Active ingredients: Indobufene
INDOBUFENE EG 200 mg tablets
Why is Indobufen used - Generic drug? What is it for?
What INDOBUFENE EG is and what it is used for
Indobuphene contains the active ingredient indobufen, belonging to a class of medicines called platelet inhibitors, which improve blood circulation by preventing the formation of clots (thrombi), which can block circulation.
INDOBUFENE EG is used:
- to prevent a narrowing of the bypasses of the arteries of the heart (coronary arteries);
- for the treatment of movement difficulties due to blood circulation problems (intermittent claudication);
Precautions for use What you need to know before taking Indobufen - Generic drug
Do not take INDOBUFENE EG
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- if you have stomach and intestinal lesions (gastro-duodenal ulcer);
- if you have "inflammation of the stomach accompanied by bleeding (haemorrhagic gastritis);
- if you have severe liver and / or kidney problems;
- if you are prone to bleeding (haemorrhagic diathesis);
- if, in the past, after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory medicines (also called NSAIDs), you have experienced breathing difficulties (asthma), allergic-type colds (rhinitis) and skin irritations (hives).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Indobufene.
Use this medicine with caution in the following cases:
- if you have kidney problems (kidney failure), in this case the dose may need to be reduced;
- if you have had stomach or bowel injuries;
- if you are using non-steroidal anti-inflammatory medicines (NSAIDs) or medicines that increase the fluidity of the blood (antiplatelet).
Tell your doctor if you notice any of the following as it may be necessary to reduce the dosage or stop treatment with this medicine:
- skin irritations (hives);
- pain in the center of the abdomen (epigastric pain) and a feeling of heartburn (heartburn), a condition called dyspepsia and which affects digestive disorders.
Interactions Which drugs or foods can modify the effect of Indobufen - Generic drug
Other medicines and INDOBUFENE EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have diabetes and are taking oral (by mouth) medicines that lower blood sugar levels (hypoglycaemics), such as sulfonylureas, you should have blood tests periodically to check your sugar levels.
If you are taking medicines by mouth that increase blood fluidity (oral anticoagulants), such as coumarin and / or heparin derivatives, you should perform the following tests to check for blood clotting:
- prothrombin time;
- other coagulation tests.
Warnings It is important to know that:
Pregnancy, breastfeeding 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.
The use of this medicine is not recommended in case of known or suspected pregnancy, and during breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
INDOBUFENE EG contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Indobufen - Generic drug: Posology
How to take INDOBUFENE EG
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 400 mg per day, to be taken in two divided doses, one every 12 hours.
Take one tablet in the morning after breakfast and one in the evening after dinner.
Elderly patients and / or patients with kidney problems
Your doctor will adjust your dose based on your kidney function as assessed by creatinine clearance (clearance).
In elderly patients over the age of 65, the dose should be evaluated by the physician.
If you forget to take INDOBUFENE EG
Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Indobufen - Generic Medication
If you take more Indobufene than you should
There have been no reported cases of overdose with this medicine. In case of accidental ingestion of an excessive dose, contact your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Indobufen - Generic drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effects concern the gastrointestinal tract and consist of:
- difficulty in digestion (dyspepsia);
- burning sensation in the stomach (heartburn);
- stomach pain (epigastric and abdominal pain);
- constipation or diarrhea;
- abdominal bloating;
- nausea and vomit.
They have rarely been reported
- allergic skin irritations;
- purpura associated with thrombocytopenia, which is a skin disorder associated with bleeding lesions due to a decrease in platelets;
- severe headache (headache).
Cases of
- inflammation of the stomach and / or intestines, accompanied by lesions (erosive peptic ulcer and / or haemorrhagic gastritis), also associated with the presence of blood in the vomit or faeces and with cases of cerebral haemorrhage.
Cases of:
- itching (frequency not known);
- nose bleeding (epistaxis);
- minor bleeding from the gums, lower eye (conjunctiva), lips, bladder and anus (rectum);
- bleeding from the mouth, often after a cough (hemoptysis);
- alteration of some parameters of liver function (increase in transaminase levels and azotemia);
- alteration of some parameters of kidney function (decrease in creatinine clearance).
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 national reporting system at: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
How to store INDOBUFENE EG
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 package after "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What INDOBUFENE EG
- The active ingredient is indobufen. Each tablet contains 200 mg of indobufen
- The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), sodium laurilsulfate, magnesium stearate.
What Indobufene looks like and contents of the pack
Box of 30 divisible tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
INDOBUFENE EG 200 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains: indobufene 200 mg.
Excipients with known effects: This medicinal product contains lactose monohydrate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
The tablets should be administered orally.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Indobuphene is indicated:
• in the prevention of coronary artery bypass occlusion
• for the treatment of intermittent claudication secondary to occlusive pathologies of the peripheral arteries.
04.2 Posology and method of administration
Normally the daily dose is equal to 400 mg, to be administered in two divided doses at 12 hour intervals. It is recommended to take one tablet (200 mg) in the morning after breakfast and one in the evening after dinner.
Since indobufen is mainly eliminated by the kidney, it is necessary to reduce the dosage in proportion to the degree of renal function.
Especially in elderly patients (over 65 years) the dosage must be carefully established by the doctor, bearing in mind that renal function progressively decreases with age.
The following dosage schedule is suggested:
04.3 Contraindications
Indobufen should not be administered to subjects who have shown hypersensitivity to the drug, nor should it be used in the presence of gastro-duodenal ulcer, haemorrhagic gastritis, severe impairment of liver and / or renal function, nor in subjects with haemorrhagic diathesis.
There is a possibility of cross-sensitivity with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs; for this reason the drug should not be administered to patients in whom these drugs have induced symptoms of asthma, rhinitis or urticaria.
04.4 Special warnings and appropriate precautions for use
Caution is recommended in the use of the drug in the presence of previous lesions of the gastrointestinal tract as well as with the simultaneous administration of other antiplatelet drugs or non-steroidal anti-inflammatory drugs. If dyspepsia occurs (e.g. heartburn, epigastric pain) the dose should be reduced or treatment temporarily stopped.
In patients with renal insufficiency the dose should be reduced in relation to the degree of renal function.
Keep out of reach of children.
If allergic reactions occur, such as hives rash, treatment should be discontinued.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
As a consequence of the high degree of binding of indobufen to plasma proteins, there is the possibility of shifting other medicines that bind to proteins. For this reason, periodic assessments of plasma glucose levels should be performed in diabetic patients treated with oral hypoglycemic drugs such as sulfonylureas.
For the same reason the effects of oral anticoagulants (coumarin derivatives) and / or heparin could be increased.
When administered concomitantly with these drugs, prothrombin time and other clotting tests should be determined regularly.
04.6 Pregnancy and breastfeeding
Although animal experiments have not shown fetal harm, it is not recommended to use the drug in known or suspected pregnancy and during lactation.
04.7 Effects on ability to drive and use machines
There is no known interference of indobufen on the ability to drive and use machines.
04.8 Undesirable effects
The most frequent side effects concern the gastrointestinal tract and consist of: dyspepsia, heartburn, epigastric and abdominal pain, constipation, diarrhea, abdominal distension, nausea and vomiting.
Cases of peptic ulcer, erosive ulcer and / or haemorrhagic gastritis, sometimes associated with haematemesis and / or melaena and cases of cerebral haemorrhage, have been reported very rarely.
Cases of epistaxis, hemoptysis, light uncomplicated haemorrhages from the conjunctiva, gums, lips, rectum and bladder have been observed.
Occasionally, increases in transaminase and azotemia values and a decrease in creatinine clearance have been reported. Rarely, allergic skin reactions, purpura associated with thrombocytopenia, headache have been reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported, either accidental or intentional.
Treatment of overdose should be symptomatic and appropriate.
Forced diuresis is effective in enhancing the rate of elimination.
Hemodialysis is not effective in eliminating indobuphene from the general circulation. Possible gastrointestinal alterations can be treated with H2 antagonist antacids.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antiplatelet agents, indobufen.
ATC code: B01AC10.
Indobufen intervenes in platelet function by reversibly blocking platelet cyclooxygenase and thus inhibiting the biosynthesis of thromboxane A2.
The drug exerts its activity rapidly, within the first hours of administration, inhibiting approximately 95% of the production of platelet thromboxane. These effects remain constant during repeated administration twice daily (steady state).
Inhibition of platelet activity (aggregation, adhesiveness, platelet factor 3 and 4 and beta-thromboglobulin) has been extensively documented in various animal species and in humans.
Indobuphene does not interfere with blood clotting parameters; bleeding time prolongation is modest and rapidly reversible upon discontinuation of treatment.
The results of thrombosis studies conducted on different experimental models have shown that indobuphene reduces the thrombogenic potency of vascular prostheses and also prevents death from pulmonary embolism induced by platelet aggregates. An increase in the deformability of red blood cell membranes has been observed in in vivo and in ex vivo studies performed on erythrocytes obtained from patients with peripheral vascular disease treated with indobufen.
Indobufen has an antiplatelet effect due to inhibition of the release reaction of platelet constituents (ADP, serotonin, platelet factor 4, beta-thromboglobulin).
Research in laboratory animals and in humans has shown that indobufen does not interfere with blood clotting parameters and the prolongation of bleeding time is modest and rapidly reversible upon discontinuation of treatment.
05.2 Pharmacokinetic properties
The pharmacokinetics of indobufen are characterized by a high bioavailability, a rapid and complete absorption after oral administration. Peak plasma levels are reached within approximately 2 hours. Food does not affect the bioavailability of the drug. The biological half-life of the drug is approximately 8 hours with an apparent volume of distribution of 15 liters.
About 99% of indobufen is bound to plasma proteins and elimination occurs mainly by the kidney, 75% in the form of conjugated product (glucurunate) and to a small extent as an unaltered compound.
The kinetics of indobufen are linear up to a single administration of 400 mg.
05.3 Preclinical safety data
Acute, subacute and chronic toxicity studies conducted on various animal species (rat, dog, rabbit) have shown that indobufen is well tolerated. It has no teratogenic and embryotoxic effects and is not mutagenic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate
Microcrystalline cellulose
Sodium carboxymethyl starch (type A)
Sodium lauryl sulfate
Magnesium stearate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
30 months.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Cardboard box containing PVC / Aluminum blisters of 30 divisible tablets.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
EG S.p.A., Via Pavia, 6 20136-MILAN
08.0 MARKETING AUTHORIZATION NUMBER
INDOBUFENE EG 200 mg tablets, 30 divisible tablets AIC n. 036765016
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
29 November 2005/13 April 2011