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BRUFEN TABLETS 400 MG - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - BRUFEN TABLETS 400 MG

4. possible side effects of brufen tablets

As with all medicines, Brufen Tablets may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.

STOP TAKING Brufen Tablets and seek immediate medical help if you experience:

  • Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or intolerance to bright light.
  • Signs of intestinal bleeding such as
  • Passing blood in your faeces (stools/motions)
  • Passing black tarry stools
  • Vomiting any blood or dark particles that look like coffee grounds

TELL YOUR DOCTOR AND STOP TAKING BRUFEN TABLETS IF YOU EXPERIENCE:

  • Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
  • Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms of an allergic reaction).
  • Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
  • Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’ and ‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness)
  • A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Medicines such as Brufen Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.

Medicines such as Brufen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles

Blood disorders such as reduction in blood cells and platelet counts – the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen. Brufen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

Other side effects

Common (affects up to 1 in 10 people):

  • feeling dizzy or tired
  • diarrhoea, wind, constipation
  • headache – if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

Uncommon (affects up to 1 in a 100 people):

  • feeling drowsy
  • feeling anxious
  • feeling a tingling sensation or ‘pins and needles’
  • difficulty sleeping
  • hives
  • skin becomes sensitive to light
  • hearing problems
  • sneezing, blocked, itchy or runny nose (rhinitis)
  • stomach or gut ulcer, hole in the wall of the digestive tract
  • inflammation of your stomach lining
  • ringing in ears (tinnitus)
  • sensation of spinning (vertigo)
  • mouth ulcers

Rare (affects up to 1 in a 1000 people):

  • feeling depressed or confused

Very rare (affects up to 1 in 10,000 people):

  • inflammation of the pancreas

Not known (cannot be estimated from the available data):

  • A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Brufen Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the National reporting systems listed below:

UK:

The Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

MALTA:

ADR Reporting

Website:

By reporting side effects, you can help provide more information on the safety of this medicine.

  • 5. How should you store Brufen Tablets?

Your tablets should not be stored above 25° C. They should be kept in a safe place out of the reach and sight of children as your medicine could harm them.

They should be kept in their original packaging. Do NOT take Brufen Tablets after the ‘use by’ date shown on the carton. If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist.

Only keep the tablets if your doctor tells you to.

  • 6. Further information about Brufen Tablets

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Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Brufen Tablets 400 mg used for?

Brufen Tablets 400 mg is commonly used to relieve pain and reduce inflammation. It's often prescribed for conditions like arthritis, headache, toothache, and menstrual cramps.

How does Brufen work in the body?

Brufen contains ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking substances in the body that cause inflammation and pain.

Can I take Brufen Tablets 400 mg with other medications?

It's important to consult with your healthcare provider before taking Brufen with other medications, especially blood thinners or other NSAIDs, to avoid adverse interactions.

What are common side effects of Brufen Tablets 400 mg?

Common side effects may include stomach upset, nausea, headache, dizziness, and rash. If you experience severe side effects like stomach bleeding or allergic reactions, seek medical help immediately.

Should I take Brufen on an empty stomach?

For best results and to minimize stomach upset, it’s recommended to take Brufen after meals. However, follow your healthcare provider's guidance on how to take it.

Is Brufen safe for long-term use?

Long-term use of Brufen should be monitored by a healthcare provider due to potential risks such as gastrointestinal bleeding or kidney issues. Regular check-ups are advisable.

Can I drive after taking Brufen Tablets 400 mg?

Brufen may cause dizziness or drowsiness in some individuals. If you experience these effects, avoid driving or operating heavy machinery until you feel alert.

What should I do if I miss a dose of Brufen?

If you miss a dose of Brufen, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double up doses.

Can children take Brufen Tablets 400 mg?

Brufen Tablets are generally not recommended for children under certain ages. Consult your child's healthcare provider for proper dosage and age guidelines.

Is there a maximum daily limit for Brufen Tablets?

The maximum recommended daily limit for adults is usually 1200 mg (3 tablets) unless directed otherwise by a healthcare provider. Always adhere to medical advice.

What should I do if I overdose on Brufen Tablets?

If you suspect an overdose of Brufen, seek emergency medical attention immediately. Symptoms may include severe headache, dizziness, gastrointestinal bleeding, or difficulty breathing.

How quickly does Brufen start working?

Brufen typically starts to relieve pain within 30 minutes to an hour after ingestion. However, this can vary based on individual factors and the severity of the condition treated.

Can pregnant women take Brufen Tablets 400 mg?

Pregnant women should avoid taking Brufen especially during the third trimester unless prescribed by a doctor as it can affect fetal development and labor.

Is it safe to consume alcohol while taking Brufen?

It's best to limit alcohol intake while taking Brufen since both can irritate the stomach lining and increase the risk of gastrointestinal problems.

How should I store Brufen Tablets 400 mg?

Store Brufen tablets at room temperature away from moisture and heat. Keep them out of reach of children and never use them past their expiration date.

What if I have a history of heart disease; can I take Brufen?

If you have a history of heart disease or related conditions, consult your healthcare provider before taking Brufen as it may increase cardiovascular risks in some individuals.

Does Brufen interact with any food items?

There are no major food interactions with Brufen; however, it’s advisable to avoid high-fat meals which may affect absorption. Always check with your doctor if unsure.

Can older adults safely use Brufen Tablets 400 mg?

Older adults may be at higher risk for side effects from NSAIDs like Brufen. It's essential they discuss their health status with their physician before use.

Can I use topical pain relief alongside oral Brufen tablets?

Using topical pain relief products alongside oral doses can be done but consult with your healthcare professional for personalized advice to ensure safety and effectiveness.