Patient Information Leaflet

Ibuprofene Laboratori Alter 400 mg film-coated tablets

Ibuprofene Laboratori Alter 600 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ibuprofene Laboratori Alter is and what it is used for

Ibuprofene Laboratori Alter contains ibuprofen, an active ingredient belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are medications used to relieve pain and inflammation. Ibuprofene Laboratori Alter is used to treat pain caused, for example, by:

injuries (e.g. those caused by sports), toothache (e.g. following tooth extraction or dental and oral surgery), postpartum pain, menstrual pain, eye pain (e.g. following eye surgery), headache, pain after surgical procedures;
rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthritis of the shoulder, radiculoneuritis, tenosynovitis, myositis, fibrositis), back pain (lumbago), leg pain due to sciatic nerve inflammation (sciatica), degenerative joint diseases (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, shoulder, hip, knee osteoarthritis or generalized osteoarthritis, a progressive chronic autoimmune disease primarily affecting the joints (rheumatoid arthritis), and a rare inflammatory disease called Still's disease.

2. What you need to know before taking Ibuprofene Laboratori Alter

Do not take Ibuprofene Laboratori Alter

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other painkillers, fever-reducing medicines, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema), and/or asthma;
if you have a lesion in the wall of the stomach or intestine (severe or active peptic ulcer);
if you have previously experienced an episode of perforation or bleeding in the stomach or intestine caused by taking medicines;
if you have had two or more separate episodes of bleeding or injury to the stomach or intestine (recurrent peptic ulcer);
if you have severe liver or kidney problems;
if you suffer from severe heart problems (severe heart failure);
if you have any disease that increases the risk of bleeding;
if you are severely dehydrated, for example due to severe episodes of vomiting, diarrhoea, or very low fluid intake;
after the sixth month of pregnancy.

Do not use Ibuprofene Laboratori Alter in children under 12 years of age.
Warnings and precautions
Talk to your doctor before taking Ibuprofene Laboratori Alter if:

you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, conditions affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs;
you have had stomach or intestinal problems, such as ulcers, Crohn’s disease, or ulcerative colitis (see the section below “PAY ATTENTION” on gastrointestinal risks and “Do not take Ibuprofene Laboratori Alter”);
you have reduced kidney function;
you have liver problems;
you have blood clotting disorders;
you have or have had allergies (e.g., hay fever);
you have chronic nasal inflammation (chronic rhinitis) or nasal polyps;
you suffer from asthma or long-standing (chronic) respiratory diseases;
you have previously experienced facial, throat, lip, or other body swelling (angioedema);
you are elderly, as you are more likely to develop adverse reactions to this medicine, particularly bleeding and perforations of the stomach and intestine, which can be life-threatening (see the section below “PAY ATTENTION” on gastrointestinal risks);
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;
if you are a dehydrated adolescent or an elderly person, as you are more likely to experience kidney problems;
you have an infection – see the section “Infections” below.

Signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop treatment with Ibuprofene Laboratori Alter and contact your doctor or emergency medical service if you notice any of these signs.
Heart attack and stroke
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 Ibuprofene Laboratori Alter 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 ischemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Serious skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized exanthematic pustulosis (GEP).
Stop using Ibuprofene Laboratori Alter and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Infections
Ibuprofene Laboratori Alter may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene Laboratori Alter could delay appropriate treatment of the infection, 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 the symptoms persist or worsen, contact your doctor immediately.
PAY ATTENTION, because during treatment with all non-steroidal anti-inflammatory drugs (NSAIDs) used for pain and inflammation:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take Ibuprofene Laboratori Alter”). If you are elderly or have previously had such problems, the risk of these events increases with higher doses. In this case, your doctor will advise starting treatment with the lowest available dose and may prescribe a stomach-protecting medicine (gastroprotectants such as misoprostol or proton pump inhibitors) to be taken alongside Ibuprofene Laboratori Alter;
although very rare, serious skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). The risk of such reactions is higher in the early stages of treatment, particularly within the first month;
severe allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
eye problems may occur with the use of Ibuprofene Laboratori Alter. Regular eye examinations are recommended during treatment, especially for prolonged therapy;
headache may occur, especially with prolonged use and high doses. In such cases, do not increase the dose of Ibuprofene Laboratori Alter to relieve pain.

If you have reduced heart, liver, or kidney function (especially if you have systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly for prolonged treatments, and will recommend the lowest effective dose for the shortest duration necessary to control symptoms.
The risk of side effects can be reduced by using the lowest effective dose for the shortest duration needed to control symptoms. Do not exceed the recommended dose of Ibuprofene Laboratori Alter or take it for long periods; always follow your doctor’s instructions carefully.
STOP treatment and contact your doctor if:

you notice any gastrointestinal symptoms, especially bleeding, particularly if this occurs early in treatment, if you are elderly, or if you have previously had gastrointestinal problems;
a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, facial or throat swelling, sudden drop in blood pressure);
you experience vision problems;
you develop liver problems.

Children
Do not use Ibuprofene Laboratori Alter in children under 12 years of age. If necessary, consult your doctor, as lower specific doses are available for such patients.
Other medicines and Ibuprofene Laboratori Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofene Laboratori Alter may interact with or be affected by other medicines. For example:

other pain and anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, as this may increase the risk of gastrointestinal ulcers or bleeding;
cardiac glycosides (e.g., digoxin), medicines used for heart conditions; sulfonylureas, medicines used for diabetes; anticoagulant medicines (i.e., substances that thin the blood to prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
cyclosporine and tacrolimus, medicines that suppress the immune system;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
medicines containing cortisone or cortisone-like substances used to treat inflammation (corticosteroids);
medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
aminoglycoside and quinolone antibiotics;
zidovudine and ritonavir, medicines used in HIV infections;
methotrexate, used in cancer treatment and certain immune system disorders, such as rheumatoid arthritis;
cholestyramine, a medicine used to lower blood cholesterol levels;
lithium, used in depression;
medicines that inhibit CYP2C9, such as voriconazole and fluconazole, used in fungal infections;
Ginkgo Biloba, a herbal extract used to improve circulation;
probenecid, a medicine used for gout;
phenytoin, a medicine used for epilepsy;
bisphosphonates, medicines used to treat osteoporosis;
oxpentifylline, a medicine used for blood vessel problems;
baclofen, a medicine used to relax muscles;
mifepristone, a medicine used for medical termination of pregnancy;
moclobemide, a medicine used to treat depression.

Other medicines may also interact with or be affected by Ibuprofene Laboratori Alter. Therefore, always consult your doctor or pharmacist before taking Ibuprofene Laboratori Alter with other medicines.
Ibuprofene Laboratori Alter and alcohol
Some side effects, particularly those affecting the stomach, intestine, or nervous system, may be more likely when alcohol is consumed during treatment with Ibuprofene Laboratori Alter.
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.
Pregnancy
Do not use Ibuprofene Laboratori Alter during the last three months of pregnancy, as it may cause heart, lung, or kidney problems in the unborn baby and complications during delivery (see section 2 “Do not take Ibuprofene Laboratori Alter”). It may affect your and your baby’s tendency to bleed and may delay or prolong labour.
During the first six months of pregnancy, take this medicine only if clearly needed and under direct medical supervision, as treatment may negatively affect pregnancy and fetal development. If treatment is necessary 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 Laboratori Alter may cause kidney problems in the fetus if taken for more than a few days, leading to reduced amniotic fluid surrounding the baby (oligohydramnios) or 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
Avoid taking Ibuprofene Laboratori Alter while breastfeeding, as the medicine may pass into breast milk in small amounts.
Fertility
If you are planning a pregnancy or have difficulty conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
Ibuprofene Laboratori Alter may cause side effects that could 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 performing any activity requiring alertness. This is particularly important if you consume alcohol during treatment with Ibuprofene Laboratori Alter.
Ibuprofene Laboratori Alter contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Ibuprofene Laboratori Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Ibuprofene Laboratori Alter

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
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 (such as fever and pain) persist or worsen (see section 2).

Adults and children over 12 years of age
Ibuprofene Laboratori Alter 400 mg – The recommended dose is 2–4 tablets per day according to your doctor’s advice. The maximum dose is 4 tablets per day.
Ibuprofene Laboratori Alter 600 mg – The recommended dose is 1–3 tablets per day according to your doctor’s advice. The maximum dose is 3 tablets (1800 mg) per day.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, possibly reducing the doses indicated above. If you have severe kidney or liver problems, you must not take this medicine (see “Do not take Ibuprofene Laboratori Alter”).

Elderly patients
If you are elderly, your doctor will determine the most appropriate dose for you, possibly reducing the doses indicated above.

Method of administration
Ibuprofene Laboratori Alter should be taken orally with a full glass of water. Swallow the tablets whole, without chewing, breaking, crushing, or sucking them.
If you are taking Ibuprofene Laboratori Alter for rheumatic diseases, take the first dose in the morning upon waking and subsequent doses with meals.

If you take more Ibuprofene Laboratori Alter than you should, or if your child has accidentally taken this medicine, contact your doctor or go to the nearest hospital immediately for advice on the risk and necessary actions.
Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with blood traces), blood in urine, diarrhoea, abdominal or chest pain, gastrointestinal bleeding, heart problems such as low blood pressure or changes in heart rhythm (bradycardia, tachycardia), circulatory problems, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion, involuntary and oscillating eye movements (nystagmus), decreased blood pH (metabolic acidosis), weakness and dizziness, low potassium levels in the blood, fainting, seizures (especially in children), disorientation, state of excitement, breathing difficulties (including apnea), and symptoms of central nervous system depression such as drowsiness, feeling cold (hypothermia), loss of consciousness, deep sleep (lethargy), coma.

If you forget to take Ibuprofene Laboratori Alter
Do not take a double dose to make up for the 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 will experience them.
Serious side effects
Stop taking Ibuprofene Laboratori Alter and contact your doctor immediately if you experience any of the following conditions:

severe stomach problems, burning sensation or abdominal pain due to injury of the stomach or intestinal wall (peptic ulcer), sudden and severe pain in the upper abdomen or stomach area (gastrointestinal perforation). These side effects are not common;
vomiting blood (haematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal haemorrhage). These conditions are common side effects;
allergic reactions, even severe, manifesting as more or less sudden onset of skin lesions, for example with widespread or spotted redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, throat oedema with possible difficulty in breathing and swallowing (angioedema). These conditions occur with uncommon frequency. Rarely, a severe allergic reaction, which may be life-threatening, may also occur, characterized by

an increased heart rate and sudden drop in blood pressure (anaphylactic reaction,
anaphylaxis);

non-elevated reddish patches, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
difficulty breathing (asthma, even severe, bronchospasm or dyspnoea). These conditions are uncommon side effects;
systemic lupus erythematosus (SLE), a disease affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs. This condition occurs rarely.
worsening of infections, such as the onset of necrotizing fasciitis, manifesting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
inflammation of the meninges (aseptic meningitis) manifesting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness, and light sensitivity. This condition occurs rarely.
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
widespread, red, scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

Stop using Ibuprofene Laboratori Alter if you develop these symptoms and contact your doctor immediately.
See also section 2.
Other side effects
Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)

nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), abdominal pain;
headache, dizziness;
fatigue.

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

inflammation of the nose (rhinitis);
inflammation of the stomach (gastritis), mouth ulcers;
dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
impaired hearing, ringing in the ears (tinnitus), vision disturbances;
skin reaction following exposure to sunlight (photosensitivity);
changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

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

decrease in the number of white blood cells (leucopenia) or of certain types of white blood cells (neutropenia, agranulocytosis), decrease in the number of platelets (thrombocytopenia), decrease in the number of red blood cells due to destruction (haemolytic anaemia) or due to bone marrow problems (aplastic anaemia);
depression, confusion;
vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
swelling (oedema).

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

reduced liver function, inflammation of the pancreas (pancreatitis);
sensation of heart pounding (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
breathing problems due to fluid accumulation in the lungs (pulmonary oedema).

Other side effects

pain or burning sensation (pyrosis) in the upper stomach, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis),
worsening of inflammation of the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be estimated from the available data);
worsening of skin infections caused by chickenpox;
stroke;
hallucinations, malaise;
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Laboratori 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. The expiry date refers to the last day of that month.
Do not store above 30°C.
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. Contents of the pack and other information

What Ibuprofene Laboratori Alter contains
The active substance is: ibuprofen.
One coated tablet of Ibuprofene Laboratori Alter contains: 400 mg of ibuprofen.
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose, lactose monohydrate,
pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Coating film: hypromellose, titanium dioxide (E-171), talc, propylene glycol (E 1520).
One coated tablet of Ibuprofene Laboratori Alter contains: 600 mg of ibuprofen.
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose, lactose monohydrate,
pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Coating film: hypromellose, titanium dioxide (E-171), talc, propylene glycol (E 1520).

Description of the appearance of Ibuprofene Laboratori Alter and contents of the pack
Ibuprofene Laboratori Alter 400 mg
This medicinal product is available in packs of 30 tablets in Al/PVC/PVDC blisters.
Ibuprofene Laboratori Alter 600 mg
This medicinal product is available in packs of 30 tablets in Al/PVC/PVDC blisters.

Marketing Authorization Holder and Manufacturer
LABORATORI ALTER S.r.l.,
Via Egadi, 7
20144 Milano
Manufacturers:
ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Vía Complutense 140,
E-28805 Alcalá de Henares (Madrid), Spain
TOLL MANUFACTURING SERVICES S.L.
C/ Aragoneses, 2
28108 (Alcobendas-Madrid), Spain
FARMALIDER, S.A.
C/ Aragoneses, 2
28108 Alcobendas (Madrid), Spain