LLOYDSPHARMACY IBUPROFEN 200 MG LONG LASTING CAPSULES, SAINSBURYS HEALTHCARE LONG LASTING PAIN RELIEF 200 MG MODIFIED RELEASE CAPSULES, GALPROFEN LONG LASTING IBUPROFEN CAPSULES, TESCO HEALTH LONG LASTING PAIN RELIEF 200 MG MODIFIED RELEASE CAPSULES HARD, - patient leaflet, side effects, dosage

What this medicine looks like and contents of the pack

Asda Long Lasting Pain Relief are blue and clear capsules containing white coated beads, available in pack sizes of 6, 8, 12 or 16 capsules (not all pack sizes may be marketed).

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturers: Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom. Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom

Text revised: January 2021.

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PATIENT INFORMATION LEAFLET

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

Q WHAT THIS MEDICINE IS FOR

This medicine contains ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature.

This medicine is used to relieve:

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

BE BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if you:

• have or have had a stomach ulcer, perforation or bleeding of the stomach

L _ _ _ _ _ _ _

• 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 kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day
• are in the last 3 months of pregnancy.

Warnings and precautions

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.

Skin reactions

Serious skin reactions have been reported in association with this medicine 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.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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 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 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
• have an infection – please see heading ‚Infections‘ below.

Infections

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased 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 your symptoms of the infection persist or worsen, consult a doctor without delay.

Children and adolescents:

There is a risk of renal impairment in dehydrated adolescents.

Other medicines and Asda Long Lasting Pain Relief

You must not take these capsules if you are taking certain other medicines – see section 2 ‚Do not take this medicine if‘.

• This medicine may affect or may 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)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• cyclosporin 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).

Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

Pregnancy and Breastfeeding

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

Asda Long Lasting Pain Relief 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 capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

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HOW TO TAKE THE MEDICINE

Age	Dose and how often to take
Adults, the elderly and children over 12 years	Take 2 capsules (400mg) each morning and evening, as required. Swallow capsules whole (do not chew) with a glass of water preferably with or after food. Do not exceed 4 capsules in 24 hours.
This medicine is for short-term use only Take the lowest effective dose for the shortest duration necessary to relieve symptoms.
In Adults: Do not take this medicine 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 Children and Adolescents between 12 and 18 years: If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Do not give to children under 12 years.

If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

If you take more Asda Long Lasting Pain Relief than you should:

If you have taken more capsules 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 on action 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.

□ POSSIBLE SIDE EFFECTS

Most people take this medicine without any problems, but it 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: Allergic reactions:

• The following reactions may mean you are having an allergic reaction to this medicine: 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, collapse
• also, there may be skin reaction (including hives, rash and itching) – very rarely these can be severe with blistering and peeling skin.

Skin problems:

• 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 this medicine if you develop these symptoms and seek medical attention immediately. See also section 2
• Skin becomes sensitive to light – frequency unknown.

Stomach and bowel problems including: ^3

• indigestion or heartburn