IBUPROFEN PERRIGO 400 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Ibuprofen Perrigo 400mg Film-coated Tablets

For adults and adolescents weighing from 40 kg body weight (12 years of age and above) Ibuprofen Lysine

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.
• In Adults: You must talk to a doctor if your symptoms worsen or do not improve after 3 days when you are suffering from a fever or 4 days when you are suffering from pain.
• 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.

What is in this leaflet

• 1.

What this medicine is and what it is used for

• 2.

What you need to know before you take this medicine

• 3.

How to take this medicine

• 4.

Possible side effects

• 5.

How to store this medicine

• 6.

Contents of the pack and other information

1. what this medicine is and what it is used 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 and fever. –

This medicine is used for the symptomatic treatment of mild to moderate pain, such as headache, period pain and dental pain, and fever and pain associated with the common cold in Adults, the elderly and adolescents over 12 years of age.

2. what you need to know before you take this medicine are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

• have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after

using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs)

• have (or have had two or more episodes of) a stomach ulcer, or bleeding of the stomach
• have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy
• have severe kidney or severe heart failure or severe liver failure
• are bleeding, including any bleeding within the brain (cerebrovascular bleeding)
• are suffering from blood clotting disorders
• suffer from a currently undiagnosed problem with your body’s ability to form blood
• are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)
• are in the last 3 months of pregnancy
• LOW DOSE ASPIRIN: Do not take this medicine if you are taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen Perrigo 400mg Film-coated Tablets.

Warnings and precautions

• if you have hereditary blood formation disorder (acute intermittent porphyria)
• if you are elderly because you may be at more risk of having side effects, particularly

stomach problems

• if you have or have suffered from asthma or have allergies as shortness of breath may occur
• if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an
• increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
• during chickenpox (varicella) it is advisable to avoid use of Ibuprofen Perrigo 400mg Film-coated Tablets
• if you have reduced liver or kidney function
• If you have an infection – please see heading “Infections” below.
• directly after major surgery
• if you have stomach or bowel disorders including Crohn’s disease or a condition known as Ulcerative colitis
• if you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease -illnesses which affects your immune system. They cause joint pains, skin changes and problems with other parts of your body.
• In prolonged administration of Ibuprofen Perrigo 400mg Film-coated Tablets regular checking of your liver values, the kidney function, as well as of the blood count, is required
• The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions (see section “If you are taking other medicines” below) and 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 Perrigo 400mg Film-coated 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 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.

Undesirable effects are minimised by using the minimum effective dose for the shortest period of time.

In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided. There is a risk of renal impairment in dehydrated adolescents.

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. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Consult a doctor before using Ibuprofen Perrigo 400mg Film-coated Tablets if any above mentioned conditions concerns you.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen Perrigo 400mg Film-coated Tablets treatment. You should stop taking Ibuprofen Perrigo 400mg Film-coated Tablets 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.

Infections

Ibuprofen Perrigo 400mg Film-coated Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Perrigo 400mg Film-coated Tablets 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 children and adolescents.

Other medicines and Ibuprofen Tablets

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

Ibuprofen 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 antagonist such as losartan).

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking:

Taking Ibuprofen Perrigo 400mg Film-coated Tablets with food and drink

It is recommended that patients with sensitive stomachs take Ibuprofen Perrigo 400mg Film-coated Tablets with food. Some side effects, such as those affecting the gastrointestinal system can be more likely whenalcohol is taken at the same time as Ibuprofen Perrigo 400mg Film-coated Tablets.

Driving and using machines

For short-term use and at normal dosage this medicine has no or negligible influence on the ability to drive and use machines.

Pregnancy, breast feeding and fertility

Tell your doctor if you become pregnant during intake of this medicine. Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking Ibuprofen Perrigo 400mg Film-coated Tablets if you are in the first 6 months of pregnancy.

This medicine may be used during breast feeding for a maximum of 3 days (when you are treating a fever) or 4 days (for the treatment of pain), as only small amounts of this medicine pass into breast milk.

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

3. how to take this medicine

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

For oral use.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you expected.

If you take more Ibuprofen Tablets than you should

If you have taken more ibuprofen tablets than you should, or if children have been taken 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Ibuprofen Perrigo 400mg Film-coated Tablets can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to

relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below).

If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.

The following frequencies are taken as a basis when evaluating side effects:

STOP TAKING this medicine and seek immediate medical help if you develop:

• signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools,

vomiting blood or dark particles that look like coffee grounds.

• signs of very rare but serious allergic reaction such as worsening of asthma or

shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.

• severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.

Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.

Common

• gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick and indigestion, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.

Uncommon

• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of

the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease

• central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness
• visual disturbances
• allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking Ibuprofen Perrigo 400mg Film-coated Tablets and inform your doctor at once.

Rare

• tinnitus (ringing in the ears)
• kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood

Very rare

• swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in association with NSAID treatment.

• inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures)
• serious infections of the skin and soft-tissue complications have occurred during chicken pox (varicella) infection.
• passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney failure. If one of the above mentioned symptoms occur or if you have a general miserable feeling, stop taking Ibuprofen Perrigo 400mg Film-coated Tablets and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.
• problems in the blood cell production – first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce fever (antipyretic medicinal products) mustn’t be done.
• psychotic reactions and depression
• exacerbation of infection-related inflammations (e.g. necrotising fasciitis) associated with use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse during use of Ibuprofen Tablets, you must go to a doctor without delay. It is to be investigated whether there is an indication for an antiinfective/an­tibiotic therapy.
• high blood pressure, palpitations, heart failure, heart attack.
• liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• the symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.
• severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Ly­ell’s syndrome), hair loss (alopecia).
• severe general hypersensitivity reactions.
• worsening of asthma, bronchospasm, dyspnoea.

Not known:

• 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).
• Skin becomes sensitive to light.
• 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 Ibuprofen Perrigo 400mg Film-coated Tablets if you develop these symptoms and seek medical attention immediately. See also section 2

Medicines such as Ibuprofen Perrigo 400mg Film-coated Tablets may be associated with a small increased risk of heart attack („myocardial infarction“) or stroke.

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store

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

5. how to store this medicine

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

Store in the original container.

Keep out of the reach and sight of children.

6. contents of the pack and other information

What is in this medicine:

The active ingredient is: Ibuprofen 400 mg (as ibuprofen lysine 684mg) per coated tablet.

The other ingredients are: Crospovidone, copovidone, microcrystalline cellulose and magnesium stearate. The tablet coating ingredient is: 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 ‘L684’ on one side.

This product is available in a pack size of 8, 12, 16 or 24 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Omega Pharma Limited, 32 Vauxhall Bridge Road, London, UK

Manufacturer: Wrafton Laboratories Limited (Trading as Perrigo), Braunton, Devon, EX33 2DL, United Kingdom.

The leaflet was revised in : January 2021