Download Package leaflet: Information for the user Ibuprofen Sandoz 600 mg

Package leaflet: Information for the user
Ibuprofen Sandoz 600 mg, filmomhulde tabletten
Ibuprofen
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- 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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Ibuprofen Sandoz is and what it is used for
2. What you need to know before you take <Product Name>
3. How to take <Product Name>
4. Possible side effects
5. How to store <Product Name>
6. Contents of the pack and other information
1. What Ibuprofen Sandoz is and what it is used for
<Product Name> belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). These medicines provide relief by changing how the body responds to pain and swelling.
Ibuprofen Sandoz is used for the symptomatic treatment of pain and inflammation in arthritic diseases,
(e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and
inflammation after soft tissue injuries.
2. What you need to know before you take <Product Name>
Do not take <Product Name>
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
- if you have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using
acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs)
- if you have (or have had two or more episodes of ) a stomach ulcer or bleeding of the stomach
- if you have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy
- if you have severe liver, kidney, coronary heart disease or heart failure
- if you suffer from cerebrovascular or other active bleeding
- if you suffer from unclarified blood-formation disturbances
- if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
- during the last three months of pregnancy (see below)
- if the patient is a child or adolescent
Warnings and precautions
Talk to your doctor before taking <Product Name>
•
if you have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective
tissue disease). If you suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson
syndrome and toxic epidermal necrolysis. The use of <Product Name> should be stopped immediately at
the first appearance of skin rash, mucosal lesions, or any other sings of allergic reactions
•
if you have hereditary blood formation disorder (acute intermittent porphyria)
•
if you have or have ever had bowel disease (ulcerative colitis or Crohn’s disease)
•
if you have ever had a high blood pressure and/or heart failure
•
if you have reduced renal function
•
if you have liver disorders
•
directly after major surgery
•
if you have or have had asthma or allergic disease as shortness of breath may occur
•
if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased
risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic
asthma). Quincke’s oedema or hives
•
During chicken pox (varicella) it is advisable to avoid use of <Product Name>
•
medicines such as Ibuprofen Sandoz 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 have heart problems, previous stroke or think that you might be at risk of these 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
•
if you suffer from coagulation disturbances
•
In prolonged administration of Ibuprofen Sandoz regular checking of your liver values, the kidney
function, as well as of the blood count, is required
•
The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases
risk of adverse reactions (see section “Taking other medicines” below) and should be avoided
Undesirable effects are minimised by using the minimum effective dose for the shortest period of time.
The elderly are at increased risk of side effects.
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This
risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it
should be avoided.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is
experienced or suspected, medical advice should be obtained and treatment should be discontinued. The
diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or
daily headaches despite (or because of) the regular use of headache medications.
NSAIDs such as ibuprofen may mask the symptoms of infection and fever.
Other medicines and <Product name>
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidin),
some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking
medicines, angiotensin II antagonists), and even some other medicines may effect or be effected by the
treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other
medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In
particular, tell them if you are taking:
acetylsalicylic acid, or other NSAIDs (antiinflammatories and analgesics)
since this may increase the risk of gastrointestinal
ulcers or bleeding
digoxin (for heart insufficiency)
since the effect of digoxin may be enhanced
glucocorticoids (medicinal products containing
cortisone or cortisone-like substances)
since this may increase the risk of gastrointestinal
ulcers or bleeding
anti-platelet agents
since this may increase the risk of bleeding
acetylsalicylic acid (low dose)
since the blood-thinning effect may be impaired
medicines for thinning the blood (such as warfarin)
since ibuprofen may enhance the effects of these
medicines
phenytoin (for epilepsy)
since the effect of phenytoin may be enhanced
selective serotonin reuptake inhibitors (medicines
used for depression)
as these may increase the risk of gastrointestinal
bleeding
lithium (a medicine for manic depressive illness and since the effect of lithium may be enhanced
depression)
probenecid and sulfinpyrazones (medicines for
gout)
since the excretion of ibuprofen may be delayed
medicines for high blood pressure and water tablets
since ibuprofens may diminish the effects of these
medicines and there could be a possible increased
risk for the kidney
potassium sparing diuretics
since this may lead to hyperkalaemia
methotrexate (a medicine for cancer or rheumatism)
since the effect of methotrexate may be enhanced
tacrolimus and cyclosporine (immunosuppressive
medicines)
since kidney damage may occur
zidovudine: (a medicine for treating Aids)
since the use of Ibuprofen Sandoz may result in an
increased risk of bleeding into a joint or a bleeding
that leads to swelling in HIV (+) haemophiliacs
sulfonylureas (antidiabetic medicines)
interactions may be possible
quinolone antibiotics
since the risk for convulsions may be increased
<Product Name> with food, drink and alcohol
Swallow the tablets with water. It is recommended that patients with sensitive stomachs take Ibuprofen
Sandoz with food. Some side effects, such as those affecting the gastrointestinal system can be more likely
when alcohol is taken at the same time as <Product Name>.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Do not take Ibuprofen Sandoz in the last 3 months of pregnancy.
Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.
This medicine passes into breast milk but may be used during breast-feeding if it is used at the
recommended dose and for the shortest possible time.
This product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This
product is not recommended in women trying to conceive. This effect is reversible on stopping the
medicine.
Driving and using machines
Ibuprofen has no or negligible influence on the ability to drive and use machines. However since at high
dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances
(reported as uncommon) may be experienced, the ability to drive a car or operate machinery may be
impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol.
Ibuprofen Sandoz contains lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take <Product Name>
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose is:
The ibuprofen dose depends on the patient’s age and body weight. The recommended dose range for
adults 1200 mg and 2400 mg ibuprofen per day. The maximum single daily dose for adults should not
exceed 800 mg of ibuprofen.
Adults:
The usual dose is 600 mg spread throughout the day in 3 doses. Your doctor may choose to increase this
depending on what you are being treated for, but no more than 2400 mg should be taken in one day in 4
divided doses.
Age
Adults
Single dose in
mg ibuprofen
(tablets)
600 mg
(1 tablet)
Total daily dose
in mg ibuprofen
(tablets)
1200 - 2400 mg
(2 - 4 tablets)
Children and Adolescents
This product is contraindicated in children and adolescents.
Elderly
NSAIDs should be used with particular caution in elderly patients who are more sensitive to adverse
events and are at increased risk of potentially fatal gastrointestinal bleeding, ulceration or perforation. If
treatment is considered necessary, the lowest dose for the shortest duration necessary to control symptoms
should be used. Treatment should be reviewed at regular intervals and stopped if no benefit is seen or
intolerance occurs.
Impaired renal function
In patients with mild or moderate reduction of renal function, the dose should be kept as low as possible
for the shortest duration necessary to control symptoms and renal function monitored.
Impaired liver function
In patients with mild or moderate reduction of liver function the dose should be kept as low as possible for
the shortest duration necessary to control symptoms and liver function monitored.
Method of administration
For oral use. Do not chew.
The tablet should be swallowed with a glass of water during or after a meal. It is recommended that
patients with sensitive stomachs take Ibuprofen Sandoz with food.
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than
you expected.
In rheumatic diseases the use of Ibuprofen Sandoz can be required for a longer period. Your doctor will
decide about the duration of treatment.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration
necessary to control symptoms.
If you take more Ibuprofen Sandoz than you should
Consult a doctor immediately. Central nervous disturbances such as headache, dizziness, light-headedness
and unconsciousness (also myoclonic convulsions in children), as well as abdominal pain, nausea and
vomiting, may occur as symptoms of an overdose. In addition, gastrointestinal bleeding, as well of
functional disturbances of the liver and kidneys, is possible. There may furthermore be hypotension,
reduced breathing (respiratory depression) and blue discolouring of the skin and mucosa (cyanosis).
If you forget to take <Product Name>
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the
symptoms. Although side effects are uncommon, you may suffer one of the known side effects of
NSAIDs. If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as
possible. Elderly people using this product are at increased risk of developing problems associated with
side effects.
The following frequencies are taken as a basis when evaluating side effects:
very common
common
uncommon
rare
very rare
not known
may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1000 people
may affect up to1 in 10,000 people
frequency cannot be estimated from the available data.
Side effects may include:
Infections
Very rare: Exceptionally, severe skin infections and soft-tissue complications during chicken pox.
Exacerbation of infection-related inflammations (e.g. necrotising fasciitis) associated with use of certain
painkillers (NSAIDs) has been described.
If signs of an infection occur or get worse during use of <Product Name>, you must go to a doctor without
delay. It is to be investigated whether there is an indication for an anti-infective/antibiotic therapy. The
symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or consciousness
clouding have been observed under ibuprofen. Patients with autoimmune disorders (SLE, mixed
connective-tissue disease) appear to be predisposed.
Blood disorders
Very rare: Problems in the blood cell production - first signs are: fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the
therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that
reduce fever (antipyretic medicinal products) mustn’t be done.
Problems of the immune system
Uncommon: Hypersensitivity reactions with hives and itch, as well as asthma attacks. You must stop
taking Ibuprofen Sandoz and inform your doctor at once.
Very rare: Severe hypersensitivity reactions – signs could be: swelling of face, tongue and throat,
shortness of breath, accelerated heartbeat, low blood pressure, severe shock. If one of these symptoms
occurs, which can happen even on first use, the immediate assistance of a doctor is required.
Psychiatric disorders
Very rare: Psychotic reactions, depression, hallucinations
Nervous system disorders
Common: Central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability
and tiredness
Eye disorders
Uncommon: visual disturbances
Ear and balance disorders
Rare: Tinnitus
Cardiac disorders
Very rare: palpitations, heart failure, myocardial infarction, oedema, hypertension and cardiac failure have
been reported in association with NSAID treatment at high doses
Vascular disorders
Very rare: arterial hypertension
Stomach and bowel disorders
Very common: Stomach complaints, such as acid burn, stomach pain and nausea, diarrhoea, vomiting,
flatulence (wind) and constipation, and slight blood losses in stomach and/or bowel that may cause
anaemia in exceptional cases.
Common: Gastrointestinal ulcers, potentially with perforation and bleeding, ulcerative stomatitis,
worsening of colitis and Crohn’s disease
Uncommon: gastritis
Very rare: Oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures
In case of strong pain in the upper abdomen, vomiting of blood or black stools you must stop the treatment
and consult a doctor.
Liver disorders
Very rare: Damage to the liver (first signs could be discoloration of the skin), hepatic damage especially in
long-term therapy, hepatic failure, acute hepatitis, jaundice
Skin disorders
Very rare: Severe forms of skin reactions including rash with redness and blistering, Stevens-Johnson
syndrome and mortification of tissue, alopecia.
Kidney disorders
Rare: Medicines such as Ibuprofen Sandoz may very rarely lead to kidney disease. Pain in the flanks
and/or abdomen, blood in the urine, and a fever may be signs of damage to the kidneys (papillary
necrosis). Elevated urea concentration in blood may also occur rarely.
Uncommon: Passing less urine than normal and swelling (especially in patients with high blood pressure
or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory
kidney disease (interstitial nephritis) that may lead to acute kidney failure. If one of the above mentioned
symptoms occurs of if you have a general miserable feeling, stop taking Ibuprofen Sandoz and consult
your doctor immediately as these could be first signs of a kidney damage or kidney failure.
Medicines such as Ibuprofen Sandoz may be associated with a small increased risk of heart attack
("myocardial infarction") or stroke.
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 the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store <Product Name>
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ibuprofen Sandoz contains
-The active substance is ibuprofen.
Each film-coated tablet contains 600 mg ibuprofen.
The other ingredients are:
Tablet core:
Lactose monohydrate
Maize starch (Corn Starch (400L))
Hypromellose 6 CPS (Pharmacoat 606) (E464)
Colloidal Anhydrous Silica (E551)
Microcrystalline Cellulose (E460)
Croscarmellose Sodium (E468)
Magnesium Stearate (E572)
Film coating:
Hydroxy Propyl Methyl Cellulose
Polyethylene Glycol 400
Polyethylene Glycol 6000
Titanium dioxide (E171)
What <Product Name> looks like and contents of the pack
Film-coated tablets.
White coloured, film coated pillow shaped tablets debossed with ‘237’ on one side and plain on the other.
Pack sizes:
10, 20, 30, 48, 50, 98, 100, 250 tablets
Not all pack sizes may be marketed.
In het register ingeschreven onder nummer:
RVG 117346
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
Manufacturer
Medicofarma S.A.
ul. Kozienicka 97,
26-600 Radom
Poland
Pharmadox Healthcare Ltd
KW 20A Kordin Industrial Park
Paola PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last approved in september 2015.