ORUVAIL 100 MG PROLONGED-RELEASE CAPSULES HARD

Active substance: KETOPROFEN

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Oruvail® 100mg or 200mg
Prolonged-Release
Capsules, Hard
Ketoprofen

Is this leaflet hard to see or
read?
Phone 01483 505515 for help

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 Oruvail Capsules are and what they
are used for
2. Before you take Oruvail Capsules
3. How to take Oruvail Capsules
4. Possible side effects
5. How to store Oruvail Capsules
6. Further information
1. What Oruvail Capsules are and
what they are used for
What Oruvail Capsules are and how they
work
The name of your medicine is Oruvail 100mg
or 200mg Prolonged-Release Capsules, Hard
(called Oruvail Capsules in this leaflet).
Oruvail Capsules contain a medicine called
ketoprofen. This belongs to a group of
medicines called ‘Non-Steroidal
Anti-Inflammatory Drugs’ (NSAID’s). It works
by blocking chemicals in your body that
normally cause inflammation.
What Oruvail Capsules are used for
Oruvail Capsules are used to treat the
swelling, pain, heat, redness and stiffness in
your joints and muscles in the following:
• Rheumatoid arthritis (inflammation of
your joints)

• Osteoarthritis (where the cushioning
(cartilage) between your bone joints is
damaged)
• Pain due to problems with your spine
(such as ankylosing spondilitis)
• Lower back pain
• Sprains and strains
• Painful periods
• Pain and inflammation after an operation
• Other painful inflammatory joint, tendon,
nerve or muscle problems
• Gout (painful, red, swollen joints)
2. Before you take Oruvail Capsules
Do not take this medicine and tell
your doctor if:
 You are allergic (hypersensitive) to:
- ketoprofen
- aspirin
- any other Non-Steroidal
Anti-Inflammatory Drug (NSAID) such
as ibuprofen or indometacin
- any of the other ingredients of Oruvail
Capsules (listed in Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
 You have or have ever had an ulcer or
bleed in your stomach or intestine (gut)
 You have severe heart problems
 You have severe liver or kidney problems
 You bruise more easily than usual and
have bleeding that lasts a long time
 You are pregnant (see ‘Pregnancy and
breast-feeding’ below)
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before using Oruvail
Capsules.
Take special care with Oruvail
Capsules
Check with your doctor or pharmacist
before taking your medicine if:
 You are asthmatic
 You have ulcerative colitis or Crohn’s
disease
 You have a disease affecting the skin,
joints or kidneys called ‘Systemic Lupus
Erythematosus’ (SLE)
 You are 65 years of age or older
 You are planning to become pregnant or
you have problems becoming
pregnant. Oruvail Capsules may
make it more difficult to become
pregnant.

11503340-04

 You have heart problems, previous stroke
or think that you might be at risk of these
conditions (if you have high blood
pressure, diabetes or high cholesterol or
are a smoker).
Medicines such as Oruvail Capsules 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 or duration of treatment.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Oruvail Capsules.
Your doctor may need to keep a close
check on you or give you a shorter course
of treatment if:
 You have high cholesterol or blood fats
 You are diabetic
 You smoke
 You have kidney or liver problems
 You are taking water tablets (diuretics)
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Oruvail Capsules.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Oruvail Capsules
can affect the way some other medicines
work. Also some medicines can affect the
way Oruvail Capsules work.
In particular, tell your doctor if you are
taking any of the following:
• Other Non-Steroidal Anti-Inflammatory
Drugs such as aspirin or ibuprofen
• Water tablets (diuretics)
• Medicines for high blood pressure or
heart failure
• Digoxin - used for controlling heart rate
or helping in heart failure
• Medicines to stop your blood clotting
such as heparin, warfarin or clopidogrel,
ticlopidine
• Medicines to dissolve blood clots such as
streptokinase, alteplase, reteplase or
tenecteplase
• Medicines for infections (antibiotics) such
as ciprofloxacin, levofloxacin or ofloxacin
• Medicines for depression such as fluoxetine,
sertraline, citalopram or paroxetine

• Corticosteroids - used for inflammation
such as hydrocortisone, betamethasone
or prednisolone
• Ciclosporin - used after an organ
transplantation to help prevent rejection
• Mifepristone – used to terminate a
pregnancy. It is important that Oruvail
Capsules are not taken for 8-12 days after
taking Mifepristone
• Lithium – used for some types of mental
illness
• Methotrexate – used for some types of
cancer or psoriasis
• Pentoxifylline - used to help poor blood
circulation in limbs
• Tacrolimus - used after an organ
transplant
• Probenecid - used for gout
• Zidovudine – used for HIV
Pregnancy and breast-feeding
Do not take this medicine if you are
pregnant, might become pregnant, or think
you may be pregnant.
You should not breast-feed if you are using
Oruvail Capsules. This is because small
amounts may pass into mothers’ milk.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.
Driving and using machines
You may feel sleepy, dizzy, faint, your
eyesight may be affected or you may have a
fit while taking this medicine. If this
happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Oruvail capsule
Oruvail Capsules contain sugar. Take this
into account if you have diabetes.
3. How to take Oruvail Capsules
Always take Oruvail Capsules exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink
of water
• Take with or after food
• Do not crush or chew your capsules
• The dose will depend on your body weight
and how severe your pain is
11503340-04

• If you feel the effect of your medicine is
too weak or too strong, do not change the
dose yourself, but ask your doctor
• These are slow release capsules so you will
feel the effects for up to 16 hours
How much to take
Adults
The usual dose is one capsule each day.
Children
Oruvail Capsules are not recommended
for children.
The elderly
You are more likely to get side effects
while taking Oruvail Capsules. Your
doctor may start you on the lowest
strength
If you take more Oruvail Capsules than
you should
If you take more capsules than you should,
tell a doctor or go to a hospital casualty
department straight away. Take the
medicine pack with you. This is so the
doctor knows what you have taken.
The following effects may happen, feeling
drowsy, stomach pains, being sick, feeling
faint due to low blood pressure, difficulty
breathing, wheezing, tightness in the chest
or blood in your stools.
If you forget to take Oruvail Capsules
If you forget a dose, take it as soon as you
remember. However, if it is nearly time for
the next dose, skip the missed dose. Do not
take a double dose to make up for a
forgotten capsule.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Oruvail Capsules can
cause side effects, although not everybody
gets them.
Stop taking and see your doctor or go to
a hospital straight away if:
Rare (affects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your
stomach, with an empty feeling and
hunger. This may be caused by an ulcer in
your stomach or gut.

Frequency not known
• You get blistering, peeling or bleeding on
any part of your skin with or without an
itchy, lumpy rash. This includes your lips,
eyes, mouth, nose, genitals, hands or feet.
You may also have flu like symptoms at
the same time. You may have a serious
skin problem that needs urgent medical
treatment
• You have blood in your urine, change in
the amount of urine you produce or
swelling especially of your legs, ankles or
feet. This may be caused by serious kidney
problems
• You get chest pain or a sudden severe
headache. Medicines such as Oruvail
Capsules may be associated with a small
increased risk of heart attack (myocardial
infarction) or stroke
• You get swelling of your face, lips or
throat which makes it difficult to swallow,
breathe or you may have wheezing or
tightness in the chest, as well as itching
and rashes. This may mean you are
having a severe allergic reaction
• You are vomiting blood, have severe
stomach pains or pass dark, tarry stools
Tell your doctor as soon as possible if you
have any of the following side effects:
Rare (affects less than 1 in 1,000 people)
• Unusual skin sensations such as
numbness, tingling, pricking, burning or
creeping on your skin (paraesthesia)
• You bruise more easily than usual or have
bleeding that lasts a long time. This could
be because of a serious blood problem
• You have pale skin and feel tired, faint or
dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This
may be a sign of liver problems.
Frequency not known
• Worsening of your Crohn’s disease or
colitis
• Skin reaction to light or sunlamps
(photosensitivity)
• Hair loss
• You may get more infections more easily
than usual. This could be because of a
serious blood disorder.
• Fits
• Pain in your eyes
11503340-04

Other side effects
Common (affects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain,
these are reduced by taking the medicine
with food
• Feeling sick (nausea) or being sick
(vomiting)
Uncommon (affects less than 1 in 100
people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen
arms or legs
• Headaches, feeling dizzy, feeling drowsy
or sleepy, feeling tired or unwell
Rare (affects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• Inflamed mouth
Very rare (affects less than 1 in 10,000
people)
• Severe stomach or back pain. These could
be signs of pancreatitis.
Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep,
changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stuffy
nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there
Blood tests
The results of a blood test may show
changes in the way your liver or kidney is
working.
These side effects may go away during
treatment as your body gets used to the
medicine.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
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 Oruvail Capsules
Keep this medicine in a safe place where
children cannot see or reach it.
Do not take Oruvail Capsules after the expiry
date which is stated on the carton and blister
after EXP. The expiry date refers to the last
day of that month.
Store the blister packs in a dry place below
25°C. Keep the blister strip in the outer
carton in order to protect from light.
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 Oruvail Capsules contain
• Each of the 100mg capsule contains 100mg
of the active substance, ketoprofen
• Each of the 200mg capsule contains 200mg
of the active substance, ketoprofen The other
ingredients are sugar spheres, colloidal
anhydrous silica, shellac, ethylcellulose,
talc, gelatine, titanium dioxide (E171).
Oruvail 100mg Capsules also contain
aerythrosine (E127) and patent blue V (E131).
What Oruvail Capsules look like and
contents of the pack
• Oruvail 100mg Capsules are half pink and
half purple marked with Oruvail 100 in
white. They are supplied in blister packs
of 8, 28, 30 & 56 capsules
• Oruvail 200mg Capsules are half pink and
half white marked Oruvail 200 in blue.
They are supplied in blisters packs of 4, 8,
14, 28 & 56 capsules
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.,
Avda. Leganés, 62,
Alcorcón 28923 Madrid,
Spain.
This leaflet was last revised in 08/2013
© sanofi, 1982-2013
11503340-04

Expand view ⇕

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.

Got questions about Rheumatoid Arthritis? Get answers from our expert Dr. Carteron. Click Here

Close
Hide
(web2)