Ibusoft 400mg Capsules Soft
^bvrprrofigri1 c28\5nrrig.3/ F^profTn b40'0gmg paapagL?Ief asc>:ft _ UK/H/5306-07/001-002/DC name
change
Drug Product: Ibusoft 200mg gel cps UK-H-5306-01
Package leaflet - Information for the patient
<PRODUCT NAME> 200 mg <PRODUCT NAME> 400 mg Capsule, soft 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 <PRODUCT NAME> 200 mg or <PRODUCT NAME> 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 liquid capsules 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 Do not 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
Talk to your doctor or pharmacist before taking IBUPROFEN (or any other ibuprofen-containing)
- if you suffer from kidney or liver disorder
- if you suffer from bronchial asthma
- if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders due to an increased risk of allergic reactions
- if you are also taking drugs which could increase the risk of gastrotoxicity or bleeding (see below)
- if you suffer from systemic lupus erythematosus (immunity system disorder) or mixed connective tissue disease (the risk of aseptic meningitis).
- if you suffer from inflammatory ulcerous disease of digestive tract such as Crohn's disease or ulcerative colitis
- if you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist
Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Gastrointestinal bleeding, ulceration or perforation can occur at anytime 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. In particular, tell them if you are taking:
- acetylsalicylic acid or 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,
- acetylsalicylic acid (low dose) since the blood-thinning effect may be impaired,
- medicines against high blood pressure and 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 clearence 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), medicines for thinning the blood (such as warfarin) 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.
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
Drug Product: Ibusoft 200mg gel cps UK-H-5306-01
^bvrprrofigri1 c28\5nrrig.3/ F^profTn b40'0gmg paapagL?Ief asc>:ft _ UK/H/5306-07/001-002/DC name change
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.
This product contains sorbitol. 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
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.
Drug Product: Ibusoft 200mg gel cps UK-H-5306-01
^bvrprrofigri1 c28\5nrrig.1/ F^profn b40'0gmg paapagL?Ief asc>:ft _ UK/H/5306-07/001-002/DC name change
• 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. Patients with impaired kidney or liver function
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
Seek for a medical assistance immediately in case of overdose or an accidental ingestion of capsules by a child.
If you forget to take IBUPROFEN
If you have forgotten to take your dose, do not take more than the usual recommended amount at your next 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 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, hypersensivity reactions (such as hives and itching),
Rare (may affect up to 1 in 1,000 people):
being sick (vomiting), diarrhoea, constipation, flatulence, disturbance of colour perception, blurred vision, tinnitus, (usually reversible).
<PRODUCT NAME> 400 mg is transparent, pink/red colour (carmine red) oval capsule (approximately 15 x 10 mm).
<PRODUCT NAME>200 mg: The size of packing is 12, 24 capsules.
<PRODUCT NAME>400 mg: The size of packing is 10, 12, 20 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally] Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
UK/H/5306/001-002/DC
United Kingdom
Bulgaria
Czech Republic
Hungary
Italy
Poland
Romania
Slovakia
IBUSOFT 200mg
IBUSOFT 400mg_
HBARrUH PAnU^ ^YHUBP 200 HBARrUH PAnH^ 400 mg IBALGIN RAPIDCAPS 200mg IBALGIN RAPIDCAPS 400mg ALGOFLEX RAPID MINI 200 mg ALGOFLEX RAPID 400 mg NOVALGIDOL 200mg NOVALGIDOL 400mg IBALGIN RAPID IBALGIN RAPID FORTE IBALGIN EXPRESS 200 mg IBALGIN EXPRESS 400 mg IBALGIN RAPIDCAPS 200mg IBALGIN RAPIDCAPS 400mg
mg
|
UK/H/5307/001-002/DC | ||
|
IBUSAN 200 mg IBUSAN 400 mg | ||
|
United Kingdom | ||
|
Italy |
IBUPROFENE ZENTIVA | |
|
France |
DOLOROFEN 200 mg (or DOLOPRAFEN 200 mg) | |
|
DOLOROFEN 400 mg (or DOLOPRAFEN 400 mg) | ||
|
Portugal |
IBALGIN | |
This leaflet was last revised in <MM/YYYY>
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), difficulty in breathing (predominantly in patients with bronchial asthma), aggravation of asthma, inflammation, ulceration or perforation of digestive tract mucous membrane (black stools and vomiting of blood), mouth inflammation, worsening of existing bowel disease (colitis or Crohn’s disease), 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 hypersensivity reactions (face, tongue and larynx oedema, dyspnoea, tachycardia, hypotension, severe shock).
Not known (frequency cannot be estimated from available data) hearing impairment
Z NTIVA CONFIDENTIAL Module 1 Page 27
Part of the sanofi-aventis group
Reporting of side effects