Ibuprofen Alter: detailed information

Package leaflet: Information for the patient

IBUPROFENE ALTER 400 mg Film-coated tablets, 600 mg Film-coated tablets

Ibuprofen
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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What IBUPROFENE ALTER is and what it is used for

IBUPROFENE ALTER contains ibuprofen, which belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These medicines work by reducing pain and swelling caused by inflammation, as well as fever, 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);
sports-related injuries;
rheumatoid arthritis (a progressive, chronic autoimmune disease affecting the joints);
Still's disease.

IBUPROFENE ALTER is used to treat pain of various origins and types (e.g. trauma or inflammation): headache (migraine, cephalalgia), toothache following tooth extraction or other procedures, menstrual pain, postpartum pain, and pain occurring after surgical operations.

2. What you need to know before taking IBUPROFENE ALTER

Do not take IBUPROFENE ALTER

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 discharge, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other painkillers, antipyretics, or anti-inflammatory drugs (NSAIDs);
if you have previously suffered from stomach or small intestine (duodenum) ulcer or bleeding related to the use of painkillers or anti-inflammatory medicines (NSAIDs);
if you currently have a stomach or small intestine (duodenum) ulcer or bleeding, or if you have had two or more episodes of such conditions;
if you suffer from severe liver, kidney, or heart problems (severe hepatic or renal insufficiency, severe heart failure);
if you are in the last three months of pregnancy or if you are breastfeeding (see section “Fertility, pregnancy and breastfeeding”);
if you have significant dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
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 ALTER.
Take this medicine with caution in the following situations:

if you suffer from systemic lupus erythematosus (SLE);
if you have chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), gastrointestinal inflammation (Crohn’s disease), or other stomach and intestinal disorders;
if you have problems with normal blood clotting mechanisms; in this case, your doctor should monitor you during treatment;
if you suffer from allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses, or adenoids, or chronic obstructive respiratory diseases, as there is an increased risk of airway narrowing causing breathing difficulties (bronchospasm). Allergic reactions may manifest as breathing difficulties (asthma), facial swelling (Quincke’s oedema), or skin irritation (urticaria). If you notice the first signs of an allergic reaction, stop treatment immediately and consult your doctor;
if you have liver, kidney, heart problems or high blood pressure;
if you have an infection – see section “Infections” below.

Infections
IBUPROFENE ALTER may mask symptoms of infections such as fever and pain. Therefore, IBUPROFENE ALTER might 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.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You must discuss treatment with your doctor or pharmacist before taking IBUPROFENE ALTER:

if you experience any unusual abdominal symptoms, especially if these occur at the beginning of treatment. In such cases, the risk of bleeding or ulceration of the gastrointestinal tract is higher, particularly if you are elderly, taking high doses of this medicine, or taking other medicines (see section “Other medicines and IBUPROFENE ALTER”). If gastrointestinal bleeding or ulceration occurs, treatment must be stopped, as these may be fatal. Pay particular attention if you have previously had a gastric or intestinal ulcer, especially if complicated by perforation or accompanied by bleeding;
if you have heart problems including heart attack, angina (chest pain), or a 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);
if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
if you develop swelling in the legs (oedema), heart problems (heart failure), or high blood pressure, which may be symptoms of kidney problems. Be cautious if you are significantly dehydrated. IBUPROFENE ALTER may cause kidney problems, especially in elderly individuals or those with pre-existing kidney, heart, or liver conditions, or those taking diuretics or ACE inhibitors. Discontinue treatment if kidney problems occur. In adolescents, these problems may occur more easily if they have low fluid levels (dehydration).

This medicine may cause:

brain problems (aseptic meningitis) in rare cases. This may occur especially in people suffering from conditions such as systemic lupus erythematosus or related connective tissue diseases;
permanent kidney damage, with risk of kidney failure. This may occur if you regularly take this medicine;
eye problems. If you take this medicine for prolonged periods, you should undergo regular check-ups.

Skin reactions
Serious skin reactions have been reported in association with treatment with IBUPROFENE ALTER.
Stop taking IBUPROFENE ALTER and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
IBUPROFENE ALTER may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.

Children
This medicine must not be used in children under 12 years of age.

Elderly
If you are elderly, you may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal.

Other medicines and IBUPROFENE ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

The side effects of IBUPROFENE ALTER may be increased if taken simultaneously with certain medicines. IBUPROFENE ALTER may affect or be affected by other medicines. For example:
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;
medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
platelet aggregation inhibitors (used to prevent clot formation), methotrexate (used in the treatment of cancer and autoimmune diseases);
phenytoin (used to prevent epileptic seizures);
lithium (used to treat depression and mania);
diuretics, including potassium-sparing diuretics;
medicines that lower high blood pressure (ACE inhibitors, e.g. captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
cholestyramine (used to treat high cholesterol);
aminoglycosides (medicines against certain types of bacteria);
SSRIs (medicines for depression);
moclobemide (a medicine used to treat depressive illness or social phobia);
ciclosporin, tacrolimus (used for immunosuppression after organ transplantation);
zidovudine and ritonavir (used to treat HIV-positive patients);
mifepristone (used for medical abortion);
probenecid or sulfinpyrazone (used to treat gout);
quinolone antibiotics;
sulfonylureas (used to treat type 2 diabetes);
corticosteroids (used against inflammation);
Ginkgo biloba extracts, used to treat certain circulatory problems, which may increase the risk of bleeding when combined with NSAIDs;
bisphosphonates (used in osteoporosis, Paget’s disease, and to reduce high blood calcium levels);
oxpentifylline [(pentoxifylline), used to treat circulatory disorders of arteries in the legs or arms];
baclofen (a muscle relaxant);
CYP2C9 inhibitors (such as voriconazole and fluconazole) used to treat fungal infections.

Other medicines may also affect or be affected by treatment with IBUPROFENE ALTER. Always seek advice from your doctor or pharmacist before using IBUPROFENE ALTER with other medicines.
If you need to take other medicines during treatment with IBUPROFENE ALTER, you should drink an adequate amount of fluids and undergo regular kidney checks.

IBUPROFENE ALTER and alcohol
Avoid drinking alcohol, as it may increase the undesirable effects of IBUPROFENE ALTER, particularly those affecting the stomach, intestines, or brain.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take IBUPROFENE ALTER during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labour. You should not take IBUPROFENE ALTER during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used.
From week 20 of pregnancy, IBUPROFENE ALTER may cause kidney problems in the fetus if taken for more than a few days, leading to reduced 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 required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Avoid taking IBUPROFENE ALTER, as it passes into breast milk in very small amounts and breastfeeding does not usually need to be interrupted during short-term treatment. However, if prolonged treatment is prescribed, your doctor should consider the possibility of early weaning.

Fertility
IBUPROFENE ALTER may reduce the likelihood of becoming pregnant. Inform your doctor if you are planning a pregnancy or have fertility problems.

Driving and using machines
IBUPROFENE ALTER may affect your ability to drive or operate machinery. If you experience effects such as fatigue, drowsiness, dizziness (reported as common) or visual disturbances (reported as uncommon), which may be worsened by alcohol consumption during treatment with IBUPROFENE ALTER, avoid driving and using machinery.

3. How to take IBUPROFENE ALTER

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.
Swallow the tablet whole with water.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If you have an infection, contact your doctor immediately if symptoms (such as fever and
pain) persist or worsen (see section 2).
Recommended dose:
Adults and adolescents over 12 years of age
IBUPROFENE ALTER 400 mg
The recommended dose is 2–4 tablets per day, according to medical prescription.
IBUPROFENE ALTER 600 mg
The recommended dose is 1–3 tablets per day, according to medical prescription.
Do not exceed the maximum daily dose of 1800 mg.
If you are taking this medicine for the treatment of rheumatic pain, take the first dose in the morning upon
waking, and subsequent doses with meals.
Elderly patients and patients with liver or kidney problems
Your doctor will determine the appropriate dose in these cases.
If you take more IBUPROFENE ALTER than you should
If you have taken more IBUPROFENE ALTER than you should, or if your child has accidentally taken this
medicine, contact a doctor or the nearest hospital immediately for advice on the risk and necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, tinnitus,
confusion, and uncontrolled eye movements. At high doses, marked drowsiness (lethargy), chest pain,
palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine,
feeling cold, and breathing difficulties may occur. Symptoms of overdose usually appear within 4–6 hours.
Rarely, rhythmic and uncontrolled eye movements (nystagmus), increased blood acidity (metabolic acidosis),
lowered body temperature (hypothermia), kidney problems, increased tendency to bleeding in the stomach and
intestine, coma, reduced breathing (apnea), diarrhea, and decreased activity of the central nervous system and
respiration have also been reported.
Disorientation, excited state, fainting, low blood pressure, decreased or increased heart rate (bradycardia or
tachycardia) have been reported. In cases of significant overdose, kidney failure and liver damage are possible.
In case of accidental ingestion or overdose of this medicine, consult your doctor immediately or go to the
nearest hospital.
If you forget to take IBUPROFENE ALTER
If you forget to take a dose, do not take a double dose to make up for the missed 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 everybody gets them.
Side effects are more likely with higher doses and longer duration of treatment.
Stop treatment with IBUPROFENE ALTER and contact your doctor immediately if you experience any of the following side effects:
A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells).

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

dizziness, fatigue, malaise

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

vision problems
skin becomes sensitive to light
hypersensitivity reactions such as skin rashes (rash, urticaria, exanthema), itching, asthma attacks (sometimes accompanied by low blood pressure), severe skin irritation associated with bleeding (purpura)
drowsiness, insomnia, and anxiety
gastritis
kidney problems, kidney inflammation, and kidney failure
excessive nasal discharge (rhinitis)
breathing difficulties (bronchospasm, apnea, dyspnea), swelling of the face, tongue, or throat (larynx), which may cause severe breathing difficulties (angioedema)
ringing or buzzing in the ears, hearing disturbances, vertigo
liver problems (jaundice), liver inflammation (hepatitis), altered liver function
paresthesia

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

depression, confusion, hallucinations
systemic lupus erythematosus
reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis)
reduced platelet levels (thrombocytopenia)
reduced levels of red blood cells (hemolytic anemia)
reduced levels of all blood components (aplastic anemia)
eye nerve disorders (optic neuritis, toxic optic neuropathy), vision disturbances
swelling due to fluid retention
infection of the membranes surrounding the brain (aseptic meningitis)

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

severe allergic reaction with swelling of the face, tongue, and throat, shortness of breath, wheezing, rapid heartbeat, severe drop in blood pressure, or potentially life-threatening shock (anaphylaxis)
swelling due to fluid accumulation (edema, acute pulmonary edema)
severe skin rash with blisters on the skin, particularly on legs, arms, hands, and feet, which may spread to the face and lips (exfoliative dermatitis and bullous dermatitis including Stevens-Johnson syndrome), toxic epidermal necrolysis (a severe skin infection with destruction of the skin), and erythema multiforme (severe skin irritation)
unpleasant awareness of heartbeat (palpitations), heart failure, heart attack or high blood pressure, myocardial infarction
disorders in red blood cell formation (with symptoms such as: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding)
inflammation of the pancreas (pancreatitis)
liver failure

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

stomach burning, abdominal pain, indigestion
gastrointestinal disorders such as diarrhea, nausea, vomiting, flatulence, constipation
black stools or blood in stools (melena) or in vomit (hematemesis, gastrointestinal ulcer with bleeding)
gastrointestinal ulcer with or without perforation, even fatal (peptic ulcer, gastrointestinal hemorrhage), especially in elderly people
burning sensation in the stomach (gastritis, gastric pyrosis), inflammation of the oral mucosa associated with lesion formation (ulcerative stomatitis)
intestinal inflammation and worsening of colon inflammation (colitis) and gastrointestinal tract (Crohn's disease)
allergic reaction, even severe (non-specific allergic reaction, anaphylaxis)
a widespread, red, scaly rash with pustules under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Stop using IBUPROFENE ALTER if you develop these symptoms and contact your doctor immediately. See also section 2. Medicines such as IBUPROFENE ALTER may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. With NSAIDs, swelling due to fluid retention (edema), high blood pressure, and heart problems (heart failure) have been reported.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IBUPROFENE ALTER

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 does not require any 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 ALTER contains
IBUPROFENE ALTER 400 mg Film-coated tablets

The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
The other components are: microcrystalline cellulose, maize starch, sodium glycolate starch (type A), magnesium stearate, talc, anhydrous colloidal silica, povidone, hypromellose, titanium dioxide, glycerol triacetate.

IBUPROFENE ALTER 600 mg Film-coated tablets

The active substance is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.
The other components are: microcrystalline cellulose, maize starch, sodium glycolate starch (type A), magnesium stearate, talc, anhydrous colloidal silica, povidone, hypromellose, titanium dioxide, glycerol triacetate.

Description of the appearance of IBUPROFENE ALTER and pack contents
Pack of 30 tablets of 400 mg.
Pack of 30 tablets of 600 mg.
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 - 20144 Milano
Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 - 28036 Madrid, Spain