ALGOFEN 200 mg Coated Tablets

Зміст інструкції

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

ALGOFEN 200 mg coated tablets

Ibuprofen

Read this leaflet carefully before using this medicine as 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 ALGOFEN is and what it is used for
• 2. What you need to know before using ALGOFEN
• 3. How to use ALGOFEN
• 4. Possible side effects
• 5. How to store ALGOFEN
• 6. Contents of the pack and other information

1. What is ALGOFEN and what is it used for

ALGOFEN contains the active ingredient ibuprofen, which belongs to the class of medicines called
Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs) that work by reducing pain and
inflammation.
This medicine is used to treat pain of various origins such as: headache, toothache, nerve pain
(neuralgia), bone and joint pain (osteoarticular), muscle pain and
menstrual pain.
See a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using ALGOFEN

Do not use ALGOFEN

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics) and fever (antipyretics) or to non-steroidal anti-inflammatory drugs (NSAIDs), especially when the allergy is associated with swelling of the nasal mucosa (nasal polyps) or asthma, and presents with an asthmatic reaction (bronchospasm), urticaria or severe cold (acute rhinitis) (see section “Warnings and precautions”);
• if you have suffered from an ulcer or bleeding of the stomach or intestines after taking other medicines;
• if you suffer from an ulcer or bleeding of the stomach or the small intestine (duodenum);
• if you have suffered from two or more episodes of this type in the past;
• if you have an alteration in the production of blood cells, the cause of which is unknown;
• if you have bleeding in the brain (cerebrovascular hemorrhage) or other types of bleeding;
• if you suffer from a disease that may lead to an increased tendency to bleeding; P a g . 1 | 9
• if you have severe liver or kidney problems;
• if you are severely dehydrated (this condition may be due to vomiting, diarrhea or insufficient fluid intake);
• if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you suffer from severe heart problems (severe heart failure);
• in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using ALGOFEN.
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a modest
increased risk of heart attack or stroke, especially if administered in 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
ALGOFEN immediately and contact your doctor or emergency medical service immediately
if you notice any of these signs.
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 ALGOFEN and contact your doctor immediately if you notice any
of the symptoms related to these severe skin reactions described in section 4.
You should discuss the therapy with your doctor or pharmacist before taking ALGOFEN 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 in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including ‘mini-stroke’ or transient ischemic attack);
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• you suffer from asthma (difficulty breathing) or other allergies;
• you have seasonal allergies (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
• you have chronic obstructive pulmonary diseases or chronic respiratory tract infections;
• you have liver or kidney problems, unless you have a severe form of liver or kidney failure because in these latter cases you should not take ALGOFEN (see section 2 “Do not use ALGOFEN”). If you have doubts, consult your doctor;
• you have hepatic porphyria;
• you are using medicines that increase urine production (diuretics) or other medicines that can affect kidney function;
• you have a reduced volume of body fluids (for example before or after major surgery);
• you are undergoing or have undergone major surgery;
• you are taking other NSAIDs, including the specific type of NSAIDs called COX-2 inhibitors. In this case, taking ALGOFEN should be avoided;
• you are taking other medicines used against inflammation belonging to the corticosteroid family, or medicines used to prevent blood clotting (such as warfarin), or aspirin or medicines against depression called selective serotonin reuptake inhibitors or SSRIs;
• you suffer from chronic inflammatory diseases of the intestine such as ulcerative colitis (inflammation of the colon with ulcers), inflammatory bowel disease (Crohn's disease);
• you are elderly, as you may be more prone to side effects, which may also be serious or life-threatening (see “Elderly” and “Ulcers, perforations and bleeding in the stomach or intestines”); P a g . 2 | 9
• if you have problems with your stomach or intestines, unless you have one or more conditions for which you should not take ALGOFEN (see section “Do not use ALGOFEN”);
• you are in the first six months of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• the patient is an adolescent with dehydration, as in this case the medicine may cause kidney problems;
• you have an autoimmune disease e.g. Lupus erythematosus or connective tissue diseases;
• you have an infection (see section “Infections” below).

Effects on the heart and brain
Medicines containing ibuprofen, such as ALGOFEN, are associated with a slightly higher
risk of heart attack (myocardial infarction) or stroke. The risk is higher if you take high doses of ibuprofen
and long-term treatments. Do not exceed the recommended doses or duration of treatment.
Elderly
Elderly people may be more prone to side effects, in particular
bleeding and perforation of the digestive tract, which may be fatal.
Ulcers, perforations and bleeding in the stomach or intestines
If you have had a gastric or intestinal ulcer, especially if it has been complicated by perforation or
accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and
report them immediately to your doctor, especially if these symptoms occur at the beginning of
treatment. In fact, the risk of bleeding or ulceration of the digestive tract is higher in this
case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs,
treatment should be discontinued.
Bleeding, ulceration or perforation in the stomach or intestines can occur without
any warning signs, even in patients who have never had these problems before.
They can also be fatal.
The risk of ulcers, perforations or bleeding in the stomach or intestines generally increases
with higher doses of ibuprofen. The risk also increases if they are taken at the same time
with ibuprofen some other medicines (see “Other medicines and ALGOFEN”).

Skin reactions
Severe skin reactions have been reported in association with treatment with ALGOFEN.
Stop taking ALGOFEN and consult your doctor immediately if you develop rash,
mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs
of a very serious skin reaction. See section 4.

Infections
ALGOFEN can mask the symptoms of infections such as fever and pain. Therefore, it is possible that
ALGOFEN may delay adequate treatment of the infection, which may increase the
risk of complications. This has been observed in pneumonia caused by bacteria and 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.
ALGOFEN may decrease the chances of getting pregnant. Tell your doctor if you are planning a
pregnancy or have fertility problems (see “Pregnancy, breastfeeding and fertility”).

Children and adolescents
This medicine should not be used in children under 12 years of age (see section 2 “Do not use
ALGOFEN”).
In dehydrated adolescents, there is a risk of impaired kidney function.

Other medicines and ALGOFEN
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
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The side effects of ALGOFEN may be increased if it is taken at the same time as
certain medicines.
ALGOFEN can affect or be affected by other medicines. Pay particular attention and
tell your doctor if you need to take ALGOFEN and are already taking any of the medicines listed
below:

• acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs);
• corticosteroids, medicines used to reduce inflammation and treat allergies;
• lithium (medicine for mood disorders);
• cardiac glycosides (heart medicines);
• 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);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• diuretics, including potassium-sparing diuretics, especially if you have kidney problems;
• medicines against depression (selective serotonin reuptake inhibitors or SSRIs);
• sulfonylureas (medicines for diabetes);
• methotrexate (medicine used to treat some cancers);
• cyclosporine and tacrolimus (immunosuppressants used to modify the body's immune system response);
• medicines to fight bacterial infections of the quinolone class;
• phenytoin (medicine for epilepsy);
• cholestyramine and colestipol (medicines to lower cholesterol);
• sulfinpyrazone (antithrombotic drug);
• fluconazole and voriconazole (anti-fungal drugs);
• zidovudine (medicine for the treatment of AIDS);
• baclofen (muscle relaxant);
• bisphosphonates (medicines used to treat osteoporosis);
• pentoxifylline (medicines that dilate peripheral blood vessels);
• alcohol;
• Ginkgo Biloba plant extracts.

Also, some other medicines may affect or be affected by treatment with ALGOFEN.
Therefore, always consult your doctor or pharmacist before using ALGOFEN with other medicines.
If you are elderly or dehydrated or have kidney problems, it is particularly important that you inform your doctor
if you are taking medicines against high blood pressure (diuretic medicines, ACE inhibitors,
angiotensin II antagonists). ALGOFEN may reduce the effect of these drugs.

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 using this medicine.
Do not take ALGOFEN in the last 3 months of pregnancy as it may harm the fetus or cause
problems during childbirth. It may cause problems with the heart, lungs (pulmonary hypertension) and kidneys
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 ALGOFEN in the first 6 months of pregnancy unless absolutely necessary and
under the advice of your 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, ALGOFEN 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 the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If
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treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts, but no adverse effects on the
baby are known to date. However, do not use ALGOFEN during breastfeeding unless you have consulted your doctor.
Fertility
Ibuprofen may make it more difficult to get pregnant. Tell your doctor if you are planning a
pregnancy or have fertility problems.

Driving and using machines
ALGOFEN can cause dizziness, fatigue and visual disturbances that can affect your ability
to drive vehicles and use machines.
If you experience these symptoms, avoid driving a vehicle or using machines.

ALGOFEN contains sucrose.If you have been diagnosed with intolerance to some sugars
contact your doctor before taking this medicine.

3. How to use ALGOFEN

Use this medicine following exactly as stated in this leaflet or as instructed by 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 symptoms (such as fever and pain)
persist or worsen (see section 2).
The recommended dose in adults is 1 – 2 coated tablets 2 – 3 times a day.
Do not exceed the dose of 6 tablets per day.
Take with a full stomach.
Consult your doctor if you notice a worsening of symptoms or no improvement following
treatment.

Use in children and adolescents
The recommended dose in children over 12 years of age is 1 – 2 coated tablets 2 – 3 times a
day. If use of the medicine becomes necessary for more than 3 days, consult your
doctor.
Children under 12 years of age should not take ALGOFEN.

Use in the elderly
If you are elderly, it is recommended to take the lowest recommended dose, i.e. 1 tablet 2 times a
day. If in doubt, ask your doctor for advice on the most suitable dose for you.

If you use more ALGOFEN than you should
If you have taken more ALGOFEN than you should, or if your child has accidentally taken this medicine,
always contact a doctor or the nearest hospital to obtain advice on the risk and recommendations
regarding actions to be taken.
If you take an excessive dose (overdose) of ibuprofen, you may more commonly experience the
following symptoms: nausea, stomach pain, vomiting (possibly with traces of blood), headache,
confusion and uncontrolled eye movements, abdominal pain, deep sleep with
reduced response to normal stimuli (lethargy), ringing in the ears (tinnitus), uncontrolled movements of the
body (convulsions, especially in children) and loss of consciousness. 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 of
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coldness in the body and breathing problems have been reported. Worsening of asthma is possible in subjects who suffer
from this disease. In addition, the prothrombin time/INR may be prolonged (a sign of reduced
blood clotting ability), probably due to interference with the actions of circulating coagulation factors.
Symptoms of an overdose may appear within 4 – 6 hours of taking ibuprofen.
Rarely, it may present: increased acids in the blood (metabolic acidosis), lowering of the
body temperature (hypothermia), effects on the kidney, bleeding from the stomach and
intestines, profound loss of consciousness (coma), temporary cessation of breathing (apnea),
diarrhea, reduced activity of the nervous system (depression of the Central Nervous System) and
respiratory activity (depression of the respiratory system).
In addition, it may also manifest: disorientation, state of excitement, fainting, lowering of the
blood pressure (hypotension), decrease or increase in heartbeats (bradycardia or
tachycardia).
If you take significantly high doses of ibuprofen, you may experience serious damage to the kidneys and
liver.
In case of accidental ingestion/intake of an excessive dose of ALGOFEN, immediately notify your
doctor or go to the nearest hospital.
If you have any doubts about the use of ALGOFEN, consult your doctor or pharmacist.

If you forget to use ALGOFEN
Do not take a double dose to make up for forgetting the tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects depend on the dose and can vary from patient to patient.
Stop using ibuprofene and consult your doctor immediately if you notice any of the following
symptoms:

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and swollen lymph nodes and increased eosinophils (a type of white blood cells) (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).

Medicines containing ibuprofen for long-term treatments may be associated with a
slightly increased risk of heart attack (myocardial infarction) or stroke.
Fluid retention (edema), high blood pressure and
heart problems (heart failure) have been reported in association with NSAIDs.
The most commonly observed adverse events affect the stomach and/or intestine. Stomach or duodenal ulcers (peptic ulcer), perforation or
bleeding from the stomach and/or intestine may occur, which can also be fatal, particularly in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine depends on the dose and
duration of treatment.
P a g . 6 | 9
In addition to the side effects listed below after administration of ALGOFEN, the following have been
reported: black stools (melena), blood in vomit (ulcer of the digestive tract with
bleeding).

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

• nausea, flatulence, diarrhea, constipation, vomiting,
• difficulty digesting food (dyspepsia),
• abdominal pain,
• heartburn.

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

• skin rash,
• headache, drowsiness, dizziness, vertigo, fatigue, agitation, insomnia, irritability,
• gastric and duodenal ulcers, sometimes with bleeding and perforation, occult blood loss which can lead to anemia, tarry stools, vomiting blood, mouth ulcers, inflammation of the colon, worsening of inflammatory bowel disease, inflammation of the intestinal wall,
• visual disturbances.

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

• allergic reactions including skin rash, hives, itching and asthma attacks,
• skin irritation associated with bleeding (purpura),
• skin sensitivity to light,
• altered sensation in some parts of the body (paresthesia),
• difficulty breathing (bronchospasm),
• sneezing, runny or stuffy nose (rhinitis),
• inflammation of the stomach (gastritis),
• liver problems, inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice),
• formation of edema, especially in patients with high blood pressure or kidney problems (renal failure, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure.

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

• stroke (stroke, cerebral hemorrhages),
• ringing and buzzing in the ears (tinnitus),
• hearing impairment,
• worsening of inflammation of the colon (colitis),
• worsening of a chronic inflammatory bowel disease (Crohn's disease),
• kidney failure,
• damage to kidney tissue (papillary necrosis) (particularly with long-term therapy),
• increased concentration of uric acid in the blood,
• aseptic meningitis (infection of the meninges, membranes of the brain),
• a disease affecting the skin, joints and kidneys (lupus erythematosus syndrome),
• depression, confusion, hallucinations, mental alterations (psychotic reactions),
• increased blood urea, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased uric acid in the serum, all observed with a blood test,
• decreased visual acuity.

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

• worsening of inflammation associated with infection (e.g. development of necrotizing fasciitis),
• reduction in the number of platelets in the blood (thrombocytopenia),
• anemia,
• reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis),
• reduction in the number of all cells present in the blood (pancytopenia), P a g . 7 | 9
• blood in the urine (hematuria),
• severe allergic reaction (anaphylactic reaction),
• swelling of the face, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing (angioedema),
• alterations of tests to evaluate liver function,
• acute hepatitis,
• liver damage, especially with long-term therapy and liver failure,
• skin and mucous membrane reactions, also severe (erythema multiforme, exfoliative dermatitis, blistering reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis),
• rapid or irregular heartbeat (palpitations),
• inflammation of the esophagus, narrowing of the intestine,
• severe infections of the skin, with complications of soft tissues, can occur if you have chickenpox,
• accumulation of fluid in the lungs, symptoms include shortness of breath, which can be very severe and usually worsens when lying down (pulmonary edema),
• swelling (edema),
• heart attack,
• high blood pressure (hypertension),
• heart failure,
• inflammation of the pancreas,
• unusual hair loss (alopecia),
• menstrual irregularities.

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• 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 ALGOFEN if you develop these symptoms and contact your doctor immediately. See also paragraph 2;
• muscle stiffness (musculoskeletal rigidity);
• 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 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 ALGOFEN

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 that is reported on the pack after “Expiry”. The
expiry date refers to the last day of that month.
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

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What ALGOFEN contains

• The active ingredient is ibuprofen. One coated tablet contains 200 mg of ibuprofen.
• The other ingredients are: corn starch, stearic acid, sodium croscarmellose, anhydrous colloidal silica, povidone, sodium carboxymethylcellulose, shellac, gum arabic, titanium dioxide, calcium sulfate, sucrose, carnauba wax.

Description of the appearance of ALGOFEN and contents of the pack
ALGOFEN 200 mg coated tablets are available in PVC/PVDC and aluminum blisters of 12 or 24
coated tablets.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
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