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 it is and what it is used for
The active substance 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 period)
- Muscle, joint and back pain
- Fever associated with common cold.

Brufenlik 200 mg is used in adults and children over 6 years (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 give the lowest effective dose for the shortest possible duration of treatment to reduce the risk of side effects. Doses higher than recommended may carry risks. This also means that taking more than one NSAID 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 '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 one of these conditions;
- if you have inflammatory bowel disease, a previous stomach ulcer or an increased tendency to bleed of any kind;
- 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, 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 Brufenlik treatment.
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 problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment. Bleeding, ulceration or perforation in the stomach or intestines may occur without warning signs 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 this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Brufenlik immediately and contact your doctor or emergency 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 bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, 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 pain reliever for headaches can make the situation worse. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued.

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 1000 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 difficulty breathing.
• 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):
• Non-raised, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, 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, characterised 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 located mainly 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.
• In addition, a serious 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 cell). Symptoms of DRESS syndrome usually appear about 2-6 weeks (possibly 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 (intestinal 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 disturbances
- Hearing loss
- Tinnitus (ringing in the ears)
- Dizziness
- Cough, difficulty breathing and chest pain (bronchial spasm), asthma, shortness of breath (dyspnoea)
- 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 renal 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 (intestinal 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.