
weight loss (Anorexia) ,inability to sleep, depression, an eye discharge ( conjunctivitis ), feeling
dizzy, ringing in the ears ( tinnitus ), cardiac failure, palpitations, rapid heart rate, feeling
blushed, constipation, excessive wind (flatulence), belching, dry mouth, gastritis, gastric ulcer,
upper abdominal pain, duodenal ulcer, mouth ulcers, increase in liver tests (defined by blood
tests), rash, itching, increased sweating, brushing of the skin (erythematous), angioedema, hives
(urticaria), hair loss, arthralgia, feeling unwell (malaise), swelling of face (face oedema), weight
changes, oedema, allergy (rhinitis).
Rare: affects 1 to 10 users in 10,000
sore throat, anaemia, reductuin in the blood cell count (thrombocytopenia and leukopenia),
hypersensitivity, anaphylactoid reaction and anaphylaxis, confusion, nervousness, agitation,
feeling sleepy (somnolence), paraesthesia (tingling sensations), abnormal sense of taste, tremor,
migraine, visual disturbances, hypertension, hot flush, haemorrhage, haematoma (bruising),
difficulty in breathing (dyspnoea) , cough, black tarry faeces, gastrointestinal haemorrhage,
vomiting of blood, inflammation in the mouth, oesophagitis, gastrooesophageal reflux, difficulty
in swallowing, aphthous stomatitis (ulcers), inflammation of the tongue, abnormal liver function,
skin problems, eczema, bone pain, muscle cramp, muscle pain, passing urine at night, urinary
problems, weakness, prolonged bleeding time, rash, bronchospasm, increase in urea and
creatinine levels, perforated ulcer.
Very rare: affects less than 1 user in 10,000
Liver damage, hepatitis, jaundice, cholestasis, bruising, oedema, severe skin disorder (StevensJohnson syndrome, Toxic epidermal necrolysis), aseptic meningitis, NSAID class effects:
neutropenia, agranulocytosis, aplastic anaemia, hemolytic anaemia, renal toxicity.
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.

5.

HOW TO STORE XEFO RAPID

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Keep out of the reach and sight of children.
Do not store above 30 C.
Do not use Xefo Rapid after the expiry date which is stated on the carton and the blister. The
expiry date refers to the last day of the month.
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 Xefo Rapid contains
The active substance is lornoxicam.
One film-coated tablet contains 8 mg lornoxicam
The other ingredients are:
Core: Cellulose, microcrystalline, Sodium hydrogen carbonate, Calcium hydrogen
phosphate, anhydrous, Low substituted hydroxypropylcellulose, Hydroxypropylcellulose,
Calcium stearate
Film: Titanium dioxide E171 , Talc, Propylene glycol, Hypromellose.
What Xefo Rapid looks like and contents of the pack
Xefo Rapid 8 mg film-coated tablet is a white to yellowish round biconvex film-coated tablet.
Xefo Rapid is distributed in pack sizes of 6, 10, 20, 30, 50, 100 and 250 film-coated tablets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
Nycomed UK Limited
Three Globeside Business Park
Fieldhouse Lane
Marlow
Buckinghamshire
SL7 1HZ
Manufacturer
Nycomed Danmark A/S
Langebjerg 1
Roskilde
DK 4000
Denmark
This medicinal product is authorised in the Member States of the EEA under the following
names:
DK/H/123/006
Austria

Xefo Rapid 8 mg - Filmtabletten

DK/H/123/1-2,5-6/II/040 + DK/H/123/1-2,5-6/R/003

Belgium
Bulgaria
Czech Republic
Denmark
Estonia
France
Greece
Hungary
Ireland
Italia
Lithuania
Latvia
Luxembourg
Poland
Portugal
Romania
The Netherlands
Slovakia
Slovenia
Spain
Sweden
United Kingdom

Xefo Acute 8mg filmomhulde tabletten
Ксефо Рапид
Xefo Rapid 8 mg
Xefo Rapid
Xefo Rapid
Xefoacu
Xefo Rapid
Xefo Rapid 8 mg filmtabletta
Xefo Rapid
XEFO RAPID
Xefo Rapid 8 mg pėvele dengtos tabletės
Xefo Rapid 8 mg apvalkotā tablete
Xefo Acute 8 mg comprimés enrobés
Xefo Rapid
Acabel Rapid
Xefo Rapid 8 mg
Xefo Rapid
Xefo Rapid filmom obalené tablety 8 mg
Xefo Rapid 8 mg filmsko obložene tablete
Acabel Rapid 8 mg c omprimidos recubiertos con película
Xefo Akut
Xefo Rapid 8 mg tablets

This leaflet was last approved in January 2011.

DK/H/123/1-2,5-6/II/040 + DK/H/123/1-2,5-6/R/003

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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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