Package leaflet: Information for the user

MOMENTACT 400 mg film-coated tablets

Ibuprofen
Read all of this leaflet carefully before you start taking this medicine with itching (hives) or swelling of the skin and throat (angioedema)
because it contains important information for you. may occur, especially if you have already had allergic reactions after
Always take this medicine exactly as described in this leaflet or as your using other medicines used to treat joint or muscle pain, fever or to
doctor or pharmacist have told you. treat inflammation (NSAIDs).
- Keep this leaflet. You may need to read it again. - If you are taking other anti-inflammatory drugs, including selective
- Ask your pharmacist if you need more information or advice. COX-2 inhibitors (an enzyme involved in inflammatory processes),
- If you get any side effects, talk to your doctor or pharmacist. This includes as in these cases the risk of ulcers and bleeding may increase (see
any possible side effects not listed in this leaflet. See section 4. section “Other medicines and Momentact”).
- You must talk to a doctor if you do not feel better or if you feel worse - If you are elderly or if you have an ulcer, especially if the ulcer has
after 3 days of treatment. occurred with bleeding or perforation (see section “Do not take
Momentact”), as the risk of bleeding, ulceration or perforation is higher
What is in this leaflet: with higher doses of anti-inflammatory drugs. In these cases, you
1. What Momentact is and what it is used for should start treatment with the lowest available dose and, if necessary,
2. What you need to know before you take Momentact ask your doctor to prescribe you a medicine to protect the stomach
3. How to take Momentact (misoprostol or proton pump inhibitors). This option should be taken into
4. Possible side effects consideration even if you are taking low doses of acetylsalicylic acid
5. How to store Momentact or medications that may increase the risk of diseases of the stomach
6. Contents of the pack and other information and/or intestine (see section “Other medicines and Momentact”).
- If you have suffered, or suffer, from chronic diseases of the intestine
1. What Momentact is and what it is used for (ulcerative colitis, Crohn's disease), as they may worsen (see section
Momentact contains ibuprofen, a medicine that belongs to the class 4 “Possible side effects”).
of analgesic anti-inflammatory products, that is the group of medicinal - If you have had diseases of the stomach and intestine related to
products designed to relieve pain and inflammation. medication use, and particularly if you are elderly, you should report
Momentact is used in adults and in adolescents from 12 years to treat: any unusual intestinal symptoms (especially bleeding) to your doctor,
- pain of various types and origins (headache, toothache, neuralgia, particularly in the initial stages of treatment.
osteoarticular and muscular pain, menstrual pain) and to help reduce - If you notice a skin rash, mucosal lesions or any other sign of
the symptoms of fever and flu. hypersensitivity or persistent signs of liver malfunction. In such cases,
You must talk to a doctor if you do not feel better or if you feel worse after treatment with Momentact must be discontinued. The greatest risk
3 days of treatment. occurs at the beginning of your treatment: in the majority of cases,
onset of the reaction occurs within the first month of treatment. Severe
2. What you need to know before you take Momentact skin reactions, some of which were fatal, such as exfoliative dermatitis,
Do not take Momentact: Stevens-Johnson syndrome and toxic epidermal necrolysis, have been
- If you are allergic to ibuprofen and/or any of the other ingredients of reported very rarely in association with the use of NSAIDs (see section
this medicine (listed in section 6). “Possible side effects”).
- If you are allergic to other antirheumatic drugs (e.g. acetylsalicylic acid, - If you are taking other medicines that increase the risk of ulceration or
etc.), medicines used to treat joint or muscle pain (see section “Other bleeding of the stomach and/or the intestine, such as oral corticosteroids
medicines and Momentact”), or if you are allergic to any of the other (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin
ingredients of this medicine. inhibitors) or antiplatelet agents (e.g. acetylsalicylic acid). See also the
- If the patient is a child under 12 years of age. section “Other medicines and Momentact”. If gastrointestinal bleeding
- If you are in the last trimester of pregnancy or are breast-feeding (see or ulceration occurs in patients taking Momentact, the treatment must
section “Pregnancy, breast-feeding and fertility”). be discontinued.
- If you suffer from diseases of the stomach and intestine (e.g. active or - If you have high blood pressure and the medicines you are taking fail
severe gastroduodenal ulcer). to lower it and/or you have heart disease or a cerebral or peripheral
- If you have a history of stomach or intestinal bleeding or perforation circulatory disease or think you may be at risk for these diseases
after taking any medications. (for instance, if you suffer from high blood pressure, diabetes or high
- If you have had two or more distinct episodes of stomach ulcer or cholesterol or if you smoke).
bleeding. - If you suffer from high blood pressure and/or heart disease, since fluid
- If you have a serious heart disease. retention, increased blood pressure and swelling have been found
- If you have a serious liver or kidney disease. following treatment with NSAIDs. NSAIDs may reduce the action of
- If you have lost a lot of water from your body (severe dehydration) due medicines to lower blood pressure (see section “Other medicines and
to vomiting, diarrhoea or insufficient intake of liquids. Momentact”).
- If you have lost a considerable amount of fluid, or if swelling, heart
Warnings and precautions disorders or high pressure arise.
Talk to your doctor or pharmacist before taking Momentact: - If you have reduced kidney function, heart or liver malfunction, if you
- If you have had episodes of difficulty breathing (bronchospasm) after are elderly or being treated with medications for high blood pressure,
using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs. since you may be more predisposed to the onset of kidney problems.
- If you suffer from asthma, runny nose (chronic rhinitis), the presence In addition, habitual concomitant use of various painkillers can further
of polyps in the nose (nasal polyposis) or inflammation of the mucosa increase this risk.
of the nose (sinusitis) or if you suffer/have suffered from allergies, - If you suffer from a heart disease.
because difficulty breathing (bronchospasm), reddening of the skin - If you suffer from liver diseases (liver dysfunctions).
- If you are elderly, as the risk of bleeding, ulcers and perforations is - acetylsalicylic acid, COX-2 inhibitors or other NSAIDs (medicines used
elevated compared to other patients. to treat inflammation), as they could increase the possible side effects
- If you suffer from a blood coagulation disorder or you are taking relating to the stomach and intestine;
medicines to thin the blood (anticoagulants) (see section “Other - lithium (a medicine used to treat mental illnesses) or phenytoin (a
medicines and Momentact”). medicine used to treat epilepsy). During treatment with these medicines,
- If you suffer from a disease that can affect various organs and tissues your doctor may ask you to undergo blood tests;
of the body (widespread or systemic lupus erythematosus) or from - methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
a connective tissue disease, present in many parts of the body, e.g. - moclobemide, a medicine used to treat depression;
bones and cartilage, because on rare occasions symptoms of “aseptic - aminoglycosides (antibiotic medicines);
meningitis” have been observed in patients being treated with ibuprofen. - cardiac glycosides (medicines used to treat certain heart diseases).
Although it is more likely to occur in patients with systemic lupus Medicines like Momentact may aggravate heart diseases;
erythematosus and related connective tissue diseases, it has also been - cholestyramine (a medicine used to reduce blood lipids);
observed in patients who did not show chronic concomitant diseases. - ciclosporin (a medicine used if you have had an organ transplant), as
- If you are taking medicines to treat pain, heart disease or high blood medicines like Momentact may increase the risk of kidney damage;
pressure (see section “Other medicines and Momentact”). - plant extracts such as Ginkgo Biloba, because if they are taken
- If you are planning to become pregnant (see section “Pregnancy, together with medicines like Momentact, they may increase the risk
breast-feeding and fertility”). of gastrointestinal bleeding;
- If you are having problems becoming pregnant or if you are undergoing - mifepristone (a medicine used in women to induce abortion);
fertility tests (see section “Pregnancy, breast-feeding and fertility”). - quinolone antibiotics (medicines used to treat infections), because if
Anti-inflammatory/painkiller medicines such as ibuprofen may be they are taken together with medicines like Momentact, there may be
associated with a small increased risk of heart attack or stroke, particularly a greater risk of developing convulsions;
when used at high doses. Do not exceed the recommended dose or - sulphonylureas, medicines used to treat diabetes; in case you need
duration of treatment. concomitant treatment with these medications, your doctor may have
You should discuss your treatment with your doctor or pharmacist before you undergo blood tests;
taking Momentact if you: - tacrolimus, a medicine used to prevent and treat organ transplant
- have heart problems including heart failure, angina (chest pain), or if rejection; co-administration with Momentact may increase the risk of
you have had a heart attack, bypass surgery, peripheral arterial disease kidney damage;
(poor circulation in the legs or feet due to narrow or blocked arteries), - zidovudine and ritonavir, medicines used to treat AIDS; if concomitant
or any kind of stroke (including “mini-stroke” or transient ischaemic treatment is necessary, your doctor may have you undergo blood tests;
attack – “TIA”); - probenecid, a medicine used to treat gout;
- have high blood pressure, diabetes, high cholesterol, have a family - CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines
history of heart disease or stroke, or if you are a smoker. used to treat fungal infections);
Medicines like Momentact may: - bisphosphonates, medicines to treat bone diseases, as they may
- be associated with the onset of potentially severe kidney diseases increase side effects relating to the stomach and intestine;
(such as renal papillary necrosis, analgesic nephropathy and kidney - oxpentifylline, a medicine to treat leg ulcers, as it may increase side
failure); your doctor will therefore monitor your kidney function; effects relating to the stomach and intestine;
- mask the signs and symptoms of current infection (fever, pain and - baclofen, a medicine to relax muscles.
swelling); Some other medicines may also affect or be affected by the treatment
- give rise to eye disorders; it is therefore recommended in case of of Momentact. You should therefore always seek the advice of
prolonged treatments to carry out regular eye tests. If you experience your doctor or pharmacist before you use Momentact with other
visual disturbances, discontinue treatment with Momentact. medicines.
Adolescents
If the adolescent is dehydrated, they are at risk of developing a kidney Momentact with alcohol
disease. Do not drink alcohol during treatment with Momentact, as it may increase
possible side effects.
Other medicines and Momentact
Tell your doctor or pharmacist if you are taking, have recently taken or Pregnancy, breast-feeding and fertility
might take any other medicines. If you are pregnant or breast-feeding, think you may be pregnant or are
Momentact may affect or be affected by some other medicines. For planning to have a baby, ask your doctor or pharmacist for advice before
example: taking this medicine.
Do not take Momentact together with acetylsalicylic acid (for example
aspirin) or other anti-inflammatory drugs. Pregnancy
Seek medical advice before using Momentact with other medicines, During the first and second trimester of pregnancy, Momentact should
in particular: not be given unless absolutely necessary.
- corticosteroids (medicines used to treat inflammation, such as cortisone); Do not take Momentact in the last trimester of pregnancy, as it can
- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. cause major disorders of the heart, lungs and kidneys of the foetus;
aspirin/acetylsalicylic acid, warfarin, ticlopidine); it can cause bleeding tendencies in both the mother and foetus and
- medicines that reduce high blood pressure (ACE-inhibitors such as weaken the strength of uterine contractions, thus delaying delivery.
captopril, beta-blockers such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan). Momentact may reduce the Breast-feeding
effect of these medicines. If you are being treated with any of these Ibuprofen passes into breast milk; therefore do not take Momentact if
medicines, if you are elderly or suffer from kidney disease, your doctor you are breast-feeding.
may ask you to undergo blood tests;
- selective serotonin reuptake inhibitors (medicines used to treat Fertility
depression), as they may increase the risk of lesions or bleeding.
If you are having problems becoming pregnant or if you are undergoing
Your doctor could therefore prescribe you a medicine to protect the
fertility tests, suspend use of Momentact, because this medicine could
stomach;
temporarily affect your fertility.
Driving and using machines If you have any further questions on the use of Momentact, ask your
Momentact does not usually affect the ability to drive or use machines. doctor or pharmacist.
Nevertheless, when performing activities that require vigilance, be careful if
If you forget to take Momentact
you notice the onset of drowsiness, vertigo or depression during treatment
Do not take a double dose to make up for a forgotten tablet.
with Momentact.
4. Possible side effects
Momentact contains:
Like all medicines, Momentact can cause side effects, although not
• Lactose: if you have been told by your doctor that you have an
everybody gets them. The side effects of the medicine can be minimised
intolerance to some sugars, contact your doctor before taking this
if you use the lowest recommended dose or if you only use the medicine
medicinal product.
for the period of time necessary to control your symptoms.
• Sodium: this medicinal product contains less than 1 mmol (23 mg) of
If you get an ulcer or stomach and/or intestinal bleeding occurs or if you
sodium per dose, making it practically “sodium-free”.
find lesions of the skin and/or mucosa, you must discontinue treatment
with Momentact and contact your doctor. Usually these side effects are
3. How to take Momentact
more common in the elderly.
Always take this medicine exactly as described in this leaflet or as your
Use of Momentact can cause side effects that are generally minor or
doctor or pharmacist has told you. Check with your doctor or pharmacist
moderate or, albeit rarely, more severe allergic reactions.
if you are not sure.
If any of the following symptoms arise, IMMEDIATELY DISCONTINUE
use of Momentact and contact a doctor or go to the nearest hospital
Adults and adolescents over 12 years of age: The recommended
where they can administer appropriate, specific treatment:
dose is 1 tablet, two-three times daily.
• rashes or skin lesions,
Swallow the capsule with a glass of water.
• mucosal lesions,
Momentact can be taken on an empty stomach. Patients with gastric
• signs of allergic reaction, including severe ones (erythema, itching,
tolerability problems should take this medicinal product on a full stomach.
hives, asthma, swelling of the skin and mucosa, anaphylactic shock),
If there are no clear signs of improvement after three days of treatment,
• flaking skin,
consult your doctor.
• severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-
Consult your doctor if you notice any recent change in the characteristics
Johnson syndrome),
of your disorder.
• visual disturbances,
Do not exceed the dose of 3 capsules a day without first consulting
• liver disease (hepatic dysfunction),
your doctor. If you are elderly, you should follow the minimum dosages
• bleeding, ulcer and perforation of the stomach and intestine, which
indicated above.
could prove fatal, particularly in the elderly.
If you suffer from kidney and/or liver or heart disease, consult your doctor,
In the event of an allergic reaction listed above, go to a hospital, as
who will determine the right dose for you.
you need to have immediate access to equipment, medication and
If you suffer from severe liver disease, do not take Momentact.
staff equipped to treat emergencies. In rare cases, severe side effects
have been reported following the use of ibuprofen, sometimes with fatal
Use in the elderly
outcome, even in the absence of known allergy.
Consult your doctor, who will determine the correct dose for you by
lowering the recommended dose, especially if you suffer from kidney The risk of developing such symptoms is higher in the initial stages of
and/or liver disorders. treatment: in most cases, the reaction occurs within the first month of
treatment.
Use in adolescents Furthermore, additional side effects may occur which have also been
Consult your doctor if use of the medicine is necessary in adolescents reported with other medicines similar to Momentact and which are listed
for more than 3 days or in case of worsening symptoms. below by frequency:
common (may affect up to 1 in 10 people)
If you take more Momentact than you should • dizziness
If you have taken more Momentact than you should or if your child has • malaise
taken this medicine by accident, always contact a doctor or the nearest • fatigue
hospital to receive advice regarding the risk and what action to take.
uncommon (may affect up to 1 in 100 people)
Symptoms may include nausea, stomach ache, vomiting (possibly with
• inflammation of the stomach (gastritis)
traces of blood), headache, ringing in the ears, confusion and involuntary
• insomnia, anxiety
eye movement. At high doses, drowsiness, chest pain, palpitations, loss
• numbness in the limbs or in other parts of the body, drowsiness
of consciousness, convulsions (above all in children), weakness and
• nasal congestion (rhinitis)
vertigo, blood in the urine, feeling cold and breathing problems have
• difficulty breathing (bronchospasm, dyspnoea)
been reported.
• momentary interruption of breathing (apnoea)
If you take an excessive dose (overdose) of ibuprofen, you may also
• hearing impairment
experience the following common symptom: state of deep sleep with
• ringing in the ears (tinnitus)
reduced response to normal stimuli (lethargy). Symptoms of overdose
• vertigo
may appear within 4-6 hours after ingestion of ibuprofen. The following
• liver disorders (impaired liver function)
symptoms may rarely be experienced: lowered body temperature
• liver inflammation (hepatitis)
(hypothermia), effects on the kidneys, stomach or intestinal bleeding,
• yellowing of the skin and eyes (jaundice)
momentary interruption of breathing (apnea), diarrhoea, reduced activity of
• kidney diseases (damage to kidney function and toxic nephropathy in
the nervous system (Central Nervous System depression) and breathing
various forms, including interstitial nephritis, nephrotic syndrome and
activity (respiratory system depression).
kidney failure)
Furthermore, the following may occur: disorientation, state of excitation,
• allergic reactions such as skin rash, hives, itching, formation of red spots
fainting, lowered blood pressure (hypotension), decrease or increase of
on the skin (purpura), swelling of the skin and mucosa (angioedema),
number of heart beats (bradycardia or tachycardia).
asthma, difficulty breathing (bronchospasm or dyspnoea) and asthma
The use of a significantly higher dose of ibuprofen may cause severe
attacks with lowered blood pressure
kidney and liver damage.
• skin reactions to light (photosensitivity)
rare (may affect up to 1 in 1,000 people) 5. How to store Momentact
• reduced number of blood cells: reduction in white blood cells (leukopenia, This medicinal product does not require any special temperature storage
neutropaenia and agranulocytosis), in red blood cells (haemolytic conditions.
anaemia and aplastic anaemia) and in platelets (thrombocytopenia) Keep this medicine out of the sight and reach of children.
• depression, confusional state, hallucinations Do not use this medicine after the expiry date which is stated on the
• inflammation of the optic nerve (optic neuritis) carton after EXP.
• inflammation of the meninges, the membranes covering the brain The expiry date refers to the last day of that month.
(aseptic meningitis), especially in patients with pre-existing autoimmune Do not throw away any medicines via wastewater or household waste.
disorders (see section “Warnings and precautions”), with symptoms of Ask your pharmacist how to throw away medicines you no longer use.
nuchal rigidity, headache, nausea, vomiting, fever or disorientation These measures will help protect the environment.
• eye disorders with visual disturbances and disease of the optic nerve
(toxic optic neuropathy) 6. Contents of the pack and other information
• swelling due to the accumulation of fluid in tissues What Momentact contains
• disease that can affect various organs and tissues of the body (lupus - The active ingredient is 400 mg ibuprofen.
erythematosus) - The other ingredients are pregelatinised starch, sodium starch glycolate,
• worsening of inflammations caused by an infection already present carmellose sodium, povidone, microcrystalline cellulose, precipitated
(for example development of necrotising fasciitis) silica, talc, sodium lauryl sulphate, lactose monohydrate, hypromellose,
titanium dioxide and Macrogol 4000 (see section Momentact contains
very rare (may affect up to 1 in 10,000 people) lactose and sodium).
• inflammation of the pancreas, a gland involved in digestive processes
(pancreatitis) What Momentact looks like and the contents of the pack
• sensation of feeling one's own heartbeat (palpitations)* Momentact comes in the form of film-coated tablets for oral use.
• heart disease (heart failure)* Each pack contains 6, 12 or 20 film-coated tablets.
• heart attack (myocardial infarction)* Not all pack sizes may be marketed.
• increase in fluid around the lungs (acute pulmonary oedema)*
• liver disease (liver failure) Marketing Authorisation Holder and Manufacturer
• hypertension* Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
• severe allergic reactions, which may include symptoms such as Viale Amelia, 70
swelling of the face, tongue and throat making breathing difficult, fast 00181 Rome, Italy
heartbeat, severe allergic reaction with rapid onset which can cause
death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal Manufacturer
necrolysis, Stevens-Johnson syndrome and erythema multiforme). A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

*these side effects tend to subside on discontinuation of treatment This leaflet was last revised in
July 2018
not known (cannot be estimated from the available data)
• feeling of indigestion HEALTH EDUCATION NOTES
• nausea All of us may experience various types of pain, of varying origin, frequency
• vomiting and intensity, in particular: headache, toothache, muscle and joint pain
• diarrhoea and menstrual pain.
• flatulence Headaches are certainly one of the most common pains. When suffering
• constipation from headaches, it is important that factors capable of triggering them
• difficult digestion (irregular eating habits, particular foods, smoking, alcohol, stress, excessive
• stomach ache physical strain, excessive exposure to sunlight, loud noises, heavy scents,
• heartburn etc.) be identified and prevented.
• blood in stool Menstrual pain, at times quite intense, can be fought by using painkillers
• blood in vomit that act by reducing the amount of prostaglandins, substances produced
• lesions inside the mouth in the womb and considered largely responsible for this complaint.
• worsening of inflammatory diseases of the colon and intestine (colitis, Use the QR Code on the box or go to http://leaflet.angelini.it/L04 to read
Crohn's disease) the updated package leaflet in various languages.
• increased risk of heart attack (myocardial infarction) or lack of blood
supply to the brain (stroke)
• high blood pressure
• severe heart disease (heart failure)
• there is a possibility of a serious skin reaction known as DRESS
syndrome. The symptoms of DRESS include: skin rash, fever, swelling
of lymph nodes and increased eosinophil count (a type of white blood
cell).

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly
via the national reporting system on the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
602007_04

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