Package leaflet: Information for the user

Ibuprofene Teva 600 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Ibuprofene Teva contains ibuprofen, which belongs to a class of medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). These medicines work by reducing pain and swelling caused by inflammation in conditions such as:

osteoarthritis (a degenerative disease affecting the joints) in various parts of the body;
inflammation of muscles (myositis), muscles and tissues (fibrositis), tendons (tenosynovitis), nerve roots and nerves (radiculoneuritis), and fibrous tissues surrounding the joint (scapulohumeral periarthritis);
back pain (lumbago);
sciatica (leg pain caused by irritation of the sciatic nerve);
rheumatoid arthritis (a progressive, chronic autoimmune disease affecting the joints), including juvenile rheumatoid arthritis or Still's disease;
sprains or tears (sports-related injuries).

Ibuprofene Teva can also be used in other painful conditions such as toothache following tooth extraction or other dental procedures, postoperative pain, postpartum pain, menstrual pain, and headache, including migraine.

2. What you need to know before taking Ibuprofene Teva

Do not take Ibuprofene Teva

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced allergic reactions such as asthma, nasal congestion, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin/acetylsalicylic acid) or other painkillers or anti-inflammatory medicines (NSAIDs);
if you have previously suffered from stomach or small intestine (duodenum) ulcers or bleeding related to prior use of painkillers or anti-inflammatory medicines (NSAIDs);
if you currently have a stomach or small intestine (duodenum) ulcer or bleeding, or have had two or more episodes of such conditions;
if you have a disease that increases your tendency to bleed;
if you have severe liver, kidney, or heart problems (including coronary artery disease);
if you are in the last three months of pregnancy;
if you are significantly dehydrated (caused by vomiting, diarrhoea, or insufficient fluid intake);
if you have active bleeding (including bleeding in the brain);
if you suffer from an unknown-origin disease causing abnormal red blood cell formation;
if the person taking the medicine is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofene Teva.
Anti-inflammatory/pain-relieving 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.
You should discuss treatment with your doctor or pharmacist before taking this medicine if:

you have heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack);
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
you have systemic lupus erythematosus (SLE) or other autoimmune diseases (e.g. mixed connective tissue disease);
you have a hereditary disorder of the red blood pigment haemoglobin (porphyria);
you are in the first six months of pregnancy;
you are breastfeeding;
you have chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), Crohn’s disease (inflammation of the digestive tract), or other stomach or intestinal disorders;
you have disorders affecting red blood cell formation;
you have disorders affecting normal blood clotting mechanisms;
you have allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, or adenoids, or chronic obstructive respiratory diseases, as there is an increased risk of airway narrowing and breathing difficulties (bronchospasm);
you have liver, kidney, heart problems, or high blood pressure;
you have recently undergone surgery;
you have chickenpox, as pain and anti-inflammatory medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
you have an infection – see section “Infections” below.

Inform your doctor in the following cases:

if you experience any unusual abdominal symptoms, especially if they occur at the beginning of treatment. The risk of bleeding or ulceration of the digestive tract is higher in such cases, particularly if you are elderly, taking high doses of this medicine, or taking other medicines (see section “Other medicines and Ibuprofene Teva”). If bleeding or ulceration of the digestive tract occurs, treatment must be stopped, as these conditions can be fatal. You should pay particular attention if you have previously had a gastric or intestinal ulcer, especially if it was complicated by perforation or accompanied by bleeding.
if you develop skin irritation, urticaria, mucosal lesions, or other signs of allergy, such as breathing difficulties or swelling of the throat and tongue, as these may be early signs of severe allergic reactions or serious skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome), which may sometimes be fatal. If these problems occur, stop treatment with Ibuprofene Teva. The risk of such reactions is highest during the first month of treatment.
if you experience swelling in the legs, heart problems (heart failure), or high blood pressure, which may be symptoms of kidney problems. Ibuprofene Teva can cause kidney problems, especially in elderly people or those who already have kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors. Stop treatment if kidney problems occur.

This medicine can cause:

brain problems (aseptic meningitis) in rare cases. This may occur especially in people with conditions such as systemic lupus erythematosus or related connective tissue diseases.
headache or, if you already suffer from it, worsening of headache. This may occur especially with prolonged treatment. In such cases, consult your doctor and treatment should be discontinued.
permanent kidney damage, with risk of kidney failure. This may occur if you habitually take this medicine.
eye problems. If you take this medicine for prolonged periods, have regular check-ups.

Skin reactions
Serious skin reactions have been reported with Ibuprofene Teva treatment, including skin rash, mucosal lesions, blisters, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), or other signs of allergy. Stop using Ibuprofene Teva and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Allergic reactions and secondary cardiovascular effects
Signs of an allergic reaction to ibuprofen have been reported, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain. Stop Ibuprofene Teva immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Infections
Ibuprofene Teva may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene Teva may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Ibuprofene Teva may temporarily prolong bleeding time.
Children and adolescents
There is a risk of kidney damage in dehydrated children and adolescents. This medicine is contraindicated in children under 12 years of age.
Elderly
If you are elderly, you may be more susceptible to adverse effects, particularly bleeding and perforation of the digestive tract or kidney damage, which can be fatal.
Other medicines and Ibuprofene Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The side effects of Ibuprofene Teva may be increased if taken together with certain medicines. Ibuprofene Teva may also increase or decrease the effects of other medicines or increase their side effects if taken simultaneously.
Ibuprofene Teva 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 lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with Ibuprofene Teva.
Therefore, always consult your doctor or pharmacist before using Ibuprofene Teva with other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

Cox-2 inhibitors and other NSAIDs (e.g. acetylsalicylic acid), medicines used for inflammation;
anticoagulants (used to prevent blood clots), such as warfarin or heparin;
platelet aggregation inhibitors (used to prevent blood clots) such as ticlopidine or clopidogrel;
methotrexate (used in the treatment of cancer and autoimmune diseases);
cardiac glycosides such as digoxin (used to treat various heart conditions);
phenytoin (used to prevent epileptic seizures);
lithium (used to treat depression and mania);
diuretics, including potassium-sparing diuretics;
antihypertensives (used to treat high blood pressure) such as:
- ACE inhibitors, e.g. captopril;
- beta-blocking medicines, e.g. atenololo;
- angiotensin II antagonists, e.g. losartan;
cholestyramine (used to treat high cholesterol);
aminoglycosides (medicines against certain types of bacteria);
SSRIs (medicines for depression) such as paroxetine, sertraline, and citalopram;
moclobemide (RIMA – a medicine used to treat depressive illness or social phobia);
cyclosporine, tacrolimus (used for immunosuppression after organ transplantation);
zidovudine and ritonavir (used to treat HIV-positive patients);
Herbal extracts: Ginkgo Biloba may increase the risk of bleeding when used with NSAIDs;
mifepristone (used for medical abortion);
probenecid or sulfinpyrazone (used to treat gout);
quinolone antibiotics (used for bacterial infections);
sulfonylureas (used to treat type 2 diabetes);
corticosteroids (used against inflammation);
bisphosphonates (used in osteoporosis, Paget’s disease, and to reduce high blood calcium levels);
oxpentifylline [(pentoxifylline) used to treat circulatory disorders of arteries in legs or arms];
baclofen (a muscle relaxant);
CYP2C9 inhibitors (such as voriconazole and fluconazole) used to treat fungal infections.

Ibuprofene Teva with food, drinks and alcohol
Avoid drinking alcohol, as it may increase the side effects of Ibuprofene Teva, particularly those affecting the stomach, intestines, or brain.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofene Teva during the last three months of pregnancy, as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in the foetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond normal.
You should not take Ibuprofene Teva during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Ibuprofene Teva may cause kidney problems in the foetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of 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.
Breastfeeding
Ibuprofene Teva passes into breast milk in very small amounts and it is generally not necessary to stop breastfeeding during short-term treatment, although taking anti-inflammatory medicines during breastfeeding should be avoided when possible. However, if prolonged treatment is prescribed, your doctor may consider early weaning.
Fertility
Ibuprofene Teva may reduce fertility. This effect is reversible upon discontinuation of the medicine. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving and using machines
Ibuprofen may cause side effects that can impair your reaction to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue, and visual disturbances. Make sure you do not experience any of these side effects before driving, operating machinery, or doing anything that requires alertness. This is especially important if you consume alcohol during treatment with ibuprofen.
Ibuprofene Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Ibuprofene Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ibuprofen Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
The dose of Ibuprofen Teva depends on the patient's age and body weight. The recommended dose is:
Adults:
The recommended dose is 600 mg one to three times daily. Do not exceed the maximum daily dose of
1,800 mg.
Method of administration
Swallow the tablet with a glass of water during or after meals.
To avoid oral discomfort and throat irritation, the tablets must be swallowed whole and must not be
chewed, broken, crushed, or sucked.
Use in adolescents over 12 years of age
These tablets may not be suitable for patients in this age group and body weight range, as one tablet of Ibuprofen Teva may contain an amount of active substance higher than appropriate. Your doctor will advise you accordingly.
Use in elderly patients and in people with liver or kidney problems
Your doctor will determine the appropriate dose in these cases. If you are elderly, you may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal.
If you take more Ibuprofen Teva than you should
If you have taken more ibuprofen 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 of overdose may include: nausea, vomiting, stomach pain, drowsiness with reduced response to normal stimuli (lethargy), headache, and ringing in the ears (tinnitus).
At higher doses, symptoms such as drowsiness, seizures, loss of consciousness, and dizziness may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, the following may occur: uncontrolled eye movements (nystagmus), feeling cold, kidney problems, gastrointestinal bleeding, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
In addition, symptoms may include: disorientation, agitation, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
If significantly high doses of ibuprofen are taken, symptoms may include increased acid levels in the blood (metabolic acidosis), low potassium levels in the blood, and severe kidney and liver damage.
If you have any doubts about the use of Ibuprofen Teva, consult your doctor or pharmacist.
If you forget to take Ibuprofen Teva
If you forget to take a dose, take it as soon as possible, unless it is less than 4 hours before the next dose is due. Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects observed with ibuprofen are generally those seen with other analgesics, antipyretics, and non-steroidal anti-inflammatory drugs (NSAIDs).
Side effects are more likely with higher doses and longer duration of treatment.
Medicines such as Ibuprofene Teva may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), fatigue, high blood pressure, and heart problems (heart failure) have been reported in association with NSAIDs.

Stop treatment with Ibuprofene Teva and contact your doctor immediately:

if you experience any unusual abdominal symptoms, especially at the beginning of treatment, particularly if you are elderly, taking high doses of this medicine, taking other medicines (see section “Other medicines and Ibuprofene Teva”), or have previously suffered from gastric or intestinal ulcers;
if you develop skin irritation, urticaria, mucosal lesions, or other signs of allergy, such as difficulty breathing or swelling of the throat and tongue, as these could be early signs of severe allergic reactions or serious skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, cutaneous lupus erythematosus);
if you develop flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
if you develop widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
if you develop widespread, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption);
if you experience swelling in the legs, heart problems (heart failure), or high blood pressure, which may indicate kidney problems, especially if you are elderly, have pre-existing kidney, heart, or liver conditions, or are taking diuretics or ACE inhibitors.

Below is a list of side effects categorized by frequency of occurrence:

Very common (may affect more than 1 in 10 people):

gastrointestinal disorders, heartburn.

Common (may affect up to 1 in 10 people):

indigestion, abdominal pain;
nausea, vomiting, flatulence, diarrhea, constipation;
black stools or blood in vomit;
ulceration of the gastrointestinal tract with bleeding (gastrointestinal ulcer);
worsening of intestinal inflammation and complications of intestinal diverticula (fistula);
microscopic intestinal bleeding, which may lead to anemia;
bleeding from the stomach or intestines (gastrointestinal hemorrhage);
mouth ulceration (ulcerative stomatitis);
headache, dizziness;
restlessness, insomnia, irritability;
skin rash;
fatigue.

Uncommon (may affect up to 1 in 100 people):

blurred vision (visual disturbances);
hypersensitivity reactions (sometimes accompanied by low blood pressure), itching, urticaria;
swelling of the face, eyes, lips, or throat edema with difficulty breathing or swallowing (angioedema);
rupture of capillaries under the skin surface (purpura);
inflammation of the stomach lining (gastritis);
kidney problems including edema development, toxic nephropathy in various forms, nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), functional abnormalities (renal failure), renal impairment;
excessive nasal secretion (rhinitis);
breathing difficulties (bronchospasm, dyspnea, apnea, asthma);
altered sensation in limbs or body parts (paresthesia);
drowsiness;
hearing loss;
ringing or buzzing in the ears;
dizziness;
formation of ulcers (in mouth, stomach, or intestines) and perforation of the gastrointestinal tract;
altered liver function, hepatitis, yellowing of the skin or whites of the eyes (jaundice);
anxiety;
skin becoming sensitive to light.

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

visual disturbances (amblyopia, cases of eye disease leading to visual disturbances, toxic optic neuropathy);
depression, confusion, hallucinations;
systemic lupus erythematosus;
increased blood urea nitrogen and certain enzymes (transaminases and alkaline phosphatase), decreased hemoglobin and hematocrit, inhibition of platelet aggregation and prolonged bleeding time, decreased calcium and increased serum uric acid;
blood cell formation disorders (with symptoms such as: fever, sore throat, mouth ulcers, flu-like symptoms, fatigue, nosebleeds, and skin bleeding);
inflammation of the meninges (in absence of bacterial infection);
allergic reaction;
fluid accumulation (edema);
inflammation of the optic nerve (optic neuritis).

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

anaphylactic shock, with swelling of face, tongue, or throat (angioedema), narrowing of airways, shortness of breath, wheezing, tachycardia, and low blood pressure;
severe skin rash with blisters on the skin, particularly on legs, arms, hands, and feet, which may spread to the face and lips, and in more severe cases, skin peeling, sometimes accompanied by itching (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis). A severe skin infection with tissue destruction (necrotizing fasciitis) of the skin, subcutaneous tissue, and muscle may also occur;
sudden fluid accumulation in the lungs causing breathing difficulties, high blood pressure, fluid retention, and weight gain (acute pulmonary edema);
uncomfortable awareness of heartbeat (palpitations), heart failure, heart attack, or high blood pressure;
cardiac edema;
inflammation of the esophagus or pancreas;
intestinal narrowing;
acute liver inflammation (acute hepatitis), liver failure;
liver injury and kidney tissue damage, particularly with long-term use;
hair loss;
reduction in the number of all blood cells (pancytopenia).

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

colitis, worsening of existing colitis and Crohn’s disease;
severe skin infections and other soft tissue complications during chickenpox infection;
malaise;
a severe 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 cell);
localized and persistent skin rash (drug-induced fixed eruption);
a widespread, red, scaly rash with pustules under the skin and blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Ibuprofene Teva if you develop these symptoms and contact your doctor immediately. See also section 2;
chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Ibuprofene Teva may cause a reduction in white blood cell count and decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of general health, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, contact your doctor immediately. In such cases, you may need a blood test to check for reduced white blood cells (agranulocytosis). Inform your doctor that you are taking this medicine.
During treatment with Ibuprofene Teva, meningitis (with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or confusion) may occur in people with pre-existing immune system disorders such as systemic lupus erythematosus or mixed connective tissue disease.

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

5. How to store Ibuprofen Teva

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.
This medicine requires no special storage conditions.
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 Teva contains

The active substance is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.
The other components are: Core: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hypromellose, lactose monohydrate, talc, anhydrous colloidal silica, glycerol dibehenate; Coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide.

Description of the appearance of Ibuprofene Teva and package contents
600 mg film-coated tablets - 30 tablets.
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto De’ Stampi – Rozzano (Milan)
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)