What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL12063/0071 .


Boots Migraine Pain Relief 342mg Tablets

Patient Information Leaflet

Boots Migraine Pain Relief 342 mg Tablets

Ibuprofen Lysine

Read this leaflet carefully because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor or pharmacist if your symptoms worsen or do not improve.

In this leaflet:

1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information

1. WHAT THIS MEDICINE IS FOR

This medicine contains ibuprofen lysine which is the lysine salt of ibuprofen. Ibuprofen is one of a group of non-steroidal anti-inflammatory drugs (known as NSAIDs) which work to reduce pain, fever and swelling.

This medicine is used to relieve:

  • headache, migraine
  • rheumatic and muscular pain, backache
  • neuralgia (nerve pain)
  • dental pain, period pain
  • fever (high temperature)
  • the symptoms of colds and flu.

2. BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if you:

  • have (or have had 2 or more episodes of) a stomach ulcer, perforation or bleeding of the stomach
  • are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
  • have severe kidney, heart or liver failure
  • are taking aspirin with a daily dose above 75 mg
  • are in the last 3 months of pregnancy.

Skin reactions

Serious skin reactions have been reported in association with Boots Migraine Pain Relief 342mg Tablets treatment. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Talk to your doctor or pharmacist before taking ibuprofen tablets if you:

  • are elderly because you may be at more risk of having serious side effects, particularly stomach problems
  • have or have suffered from asthma, diabetes, high cholesterol or have allergies
  • have liver or kidney problems
  • have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis
  • have Systemic Lupus Erythematosus (SLE) – an illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body
  • have, have previously had, or are at risk of heart problems, high blood pressure or stroke.

If you are taking other medicines

You must not take these tablets if you are taking certain other medicines - see section 2 ‘Do not take this medicine if you’.

Migraine Pain Relief Tablets may affect or be affected by some other medicines. For example:

  • medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
  • medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).

Some other medicines may also affect or be affected by the treatment of Migraine Pain Relief Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Migraine Pain Relief Tablets with other medicines, especially:

  • two or more NSAID painkillers, including cyclooxygenase-2 selective inhibitors
  • antidepressants called selective-serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine
  • corticosteroids (for skin problems and allergies e.g. cortisol)
  • methotrexate (a medicine for cancer)
  • cardiac glycosides (medicines used to treat heart failure e.g. digoxin)
  • ciclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)
  • mifepristone (a medicine used to terminate pregnancy – NSAIDs should not be used for 12 days after mifepristone)
  • lithium (for depression or mental problems)
  • zidovudine (a medicine to treat viruses)
  • quinolone antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacin).

Other Warnings

  • Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Lysine Tablets if you:
    • have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”)
    • have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
  • Migraine Pain Relief Tablets belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take these tablets occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
  • There is a risk of renal impairment in dehydrated adolescents.

Pregnancy and Breastfeeding

Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking Migraine Pain Relief Tablets if you are in the first 6 months of pregnancy or are breastfeeding.

3. HOW TO TAKE THE MEDICINE

Adults, the elderly and adolescents between 12 and 18 years: Initial dose 1 or 2 tablets to be taken with water, preferably with or after food, then if necessary 1 or 2 tablets every 4 hours. Do not take more often than every 4 hours. Do not take more than 6 tablets in any 24 hour period.

Do not give to children under 12 years.

This medicine is intended for short term use only

Take the lowest dose for the shortest time necessary

In Adults: Do not take these tablets for longer than 10 days unless your doctor tells you to. Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms occur.

In Adolescents between 12 and 18 years: If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

If you take more tablets than you should: If you have taken more tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

4. POSSIBLE SIDE EFFECTS

Most people take these tablets without any problems, but they can have side effects, like all medicines.

To reduce the chance of side effects, especially if you are elderly, use the lowest effective dose for the shortest possible time.

If you get any of the following at any time during your treatment STOP TAKING, and get medical help straight away:

  • Signs of intestinal bleeding such as vomiting blood or dark particles (that look like coffee grounds), black tarry stools or motions, or blood passed in your stools or motions
  • Signs of serious allergic reaction such as:
    • asthma, worsening of asthma, unexplained wheezing or shortness of breath
    • swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
    • rapid heart rate, low blood pressure and collapse
    • also, there may be severe skin reactions with rashes, blistering and peeling skin
    • aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing auto-immune disorders such as lupus)
  • 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).
  • 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 Boots Migraine Pain Relief 342mg Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.

Tell your doctor or pharmacist if any of the following side effects persist, get worse, or if you notice any other side effects not listed:

Uncommon (affecting 1 in 1000 to 1 in 100 people)

  • Stomach discomfort or pain, nausea (feeling sick), indigestion or heartburn
  • Headache
  • Skin reactions, such as hives, rash and itching.

Rare (affecting 1 in 10,000 to 1 in 1000 people)

  • Diarrhoea, flatulence, constipation and vomiting.

Very Rare (affecting less than 1 in 10,000 people)

  • Stomach ulcer or perforation, worsening of bowel problems (ulcerative colitis or Crohn’s disease)
  • Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) – very rarely kidney failure
  • Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine
  • Blood disorders which can cause: unexplained or unusual bruising or bleeding, sore throat or mouth ulcers, fever (high temperature), extreme paleness or weakness and exhaustion.

Unknown

  • High blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke.

Medicines such as Migraine Pain Relief Tablets may be associated with a small increased risk of heart attack (myocardial infarction). If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking the tablets and see your doctor.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. STORING THE MEDICINE

Do not store above 25°C.

Do not use after the expiry date shown on the pack.

Store in the original container.

Keep out of the sight and reach of children.

6. FURTHER INFORMATION

What is in this medicine:

The active ingredient is: Ibuprofen 200 mg (as ibuprofen lysine) per coated tablet.

The other ingredients are: Crospovidone, copovidone, microcrystalline cellulose, magnesium stearate, Opadry II White (contains polyvinyl alcohol, titanium dioxide E171, macrogol and talc).

What this medicine looks like and contents of the pack

Each tablet is a film-coated white tablet, embossed with ‘IBL’ on one side.

This product is available in a pack size of 8, 12 or 16 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Wrafton Laboratories Limited
Braunton
Devon
EX33 2DL
United Kingdom

Date of revision: 11/2019

PL 12063/0071