IBUCAPS IBUPROFEN 200 MG SOFT GELATIN CAPSULES, GALPHARM IBUPROFEN 200 MG SOFT CAPSULES, OPTIPHARMA IBUPROFEN 200 MG SOFT CAPSULES, IBUPROFEN 200 MG LIQUID CAPSULES, PARAMED IBUPROFEN 200 MG LIQUID CAPSULES, ESSENTIAL WAITROSE IBUPROFEN 200 MG LIQUID - patient leaflet, side effects, dosage

CONTENTS OF THE PACK AND OTHER INFORMATION

What is in this medicine:

The active ingredient is: Ibuprofen 200mg per liquid capsule.

The other ingredients are: macrogol 600, potassium hydroxide, gelatine, sorbitol, purified water, titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose, Ponceau 4R (E124), lecithin and medium chain triglycerides. What this medicine looks like and contents of the pack

Each oval, pink capsule is printed in white with ‚I200‘. This pack contains 16 capsules.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder: Patheon Softgels B.V., De Posthoornstraat 7, 5048 AS Tilburg, The Netherlands.

Manufacturer: Wrafton Laboratories Ltd. Exeter Rd, Wrafton, Braunton, North Devon EX33 2DL United Kingdom.

Text revised: July 2021.

PL 14338/0001 C6J73H9J4

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

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. Contents of the pack and other information

Q WHAT THIS MEDICINE IS FOR

This medicine contains ibuprofen. Ibuprofen is one of a group of non-steroidal anti-inflammatory drugs (known as NSAIDs) which 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), dental pain, period pain
• headache, migraine
• fever (high temperature)
• the symptoms of colds and flu.

BEF BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if you:

• have (or have had two 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 kidney or heart failure or severe liver failure
• are taking aspirin with a daily dose above 75mg
• 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 in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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.
• 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 an intolerance to some sugars (these capsules contain sorbitol)
• 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
• serious skin reactions have been reported in association with this medicine. You should stop taking this product and seek medical attention immediately, if you develop any skin rash, lesions of the mucous

lllllllllllll­llllllllllllllllllllllll­llllllllllllllllllllllll­llllllllllllllllllllllll­lllllllllll

membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4

• have an infection – please see heading ‚Infections‘ below.

There is a risk of renal impairment in dehydrated adolescents.

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.

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

This medicine 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)
• aspirin at low dose as an anti-platelet medicine (i.e. 75mg or below daily), as taking ibuprofen may reduce the effectiveness of the aspirin or cause stomach problems
• other medicines for thinning the blood (anti-coagulants)
• other NSAID painkillers, including cyclooxygenase-2 selective inhibitors
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• 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

l __ __ _ __ __ _ __ __

(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 infection e.g. ciprofloxacin).

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, breastfeeding and fertility Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking Ibuprofen Capsules if you are in the first 6 months of pregnancy or are breastfeeding. These capsules 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.

Driving and using machines

This medicine is unlikely to cause any effect on your ability to drive or use machines.

This medicine contains sorbitol

This medicine contains 55.63mg sorbitol in each capsule. If you have an intolerance to some sugars, contact your doctor before taking this product.

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains Ponceau 4R (E124)

It may cause allergic reactions.

□ HOW TO TAKE THE MEDICINE

Age	Dose and how often to take
Adults, the elderly and adolescents	Initial dose 1 or 2 capsules to be swallowed whole with water, preferably with or after food. Do not chew. Then if necessary 1 or 2 capsules every 4 hours. Do not take more often than every 4 hours. Do not take more than 6 capsules in any 24 hour period.
Do not give to children under 12 years.
This medicine is for short-term use only. Take the lowest effective dose for the shortest duration necessary to relieve your symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). Do not take these capsules for longer than 10 days unless your doctor tells you to. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking the medicine.

If you take more capsules 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.

If you forget to take this medicine: Do not take a double dose to make up for a forgotten dose.

Q POSSIBLE SIDE EFFECTS

Most people take these capsules 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.

STOP TAKING the medicine and

seek immediate medical help if you:

• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds

STOP taking the medicine and tell your doctor if you experience:

• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms
• skin problems

STOP TAKING the capsules and contact your doctor immediately if you develop any of the following symptoms at any time while taking your medicine:

Uncommon (may affect up to 1 in 100 people) side effects are:

• itchy skin or rashes, urticaria (hives)
• abdominal pain, nausea (feeling sick), stomach and bowel problems
• headache

Rare (may affect up to 1 in 1,000 people) side effects are:

• stomach ulcer
• wind (flatulence), diarrhoea, constipation

Very rare (may affect up to 1 in 10,000 people) side effects are:

• kidney failure, liver problems, problems in the blood cell production: the first signs can be fever, sore throat, mouth ulcers, flu like symptoms, severe exhaustion, unexplained bleeding and bruising
• meningitis (inflammation of the membrane around the brain) symptoms such as fever and chills, severe headache, nausea and vomiting and stiff neck (in patients with inflammatory disease of connective tissue in the skin or joints (systemic [3 lupus erythematosus))