IBUMAL 600 mg Tabletki Powlekane

Treść ulotki

1. IBUMAL 600 mg film-coated tablets
   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

IBUMAL 600 mg film-coated tablets

Ibuprofen
Generic medicine

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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 against pain and inflammation.
IBUMAL is used to treat pain due to, for example:

• trauma (for example caused by sport), toothache (for example after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (for example caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthrosis of the shoulder, radiculoneuritis, tenosynovitis, myositis, fibrosis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis), such as cervical, dorsal, lumbar, shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that mainly affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking IBUMAL

Do not take IBUMAL

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other pain relievers, fever reducers or other non-steroidal anti-inflammatory drugs (NSAIDs) in particular if associated with nasal polyps, facial swelling (angioedema) and/or asthma;
• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding in the stomach or intestine caused by taking medications;
• if you have had two or more distinct episodes of bleeding or injury to the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have severe problems with the liver or kidneys;
• if you suffer from severe heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, 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
Pay particular attention with IBUMAL:
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment.
Stop using IBUMAL and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Talk to your doctor before taking IBUMAL if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below “PAY ATTENTION” on gastrointestinal risks and “Do not take IBUMAL”);
• you have reduced kidney function;
• you have liver problems;
• you have blood coagulation problems;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or long-lasting (chronic) respiratory diseases;
• you have had facial, throat, lip or other parts of the body swelling (angioedema) in the past;
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular 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 inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, the doctor may advise you not to use this medicine;
• you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems;
• you have an infection - see section “Infections” below.

Infections
Ibumal can mask the symptoms of infections such as fever and pain. Therefore, Ibumal may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

Heart attack and stroke
Anti-inflammatory/pain relievers 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.
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop IBUMAL immediately and contact your doctor or emergency health service immediately if you notice any of these signs.
You should discuss the therapy with your doctor or pharmacist before taking IBUMAL if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation to the legs or feet due to narrowing or blockage of the 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.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation:

• at any time, with or without warning symptoms, even in patients without a history of severe 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 had these problems in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, the doctor will tell you to start treatment with the lowest available dose, and may also prescribe a medicine to protect the stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to take together with IBUMAL;
• although very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). The risk of you developing these reactions is greater in the early stages of treatment, especially within the first month;
• severe skin reactions have been reported in association with IBUMAL treatment. Stop taking IBUMAL and consult your doctor immediately if you develop a rash, mucous membrane lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4;
• severe allergic reactions (aphylactoid reactions, up to anaphylactic shock) may occur;
• signs of an infection may be masked, which may manifest as fever, pain and swelling;
• eye changes may occur if you use IBUMAL. Periodic eye checks are necessary during therapy, especially for prolonged treatments;
• headache may occur, especially if used for prolonged periods and at high doses. In this case, do not increase the dose of IBUMAL to relieve pain.

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

• you notice any symptoms affecting the stomach and intestine (gastrointestinal), especially if it is bleeding, particularly if this occurs in the early stages of treatment, if you are an elderly patient or if you have had gastrointestinal problems in the past;
• a rash, mucous membrane lesions or any other sign of an 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, ask your doctor for advice, as specific (lower) dosages are available for these patients.

Other medicines and IBUMAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
IBUMAL can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs), including medicines called selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart disease;
• sulfonylureas, medicines used for diabetes;
• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used in HIV infections;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines 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 abortion;
• moclobemide, a medicine used to treat depression.

Some 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 with alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may be more likely when you drink alcohol during treatment with IBUMAL.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take IBUMAL in the last 3 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 in the first 6 months of pregnancy unless absolutely necessary and under the advice of a doctor.
If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week 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 causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Avoid taking IBUMAL if you are breastfeeding as the medicine can pass into breast milk in small amounts.

Fertility
If you want to become pregnant or have problems conceiving, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
IBUMAL can cause side effects that can worsen your reactivity to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do not suffer from any of these side effects before driving vehicles or using machinery or doing anything that requires attention. This is particularly important when you drink alcohol during treatment with IBUMAL.

IBUMAL contains lactose and sodium
Lactose:If you have been diagnosed with intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if the symptoms (e.g. fever and pain) persist
or worsen (see paragraph 2).

Adults and adolescents over 12 years of age
The recommended dose is 1 - 3 tablets per day as directed by your doctor. 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, even reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take IBUMAL”).

Elderly
If you are elderly, your doctor will decide the most appropriate dose for you, even reducing the dosages indicated above.
Method of administration
IBUMAL should be taken orally (oral use) with plenty of water during or after meals. Take the
tablets whole, without chewing, breaking, crushing or sucking them.
If you are using IBUMAL for rheumatic diseases, your doctor will tell you to take the first dose upon waking and the
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 taken this medicine by mistake, always contact
a doctor or the nearest hospital to obtain advice on the risk and recommendations regarding
actions to be taken.
Symptoms of an overdose may appear within 4 – 6 hours of taking ibuprofen.
If you take an excessive dose (overdose) of ibuprofen, you may more commonly experience the following
symptoms: nausea, vomiting (possibly with traces of blood), stomach pain, deep sleep
with reduced response to normal stimuli (lethargy), headache, dizziness, ringing in the ears (tinnitus).
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low potassium levels in the
blood, feeling of coldness in the body and breathing problems have been reported.
Rarely, it may present: uncontrolled eye movements (nystagmus), increased acids in the blood
(metabolic acidosis), lowering of body temperature (hypothermia), effects on the kidneys,
bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary interruption
of breathing (apnea), diarrhea, reduction of nervous system activity and respiratory activity.
In addition, it may also manifest: disorientation, state of excitement, fainting, lowering of
blood pressure (hypotension), decrease or increase in heartbeats (bradycardia or tachycardia).
If you take significantly high doses of ibuprofen, you may experience increased acids in the blood
(metabolic acidosis), severe damage to the kidneys and liver.
If you have any doubts about the use of IBUMAL, consult your doctor or pharmacist

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

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

• serious stomach problems, burning or abdominal pain due to lesions of the stomach or intestine (peptic ulcers), severe and sudden pain in the upper abdomen or stomach (gastrointestinal perforation). These side effects are uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal bleeding). These conditions are common side effects;
• allergic reactions, even severe, manifesting with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, throat edema with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a severe allergic reaction may also occur, which can be life-threatening, characterized by an increased heart rate and a sudden drop in blood pressure (anaphylactic reactions, anaphylaxis);
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 enlarged lymph nodes (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• difficulty breathing (asthma, even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, skin changes and problems with other organs. This condition occurs rarely.
• worsening of infections such as necrotizing fasciitis, which manifests with fever, chills, weakness, sweating, diarrhea, 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) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely.

Other side effects
Tell your doctor if you notice:

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

• nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain;
• headache, dizziness;
• fatigue;
• worsening of inflammatory bowel disease, complications of diverticula of the colon (perforation or fistula);
• agitation, irritability.

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

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• vertigo, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• the skin becomes sensitive to light;
• changes in liver function, yellowish discoloration 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, kidney inflammation (tubulointerstitial nephritis), changes in function (renal insufficiency).

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

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• visual impairment due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema);
• increased blood urea nitrogen and liver enzymes, decreased hemoglobin and hematocrit, inhibition of platelet aggregation and prolonged bleeding time, decreased calcium and increased uric acid in the serum.

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 esophagus (esophagitis);
• feeling of a racing heart (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs (pulmonary edema);
• decreased number of all cells in the blood (pancytopenia);
• narrowing of the intestine;
• damage to kidney tissue;
• hair loss.

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

• pain or burning (pyrosis) in the upper abdomen, inflammation of the oral mucosa with ulcers (ulcerative stomatitis);
• worsening of inflammation in the colon (colitis) or Crohn's disease;
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise;
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using IBUMAL if you develop these symptoms and contact your doctor immediately. See also paragraph
• 2.
• It is possible to develop a severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: 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, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Exp.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 IBUMAL contains
The active ingredient is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.
The other ingredients are:
Core: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hypromellose, lactose monohydrate,
talc, anhydrous colloidal silica, dibeenate glycerol.
Coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide.

Description of the appearance of IBUMAL and contents of the pack
Ibumal is presented in the form of film-coated tablets, oblong, biconvex, from white
to off-white in color.
This medicinal product is available in packs of 30 tablets in blisters.

Marketing Authorisation 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 (Milano)
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)