MOMENACTCOMPI' 25 mg Soft capsule

Зміст інструкції

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

MOMENACTCOMPÌ 25 mg soft capsules
Ketoprofen

Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after three days.

Contents of this leaflet:

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

1. What is MOMENACTCOMPÌ and what is it used for

MOMENACTCOMPÌ contains the active ingredient ketoprofen ,which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic and
anti-inflammatory properties.
MOMENACTCOMPÌ is used in adults and adolescents over 15 years of age for the treatment of pain of
various origins or nature (headache, toothache, neuralgia, menstrual pain, bone and
joint (osteoarticular) and muscle pain).
See a doctor if you do not feel better or if you feel worse after three days.

2. What you need to know before taking MOMENACTCOMPÌ

Do not take MOMENACTCOMPÌ

• If you are allergic to the active ingredient or any of the other ingredients of this medicine, such as peanuts or soy (listed in section 6)
• If you are allergic or have had previous hypersensitivity reactions (such as asthma, bronchial constriction, rhinitis, urticaria, etc.) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• If you are undergoing intensive diuretic therapy
• If you suffer from a severe form of liver failure (liver cirrhosis, severe hepatitis)
• If you suffer from certain blood disorders (leukopenia and thrombocytopenia)
• If you have bleeding (ongoing hemorrhages)
• If you are predisposed to bleeding (hemorrhagic diathesis)
• If you suffer from blood coagulation problems (hemostatic disorders)
• If you have severe heart failure
• If you suffer from a disease characterized by severe lesions of the stomach called active peptic ulcer, or have suffered in the past from bleeding in the stomach and intestines (gastrointestinal hemorrhage), ulceration or perforation
• If the person who is to take the medicine is a child under the age of 15 years.

Warnings and precautions
Consult your doctor or pharmacist before taking MOMENACTCOMPÌ.
You can minimize side effects by using the lowest effective dose for the shortest possible duration of treatment needed to control your symptoms.
Tell your doctor or pharmacist if you are taking other anti-inflammatory drugs, as you should avoid concomitant use with other drugs called NSAIDs.
Consult your doctor or nurse if you have an infection - see section «Infections» below.
During treatment with MOMENACTCOMPÌ, gastrointestinal bleeding, ulceration and perforation, which can be fatal, may occur at any time, without warning symptoms or a previous history of serious gastrointestinal events. Therefore, if gastrointestinal bleeding (bleeding from the stomach or intestines) occurs, stop taking MOMENACTCOMPÌ and contact your doctor immediately.
Pay particular attention if:

• you are an elderly person or a patient suffering from an ulcer, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with consistent doses of MOMENACTCOMPÌ;
• you are using low doses of aspirin or other drugs that may increase the risk of gastrointestinal events at the same time. You may need to take drugs called “gastro-protective” agents (misoprostol or proton pump inhibitors). If you have any doubts, consult your doctor or pharmacist;
• you suffer from problems with the stomach or intestines, especially if you are an elderly person, you should report any abdominal symptoms to your doctor, particularly in the early stages of your treatment;
• you are taking medications at the same time that may increase the risk of ulceration or bleeding, such as oral corticosteroids (cortisone), anticoagulants (blood thinners, such as warfarin), selective serotonin re-uptake inhibitors (antidepressant drugs) or antiplatelet agents (drugs to reduce blood clotting) you should use caution;
• you are a patient with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) you should use NSAIDs with caution, as these conditions may become more severe;
• you suffer from an active stomach ulcer (peptic);
• you have ever had asthmatic or allergic reactions after taking other types of non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid and its derivatives).

The doctor will need to carefully monitor you and have appropriate tests performed if any of these conditions apply to you:

• if you suffer from certain blood disorders (leukopenia and thrombocytopenia);
• if you suffer from serious heart problems (such as hypertension and/or congestive heart failure);
• if you suffer from severe impairment of kidney or liver function;
• if you have a predisposition to bleeding;
• if you suffer from diabetes mellitus;
• if you are undergoing concomitant treatment with agents that promote hyperpotassemia (e.g. potassium supplements);
• if you are an elderly person, the possibility of adverse reactions to NSAIDs is greater, especially gastrointestinal bleeding and perforation, which can be fatal.

This medicine can cause:

• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments;
• skin and mucous membrane diseases, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes. This can occur especially in the first month of treatment (See section “Possible side effects”).
• vision problems such as blurred vision (See section “Possible side effects”).

You should also consult your doctor if you are a heavy smoker, if you have had previous strokes, if you have diabetes, or if you have high cholesterol levels.
If you do not notice a decrease in pain after three days of treatment, you should consult your doctor.
Infections
MOMENACTCOMPÌ can mask the symptoms of infections such as fever and pain. It is therefore possible that MOMENACTCOMPÌ may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in skin infections related to varicella. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 15 years.

Other medicines and MOMENACTCOMPÌ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid taking the following medicines together with MOMENACTCOMPÌ:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
• medicines to make the blood more fluid (anticoagulants, e.g. heparin, warfarin, platelet aggregation inhibitors such as ticlopidine and clopidogrel, or other salicylates) (see sections “Do not take MOMENACTCOMPÌ” and “Warnings and precautions”);
• lithium, used to treat depression or similar disorders;
• methotrexate (medicine used to treat rheumatoid arthritis and cancer) used at high doses (15 mg per week).

Take MOMENACTCOMPÌ with caution if you are taking any of the following medicines:

• medicines that increase potassium levels in the blood such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim;
• diuretic medicines used to promote urine elimination (see sections “Do not take MOMENACTCOMPÌ” and “Warnings and precautions”);
• medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are dehydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for blood circulation problems;
• tenofovir, a medicine used to treat some viral infections.

The doctor will need to monitor you and may possibly reduce the dosage of ketoprofen if you are taking any of the following medicines:

• medicines used to treat high blood pressure such as beta-blockers, angiotensin converting enzyme inhibitors;
• thrombolytics and anti-aggregating agents, used for blood clotting problems;
• selective serotonin re-uptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in operations of the female genital apparatus;
• intrauterine devices (IUDs) the effectiveness of the device may be reduced with consequent pregnancy.

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

Pregnancy
Do not take MOMENACTCOMPÌ in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It can cause problems with the kidneys and heart of 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 MOMENACTCOMPÌ 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 lowest dose should be used for the shortest possible time. From the 20th week of pregnancy, MOMENACTCOMPÌ can 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 constriction 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
Do not take MOMENACTCOMPÌ while breastfeeding.

Fertility
MOMENACTCOMPÌ may cause fertility problems in women. Tell your doctor if you want to become pregnant, or need to have fertility tests, as this medicine may reduce your fertility and alter the results of your tests.

Driving and using machines
While taking MOMENACTCOMPÌ, symptoms such as drowsiness, dizziness, vertigo, convulsions or visual disturbances may occur.
Therefore, if these occur, avoid driving, using machines or performing activities that require particular attention.

MOMENACTCOMPÌ contains sorbitol, ethyl parahydroxybenzoate, propyl parahydroxybenzoate and soybean oil.

• Sorbitol:This medicine contains 3 mg of sorbitol per capsule, equivalent to 0.18 mg/Kg/day. The additive effect of the co-administration of medicines containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The sorbitol content in oral medicines can alter the bioavailability of other oral medicines taken at the same time.
• Ethyl p-hydroxybenzoate (E215)and propyl p-hydroxybenzoate (E217): may cause allergic reactions (including delayed reactions).
• Sodium: MOMENACTCOMPÌ contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.
• Soybean oil: MOMENACTCOMPÌ contains soybean oil. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take MOMENACTCOMPÌ

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and adolescents over 15 years of age: one capsule in a single or repeated dose 2-3 times a day for more intense pain, preferably on a full stomach. Do not exceed the recommended doses.
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 symptoms (such as fever and pain) persist or worsen (see section 2).

Special populations

Patients with renal impairment and the elderly
If you are a patient with renal impairment or if you are an elderly patient, your doctor may prescribe a lower dose than normally used. Therefore, carefully follow your doctor's instructions.

Patients with hepatic impairment
If you are a patient with mild or moderate hepatic impairment, you must be closely monitored by your doctor who will administer the minimum dose that is effective for you (see sections “Do not take MOMENACTCOMPÌ” and “Warnings and precautions”).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 15 years.

If you take more MOMENACTCOMPÌ than you should
In case of accidental ingestion/intake of an excessive dose of MOMENACTCOMPÌ, immediately notify your doctor or go to the nearest hospital.
If you have taken or are taking an excessive dose of MOMENACTCOMPÌ, you may experience symptoms such as headache, dizziness, confusion, and loss of consciousness, as well as pain, nausea, and vomiting. You may also experience episodes of bleeding from the stomach and intestines (gastrointestinal hemorrhage), reduced blood pressure (hypotension), difficulty breathing (respiratory depression), and a bluish-purple discoloration of the skin and mucous membranes (cyanosis).

If you forget to take MOMENACTCOMPÌ
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of MOMENACTCOMPÌ, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop using MOMENACTCOMPÌ and contact your doctor immediately if you experience:

• swelling due to fluid retention (edema)
• serious increase in blood pressure (hypertension) and reduced heart function (heart failure)
• presence of digested blood in the stool (as it may be a symptom of perforation or bleeding of the intestine, potentially fatal if you are an elderly patient)
• severe abdominal pain (which may be a symptom of pancreatitis)
• vomiting mixed with blood (as it may be a symptom of perforation or bleeding of the stomach, potentially fatal especially if you are an elderly patient)
• worsening of colitis (inflammation of the colon) and Crohn's disease, sometimes fatal, particularly in the elderly. MOMENACTCOMPÌ, like other non-steroidal anti-inflammatory drugs (NSAIDs), is associated with a modest increase in the risk of heart attack (“myocardial infarction”) or stroke.

The most commonly observed adverse events with MOMENACTCOMPÌ are:

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

• stomach ulcers (peptic)
• perforation or bleeding of the stomach and intestines (gastrointestinal), sometimes fatal, especially in the elderly
• digestive difficulties (dyspepsia)
• abdominal pain
• nausea, vomiting.

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

• diarrhea
• excessive production of gas in the intestine (flatulence)
• constipation
• inflammation of the stomach (gastritis)
• skin rash, itching
• headache, dizziness, vertigo, drowsiness
• fatigue.

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

• inflammation of the mouth with painful lesions (ulcerative stomatitis)
• stomach ulcer
• inflammation of the colon (colitis)
• asthma attacks
• tingling of the limbs (paresthesia)
• blurred vision
• ringing in the ears (tinnitus)
• inflammation of the liver (hepatitis), yellowing of the skin and the white part of the eye (jaundice)
• alteration of liver function tests (increased levels of transaminases, increased serum bilirubin)
• reduction of red blood cells (anemia) caused by bleeding
• reduction of some white blood cells (leukopenia)
• weight gain.

Not known(frequency cannot be estimated based on available data):

• increased sensitivity to light (photosensitivity reactions), rare in case of systemic administration
• skin problems (cutaneous rash)
• hair loss
• urticaria
• swelling of the face and throat (angioedema)
• erythema, blistering skin reactions (including Stevens-Johnson syndrome) and Toxic Epidermal Necrolysis (a serious skin disease with severe scaling, potentially fatal), pustule formation;
• feeling of tightness in the chest with difficulty breathing (bronchospasm) particularly in patients with known hypersensitivity to acetylsalicylic acid (ASA and other NSAIDs), rhinitis, difficulty breathing (dyspnea)
• aseptic meningitis (inflammation of the meninges not caused by bacteria)
• convulsions
• alterations of taste (dysgeusia)
• abnormal tests to check kidney function, acute kidney failure, tubulointerstitial nephritis, loss of nutrients from the body (such as proteins) through the urine (nephrotic syndrome)
• reduction in the number of granulocytes with a consequent increased risk of infections (agranulocytosis), reduction in the number of platelets in the blood (thrombocytopenia), reduced production of blood cells by the bone marrow (aplastic anemia), destruction of red blood cells (hemolytic anemia)
• anaphylactic reactions (including shock)
• depression, hallucinations, confusion, mood alteration
• heart failure, atrial fibrillation, palpitations and tachycardia
• hypertension, vasodilation, inflammation of blood vessels (including leukocytoclastic vasculitis)
• hyponatremia (reduction of sodium levels in the blood), hyperpotassemia (increase of potassium levels in the blood).

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high
doses and for long-term treatments) may be associated with a modest increase in the
risk of arterial thromboembolic events (e.g., myocardial infarction or stroke).

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after the authorization of
the medicine is important, as it allows continuous monitoring of the benefit/risk ratio of the
medicine. Healthcare professionals are required to report any suspected adverse reaction through the
national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can contribute to providing more information on the
safety of this medicine.

5. How to store MOMENACTCOMPÌ

This medicine does not require any special storage conditions.
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 pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 MOMENACTCOMPÌ contains
One capsule:

• the active ingredient is: ketoprofen 25 mg;
• the other ingredients are: vegetable oil, partially hydrogenated oils, soybean oil,yellow beeswax, soybean lecithin.

Capsule constituents:
Gelatin, glycerol (E422), sorbitol(E420) special solution, ethyl paraben, propyl paraben(E217), titanium dioxide (E171), red iron oxide (E172), purified water.

Description of the appearance of MOMENACTCOMPÌ and contents of the pack
MOMENACTCOMPÌ is presented in soft capsule form.
MOMENACTCOMPÌ 25 mg is available in packs of 10, 20 and 30 soft capsules in PVC -
PVDC/Al blisters.

Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70
00181 Roma

Manufacturer
GENETIC S.p.A – Contrada Canfora – 84084 Fisciano (SA)

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