Skip to Content

UK Edition. Click here for US version.

IBUPROFEN 400 MG CAPSULES SOFT

Active substance(s): IBUPROFEN

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules

Package leaflet: information for the user
Ibuprofen 400 mg capsule, soft
For use in adults and adolescents from 40 kg and above (12 years of age and above)
Ibuprofen

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.
-

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.
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.
2.
3.
4.
5.
6.

What Ibuprofen 400 mg capsule, soft is and what it is used for
What you need to know before you take Ibuprofen 400 mg capsule, soft
How to take Ibuprofen 400 mg capsule, soft
Possible side effects
How to store Ibuprofen 400 mg capsule, soft
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.

Date: 02-2018

Version: 3.0
Confidential

2

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules

2 What you need to know before you take Ibuprofen 400 mg
capsule, soft
Please read the following information.
Do not take Ibuprofen 400 mg capsule, soft if you:
-

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 a pharmacist or your doctor before taking your 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
suffer from serious skin reactions such as exfoliative dermatitis, StevensJohnson syndrome and toxic epidermal necrolysis. The use of Ibuprofen 400
mg capsule, soft should be stopped immediately at the first appearance of skin
rash, mucosal lesions, or any other signs of allergic reactions
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

Date: 02-2018

Version: 3.0
Confidential

3

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
-

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)

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.
The use of NSAIDs may mask the symptoms of infection.
There is a risk of renal impairment in dehydrated adolescents.
Date: 02-2018

Version: 3.0
Confidential

4

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
Other medicines and Ibuprofen 400 mg capsule, soft
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 inhibitors
(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)

Date: 02-2018

Version: 3.0
Confidential

5

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
-

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
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.
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.
Important information about some of the ingredients of
capsule, soft

Ibuprofen 400 mg

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

3 How to take Ibuprofen 400 mg capsule, soft
Always take this medicine exactly as described in this leaflet. Check with your doctor
or pharmacist if you are not sure.
For oral use.

Date: 02-2018

Version: 3.0
Confidential

6

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
For short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms.
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 should be swallowed unchewed with plenty of liquid.
Ibuprofen 400 mg capsule, soft is contraindicated in adolescents under 40 kg body
weight and in children.
The recommended dose for adults and adolescents from 40 kg and above (12 years
of age and above) is:
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.
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 have any further questions on the use of this product, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, Ibuprofen 400 mg capsule, soft can cause side effects, although
not everybody gets them.
Date: 02-2018

Version: 3.0
Confidential

7

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
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

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

affects more than 1 user in 10

common

affects 1 to 10 users in 100

uncommon

affects 1 to 10 users in 1,000

rare

affects 1 to 10 users in 10,000

very rare

affects less than 1 user in 10,000

not known

cannot be estimated from the available data

The following are side effects that may be experienced.
Infections
Very rare: 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.
Blood disorders
Very rare: 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.

Date: 02-2018

Version: 3.0
Confidential

8

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
Problems of the immune system
Uncommon: Hypersensitivity reactions with hives and itch, as well as asthma attacks.
You must stop taking Ibuprofen 400 mg capsule, soft and inform your doctor at once.
Very rare: 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.
Psychiatric disorders
Very rare: Psychotic reactions, depression, nervousness
Nervous system disorders
Uncommon: Headache, dizziness, sleeplessness, agitation, irritability and tiredness
Eye disorders
Uncommon: visual disturbances
Ear and balance disorders
Rare: Tinnitus (ringing in the ears)
Cardiac disorders
Very rare: palpitations, heart failure, myocardial infarction
Vascular disorders

Very rare: arterial high blood pressure
Respiratory, thoracic and mediastinal disorders

Very rare: Asthma, shortness of breath and wheezing
Stomach and bowel disorders
Common: 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: Perforation or gastrointestinal bleeding, black stools and vomiting of
blood, worsening of existing bowel disease (ulcerative colitis or Crohn’s disease),
gastritis
Very rare: Oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures
Liver disorders
Very rare: Damage to the liver (first signs could be discoloration of the skin), acute
hepatitis
Skin disorders
Uncommon: Various skin rashes

Date: 02-2018

Version: 3.0
Confidential

9

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
Very rare: 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.
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).
Kidney disorders
Rare: 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: Passing less urine than normal, swelling (oedema) and cloudy urine
(nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead
to acute kidney failure.
Investigations
Very rare: Low haemoglobin levels (anaemia).
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: www.mhra.gov.uk/yellowcard. 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
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
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.
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 Ibuprofen 400 mg capsule, soft contains
The active substance is ibuprofen.
Date: 02-2018

Version: 3.0
Confidential

10

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
Each capsule contains 400 mg of ibuprofen
The other ingredients are:
Macrogol 600
Potassium hydroxide
Purified water
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.
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
Banner Pharmacaps Europe
De Posthoornstraat 7
5048 AS Tilburg,
The Netherlands
PL 14338/0005
manufacturer
Patheon softgels B.V.
De Posthoornstraat 7
Date: 02-2018

Version: 3.0
Confidential

11

Module 1 – Section 3.1
Ibuprofen 400 mg soft gelatin capsules
5048 AS Tilburg,
The Netherlands
Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands
This leaflet was last revised in.
02-2018

Date: 02-2018

Version: 3.0
Confidential

12

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide