Ibuprofen Sandoz: detailed information

Package leaflet: Information for the patient

Ibuprofene Sandoz 200 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

What Ibuprofene Sandoz is and what it is used for
What you need to know before taking Ibuprofene Sandoz
How to take Ibuprofene Sandoz
Possible side effects
How to store Ibuprofene Sandoz
Contents of the pack and other information

1. What Ibuprofene Sandoz is and what it is used for

This medicinal product contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing pain (analgesic effect) and lowering fever.
Ibuprofene Sandoz is indicated for the treatment of pain of various origins: menstrual pain, headache, toothache, nerve pain (neuralgia), and pain in bones, joints, and muscles (osteo-articular and muscular pain).
The medicine is also indicated as an additional treatment for the symptoms of fever and influenza.
If you do not feel better or feel worse after 3 days of treatment, consult your doctor.

2. What you need to know before taking Ibuprofene Sandoz

Do not take Ibuprofene Sandoz

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to acetylsalicylic acid or to other medicines used to relieve pain (analgesics), fever (antipyretics), such as non-steroidal anti-inflammatory drugs (NSAIDs), particularly when the allergy is associated with swelling of the nasal mucosa (nasal polyps), angioedema, and asthma, and manifests as an asthmatic reaction (bronchospasm), urticaria, or severe cold (acute rhinitis) (see section “Warnings and precautions”);
if you suffer from severe liver or kidney problems;
if you suffer from severe heart problems (severe heart failure);
if you have had gastrointestinal bleeding and/or perforation following previous treatment with other medicines;
if you suffer or have suffered from recurrent bleeding or ulcers (two or more distinct episodes of proven ulceration or bleeding);
if you have had a severe ulcer in the stomach or the first part of the intestine;
if you currently have an ulcer;
if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
if you have a blood cell production disorder of unknown cause;
if you are in the last 3 months of pregnancy (See section “Pregnancy and breastfeeding”);
if the patient is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofene Sandoz.
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of
heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of
treatment.
Do not take this medicine if you are already taking other medicines (See section “Other medicines and
Ibuprofene Sandoz”).
Be especially careful with Ibuprofene Sandoz

Skin reactions Serious skin reactions have been reported in association with treatment with Ibuprofene Sandoz. Stop taking Ibuprofene Sandoz and consult your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

You should discuss treatment with your doctor or pharmacist before taking Ibuprofene Sandoz if you have:

heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.
if you have an infection – see section «Infections» below.

Take this medicine with caution:

if you suffer or have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
if you suffer from heart disorders (mild to moderate heart failure, congestive heart failure, confirmed ischaemic heart disease, cardiac decompensation). In such cases, your doctor should monitor you frequently, especially if you are taking the medicine for prolonged periods;
if you have hepatic porphyria;
if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids administered orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Ibuprofene Sandoz”);
if you have liver, kidney, or heart problems, except in cases of severe liver, kidney, or heart failure, as in these cases you must not take Ibuprofene Sandoz (see section 2 “Do not take Ibuprofene Sandoz”);
if you have reduced kidney function or suffer from liver problems (hepatic dysfunction). In these cases, your doctor should monitor you frequently, especially if you are taking the medicine for prolonged periods;
if you suffer from respiratory disorders (asthma), seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), other allergic diseases, or if you have previously experienced breathing difficulties (bronchospasm), including after using medicines similar to Ibuprofene Sandoz (aspirin or other NSAIDs);
if the patient is a child or adolescent with dehydration, as the medicine may cause kidney problems in such cases;
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
if you have reduced body fluid volume (e.g. before or after major surgery);
if you are undergoing or have recently undergone major surgery;
if you have stomach or intestinal problems, except in cases where you have one or more conditions that contraindicate taking Ibuprofene Sandoz (see section “Do not take Ibuprofene Sandoz”);
if you are a woman planning pregnancy;
if you are a woman with fertility problems or undergoing fertility investigations, as you should discontinue treatment with Ibuprofene Sandoz;
if you have an autoimmune disease, e.g. systemic lupus erythematosus or connective tissue disorders.

In these cases, your doctor will monitor you closely and periodically reassess the need for treatment with
Ibuprofene Sandoz. Additionally, your doctor may recommend periodic tests (such as monitoring kidney
function) to evaluate your condition during treatment with Ibuprofene Sandoz.
Infections
Ibuprofene Sandoz may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene Sandoz may
delay appropriate treatment of the infection, potentially increasing the risk of complications. This has
been observed in bacterial pneumonia and varicella-related bacterial skin infections. If you take this
medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Stop treatment and inform your doctor if, during treatment with Ibuprofene Sandoz,
you develop:

gastrointestinal bleeding or ulceration
mucosal lesions or any other sign of allergic reaction
fluid retention and swelling due to fluid accumulation (oedema)
signs and symptoms of liver problems or abnormal liver function tests (seen in blood tests)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Ibuprofene Sandoz
fever, sore throat, superficial mouth ulcers, flu-like symptoms, profound fatigue, unexplained bruising or bleeding, as you may have a reduced number of white blood cells in the blood (agranulocytosis)
neck stiffness, headache, nausea, vomiting, fever, disorientation, as you may have aseptic meningitis. Patients with autoimmune diseases (systemic lupus erythematosus, connective tissue disease) appear to be more predisposed to developing aseptic meningitis
symptoms of an infection (e.g. headache, fever) or notice worsening of an infection, as Ibuprofene Sandoz may mask signs and symptoms of infection.

In these cases, your doctor will assess whether to continue or discontinue treatment with Ibuprofene Sandoz.
Other important information:

During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal, and may happen at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal events. You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity, and your doctor may prescribe protective medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
Adverse effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Ibuprofene Sandoz”).
Avoid using ibuprofen during treatment with other NSAIDs administered orally, by injection, or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of adverse effects.

Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more
likely in patients with systemic lupus erythematosus or connective tissue disorders.
During treatment with this medicine, eye problems (ocular disturbances) may occur.
Therefore, during prolonged treatment, periodic eye examinations (ophthalmological checks) are recommended.
Children and adolescents
Ibuprofene Sandoz is contraindicated in children under 12 years of age.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly stomach or intestinal bleeding and perforation, which are generally more severe and may be fatal.
If you are elderly, you should take the lowest dose of Ibuprofene Sandoz. As a precaution, your doctor may perform kidney function tests and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment
with this medicine.
Other medicines and Ibuprofene Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofene Sandoz may affect or be affected by other medicines. For example:

medicines with anticoagulant effects (i.e. substances that thin the blood to prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan), especially if you are elderly or have kidney problems; in such cases, adequate fluid intake is necessary, and your doctor may periodically monitor your kidney function after starting treatment;
anti-inflammatory medicines such as aspirin (including cyclooxygenase-2 inhibitors), as the risk of adverse effects may increase;
medicines used to reduce inflammation and treat allergies (corticosteroids), as they may increase the risk of gastrointestinal ulcers or bleeding;
selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of gastrointestinal adverse reactions;
lithium, a medicine used for mood disorders;
methotrexate, a medicine used to treat certain cancers, rheumatoid arthritis, and other immune system disorders;
certain antibiotics (aminoglycosides, quinolones);
medicines used to treat heart problems (cardiac glycosides), colestyramine and colestipol, medicines used to lower blood cholesterol levels, as they may reduce the effectiveness of Ibuprofene Sandoz;
medicines used after organ transplantation (cyclosporine, tacrolimus), as their concomitant use with Ibuprofene Sandoz increases the risk of kidney toxicity (nephrotoxicity);
Ginkgo biloba, a herbal extract that improves blood circulation, as it may increase the risk of bleeding;
mifepristone, a medicine used to terminate pregnancy, as ibuprofen may reduce its effectiveness;
diuretics, including potassium-sparing diuretics, particularly if you have kidney problems;
medicines used to treat diabetes (sulfonylureas), as excessive lowering of blood sugar levels (hypoglycaemia) may occur;
medicines used to treat AIDS (zidovudine, ritonavir);
probenecid, used to treat gout, as it reduces the elimination of NSAIDs;
phenytoin, a medicine for epilepsy;
medicines for bacterial infections of the quinolone class;
medicines used to treat fungal infections (voriconazole, fluconazole, sulfinpyrazone), as they reduce ibuprofen elimination (CYP2C9 inhibitors). In such cases, your doctor should consider reducing the dose of Ibuprofene Sandoz.

Other medicines may also affect or be affected by treatment with Ibuprofene Sandoz. Therefore, always
consult your doctor or pharmacist before using Ibuprofene Sandoz with other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or
pharmacist before taking this medicine.
Conception, first and second trimesters of pregnancy
Do not take Ibuprofene Sandoz during the first and second trimesters of pregnancy without consulting your
doctor. Your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus.
If Ibuprofene Sandoz is used by a woman trying to conceive, or during the first and second trimesters of
pregnancy, the dose and duration of treatment should be kept as low as possible.
It may cause kidney and heart problems in the fetus. It could affect bleeding tendency in both mother and baby and delay or prolong labour beyond expectations.
You should not take Ibuprofene Sandoz during the first 6 months of pregnancy unless absolutely necessary
and under medical advice. If treatment is required during this period or during attempts to conceive, the
lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Ibuprofene
Sandoz may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid
levels surrounding the baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby’s
heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Third trimester of pregnancy
Ibuprofene Sandoz is contraindicated during the third trimester of pregnancy because it may cause serious harm to both mother and baby.
Breastfeeding
Avoid taking this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
Discontinue treatment with this medicine if you intend to start a pregnancy, have fertility problems, or are undergoing fertility investigations. Anti-inflammatory medicines, including Ibuprofene Sandoz, may cause reduced fertility in women, which returns to normal after stopping treatment.
Driving and using machines
This medicine may cause dizziness, fatigue, drowsiness, and visual disturbances, which may impair your ability to drive or operate machinery. If this occurs, avoid driving or operating machinery.
Ibuprofene Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ibuprofene Sandoz

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults, elderly patients and adolescents over 12 years of age
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
The recommended dose is 1-2 tablets, 2-3 times a day.
The maximum recommended dose is 6 tablets per day.
Do not exceed the recommended doses; especially if you are elderly, take the lowest indicated dose.
Take the medicine with food.
Swallow the tablets whole with some water or other liquid.
If you do not notice an improvement in your condition after 3 days of treatment, consult your doctor.
Be careful not to exceed the recommended dose and in any case do not exceed the maximum dose of 6 tablets (1200 mg) per day. Use this medicine only for short periods of time.
If you are elderly, you should use the lowest possible dose among those listed above.
If use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen, you must consult your doctor.
If you take more Ibuprofene Sandoz than you should
If you have taken more Ibuprofene Sandoz than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, the following may occur: rapid and involuntary eye movements (nystagmus), increased levels of acidic substances in the blood (metabolic acidosis), reduced body temperature (hypothermia), kidney problems, bleeding from the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, bluish discoloration of the skin and mucous membranes (cyanosis), reduced brain activity (central nervous system depression) and respiratory depression (respiratory depression).
In addition, disorientation, excitement, fainting, reduced blood pressure (hypotension), reduced or increased heart rate (bradycardia, tachycardia), and worsening of pre-existing respiratory problems (asthma) may also occur.
In severe cases, serious kidney problems (renal failure) and liver problems (hepatic damage) may occur.
If you forget to take Ibuprofene Sandoz
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Side effects depend on the dose and may vary from patient to patient.
If any of these side effects occur during treatment with Ibuprofene Sandoz, it is recommended to stop using the medicine and consult your doctor.
The most commonly observed adverse events affect the stomach and/or intestine. Ulcers of the stomach or the first part of the intestine (peptic ulcer), perforation or bleeding from the stomach and/or intestine may occur, which can even be fatal, particularly in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine depends on the dose and duration of treatment.
In addition to the side effects listed below, after administration of Ibuprofene Sandoz, dark, bloody stools (melena) and vomiting blood (haematemesis) due to bleeding from the stomach, oesophagus or duodenum have been reported.
Medicines such as Ibuprofene Sandoz may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions”).
The following side effects may occur, which generally resolve upon discontinuation of treatment:

Common side effects (may affect up to 1 in 10 people)

difficulty digesting (dyspepsia)
abdominal pain
nausea
vomiting

Uncommon side effects (may affect up to 1 in 100 people)

allergic reactions including skin rash, urticaria, itching, and asthma attacks
headache
dizziness
insomnia
agitation
irritability
fatigue
skin rash

Rare side effects (may affect up to 1 in 1,000 people)

ringing or buzzing in the ears (tinnitus)
hearing impairment
ulcer of the stomach or the first part of the intestine (peptic ulcer)
perforation or bleeding from the stomach and/or intestine
inflammation of the mouth lining with ulceration (ulcerative stomatitis)
inflammation of the stomach (gastritis)
worsening of inflammation of the colon (colitis)
worsening of a chronic inflammatory disease of the digestive system (Crohn's disease)
kidney failure
damage to kidney tissue (papillary necrosis) (particularly with long-term therapy)
increased concentration of uric acid in the blood

Very rare side effects (may affect up to 1 in 10,000 people)

worsening of infections-related inflammation (e.g. development of necrotizing fasciitis)
reduction in the number of platelets in the blood (thrombocytopenia)
anaemia
reduction in the number of white blood cells in the blood (leucopenia, agranulocytosis)
reduction in all blood cell types (pancytopenia)
severe allergic reaction (anaphylactic reaction)
swelling due to fluid accumulation (angioedema)
aseptic meningitis (infection of the meninges, membranes of the brain)
abnormalities in liver function tests
liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
liver damage, particularly with long-term therapy
skin and mucous membrane reactions, including severe ones (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data)

mental disturbances (psychotic reactions)
depression
visual disturbances
irregular heartbeat (palpitations)
swelling (oedema)
heart failure
heart attack
high blood pressure (hypertension)
inflammation of the oesophagus (oesophagitis)
inflammation of the pancreas (pancreatitis)
intestinal strictures (diaphragmatic intestinal stenosis)
gas release (flatulence)
diarrhoea
constipation
development of oedema, particularly in patients with high blood pressure or kidney problems (renal failure, nephrotic syndrome, interstitial nephritis), which may be accompanied by acute kidney failure.
skin becomes sensitive to light
widespread, red, scaly rash with formation of pustules under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofene Sandoz if you develop these symptoms and contact your doctor immediately. See also section 2.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
Other side effects that have been reported include: bronchospasm or dyspnoea, apnoea, epigastric pain, gastric acid reflux (pyrosis), rhinitis, anxiety, confusion, hallucinations, paraesthesia, somnolence, optic neuritis, optic neuropathy, dizziness, photosensitivity reactions, malaise.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ibuprofene Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ibuprofene Sandoz contains

The active substance is: ibuprofen. Each tablet contains 200 mg of ibuprofen.
The other components are: anhydrous colloidal silicon dioxide, talc, sodium carboxymethylcellulose, polyvinylpyrrolidone, microcrystalline cellulose, maize starch, polyethylene glycol 400, titanium dioxide, hydroxypropylmethylcellulose.

Description of the appearance of Ibuprofene Sandoz and contents of the pack
PVC/Al blisters containing 10, 12, or 24 film-coated tablets of 200 mg.
Marketing Authorization Holder
Sandoz SpA
L.go U. Boccioni 1,
21040 Origgio (VA) - Italy
Manufacturers
Mipharm S.p.A.
Via Quaranta 12, Milan - Italy
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058, Torre Annunziata (NA) - Italy