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• Brufen oral suspension PL
• Brufen oral suspension ENG PL

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Package leaflet: information for the user

Brufen 20 mg/ml oral suspension

Ibuprofen

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

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• 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.

What is in this leaflet:

1. What Brufen is and what it is used for

2. What you need to know before you take Brufen

3. How to take Brufen

6. Contents of the pack and other information

1. What Brufen is and what it is used for

Brufen oral suspension belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Brufen relieves pain, reduces fever and has an anti-inflammatory effect.

Brufen oral suspension is used for pain of mild to moderate intensity, rheumatic conditions (rheumatoid arthritis, osteoarthritis) and menstrual pain, by adults and adolescents over 12 years old.

For children 6 months -12 years, Brufen oral suspension is used during acute painful conditions and fever associated with common cold.

The effect of Brufen is achieved usually within 30 minutes.

2. What you need to know before you take Brufen

Do not take Brufen:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

• if you are in the last three months of pregnancy

• if you have an increased tendency to bleed

• if you have severe liver and kidney disease

• if you have severe heart failure

• if you have a stomach ulcer, duodenal ulcer, or if you have had a stomach ulcer or duodenal ulcer previously when treated with Brufen or a similar product.

• if you have experienced allergic reactions (e.g. breathing difficulties, nasal obstruction, rash) to acetylsalicylic acid or other anti-inflammatory drugs.

Warnings and precautions

You should discuss your treatment with your doctor or pharmacist before taking Brufen if you:

• if you have certain disorders of the immune system(mixed connective tissue disorders and systemic lupus erythematosus (SLE), conditions of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs) as there may be an increased risk of aseptic meningitis if you have impaired kidney or liver function

• 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 of 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.

• if you have asthma, chronic rhinitis (chronic stuffy and runny nose) or allergic diseases since Brufen can cause difficulty breathing, hives or a serious allergic reaction when you have any of these conditions.

• if you have inflammatory bowel diseases, previous stomach ulcer or other increased tendency to bleed.

• Always aim for the lowest possible dose and shortest possible treatment time to reduce the risk of side effects. It is generally the case that higher than recommended doses can entail risks. This also means that the combination of several NSAID products at the same administration time should be avoided.

• Like other anti-inflammatory drugs, Brufen can mask signs of infection.

• Patients who have previously had gastrointestinal tract problems, especially elderly patients, should contact a doctor in the event of abdominal symptoms, particularly at the start of treatment.

• 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.

• During chicken pox it is advisable to avoid use of this medicine.

• This product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine. See also section “Pregnancy,breast-feeding and fertility”.

• Do not take Brufen if you are planning a pregnancy. Consult your doctor first. See also section “Pregnancy,breast-feeding and fertility”.

• Stop taking Brufen and contact a doctor immediately if you develop any of the following symptoms (angioedema)

• swelling of the face, tongue or throat,

• difficulties swallowing,

• hives and difficulties breathing.

• Serious skin reactions have been reported in very rare cases when using a NSAID. Stop taking Brufen and contact a doctor if you develop a rash or mucous membrane lesions. The severe rashes may include blisters on the skin, especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson´s syndrome). This can get even more severe, where the blisters get larger and spread out and parts of the skin may slough off (toxic epidermal necrolysis). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle.

• Brufen may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

• Caution should be exercised with regards to dehydrated patients, as there is a risk of renal impairment.

Children and adolescents

There is a risk of renal impairment in dehydrated children and adolescents.

Other medicines and Brufen:

Do not use different types of pain-relieving medicines at the same time unless directed by a doctor.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines

Brufen may affect or be affected by treatment with certain medicines, including those to treat:

• tumours and immune system disorders (methotrexate)

• manic depressive illness (lithium)

• irregular heart beat (digoxin)

• pain (acetylsalicylic acid)

• medicines that are anti-coagulants (i.e. thin blood/prevent clotting, e.g. aspirin/acetylsalicylic acid, dicumarol, warfarin, ticlopidine)

• depression (medicines called SSRIs - selective serotonin reuptake 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, diuretics)

• inflammation (corticosteroids)

• fungal infections (e.g. voriconazole or fluconazole)

• diabetes mellitus (sulphonylureas)

• human immunodeficiency virus (HIV) infection (zidovudine)

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

Brufen with food and drink

Brufen could be used together with food and drinks. Brufen can be given on an empty stomach for faster relief.

Pregnancy,breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not use Brufen during the three final months of the pregnancy.

Use of Brufen should be avoided by women who are planning a pregnancy or are pregnant. Treatment at any time in pregnancy should only take place as directed by a doctor.

Ibuprofen passes into breast milk. The use of ibuprofen is therefore not recommended while breastfeeding. However, consult a doctor if using Brufen more than occasionally while breastfeeding is required.

The use of ibuprofen may affect fertility. The use of ibuprofen is not recommended while attempting to conceive or during investigation of infertility.

Driving and using machines

Brufen may impair reactions in some people, for example due to side effects such as visual disturbances, dizziness or drowsiness. This should be taken into consideration on occasions when high alertness is required, e.g. driving.

Important information about some of the ingredients of Brufen

Brufen contains 3 g sucrose and 0.5 g sorbitol per 5 ml dose. This should be taken into account in patients with diabetes mellitus. May be harmful to teeth. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Brufen contains sunset yellow which may cause allergic reactions.

Brufen contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reaction (possibly delayed).

3. How to take Brufen

Always take Brufen exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose for adults and adolescents over 12 years old:

Rheumatic conditions: 20–35 ml (400–700 mg) 3 times daily. Allow 4-6 hours between doses. For faster relief of stiffness in the morning, the first dose can be given on an empty stomach.

Maximum daily dose: 2400 mg.

Menstrual pain:20 ml (400 mg) 1-3 times daily, as required. Allow 4-6 hours between doses. Start treatment at the first signs of menstrual pain.

Pain of mild to moderate intensity, adults:10–20 ml (200–400 mg) as a single dose or 3-4 times daily. Allow 4-6 hours between doses.

Use in children

Acute pain and feverassociated with cold, children 6 months - 12 years:5–7.5 mg ibuprofen/kg body weight as a single dose or 20–30 mg/kg body weight per day according to the table below.

Body weight should be used when calculating the dose (the ages given are approximate).

Weight	Age	Dose
7–10 kg	6–12 months	2.5 ml 3 times daily
10–14.5 kg	1–2 years	2.5 ml 3–4 times daily
14.5–25 kg	3–7 years	5 ml 3–4 times daily
25–40 kg	8–12 years	10 ml 3–4 times daily

The dose should be given every 6 hours, up to four times daily. Brufen oral suspension should not be given to children under the age of 6 months or children who weigh less than 7 kg.

If you have severe liver and kidney disease or are elderly your doctor will tell you the correct dose to take which will be the lowest dose possible.

For a faster onset of action, Brufen may be taken on an empty stomach. However, if you have a sensitive stomach, take ibuprofen with food.

To help prevent a passing feeling of a burning sensation in the throat or mouth, ensure the bottle is thoroughly shaken before use.

If you take more Brufen than you should

If you have taken more Brufen than you should, or if a child has taken the 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, 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 Brufen

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can causeside effects, although not everybody gets them.

Most serious side effects

• swelling of the face, tongue or throat,

• difficulties swallowing,

• hives and difficulties breathing.

Other side effects

Common (may affect up to 1 in 10 people):

• Headache, lightheadedness

• Gastrointestinal side effects (indigestion, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, bleeding in stomach and intestine, vomiting blood)

• Tiredness

• Rash

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

- Rhinitis

- Insomnia, anxiety

- Visual disturbances, hearing impairment

- Bronchial spasm, asthma

- Mouth ulceration

- Stomach ulcer, ruptured stomach ulcer, inflammation of mucous membrane of stomach

- Hepatitis, jaundice, abnormal liver function

- Itching, mall bruises in skin and mucous membranes

- Photosensitivity

- Impaired kidney function

- Changes in blood count

- Anaemia (a reduction in red blood cells or hemoglobin, which can make the skin pale and may lead to weakness)

- Drowsiness

- Tingling sensation

- Hearing loss

Rare(may affect up to 1in 1000 people):

- Non-bacterial meningitis

- Allergic reaction

- Depression, confusion

- Impaired vision, tinnitus (ringing in ears), dizziness

- Liver damage and fluid retention in body

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

- Inflammation of the pancreas, liver failure

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

- Colitis and Crohn’s Disease

- Heart failure, heart attack, high blood pressure

Please note that Brufen can prolong bleeding time.

There have been reports of high blood pressure and heart failure as well as worsening of ulcers in the large intestine and Crohn’s disease (bowel disease) in treatment with pain-relieving medicines (NSAIDs).

Exceptional serious infections of the skin in case of chicken pox.When an NSAID is used, an infection-related inflammation of the skin could develop or become more severe (e.g. a condition such as necrotising fasciitis may develop characterized by intense pain, high fever, swollen and hot skin, blistering, necrosis). If signs of an infection of the skin occur or get worse during use of Ibuprofen you are recommended to see your doctor immediately.

Medicines like Brufen may entail a slightly increased risk of heart attack or stroke.

A passing feeling of a burning sensation in the throat or mouth has also been reported with Brufen oral suspension.

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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Brufen

Keep this medicine out of the sight and reach of children.

Do not use Brufen after the expiry date stated on the package and bottle, after EXP. The expiry date refers to the last day of that month.

Openedbottle should be used within 12 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Brufen contains

• The active substance is ibuprofen.

• The other ingredients are preservatives (methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216, sodium benzoate E211), sucrose, citric acid monohydrate, glycerol, sorbitol liquid (non-crystallising) E420, kaolin light, polysorbate 80, flavouring (orange), colorant (sunset yellow E110), agar, purified water.

What Brufen looks like and contents of the pack

Yellow oral suspension with orange flavour.

100 ml and 200 ml (plastic bottle). A 5 ml dosing syringe / a 2.5 ml/5 ml double dosing spoonis included.

Not all pack sizes may be marketed.

Marketing Authorisation holder and Manufacturer:

<To be completed nationally>

Manufacturer:

AbbVie S.r.l, Campoverde, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the

following names:

Country	Product Name
Bulgaria	Brufen 20mg/ml Oral Suspension
Estonia	Brufen, 20 mg/ml suukaudne suspensioon
Latvia	Brufen 20 mg/ml suspensija iekšķīgai lietošanai
Lithuania	Brufen 20 mg/ml geriamoji suspensija
Poland	Brufen, 20 mg/ml, zawiesina doustna
Romania	Brufen 20 mg/ml suspensie orală
Slovenia	Brufen 20 mg/ml peroralna suspenzija
Sweden	Brufen 20 mg/ml oral suspension

This leaflet was last revised in 2015-10-26