Ibumal

Package leaflet: Information for the patient

IBUMAL 600 mg film-coated tablets

Ibuprofen
Equivalent 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, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What IBUMAL is and what it is used for
2. What you need to know before taking IBUMAL
3. How to take IBUMAL
4. Possible side effects
5. How to store IBUMAL
6. Contents of the pack and other information

1. What IBUMAL is and what it is used for

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

• injuries (e.g. those caused by sports), toothache (e.g. after 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 (e.g. scapulo-humeral periarthritis, radiculoneuritis, tenosynovitis, myositis, fibrositis), back pain (lumbago), leg pain due to sciatic nerve inflammation (sciatica), degenerative joint diseases (osteoarthritis), such as cervical, dorsal or lumbar osteoarthritis, shoulder, hip or knee osteoarthritis, or generalized osteoarthritis, a chronic progressive autoimmune disease primarily affecting the joints (rheumatoid arthritis), and a rare inflammatory disease called Still's disease.

2. What you should know before taking IBUMAL

Do not take IBUMAL

• 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), particularly 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 medications;
• if you have had two or more separate episodes of bleeding or injury to the wall of 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 condition that increases the risk of bleeding;
• if you are severely dehydrated, for example if you have had severe episodes of vomiting, diarrhea, or drink very little;
• after the sixth month of pregnancy.

Do not use IBUMAL in children under 12 years of age.
Warnings and precautions
Exercise particular caution with IBUMAL:
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 acute generalized exanthematous pustulosis (AGEP).
Stop using IBUMAL and contact your doctor immediately if you notice any of the symptoms related to
these serious skin reactions described in section 4.
Consult your doctor before taking IBUMAL 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 “BE CAREFUL” on gastrointestinal risks and “Do not take IBUMAL”);
• 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 nasal inflammation (chronic rhinitis) or nasal polyps;
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• you have previously experienced swelling of the face, throat, lips, or other body parts (angioedema);
• you are elderly, as you are more likely to develop adverse effects from this medicine, particularly bleeding and perforations of the stomach and intestine, which can be life-threatening (see the section below BE CAREFUL on gastrointestinal risks);
• you have chickenpox, since pain and anti-inflammatory medicines (NSAIDs) could worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
• you are a dehydrated adolescent or elderly person, as you are more likely to experience kidney problems;
• you have an infection – see the section “Infections” below.

Infections
IBUMAL may mask symptoms of infections such as fever and pain. Therefore, IBUMAL 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 infection symptoms persist or worsen, contact your
doctor immediately.
Heart attack and stroke
Anti-inflammatory/pain-relief medicines like ibuprofen may be associated with a slight 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.
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck
(angioedema), and chest pain, have been reported with ibuprofen. Stop taking IBUMAL immediately and
contact your doctor or emergency medical services if you notice any of these signs.
You should discuss treatment with your doctor or pharmacist before taking IBUMAL 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 ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

BE CAREFUL, because during treatment with all non-steroidal anti-inflammatory medicines used for
pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take IBUMAL”). If you are elderly or have previously had such problems, your risk of experiencing these events increases when taking higher doses of the medicine. In this case, your doctor will advise starting treatment with the lowest available dose and may also prescribe a medicine to protect your stomach (gastroprotective agents such as misoprostol or proton pump inhibitors) to be taken together with IBUMAL;
• although very rarely, serious skin reactions, some of which fatal, have been reported, manifesting as redness, blistering, and peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Your risk of developing these reactions is higher in the early stages of treatment, particularly within the first month;
• serious skin reactions have been reported in association with treatment with IBUMAL. Stop taking IBUMAL and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as they may be early signs of a very serious skin reaction. See section 4;
• serious allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
• signs of infection may be masked, such as fever, pain, and swelling;
• eye problems may occur when using IBUMAL. Regular eye examinations are necessary during treatment, especially for prolonged therapy;
• headache may occur, particularly if used for long periods and at high doses; in such cases, do not increase the dose of IBUMAL to relieve the pain.

If you have reduced function of the heart, liver, or kidneys (especially if you suffer from systemic lupus
erythematosus), your doctor will prescribe periodic specific tests, particularly in case of prolonged treatment,
and will prescribe the lowest effective dose for the shortest possible duration needed to control symptoms.
The risk of experiencing side effects can be reduced by using the lowest effective dose for the shortest
possible duration needed to control symptoms. Do not exceed the dose of IBUMAL or take it for long periods;
always follow your doctor's instructions carefully.
STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestine (gastrointestinal), 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 allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure);
• you experience vision problems;
• you experience liver problems.

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

• other medicines that reduce pain and inflammation (NSAIDs), including selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g., digoxin), medicines used for heart conditions;
• sulfonylureas, medicines used for diabetes;
• medicines with anticoagulant effect (i.e., substances that thin the blood and prevent clot formation, 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, e.g., 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 affect or be affected by treatment with IBUMAL. Therefore, always consult your
doctor or pharmacist before taking IBUMAL with other medicines.
IBUMAL and alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may be more likely
when consuming alcohol during treatment with IBUMAL.
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 take IBUMAL during the last three months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s
tendency to bleed and delay or prolong labor more than expected.
You should not take IBUMAL 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 possible dose for the
shortest possible time should be used. From week 20 of pregnancy, IBUMAL may cause kidney problems in
the fetus if taken for more than a few days, 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
Avoid taking IBUMAL 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 drug.
Driving and using machines
IBUMAL 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 attention. This is particularly important
when consuming alcohol during treatment with IBUMAL.
IBUMAL contains lactose and sodium
Lactose: If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking
this medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take IBUMAL

Take this medicine exactly as directed by your doctor or pharmacist. 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 adolescents over 12 years of age
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 IBUMAL").

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
IBUMAL should be taken by mouth (oral use) with plenty of water, during or after meals. Swallow the tablets whole, without chewing, breaking, crushing, or sucking them.
If you are using IBUMAL for rheumatic diseases, your doctor will advise you to take the first dose upon waking and subsequent doses with meals.

If you take more IBUMAL than you should
If you have taken more IBUMAL than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risks and actions to take.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Common symptoms of ibuprofen overdose include: nausea, vomiting (possibly with traces of blood), stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), headache, dizziness, ringing in the ears (tinnitus).
At higher doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Rarely, the following may occur: uncontrolled eye movements (nystagmus), increased acid levels in the blood (metabolic acidosis), decreased body temperature (hypothermia), effects on the kidneys, gastrointestinal bleeding, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system and respiratory depression.
Additionally, symptoms may include: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
If significantly high doses of ibuprofen are taken, increased acid levels in the blood (metabolic acidosis), and serious kidney and liver damage may occur.

If you have any doubts about how to use IBUMAL, consult your doctor or pharmacist.

If you forget to take IBUMAL
Do not take a double dose to make up for the forgotten 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 everybody gets them.

Serious side effects
Stop taking IBUMAL and contact your doctor immediately if you notice any of the following symptoms:

• severe stomach problems, burning or abdominal pain due to injury of the stomach or intestine (peptic ulcers), sudden and severe pain in the upper abdomen or belly (gastrointestinal perforation). These side effects are uncommon;
• vomiting blood (haematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal haemorrhage). These conditions are common side effects;
• allergic reactions, even severe ones, appearing more or less suddenly, with skin lesions such as widespread or spotted redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, angioedema of the throat possibly causing difficulty breathing or swallowing. These conditions occur with uncommon frequency. Rarely, a severe, potentially life-threatening allergic reaction may occur, characterized by increased heart rate and sudden drop in blood pressure (anaphylactic reactions, anaphylaxis);
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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, bullous dermatitis). These conditions occur very rarely;
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption);
• 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, presenting 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), presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely.

Other side effects
Tell your doctor if you notice any of the following:

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

• nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue;
• worsening of intestinal inflammation, complications of colonic diverticula (perforation or fistula);
• restlessness, irritability.

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

• inflammation of the nose (rhinitis);
• stomach inflammation (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
• impaired hearing, ringing in the ears (tinnitus), vision disturbances;
• skin becomes sensitive to light;
• 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 kidney 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 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);
• increased blood urea nitrogen and liver enzymes, decreased haemoglobin and haematocrit, inhibition of platelet aggregation and prolonged bleeding time, decreased calcium and increased serum uric acid.

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

• reduced liver function, liver damage, inflammation of the pancreas (pancreatitis), inflammation of the oesophagus (oesophagitis);
• sensation of heart pounding (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs (pulmonary oedema);
• decrease in all blood cells (pancytopenia);
• narrowing of the intestine;
• kidney tissue damage;
• hair loss.

Other side effects not known (frequency cannot be estimated from available data)

• pain or burning sensation (pyrosis) in the upper abdomen, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
• worsening of colon inflammation (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise;
• 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 eruption). Stop taking IBUMAL if you develop these symptoms and contact your doctor immediately. See also section 2.
• 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);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 IBUMAL

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 IBUMAL 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, glyceryl dibehenate.
Coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide.
Description of the appearance of IBUMAL and pack contents
Ibumal is presented as film-coated tablets, oblong, biconvex, white to almost white in colour.
This medicine is available in packs of 30 tablets in blisters.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
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)