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Package leaflet: Information for the user

Ibuprofen 2care4 200 mg film-coated tablets

ibuprofen

[For medicines available only on prescription:]

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

[For medicines available without a prescription:]

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.

- For adults: You must talk to a doctor if you do not feel better or if you feel worse after 3 days with a fever and 5 days with pain.

- For children and adolescents: a doctor should be consulted if in children and in adolescents this medicinal product is required for more than 3 days or if symptoms worsen.

What is in this leaflet

1. What Ibuprofen 2care4 is and what it is used for

2. What you need to know before you take Ibuprofen 2care4

3. How to take Ibuprofen 2care4

Ibuprofen 2care4 belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which reduces fever, relieves pain and has an anti-inflammatory effect.

Ibuprofen 2care4 is used for short term symptomatic treatment of mild to moderate pain such as headache, period pain, dental pain, and fever and pain in common cold.

Children 6-12 years can be treated with Ibuprofen 2care4 200 mg tablets during acute painful conditions and fever associated with common cold.

2. What you need to know before you take Ibuprofen 2care4

Do not take Ibuprofen 2care4:

• 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 ibuprofen 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.

• if you have a connective tissue disease

• if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

• if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells

Warnings and precautions

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.

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 2care4 if you:

• have systemic lupus erythematosus (connective tissue disease)

• have impaired kidney or liver function, mild to moderate heart failure

• have asthma

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

• have an inherited disorder of the metabolism of red blood cell pigment (porphyria)

• have just had major surgery.

• 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.

Like other anti-inflammatory drugs, Ibuprofen 2care4 can mask signs of infection.

This product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

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.

Serious skin reactions have been reported in very rare cases when using a NSAID. Stop taking ibuprofen and contact a doctor if you develop a rash or mucous membrane lesions.

In patients with systemic lupus erythematosus and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Do not take Ibuprofen 2care4 if you are planning a pregnancy. Consult your doctor first. See also in section 2 “Pregnancy, breast-feeding and fertility”.

During varicella it is advisable to avoid use of this drug.

Ibuprofen 2care4 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.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.

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

Other medicines and Ibuprofen 2care4

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, have recently taken or might take any other medicines.

Ibuprofen 2care4 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, dicumarol, warfarin, ticlopidine),

• medicines that reduce high blood pressure (diuretics, 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 Ibuprofen 2care4. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen 2care4 with other medicines.

• tumours and immune system disorders (methotrexate),

• manic depressive illness (lithium),

• irregular heart beat (digoxin),

• epilepsy (phenytoin),

• pain (acetylsalicylic acid),

• depression (medicines called SSRIs),

• depressive illness or social phobia (moclobemide),

• inflammation (corticosteroids),

• fungal infections (antifungals particularly voriconazole or fluconazole),

• infections (quinolone antibiotics such as ciprofloxacine or moxifloxacine),

• diabetes mellitus (sulphonylureas),

• human immunodeficiency virus (HIV) infection (zidovudine or ritonavir),

• circulatory disease of the arteries of the legs or arms (oxpentifylline, pentoxifylline),

• gout (probenecid or sulfinpyrazone),

• lung cancer (pemetrexed),

• osteoporosis (bisphosphonates such as alendronic acid and ibandronic acid),

For this reason, the doctor treating you needs to know about all the medicines you are taking.

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 must not use Ibuprofen 2care4 during the three final months of the pregnancy.

Use of Ibuprofen 2care4 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 Ibuprofen 2care4 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

Ibuprofen 2care4 may impair reactions in some people. This should be taken into consideration on occasions when high alertness is required, e.g. driving.

Ibuprofen 2care4 contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Ibuprofen 2care4

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Mild to moderate pain and fever:

Adult and adolescents over 12 years (over 40 kg)

One or two 200 mg tablets as a single dose or 3-4 times daily. Allow 4-6 hours between doses. The maximum daily dose should not exceed 6 tablets (1200 mg).

Period Pain:

One or two 200 mg tablets 1-3 times daily, as needed. An interval of at least 4-6 hours should be allowed between doses. Treatment is started at the first sign of menstruation problems. The maximum daily dose should not exceed 6 tablets (1200 mg).

Children 6-12 years (over 20 kg)

Acute pain and fever associated with cold

Children 6-9 years (20-29 kg): One tablet 1-3 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 3 tablets (600 mg).

Children 10-12 years (30-40 kg): One tablet 1-4 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 4 tablets (800 mg).

Adults:

If your condition has not improved or has worsened within 3 days with a fever and 5 days with pain, you should contact a doctor.

Children and adolescents:

If in children and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If you have a sensitive stomach, the tablet is preferably taken with or after food. To help prevent a passing feeling of a burning sensation in the throat or mouth, swallow the tablets whole with at least half a glass of water.

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.

If you take more Ibuprofen 2care4than you should

If you have taken more Ibuprofen 2care4 than you should, or if children have been taken medicine by accident always contact a doctor or 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 Ibuprofen 2care4

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.

Stop taking Ibuprofen 2care4 and contact a doctor immediately if you develop any of the following symptoms:

Angioedema (occurs uncommonly)

• swelling of the face, tongue or throat,

• difficulties swallowing,

• hives and difficulties breathing.

Severe skin reactions such as a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature (symptoms of skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis) (occurs rarely).

Other possible 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)

• Rash.

• Tiredness

Uncommon (may affect up to 1 in 100 people)

• Rhinitis

• Insomnia, anxiety,

• Visual disturbances, hearing impairment

• Difficulty breathing, bronchial spasm, asthma

• Mouth ulceration

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

• Hepatitis

• Jaundice. Abnormal liver function

• Hives, itching, small bruises in skin and mucous membranes

• Photosensitivity

• Impaired kidney function

• Changes in blood count including agranulocytosis

• Drowsiness. Tingling sensation

Rare (may affect up to 1 in 1,000 people)

• Non-bacterial meningitis

• Allergic reaction

• Depression, confusion

• Impaired vision, tinnitus (ringing in ears)

• 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)

Please note that Ibuprofen 2care4 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 varicella.

Medicines like Ibuprofen 2care4 may entail a slightly increased risk of heart attack or stroke.

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 Ibuprofen 2care4

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

Do not store above 30C.

Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP. The expiry date refers to the last day of that month.

After first opening of the tablet container the product should be used within 1 year.

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.

What Ibuprofen 2care4 contains

One tablet contains 200 mg ibuprofen

• The active substance is ibuprofen.

• The other ingredients are: maize starch, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, stearic acid, sodium lauryl sulfate, povidone (K-30), talc, hypromellose (2910, E 464), lactose monohydrate, triacetin and titanium dioxide (E 171)

What Ibuprofen 2care4 looks like and contents of the pack

White coloured, capsule shaped, 13 x 6 mm, biconvex, film coated tablets, plain on both sides

200 mg:

Blister: 12, 16, 20, 24 and 30 film-coated tablets

Bottle: 16, 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<[To be completed nationally]>

{Name and address}

Manufacturer

S.C. SANTA S.A.

Address: Str. Carpatilor nr. 60, obiectiv nr. 47, 48, 58, 133, 156 Brasov, jud. Brasov,

Cod 500269, Romania

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

Sweden Ibuprofen 2care4

Greece Prabex

Ireland Miofen 200mg Film-coated Tablets

France Ufinalgin

This leaflet was last revised in 18 October 2016