BRUFENLIK 400 MG ORAL SUSPENSION IN SACHET 20 PET/AL/PET/PE SACHETS OF 10 ML

Name
Brufenlik 200 mg oral suspension in sachet
Ibuprofen


What is it and what is it for?
The active ingredient in this medicine is ibuprofen. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Brufenlik reduces fever and relieves pain.

Brufenlik is used for the short-term treatment of mild to moderate pain such as
- Headache and migraine
- Toothache
- Dysmenorrhea (painful cycle)
- Muscle, joint and back pain
- Fever associated with the common cold.

Brufenlik 200 mg is used in adults and children over 6 years of age (weighing more than 20 kg).


What you need to know before taking the medicine
Do not take Brufenlik
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction (such as asthma, skin rash, swollen face or lips or shortness of breath) after taking ibuprofen, acetylsalicylic acid or other NSAIDs;
• has severe heart failure;
• has severe liver or kidney failure;
• has active bleeding or an increased tendency to bleed;
• have (or have had two or more episodes of) stomach ulcer, duodenal ulcer or bleeding;
• have or have ever had an ulcer or bleeding in your stomach or small intestine while taking NSAIDs;
• if you are in the last 3 months of pregnancy.


Warnings and precautions
Always administer the lowest effective dose for the shortest possible duration of treatment to reduce the risk of side effects. Doses higher than recommended may pose risks. This also means that taking multiple NSAIDs at the same time should be avoided.

Talk to your doctor or pharmacist before taking Brufenlik:
- if you have certain immune system disorders (mixed connective tissue disorders and systemic lupus erythematosus (SLE), immune system conditions affecting the connective tissue resulting in joint pain, skin changes and disorders of other organs) as there may be an increased risk of aseptic meningitis;
- if you suffer from kidney or liver failure;
- if you have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including a "mini-stroke" or "TIA" - transient ischaemic 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 asthma, chronic rhinitis (chronic runny and blocked nose) or allergic diseases as Brufenlik may cause breathing difficulties, hives or a severe allergic reaction in the presence of any of these conditions;
- if you have inflammatory bowel disease, a previous stomach ulcer or an increased tendency to bleed of another nature;
- if you have an infection – see section “Infections” below.

Ibuprofen can cause serious allergic reactions, especially if you are allergic to acetylsalicylic acid. Symptoms may include hives, swelling of the face, tongue, or throat, difficulty swallowing, and difficulty breathing. Stop taking Brufenlik and contact a doctor immediately if you experience any of these symptoms (see section 4, Possible side effects).

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 treatment with Brufenlik.
Stop using Brufenlik and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Ulcers and bleeding in the gastrointestinal tract
• Patients who have previously had gastrointestinal problems, especially elderly patients, should contact a doctor if they experience abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment. Bleeding, ulceration, or perforation of the stomach or intestines may occur without warning, even in patients who have never had such problems before.
• Elderly patients should be aware of their increased risk of adverse events, particularly bleeding and perforation of the digestive tract, which may be fatal.
• Stop treatment and consult a doctor if gastrointestinal bleeding or ulceration occurs during treatment with Brufenlik.

Cardiovascular effects
• Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.

Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Brufenlik immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Infections
• Brufenlik may hide the symptoms of infections such as fever and pain. It is therefore possible that Brufenlik 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, contact your doctor immediately.

• During chickenpox it is advisable to avoid the use of this medicine.

If he is dehydrated
• Particular caution should be exercised in dehydrated patients, as there is a risk of renal failure, particularly in children, dehydrated adolescents and the elderly.

Headache
• Prolonged use of any type of painkiller for headaches can worsen the condition. If this occurs or is suspected, consult a doctor and discontinue treatment.

Children and adolescents
In dehydrated children and adolescents there is a risk of impaired renal function.
Brufenlik 200 mg should not be taken by children under 6 years of age (weighing less than 20 kg).
For younger children, other pharmaceutical forms and more appropriate dosages are available.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact a doctor or go to the nearest emergency department immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

Rare (may affect up to 1 in 1,000 people):
• if you experience any of the following symptoms (signs of anaphylaxis, angioedema or severe shock)
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and breathing difficulties.
• if you experience a reduction in the number of white blood cells (agranulocytosis) with reduced resistance to infections. You should contact your doctor immediately if you experience an infection with symptoms such as:
- fever and severe deterioration of general condition or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems.
• Symptoms of aseptic meningitis may include - headache, neck stiffness, nausea, sensitivity to light, sound and fever.

Very rare (may affect up to 1 in 10,000 people):
• Flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Not known (frequency cannot be estimated from the available data):
• Exceptionally, serious skin infections in chickenpox. When using an NSAID, inflammation of the skin related to infections may develop or worsen (for example, a condition such as necrotizing fasciitis may develop, characterized by:
- severe pain, high fever, swollen and hot skin, blisters, necrosis). If signs of skin infection occur or worsen while using Brufenlik, it is advisable to consult your doctor immediately.
• A red, scaly rash with pustules and blisters, mainly located on the skin folds, trunk, and upper extremities, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Brufenlik if you experience these symptoms and consult a doctor immediately. See also section 2.
• Additionally, a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include:
- rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell). Symptoms of DRESS syndrome usually appear about 2-6 weeks (with the possibility of up to 8 weeks) after starting treatment.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Other side effects that may occur include:

Common (may affect up to 1 in 10 people):
- Headache, dizziness
- Gastrointestinal side effects (indigestion, diarrhea, nausea (feeling sick), vomiting (being sick), stomach pain, flatulence (gas), constipation, black stools, gastrointestinal bleeding, vomiting blood)
- Skin rash
- Tiredness

Uncommon (may affect up to 1 in 100 people):
- Rhinitis (itching, runny or stuffy nose, sneezing)
- Hypersensitivity
- Insomnia (difficulty sleeping), anxiety
- Torpor
- Vision disorders
- Hearing loss
- Tinnitus (ringing in the ears)
- Dizziness
- Cough, difficulty breathing and chest pain (bronchial spasm), asthma, shortness of breath (dyspnea)
- Mouth ulceration
- Stomach ulcer, intestinal ulcer, perforated gastric ulcer, inflammation of the stomach mucosa
- Hepatitis (inflammation of the liver), jaundice, abnormal liver function
- Rash, itching, small bruises on the skin and mucous membranes
- Photosensitivity (sensitivity of the skin to the sun)
- Impaired kidney function
- Paresthesia

Rare (may affect up to 1 in 1,000 people):
- Depression, confusion
- Changes in vision
- Loss of vision, eye pain that is worsened by eye movement, loss of color vision caused by inflammation or damage to the optic nerve (optic neuritis, toxic optic neuropathy)
- Water retention
- Blood count changes
- Anemia (reduction in red blood cells or hemoglobin)

Very rare (may affect up to 1 in 10,000 people):
- Inflammation of the pancreas, liver failure
- Heart failure, heart attack
- Hypertension

Not known (frequency cannot be estimated from the available data):
- Worsening of ulcers in the large intestine (colitis) and Crohn's disease (bowel disease)

Please note that Brufenlik may prolong bleeding time.

Medicines like Brufenlik may carry a slightly increased risk of heart attack or stroke.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.