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

Patient leaflet - IBUSAN 400 MG CAPSULES SOFT

Ibusan 200 mg soft capsule

Ibusan 400 mg soft capsule 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 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.
– You must talk to a doctor if you do not feel better or if you feel worse after 3 days in children and adolescents or in adults after 4 days for pain or 3 days for migraine headache or fever.

What is in this leaflet

1. What IBUPROFEN is and what it is used for
2. What you need to know before you take IBUPROFEN
3. How to take IBUPROFEN
4. Possible side effects
5. How to store IBUPROFEN
6. Contents of the pack and other information

1. what ibuprofen is and what it is used for

The name of this medicine is Ibusan 200 mg or Ibusan 400 mg (called IBUPROFEN throughout this leaflet).

The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature.

IBUPROFEN in the form of soft capsules with liquid content break down easily in the body, the active substance is faster absorbed into the bloodstream and so gets to the site of pain quickly.

IBUPROFEN is used for the relief of headaches, migraine, dental pain, back pain, period pain, muscular pain, feverishness and symptoms of cold and flu.

Additionally, upon medical advice, IBUPROFEN is also used for the relief of pain that is felt along the length of a nerve (neuralgia), swelling and pain in the joints (rheumatic pain) and for non-serious inflammation of joints (non-serious arthritis).

IBUPROFEN 400 mg is recommended for adults and adolescents over 12 years (from 40 kg bodyweight).

Due to the amount of active substance in one capsule IBUPROFEN 200 mg is recommended for adults and children over 6 years (from 20 kg bodyweight).

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

– if you are hypersensitive to Non-Steroidal Anti-Inflammatory Drugs manifested as shortness of breath, asthma, a runny nose, swelling or urticaria;
– if you have active or recurrent ulcer or bleeding to the stomach or duodenum or if you have ever had it repeatedly (i.e. at least twice) in the past;
– if you have ever had gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
– if you suffer from disorder of blood formation or disorder of blood clotting;
– if you have severe heart, liver or kidney failure;
– if you are a women in the third trimester of pregnancy.

Warnings and precautions

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

– suffer from kidney or liver disorder;
– suffer from bronchial asthma;
– suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders due to an increased risk of allergic reactions;
– are also taking drugs which could increase the risk of gastrotoxicity or bleeding (see below);
– suffer from systemic lupus erythematosus (immunity system disorder) or mixed connective tissue disease (the risk of aseptic meningitis);
– suffer from inflammatory ulcerous disease of digestive tract such as Crohn's disease or ulcerative colitis;
– 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 or high cholesterol, have a family history of heart disease or stroke, or if you are a smoker).

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. Any risk is more likely with high doses and prolonged treatment.

Gastrointestinal bleeding, ulceration or perforation can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses, in patients with a history of ulcer and in the elderly. Some concomitant medications could increase the risk of gastrotoxicity or bleeding (other non-steroidal anti-inflammatory drugs, corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or anti-platelet agents such as acetylsalicylic acid).

In patients with increased risk of gastrointestinal toxicity concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

Prolonged use of any type of painkiller for headaches can make them worse. If you experience frequent or daily headaches despite (or because of) the regular use of headache medications consult your doctor before taking another painkiller. The treatment should be discontinued if medication overuse headache (MOH) is diagnosed.

Ibuprofen may mask the symptoms of an infection (fever, pain and swelling).

Children and adolescents

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

Other medicines and IBUPROFEN

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

IBUPROFEN 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, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).

Also tell them if you are taking:

– any other NSAIDs (anti-inflammatories and analgesics) and glucocorticoids (medicinal products containing cortisone or cortisone-like substances) since these medicine may increase the risk of gastrointestinal ulcers or bleeding;
– selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression) as these may increase the risk of gastrointestinal bleeding;
– anti-platelet agents since this may increase the risk of bleeding;
– water tablets since ibuprofen may diminish the effects of these medicines and there could be a possible increased risk for the kidney;
– potassium sparing diuretics since this may lead to hyperkalaemia;
– quinolone antibiotics since the risk for convulsions may be increased;
– aminoglycosides (antibiotics) since ibuprofen may decrease the clearance of aminoglycosides, their co-administration may increase the risk of nephrotoxicity and ototoxicity;
– sulphonylureas (antidiabetic drugs) since possible interactions with ibuprofen;
– products containing lithium (a medicine for manic depressive illness and depression), digoxin (for heart insufficiency) and methotrexate (a medicine for cancer or rheumatism) since ibuprofen may enhance the effects of these medicines;
– sulfinpyrazone, probenecid (medicines for gout) since the excretion of ibuprofen may be delayed;
– there are clinical data indicating that NSAIDs may increase the plasma level of baclofen;
– mifepristone (a medicine for pregnancy termination) since ibuprofen may reduce the effect of this medicine;
– ciclosporin, tacrolimus (immunosuppressive medicines) since kidney damage may occur;
– pemetrexed (a medicine for cancer) since ibuprofen may increase the toxic effects of this medicine;
– zidovudine (a medicine for treating HIV/Aids) since the use of IBUPROFEN may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs.

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

IBUPROFEN with food, drink and alcohol

Capsules should be swallowed whole with a sufficient amount of liquid.

If gastrointestinal problems appear during the treatment, it is recommended to use the product during meal.

Drinking of alcoholic beverages and smoking is not suitable during treatment.

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 for advice before taking this medicine.

Pregnancy and breast-feeding

Do not take in the last 3 months of pregnancy or if you are breastfeeding.

Speak to your doctor if you are in the first 6 months of pregnancy.

Fertility

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

Driving and using machines

Ibuprofen has no or negligible influence on the ability to drive and use machines.

IBUPROFEN contains sorbitol.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. how to take ibuprofen

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.

This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.

Adults and adolescents aged 12 years and older (from 40 kg bodyweight)

Take one or two capsules of IBUPROFEN 200 mg or one capsule of IBUPROFEN 400 mg with water, up to three times a day as required.

Leave at least 4 hours between doses.

For the relief of pain that is felt along the length of a nerve (neuralgia), swelling and pain in the joints (rheumatic pain) and for non-serious inflammation of joints (non-serious arthritis) the product should be used on the recommendation of a physician, who will also determine the dosage.

Do not take more than 6 capsules of IBUPROFEN 200 mg or 3 capsules of IBUPROFEN 400 mg in 24 hours.

Children over 6 years (from 20 kg to 39 kg bodyweight)

For this age group, IBUPROFEN 200 mg is recommended.

The maximum total daily dose of ibuprofen is 20–30 mg per kg of body weight, divided into 3 to 4 single doses.

Children over 6 years (20 kg – 39 kg bodyweight), take 1 capsule of IBUPROFEN 200 mg;

Children 20 kg – 29 kg up to three times a day as required. No more than 3 capsules (up to 600 mg Ibuprofen) in any 24 hour period. Leave at least 8 hours between doses.
Children 30 kg – 39 kg up to four times a day as required. No more than 4 capsules (up to 800 mg Ibuprofen) in any 24 hour period. Leave at least 6 to 8 hours between doses.

If in children aged from 6 years and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Children under 6 years (< 20 kg bodyweight)

IBUPROFEN 200 mg and IBUPROFEN 400 mg must not be used in children under 20 kg bodyweight (under 6 years of age) due to the amount of active substance in one capsule.

Elderly

In elderly patients the dosage is the same as in adults, but increased caution is necessary.

Hepatic or renal impairment

If you suffer from reduced kidney or liver function, always consult your doctor before using IBUPROFEN. Your doctor will advise you accordingly.

If you do not feel better or if you feel worse after 4 days for pain or 3 days for migraine headache or fever, or if any new symptoms occur, consult your doctor or pharmacist. Do not take for longer than 10 days unless your doctor tells you to.

If you take more IBUPROFEN than you should

If you have taken more IBUPROFEN than you should, or if children have 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 IBUPROFEN

If you have forgotten to take your dose, do not take a double dose to make up for a forgotten dose.

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

4. possible side effects

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

Discontinue use of this product and seek for an immediate medical assistance at the first appearance any of hypersensitivity reaction such as skin rash, mucosal lesions, nettle-rash, a rash of purple spots, a sudden occurrence of swelling around eyes, feeling of distress on the chest with difficult breathing or swallowing, further in epigastric pain or at bleeding from digestive tract (vomiting of blood or stools of black colour).

The side effects which may occur are listed below in groups according to the frequency:

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

headache;
abdominal pain, feeling sick (nausea), indigestion;
various skin rashes, hypersensitivity reactions (such as hives and itching).

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

being sick (vomiting), diarrhoea, constipation, flatulence.

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

problems in the blood cell production (first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, exhaustion, nose and skin bleeding);
sterile inflammation in the meninges (especially in patients with connective tissue disease or systemic lupus erythematosus);
inflammation, ulceration or perforation of digestive tract mucous membrane (black stools and vomiting of blood), mouth inflammation;
inability of the kidneys to excrete wastes (acute kidney failure), blood in the urine and a fever may be signs of damage to the kidneys (papillary necrosis);
liver functions disorders;
severe forms of skin reactions including rash with redness and blistering;
severe hypersensitivity reactions (face, tongue and larynx oedema, dyspnoea, tachycardia, hypotension, severe shock).

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

hearing impairment;
cardiac failure, oedema, high blood pressure;
worsening of existing bowel disease (colitis or Crohn’s disease);
renal insufficiency;
difficulty in breathing (predominantly in patients with bronchial asthma), aggravation of asthma;
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);
increased sensitivity of the skin to sun.

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 internet 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 ibuprofen

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

Store below 25°C, store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the package. 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 informationthe active substance is ibuprofen.

Each capsule contains 200 mg or 400 mg of ibuprofen.

The other ingredients are: macrogol 600, potassium hydroxide 85% (E525), gelatine, purified water, partially dehydrated liquid sorbitol (E420), carmine red 43% (E120).

What IBUPROFEN looks like and contents of the pack

Ibusan 200 mg is transparent, pink colour (carmine red) oval capsule (approximately 13 × 8 mm).

Ibusan 400 mg is transparent, pink/red colour (carmine red) oval capsule (approximately 15 × 10 mm).

Ibusan 200 mg: The size of packing is 12, 24 capsules.

Ibusan 400 mg: The size of packing is 10, 12, 20 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.

Manufacturer

Zentiva A.S, Hlohovec 920 27, Nitrianska 100, Slovak Republic or Sanofi-Aventis

S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy.

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

United Kingdom	IBUSAN 200 mg IBUSAN 400 mg
Italy	IBUPROFENE ZENTIVA
France	IBUPRADOLL 200 mg IBUPRADOLL 400 mg
Portugal	IBALGIN

This leaflet was last revised in 05/2020