Algofen

Package leaflet: Information for the patient

ALGOFEN 200 mg coated tablets

Ibuprofen
Please read this leaflet carefully before using 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

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

1. What ALGOFEN is and what it is used for

ALGOFEN contains the active substance ibuprofen, which belongs to a class of medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that work by reducing pain and
inflammation.
This medicine is used to treat pain of various origins, such as: headache, toothache, nerve-related pain (neuralgia), bone and joint pain (osteoarticular), muscle pain, and menstrual pain.
Consult your 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 to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or to other medicines used to relieve pain (analgesics) and fever (antipyretics), or to non-steroidal anti-inflammatory drugs (NSAIDs), particularly when allergy is associated with swelling of the nasal mucosa (nasal polyps) or asthma, and manifests as an asthmatic reaction (bronchospasm), hives (urticaria), or severe runny nose (acute rhinitis) (see section “Warnings and precautions”);
• if you have previously experienced stomach or intestinal ulcer or bleeding after taking other medicines;
• if you currently have a stomach or small intestine (duodenum) ulcer or bleeding;
• if you have had two or more such episodes in the past;
• if you have a blood cell production disorder of unknown cause;
• if you have bleeding in the brain (cerebrovascular haemorrhage) or other types of bleeding;
• if you suffer from a disease that may lead to an increased tendency to bleed; P a g . 1 | 9
• if you have severe liver or kidney problems;
• if you are severely dehydrated (this condition may result from vomiting, diarrhoea, 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 taking ALGOFEN.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight
increase in the risk of heart attack or stroke, especially when administered at high doses. Do not
exceed the recommended dose or duration of treatment.
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop taking ALGOFEN and contact your doctor or emergency medical services
if you notice any of these signs.
Severe skin reactions have been reported in association with treatment using ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). 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 treatment with your doctor or pharmacist before taking ALGOFEN if:

• you have heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including 'mini-stroke' or TIA, transient ischemic attack);
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke;
• you suffer from asthma (difficulty breathing) or other allergies;
• you have seasonal allergic rhinitis, swelling of the nasal mucosa (e.g., nasal polyps);
• you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• you have liver or kidney problems, except in cases of severe liver or kidney failure, in which case you must not take ALGOFEN (see section 2 “Do not use ALGOFEN”). If in doubt, consult your doctor;
• you have hepatic porphyria;
• you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
• you have reduced body fluid volume (e.g., before or after major surgery);
• you are undergoing or have recently undergone major surgery;
• you are taking other NSAIDs, including the specific type of NSAID known as COX-2 inhibitors. In this case, taking ALGOFEN should be avoided;
• you are taking corticosteroids (medicines used to reduce inflammation), or medicines used to prevent blood clotting (such as warfarin), aspirin, or antidepressants known as selective serotonin reuptake inhibitors (SSRIs);
• you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers) or Crohn’s disease (inflammation of the digestive tract);
• you are elderly, as you may be more susceptible to adverse effects, which can be serious or life-threatening (see “Elderly” and “Ulcers, perforations and bleeding in the stomach or intestine”); P a g . 2 | 9
• if you have stomach or intestinal problems, except in cases where 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 the medicine may cause kidney problems;
• you have an autoimmune disease, e.g., systemic lupus erythematosus or connective tissue disorders;
• 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 undergo long-term treatment. Do not exceed the recommended doses or duration of treatment.
Elderly
Elderly patients may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal.
Ulcers, perforations and bleeding in the stomach or intestine
If you have had a gastric or intestinal ulcer, especially if complicated by perforation or accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and report them immediately to your doctor, particularly if these symptoms occur at the beginning of treatment. The risk of gastrointestinal bleeding or ulceration is higher in such cases, especially in elderly patients. If gastrointestinal bleeding or ulceration occurs, treatment must be stopped.
Bleeding, ulceration, or perforation in the stomach or intestine may occur without warning signs, even in patients who have never previously experienced such problems. These events can also be fatal.
The risk of ulcers, perforations, or bleeding in the stomach or intestine generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken concurrently with ibuprofen (see “Other medicines and ALGOFEN”).
Skin reactions
Severe skin reactions have been reported in association with ALGOFEN treatment.
Stop taking ALGOFEN and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.
Infections
ALGOFEN may mask symptoms of infections such as fever and pain. Therefore, ALGOFEN may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
ALGOFEN may reduce the likelihood of becoming pregnant. Inform your doctor if you are planning a pregnancy or have fertility problems (see “Pregnancy, breastfeeding and fertility”).
Children and adolescents
This medicine must 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The adverse effects of ALGOFEN may be increased if taken together with certain medicines.
ALGOFEN may affect or be affected by other medicines. Pay particular attention and inform your doctor if you need to take ALGOFEN while already taking any of the following medicines:

• acetylsalicylic acid (e.g., aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs);
• corticosteroids, medicines used to reduce inflammation and treat allergies;
• lithium (a medicine for mood disorders);
• cardiac glycosides (heart medicines);
• medicines with anticoagulant effects (i.e., substances that thin the blood to prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high 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;
• antidepressants (selective serotonin reuptake inhibitors or SSRIs);
• sulfonylureas (medicines for diabetes);
• methotrexate (a medicine used to treat certain cancers);
• cyclosporine and tacrolimus (immunosuppressants used to modify the body’s immune response);
• antibacterial medicines of the quinolone class;
• phenytoin (a medicine for epilepsy);
• colestipol and cholestyramine (cholesterol-lowering medicines);
• sulfinpyrazone (an antithrombotic medicine);
• fluconazole and voriconazole (antifungal medicines);
• zidovudine (a medicine for the treatment of AIDS);
• baclofen (a muscle relaxant);
• bisphosphonates (medicines used to treat osteoporosis);
• pentoxifylline (medicines that dilate peripheral blood vessels);
• alcohol;
• herbal extracts of Ginkgo biloba.

Other medicines may also 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, dehydrated, or have kidney problems, it is particularly important that you inform your doctor if you are taking medicines for high blood pressure (diuretics, ACE inhibitors, angiotensin II antagonists). ALGOFEN may reduce the effectiveness of these medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take ALGOFEN during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause heart, lung (pulmonary hypertension), and kidney problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labour beyond normal duration.
You should not take ALGOFEN during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used.
From the 20th week of pregnancy, ALGOFEN may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts, but no effects on the infant are currently known. However, do not use ALGOFEN during breastfeeding unless you have first consulted your doctor.
Fertility
Ibuprofen may make it more difficult to conceive. Inform your doctor if you are planning a pregnancy or have fertility problems.
Driving and using machines
ALGOFEN may cause dizziness, fatigue, and visual disturbances that may affect your ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.
ALGOFEN contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to use ALGOFEN

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The recommended dose in adults is 1–2 film-coated tablets 2–3 times daily.
Do not exceed 6 tablets per day.
Take with food.
Contact your doctor if you notice a worsening of symptoms or no improvement during treatment.

Use in children and adolescents
The recommended dose in children over 12 years of age is 1–2 film-coated tablets 2–3 times daily. If use beyond 3 days is required, consult your doctor.
Children under 12 years of age must not take ALGOFEN.

Use in the elderly
If you are elderly, it is recommended to take the lowest recommended dose, i.e. 1 tablet twice daily. If in doubt, consult your doctor to determine the most appropriate dose for you.

If you take more ALGOFEN than you should
If you have taken more ALGOFEN than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, stomach ache, vomiting (possibly with traces of blood), headache, confusion, uncontrolled eye movements, abdominal pain, deep drowsiness with reduced response to normal stimuli (lethargy), ringing in the ears (tinnitus), uncontrolled body movements (convulsions, especially in children), and loss of consciousness. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Worsening of asthma is possible in individuals suffering from this condition. In addition, prothrombin time/INR may be prolonged (indicating reduced blood clotting ability), likely due to interference with circulating clotting factors.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, the following may occur: increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney effects, gastrointestinal bleeding, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia) may also occur.
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur.
In case of accidental ingestion or overdose of ALGOFEN, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use ALGOFEN, consult your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not all people will experience them.
Adverse effects depend on the dose and may vary from patient to patient.
Stop using ibuprofen and consult your doctor immediately if you notice any of the following symptoms:

• flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in 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, swollen lymph nodes, and increased eosinophils (a type of white blood cells) (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis).

Medicines containing ibuprofen used for long-term treatment 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 the intestine. Ulcers of the stomach or the first part of the intestine (peptic ulcer), perforation, or bleeding from the stomach and/or intestine may occur, which can be fatal, especially in elderly patients.
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 adverse effects listed below after administration of ALGOFEN, the following have been reported: black stools (melena), presence of blood in vomit (digestive tract ulcer with bleeding).

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

• nausea, flatulence, diarrhoea, constipation, vomiting,
• difficulty in digesting (dyspepsia),
• abdominal pain,
• heartburn.

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

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

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

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

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

• cerebrovascular accident (stroke, cerebral haemorrhage),
• ringing or buzzing in the ears (tinnitus),
• hearing impairment,
• worsening of inflammation of the colon (colitis),
• worsening of a chronic inflammatory disease of the digestive tract (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 surrounding the brain),
• a disease affecting the skin, joints, and kidneys (lupus erythematosus syndrome),
• depression, confusion, hallucinations, mental disturbances (psychotic reactions),
• increased blood urea nitrogen, transaminases, and alkaline phosphatase; decreased haemoglobin and haematocrit values; inhibition of platelet aggregation; prolonged bleeding time; decreased serum calcium; increased serum uric acid—all observed in blood tests,
• decreased visual acuity.

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

• worsening of infections-related inflammation (e.g., development of necrotizing fasciitis),
• reduced number of platelets in the blood (thrombocytopenia),
• anaemia,
• reduced number of white blood cells in the blood (leucopenia, agranulocytosis),
• reduced number of all blood cells (pancytopenia), P a g . 7 | 9
• presence of blood in the urine (haematuria),
• severe allergic reaction (anaphylactic reaction),
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema),
• abnormalities in liver function tests,
• acute hepatitis,
• liver damage, particularly with long-term therapy, and liver failure,
• skin and mucous membrane reactions, including severe ones (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis),
• rapid or irregular heartbeat (palpitations),
• inflammation of the oesophagus, intestinal narrowing,
• severe skin infections with complications in soft tissues, which may occur if you have chickenpox,
• fluid accumulation in the lungs; symptoms include shortness of breath, which can be very severe and usually worsens when lying down (pulmonary oedema),
• swelling (oedema),
• heart attack,
• high blood pressure (hypertension),
• heart failure,
• inflammation of the pancreas,
• unusual hair loss (alopecia),
• menstrual disorders.

Adverse effects with unknown frequency (the frequency cannot be determined from the available data)

• a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using ALGOFEN if you develop these symptoms and contact your doctor immediately. See also section 2;
• muscle stiffness (musculoskeletal rigidity);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

P a g . 8 | 9
What ALGOFEN contains

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

Description of the appearance of ALGOFEN and the contents of the pack
ALGOFEN 200 mg coated tablets are available in PVC/PVDC and aluminium blisters containing 12 or 24 coated tablets.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
P a g . 9 | 9