ANTALGIL 200 mg Tablets

Зміст інструкції

1. ANTALGIL 200 mg tablets
   1. What is ANTALGIL and what is it used for
   2. What you need to know before taking ANTALGIL
   3. How to take ANTALGIL
   4. Possible side effects
   5. How to store ANTALGIL
   6. Contents of the pack and other information

ANTALGIL 200 mg tablets

Ibuprofen

Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always use 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 3 days.

Contents of this leaflet

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

1. What is ANTALGIL and what is it used for

Antalgil contains the active ingredient ibuprofen belonging to the category of non-steroidal anti-inflammatory analgesic drugs.
Antalgil is used for the symptomatic treatment of pain of various origins and nature (headache,
toothache, neuralgia, menstrual pains, osteoarticular and muscle pains).
See your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking ANTALGIL

Do not take ANTALGIL

• If you are allergic to ibuprofen, to other substances similar from a chemical point of view (in particular to acetylsalicylic acid or other anti-rheumatic drugs), or to any of the other components of this medicine (listed in paragraph 6).
• If you have a history of gastrointestinal bleeding or perforation following previous treatments or a history of recurrent bleeding/peptic ulcer (two or more distinct episodes of ulcer or bleeding in the stomach).
• If you suffer from active gastro-duodenal ulcer or other stomach diseases.
• If you suffer from severe heart failure.
• If you are in the last trimester of pregnancy or if you are breastfeeding.
• If you suffer from severe kidney or liver failure.

Antalgil is contraindicated in children under 12 years of age.

Warnings and precautions
See your doctor or pharmacist before taking ANTALGIL.
The use of ANTALGIL is contraindicated in pregnancy and during breastfeeding or if you are planning
a pregnancy. Stop taking Antalgil if you have fertility problems or if you are
undergoing fertility investigations (see paragraph “Pregnancy, breastfeeding and fertility”).
Do not take Antalgil together with other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). You can
reduce undesirable effects by using the minimum effective dose for the shortest possible treatment duration
needed to control the symptoms (see paragraph “Other medicines and ANTALGIL”). Do not take several analgesic substances at the same time because they can
cause permanent kidney damage and the risk of kidney failure (analgesic nephropathy).
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.
Immediately stop ANTALGIL and contact your doctor or emergency health service immediately if you notice any of these signs.
Elderly:
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially
bleeding and perforation of the stomach and intestines, which can be fatal. If you belong
to this category of patients and treatment is considered necessary, use the lowest dose
for the shortest duration necessary to control the symptoms. If you do not notice any benefit or
if you experience any adverse reactions, contact your doctor who will review the
treatment at regular intervals and/or interrupt it.
Gastrointestinal bleeding, ulceration and perforation:
During treatment with all NSAIDs, at any time, with or without warning symptoms
or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal.
If you are elderly and have a history of ulcer, especially if complicated by bleeding or
perforation (see paragraph “Do not take Antalgil”), the risk of gastrointestinal bleeding, ulceration or perforation is higher with higher doses of NSAIDs. If
you belong to these categories of patients, you should start treatment with the lowest available dose.
If you belong to these categories of patients or if you take low doses of aspirin or
other drugs that may increase the risk of gastrointestinal events (see paragraph “Other medicines and ANTALGIL”), take a medicine to protect the
stomach (gastroprotectors: misoprostol or proton pump inhibitors) at the same time.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report
any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) in
particular in the early stages of treatment.
You should be cautious if you are taking medicines that could
increase the risk of ulcer or bleeding, such as oral corticosteroids, anticoagulants such as
warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin
(see paragraph “Other medicines and ANTALGIL”).
If gastrointestinal bleeding or ulcer occurs while taking Antalgil, you should
stop treatment.
If you have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), you should
take NSAIDs with caution as these conditions may be exacerbated (see
paragraph “Possible side effects”).
Cardiovascular and cerebrovascular effects:
If you have a history of hypertension and/or heart failure, you should be cautious because,
in association with NSAID therapy, fluid retention, hypertension and
edema have been reported.
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a
modest increase in the risk of heart attack or stroke, especially when administered in high doses.
Do not exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking ANTALGIL if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the 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 if you are being treated with diuretics, ACE inhibitors and angiotensin II antagonists
(see paragraph “Other medicines and ANTALGIL”).
If you experience uncontrolled high blood pressure, congestive heart failure, ischemic heart disease, peripheral arteriopathy and/or cerebrovascular disease, you can only take ibuprofen after careful consideration by
the doctor. The same doctor will make similar considerations before starting long-term treatment if you have risk factors for cardiovascular events (e.g.
hypertension, hyperlipidemia, diabetes mellitus and smoking).
Renal effects:
If you suffer from mild or moderate kidney function impairment, your doctor will tell you to take
the lowest possible dose for the shortest duration necessary to control the symptoms and the
kidney function must be monitored.
Ibuprofen can cause sodium retention, potassium retention and fluid retention in patients who
have never suffered from kidney disorders due to its effects on renal perfusion. This may
cause edema or even lead to heart failure or hypertension if predisposed.
Prolonged use of ibuprofen, as with other NSAIDs, can cause kidney disease with blood in the urine (acute interstitial nephritis with hematuria), protein in the urine (proteinuria) and nephrotic syndrome. If you have kidney problems, heart failure, liver problems, if you are taking diuretics and ACE inhibitors and if you are elderly, you are
at higher risk of developing kidney problems. These problems resolve with discontinuation
of treatment.
Liver failure:
If you have mild or moderate liver function impairment, your doctor will tell you to
take the lowest possible dose for the shortest duration necessary to control the
symptoms and will monitor the function of your liver.
Skin reactions:
Serious 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 ANTALGIL and contact
your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in paragraph 4.
Infections:
Antalgil can mask the symptoms of infections such as fever and pain. It is therefore possible that
Antalgil may delay adequate treatment of the infection, which could increase the
risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to varicella. If you are taking this medicine while you have an infection
and the symptoms of the infection persist or worsen, see your doctor immediately.
Other precautions:
If you suffer from or have suffered from bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or
allergic diseases, symptoms such as bronchospasm, urticaria or angioedema may worsen.
If you are an asthmatic patient, use this medicine with caution, and only after consulting
the doctor.
Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling).
During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as
nuchal rigidity, headache, nausea, vomiting, fever or disorientation, have been observed in patients
with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
If you suffer from blood coagulation disorders or are taking anticoagulant drugs
you should undergo careful medical monitoring, as ibuprofen may
prolong bleeding time and slow down coagulation.
Report to your doctor signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema.
If you are a high-risk patient, in case of long-term treatment with ibuprofen you should
undergo periodic monitoring of liver and kidney function and blood tests.

Children and adolescents
The use of Antalgil is not indicated in children under 12 years of age.
In dehydrated adolescents there is a risk of impaired kidney function.

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

Do not take ibuprofen together with the following substances:

• 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).
• Other NSAIDs:concomitant use may increase the risk of ulcers and gastrointestinal bleeding.
• Methotrexate:ibuprofen administered within 24 hours before or after methotrexate administration may lead to high concentrations of methotrexate and increased toxic effects. In addition, the potential risk of interactions in low-dose methotrexate treatment should be considered, especially if you suffer from impaired kidney function. In combined treatment, kidney function must be monitored.

Take ibuprofen (like other NSAIDs) with caution in combination with the following
substances:

• Phenytoin, lithium and cardiac glycosides (e.g. digoxin):concomitant administration of ibuprofen may increase the serum levels of these medicines. If you take ibuprofen with these substances, your doctor will tell you to monitor your serum levels of lithium, phenytoin and digoxin.

Medicines that reduce high blood pressure(ACE inhibitors such as captopril, beta-blockers
such as atenolol, angiotensin II receptor antagonists such as losartan). If you suffer from
reduced kidney function (e.g. you are dehydrated or elderly with reduced kidney function),
concomitant use of an ACE inhibitor and angiotensin II antagonist with a drug-
inhibition of cyclooxygenase may lead to a further worsening of kidney function, including a possible acute renal failure, generally reversible.
In this case, use caution when taking these medicines, especially if you are elderly.
Immediately after starting combination therapy with ibuprofen and diuretics/antihypertensives, always
drink enough fluids and undergo periodic monitoring of kidney values.
Concomitant administration of ibuprofen and potassium-sparing diuretics or
ACE inhibitors may cause an excessive increase in potassium in the blood (hyperkalaemia), so it
is necessary to undergo careful monitoring of potassium levels.

Corticosteroidsbecause they may increase the risk of ulceration or gastrointestinal bleeding (see section “Warnings and precautions”).

• Cholestyramine:concomitant treatment with cholestyramine and ibuprofen may interfere with the absorption of ibuprofen. Take these medicines with at least a one-hour interval.
• Zidovudine:there is evidence of an increased risk of haemarthrosis (bleeding into a joint) and haematoma (bruising) in HIV-positive haemophiliac patients who had received concomitant treatment with zidovudine and ibuprofen. If you take ibuprofen and zidovudine, undergo a haematological examination 1-2 weeks after starting this treatment.
• Sulfonylureas:NSAIDs may increase the hypoglycaemic effect of sulfonylureas, i.e. reduce blood sugar levels. If you are taking this type of medicine at the same time, undergo careful monitoring of blood glucose levels.
• Medicines that prevent blood clotting (antiplatelet agents such asclopidogrel and ticlopidine) and antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding (see section “Warnings and precautions”).

Other possible interactions:

• Cyclosporineand Tacrolimus:because there is a risk of kidney damage.
• Probenecid and sulfinpyrazone:because they may cause a delay in the elimination of ibuprofen.
• Quinolone antibiotics:if you take NSAIDs and quinolones, you may have an increased risk of developing convulsions.
• Other medicines such as mifepristone, moclobemide, ritonavir, aminoglycosides,alcohol,bisphosphonates, oxpentifylline (pentoxifylline)and baclofenmay interact with ibuprofen treatment. Consult your doctor before using ibuprofen with other medicines.

Even some other medicines may influence or be influenced by treatment with
ANTALGIL. Therefore, always consult your doctor or pharmacist before using ANTALGIL
with other medicines.

ANTALGIL with alcohol
Consumption of alcohol should be avoided as it may intensify the undesirable effects of
NSAIDs, especially if it affects the gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
You should not take ANTALGIL during the first and second trimester of pregnancy unless
in strictly necessary cases and after consulting your doctor, as an increased risk of abortion, heart malformation and abdominal wall defects has been observed.
If you are planning a pregnancy or during the first and second trimester of pregnancy, the dose
and duration of treatment should be kept as low as possible. If taken for more than
a few days starting from the 20th week of pregnancy, ANTALGIL may cause kidney problems
in the fetus that may lead to low levels of amniotic fluid surrounding the baby
(oligohydramnios) or to the narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment continues for more than a few days, your doctor may advise
further monitoring.
During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis, such as
ANTALGIL, may expose:

• your baby to:
• cardiopulmonary toxicity with premature closure of the artery that carries blood to the lungs and increased blood pressure in the lungs (pulmonary hypertension);
• renal dysfunction, which may degenerate into renal failure with reduced production of amniotic fluid;
• you and your baby to:
• possible prolongation of bleeding time, which may occur even at very low doses;
• inhibition of uterine contractions with consequent delay or prolongation of labour. ANTALGIL is contraindicated during the third trimester of pregnancy.

Breastfeeding
The use of ANTALGIL is contraindicated during breastfeeding.
Ibuprofen is excreted in breast milk, but at therapeutic doses and during short-term treatment,
the risk of influence on the newborn appears unlikely. If, however, the
treatment is long-term, you should consider interrupting breastfeeding.
Fertility
Medicines such as ANTALGIL may impair female fertility by acting
on ovulation. This condition, however, is reversible with discontinuation of treatment.

Driving and operating machinery
Due to the possible occurrence of dizziness, headache or insomnia, ANTALGIL may
impair the ability to drive vehicles and operate machinery.

ANTALGIL contains Sunset Yellow (E 110 aluminium lake) which may cause
allergic reactions.
ANTALGIL contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
‘sodium-free’.

3. How to take ANTALGIL

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years:
The recommended dose is 1-2 tablets 2-3 times a day.
Do not exceed the dose of 6 tablets per day.
Do not exceed the recommended doses; in particular, if you are an elderly patient, you should consult your doctor
and follow the minimum dosages indicated above.
Take the medicine with a full stomach.
This medicine is only for short-term use and should not exceed 3 days of treatment.
If symptoms persist or worsen, consult a doctor.
If the use of the medicine is necessary for more than 3 days in adolescents, or if the
symptoms worsen, consult a doctor.
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 (for
example, fever and pain) persist or worsen (see paragraph 2).
Method of administration
Swallow the tablets with a glass of water during or after a meal.
Ingest with plenty of fluids.

If you take more ANTALGIL than you should
If you have taken more Antalgil than you should or if your child has taken this medicine by
mistake, always contact a doctor or the nearest hospital to receive an opinion on
the risk and advice on the actions to be taken.
Symptoms
Most patients who ingest significant amounts of ibuprofen
will manifest symptoms within 4-6 hours.
The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain,
lethargy (deep sleep) and drowsiness.
Effects on the central nervous system (CNS) include headache, tinnitus (perception of
noises in the ear such as whistling or buzzing), dizziness, convulsions and loss of consciousness.
Nystagmus (involuntary oscillatory movement of the eyeballs), metabolic acidosis, hypothermia (lowering of body temperature), renal effects, gastrointestinal bleeding (see also paragraph 4 below), coma, apnea
(cessation of breathing), diarrhea, and depression of the CNS and respiratory system have also been rarely reported. If you are an
asthmatic patient, an exacerbation of asthma may occur.
Symptoms of metabolic acidosis may include nausea, stomach pain, vomiting (with
possible traces of blood), headache, ringing in the ears, confusion and
involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and
dizziness, blood in the urine, low potassium levels in the blood, feeling cold to the body and
breathing problems have been reported.
Disorientation, excitement, fainting and cardiovascular toxicity have been reported
including hypotension (lowering of blood pressure), bradycardia (slowing of the
heart rate) and tachycardia (increased heart rate). In
cases of significant overdose, acute renal failure and liver damage are possible.
Children may also develop cramps due to significant and involuntary
muscle contraction.
Treatment
There is no substance specifically capable of reversing the effects of an ibuprofen overdose.
Therefore, symptomatic and supportive treatment is indicated in case of overdose.
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 everyone will experience them.

Stop using Ibuprofene and consult your doctor immediately if you notice any of these symptoms:

• Reddish, non-raised, target-shaped or circular patches 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].
• Widespread rash, high body temperature and swollen 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).

Side effects are mostly dependent on the dose you have taken. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment.
Ibuprofen, particularly at high doses (2400 mg per day) and in long-term treatment, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Edema (fluid retention in the tissues with consequent swelling), hypertension (increased blood pressure), heart failure and chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome, have been reported in association with NSAID treatment.
Below are the side effects listed in order of frequency of occurrence:

Very common (may affect more than 1 in 10 people):

• Gastrointestinal disorders, such as heartburn, dyspepsia (difficulty in digestion), abdominal pain, nausea, vomiting, diarrhea, flatulence (meteorism), constipation.

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

• Headache, drowsiness, dizziness, fatigue, insomnia, irritability.
• Gastrointestinal ulcers sometimes with bleeding and perforation (see section “Warnings and precautions”), occult blood loss (not visible to the naked eye), which can lead to anemia, melena, hematemesis (loss of blood from the stomach, esophagus and intestine), ulcerative stomatitis, colitis, worsening of inflammatory bowel disease, complications of colon diverticula (perforation, fistula).

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

• Visual disturbances
• Rhinitis, bronchospasm
• Gastritis
• Development of edema especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal failure
• Photosensitivity
• Hypersensitivity reactions such as urticaria, pruritus, purpura and rash as well as asthma attacks (sometimes with hypotension)

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

• Increased azotemia, serum transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid.
• Weakening of vision in one eye, also known as “lazy eye” (Toxic Amblyopia).
• Lupus erythematosus syndrome (i.e. a syndrome similar to systemic lupus erythematosus which however regresses upon discontinuation of the drug).
• Depression, confusion, hallucinations.

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

• Palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema.
• Hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin.
• Aseptic meningitis (non-infectious)
• Tinnitus
• Esophagitis, pancreatitis, intestinal stenosis
• Papillary necrosis in long-term use (see section “Warnings and precautions”).
• Bullous reactions, severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), alopecia, necrotizing fasciitis, i.e. a significant and serious infection of the skin with destruction of tissues.
• Hypertension
• Severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the internal larynx, swelling with constriction of the airways, dyspnea, tachycardia, drop in blood pressure to the point of shock and life-threatening.
• Liver dysfunction, liver damage, especially with long-term use, liver failure, acute hepatitis, jaundice.

Not known(frequency cannot be estimated on the basis of available data):

• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• 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 Antalgil if you develop these symptoms and contact your doctor immediately. See also paragraph 2.

Additional side effects in children and adolescents
In dehydrated adolescents there is a risk of impaired renal function.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://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 ANTALGIL

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.
This medicine does not require any special 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 ANTALGIL contains

• The active ingredient is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other ingredients are: corn starch, pregelatinized starch, hypromellose, microcrystalline cellulose, sodium starch glycolate, precipitated silica, sodium lauryl sulfate, E 104 aluminium lake, E 110 aluminium lake, titanium dioxide, propylene glycol, carnauba wax.

Description of the appearance of ANTALGIL and contents of the pack
Antalgil is presented in the form of tablets for oral use.
The pack contains 10 tablets or 30 tablets for oral use of 200
mg.

Marketing Authorisation Holder
V.I.M. G. Ottaviani S.p.A.
Piazza Giovanni XXIII, 5
06012 Città di Castello (PG)

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni
(Frosinone).