BUSCOFENACT*12CAPS 400MG

BuscofenAct 400 mg soft capsules
Ibuprofen

What it is and what it is used for
BuscofenAct contains the active ingredient ibuprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve discomfort by modifying the body's response to pain and fever.

BuscofenAct is indicated for the short-term symptomatic treatment of:
- mild to moderate pain such as headache, toothache, and menstrual pain;
- fever and pain associated with the common cold.

BuscofenAct is indicated for adults and adolescents weighing over 40 kg (12 years and over).

Consult your doctor if you do not feel better or if you feel worse:
- after 3 days in adolescents;
- after 3 days in case of fever, or after 4 days for pain treatment in adults.

What you need to know before taking the medicine
Do not take BuscofenAct
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have ever suffered from shortness of breath, asthma, runny nose, swelling or hives after using acetylsalicylic acid or other NSAIDs;
- if you have or have had a history of recurrent stomach/duodenal ulcer (peptic ulcer) or bleeding (two or more distinct episodes of proven ulceration or bleeding);
- if you have had a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
- if you suffer from severe heart failure;
- if you suffer from severe liver failure or severe kidney failure;
- if you suffer from cerebrovascular haemorrhages or other haemorrhages;
- if you suffer from haematological disorders of unknown origin;
- if you are severely dehydrated (due to vomiting, diarrhoea, or low fluid intake);
- if you are in the last trimester of pregnancy.
Do not use BuscofenAct in adolescents weighing < 40 kg and in children under 12 years of age due to the high content of active ingredient.

Warnings and precautions
You should discuss therapy with your doctor or pharmacist before taking BuscofenAct:
- if you suffer or have suffered from asthma or allergic diseases, as shortness of breath may occur;
- if you have liver problems;
- if you have reduced kidney function;
- if you have or have ever had intestinal diseases (ulcerative colitis or Crohn's disease);
- if you have heart problems including heart attack, angina (chest pain) or if you have had a 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);
- if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
- if you suffer from certain skin conditions (Systemic Lupus Erythematosus (SLE) or a mixed connective tissue disease);
- if you have any hereditary diseases related to the production of blood cells (acute intermittent porphyria);
- if you have had high blood pressure and/or heart failure;
- if you have undergone major surgery. In this case, medical supervision is particularly required;
- if you suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases, as in such cases there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria;
- if you have a chickenpox infection, it is advisable to avoid the use of BuscofenAct;
- if you suffer from clotting disorders;
- in cases of prolonged administration of BuscofenAct, periodic monitoring of liver function, kidney function and blood count is necessary;
- the concomitant use of NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see paragraph Taking BuscofenAct with other medicines) and should be avoided;
- if you have an infection - see paragraph Infections below.

Skin reactions
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 BuscofenAct and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections
BuscofenAct can mask the symptoms of infections such as fever and pain. It is therefore possible that BuscofenAct 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 bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

These undesirable effects can be minimised by using the lowest effective dose for the shortest treatment period. Elderly people are at higher risk of side effects. In general, habitual use of analgesics can lead to serious permanent kidney problems. This risk can be increased under physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.

Prolonged use of any type of painkiller for headache can lead to its worsening. If this situation occurs or is suspected, the doctor should be notified and treatment interrupted.

The diagnosis of medication overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) the regular use of headache medications.

Anti-inflammatory/painkiller medicines 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.

If you think any of the above conditions apply to you, consult your doctor before using BuscofenAct.

Children and adolescents
In dehydrated adolescents, there is a risk of kidney function impairment.
Do not use BuscofenAct in adolescents weighing < 40 kg and in children under 12 years of age due to the high content of active ingredient.

Possible side effects
April 2024