IBUPROFEN 400 MG CAPSULES SOFT - patient leaflet, side effects, dosage

Package leaflet: information for the user

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 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

• – Adults: You must talk to a doctor if you do not feel better or if you feel worse after 4 days for pain or 3 days for fever and migraine headaches.

• – Adolescents (12 – 18 years old): You must talk to a doctor if the adolescent does not feel better or feels worse after 3 days.

What is in this leaflet:

• 1. What Ibuprofen 400 mg capsule, soft is and what it is used for

• 2. What you need to know before you take Ibuprofen 400 mg capsule, soft

• 3. How to take Ibuprofen 400 mg capsule, soft

• 4. Possible side effects

• 5. How to store Ibuprofen 400 mg capsule, soft

• 6. Contents of the pack and other information

1 what ibuprofen 400 mg capsule, soft is and what it is used for

Ibuprofen 400 mg capsule, soft contains a medicine called ibuprofen. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain and fever.

Ibuprofen 400 mg capsule, soft is indicated in adults and adolescents from 40 kg and above (12 years of age and above) for the relief of mild to moderate pain such as headache, acute migraine headaches with or without aura, muscular pain, period pain, feverishness and pain associated with a common cold.

2 what you need to know before you take ibuprofen 400 mg capsule, soft- are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

• – ever suffered shortness of breath, asthma, runny nose, swelling or (itching) rash after you have used acetylsalicyl acid (aspirin) or other related painkillers (NSAIDs)

• – have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy

• – have (or have had two or more episodes of) a stomach ulcer or bleeding of the stomach

• – suffer from a blood coagulation disorder or if you have another bleeding disorder

• – suffer from severe liver, kidney or heart failure

• – suffer from cerebrovascular or other active bleeding

• – suffer from unclarified blood-formation disturbances

• – suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

• – are in the last 3 months of pregnancy

• – are already taking other NSAID painkillers (including COX 2 inhibitors) or aspirin at doses above 75 mg daily

Do not use Ibuprofen 400 mg capsule, soft in adolescents under 40 kg body weight and in children.

Warnings and precautions

Talk to your doctor before taking this medicine if you:

• – suffer from Systemic Lupus Erythematosus (SLE) – a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs – or a mixed connective tissue disease

• – serious skin reactions have been reported in association with Ibuprofen 400 mg capsule capsule treatment. You should stop taking this product 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.

• – have hereditary blood formation disorder (acute intermittent porphyria)

• – have or have ever had bowel problems or disease (ulcerative colitis, Crohn’s disease)

• – have or have had asthma or allergic disease as shortness of breath may occur

• – 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.

• – are elderly, as you may be more likely to suffer from side effects

• – suffer from kidney or liver disease

• – have just had major surgery

• – have swelling (oedema), high blood pressure (hypertension) or a heart disease

• – are trying to become pregnant (ibuprofen belongs to a group of medicines, NSAIDs, that may impair fertility in women. The effect is reversible upon stopping the medicine).

• – are in the first 6 months of pregnancy

• – are taking low dose aspirin (up to 75 mg/day)

• – have an infection – please see heading “Infections” below

• – this medicine contains lecithin originating from soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

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

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 (Adults; 4 days for pain and 3 days for fever or migraine headaches. Adolescents; 3 days for pain, fever or migraine headaches).

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 400 mg capsule, soft 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.

During chicken pox (varicella) it is advisable to avoid use of Ibuprofen 400 mg capsule, soft.

In prolonged administration of Ibuprofen 400 mg capsule, soft regular checking of your liver values, the kidney function, as well as of the blood count, is required.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, you should stop taking this medicine and contact your doctor.

In general the frequent use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with dehydration. Do not take this medicine if you feel dehydrated.

Infections

Ibuprofen 400 mg capsule may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen capsule 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.

There is a risk of renal impairment in dehydrated adolescents.

Other medicines and Ibuprofen 400 mg capsule, soft

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

What should you avoid when you are taking this medicine?

Ibuprofen 400 mg capsule, soft 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, ticlopidin),

• – medicines that reduce high blood pressure (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 400 mg capsule, soft. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen 400 mg capsule, soft with other medicines.

Do not use this medicine if you are taking:

• – other NSAID painkillers (including COX-2 inhibitors).

• – aspirin above 75 mg daily.

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

Especially if it regards one of the following medicines:

• - Low-dose aspirin (up to 75 mg a day)

• - Diuretics (drug to help you pass water)

• - Anticoagulants e.g. warfarin and heparin and Anti-platelet drugs such as clopidogrel and ticlopidine (drugs that thin the blood)

• - Antihypertensives (drugs used to treat high blood pressure e.g. captopril or propranolol)

• - Lithium, digoxin, phenytoin or Selective serotonin reuptake inhibitor s (SSRI’s e.g. fluoxetine – used to treat mood disorders)

• - Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)

• - Zidovudine (used to treat HIV)

• - Corticosteroids (anti-inflammatory drugs, such as prednisone)

• - Ciclosporin or tacrolimus (used to suppress the body’s immune system)

• - Quinolone antibiotics (used to treat a wide range of infections e.g. ciprofloxacin)

• - Probenecid and sulfinpyrazone (used to treat gout)

• - Moclobemide (used to treat depression)

• - Aminoglycosides (an antibiotic)

• - Cholestyramine (used to reduce cholesterol)

• - Sulphonylureas (used to treat diabetes)

• – Any other ibuprofen preparations or NSAID painkillers, including those you can buy without a prescription.

Ibuprofen 400 mg capsule, soft with food and drink

Ibuprofen 400 mg capsule, soft may be taken on an empty stomach. However, a small number of people might experience mild indigestion with this medicinal product. If you experience mild indigestion, it is recommended to take this medicine with food or milk, to avoid gastrointestinal problems.

Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is taken at the same time as Ibuprofen 400 mg capsule, soft.

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.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant during intake of Ibuprofen 400 mg capsule, soft.

If you are in the first six months of pregnancy talk to your doctor or a pharmacist before using Ibuprofen 400 mg capsule, soft.

Ibuprofen 400 mg capsule, soft passes into breast milk, but may be used during breast-feeding at the recommended doses, for the shortest duration possible.

If you are in the last three months of pregnancy do not use this medicine because it might cause problems to the unborn child or complications during delivery.

Fertility

This product belongs to a group of medicines (NSAIDs) which might impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant however, talk to your doctor before using it if you have problems becoming pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you start to experience dizziness, drowsiness, vertigo or visual disturbances.

This medicine contains around 57.6 mg sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these capsules.

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

Ibuprofen 400 mg capsule, soft contains less than 1 mmol sodium (23 mg) per soft chewable capsule, that is to say essentially ‘sodium-free’.

3 how to take ibuprofen 400 mg capsule, soft

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

Adults and adolescents from 40 kg and above (12 years of age and above):

One capsule (400 mg ibuprofen) up to 3 times a day, as required. Take only as much as you need to relieve your symptoms and leave at least 6 hours between each dose.

Do not take more than three capsules (1200 mg ibuprofen) in any 24 hour period.

Ibuprofen 400 mg capsule, soft 400 mg capsule, soft is for oral use.

Ibuprofen 400 mg capsule, soft should be swallowed unchewed with plenty of liquid.

This medicine is for short term use only.

The minimum effective dose should be used for the shortest time 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).

It is not recommended to use this medicine in children under 12 years of age or in children weighing less than 40 kg.

Adults: You must talk to a doctor if you do not feel better or if you feel worse after 4 days for pain or 3 days for fever and migraine headaches.

Adolescents (12 – 18 years old): You must talk to a doctor if the adolescent does not feel better or feels worse after 3 days.

Ibuprofen 400 mg capsule, soft is contraindicated in adolescents under 40 kg body weight and in children.

If you take more Ibuprofen 400 mg capsule, soft than you should

If you have taken more Ibuprofen 400 mg capsule 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 forget to take <Invented Name> 400 mg capsule, soft:

Do not take 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 cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help :

• - Pass blood in your faeces (stools/motions)

• - Pass black tarry stools

• - Vomit any blood or dark particles that look like coffee grounds

• - Unexplained wheezing, shortness of breath, skin rash (which may be severe and included blister or peeling of the skin), itching or bruising, light-headedness, racing of the heart or fluid retention e.g. swollen ankles, not passing enough water

• - Stiff neck, headache, nausea, vomiting, fever and disorientation

• - Swelling of the face

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

• - Yellowing of the eyes and/or skin

• - Severe sore throat with high fever or unexplained bleeding, bruising and tiredness

• - Hypersensitivity reactions with hives and itch, as well as asthma attacks.

The following are side effects that may be experienced.

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

• – Stomach complaints, such as indigestion, acid burn, stomach pain and nausea, diarrhoea, vomiting, flatulence (wind) and constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.

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

• – Headache, dizziness, sleeplessness, agitation, irritability and tiredness

• – Visual disturbances

• – Perforation or gastrointestinal bleeding, black stools and vomiting of blood, worsening of existing bowel disease (ulcerative colitis or Crohn’s disease), gastritis

• – Various skin rashes

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

• – Tinnitus (ringing in the ears)

• – Pain in the flanks and/or abdomen, blood in the urine, and a fever may be signs of damage to the kidneys (papillary necrosis). Elevated urea concentration in blood.

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

• – Exacerbation of infection-related inflammations (e.g. necrotising fasciitis), aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or consciousness clouding. Patients with autoimmune disorders (lupus, mixed connective-tissue disease) appear to be predisposed

• – Problems in the blood cell production – first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. If this happens you must stop taking this medicine immediately and consult a doctor

• – Severe hypersensitivity reactions – signs could be: swelling of face, tongue and throat, shortness of breath, palpitations, severe shock. If one of these symptoms occurs, which can happen even on first use, the immediate assistance of a doctor is required

• – Psychotic reactions, depression, nervousness

• – Palpitations, heart failure, myocardial infarction

• – Asthma, shortness of breath and wheezing

• – Arterial high blood pressure

• – Oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures

• – Damage to the liver (first signs could be discoloration of the skin), acute hepatitis

• – Severe forms of skin reactions including rash with redness and blistering, Stevens-Johnson syndrome and dead-tissue. Exceptionally, severe skin infection and soft tissue complications during chicken pox (varicella) infection

• – Passing less urine than normal, swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney failure

• – Low haemoglobin levels (anaemia)

Side effects with frequency 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). 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 400 mg capsules if you develop these symptoms and seek medical attention immediately. See also section 2. Skin becomes sensitive to light.

Medicines such as Ibuprofen 400 mg capsule, soft 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website:. By reporting side effects you can help provide more information on the safety of this medicine.

5 how to store ibuprofen 400 mg capsule, soft

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

This medicinal product does not require any special storage conditions.

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

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 informationthe active substance is ibuprofen.

Each capsule contains 400 mg of ibuprofen

The other ingredients are:

Macrogol 600

Potassium hydroxide

Purified water

Medium Chain Triglycerides

Isopropyl alcohol

Lecithin (soya bean)

Capsule shell

Gelatin

Sorbitol Liquid, Partially Dehydrated (E420)

Capsule printing

Opacode WB black NS-78–17821

The ink contains: Black iron oxide, HPMC 2910/Hypromello­se 6cP

What Ibuprofen 400 mg capsule, soft looks like and contents of the pack

Ibuprofen 400 mg capsule, soft is a clear oval transparent soft gelatin capsule with a logo printed in black ink.

Ibuprofen 400 mg capsule, soft is available in PVC/PE/PVdC/Al blisters and in PVC/PE/PVdC/Al/PET blisters.

Packs of 4, 10, 12, 15, 16, 20 and 30 capsules.

Marketing Authorisation Holder and Manufacturer

marketing authorisation holder

75Pharma Limited

123 Buckingham Palace Road

SW1W 9SH London

United Kingdom

PL 54677/0001

manufacturer

Patheon Softgels B.V.

De Posthoornstraat 7

5048 AS Tilburg

The Netherlands

Aurobindo Pharma B.V. h.o.d.n. Aurobindo Benelux

Baarnsche dijk 1

3741 LN Baarn

The Netherlands

This leaflet was last revised in.

March 2022

Date: 03–2022

Version: 10.0.UK

10

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