Medica RCP |Irbavel Plus 300mg/12.5mg | Indications | Side Effects | Composition | Route | all.price

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03-05-2023 : 769 Pharmacists work as Medical Representative, of which 39 work as Senior Medical Representative * 02-06-2020 : 216 non Pharmacists work as Medical Representative, and 54 work as Senior Medical Representative * 05-06-2023 : In Lebanon, 88 generic medicinal products are more expensive than their Originators * 31-12-2019 : A medicinal product refused in Europe is marketed in Lebanon * 05-06-2023 : At least 332 medicinal products are available on the Lebanese market and are not available in the country of origin * 05-06-2023 : The price of the most expensive medicine available in Lebanon is 30434557 LL * 05-06-2023 : At least 1309 medicinal products are more expensive in Lebanon than in the countries of origin * 01-01-2019 : Daktavira, a generic of Daklinza, is registered in Lebanon but has no public price * 31-12-2019 : 352 medicinal products have been declared as non-marketed or withdrawn * 09-11-2021 : 64.72% of lebanese pharmacists are female * 31-12-2019 : 486 medicines were submitted to the Ministry of Health for a marketing authorization, and 514 medicines were registered to date * 15-06-2018 : The Minister of Public Health, has decided to suspend the commercialization of AB Slim (Ab Care Medical Herbs), which contains sibutramine, sildenafil and phenolphthalein * 01-06-2020 : Some Non-Marketed medicines are still imported * 01-06-2020 : Ixempra, a medicinal product withdrawn in Europe is imported to lebanon * 01-06-2020 : A vaccine made in India, removed from WHO list of prequalified vaccines, is submitted for registration in Lebanon * 01-06-2020 : Lebanon has 14 CROs, and is ranked as one of the largest countries in the world in clinical studies. According to the WHO, 817 clinical studies are currently conducted in Lebanon. * 05-01-2021 : * 01-10-2023 : Adakveo is now withdrawn from use in the European Union due to lack of therapeutic efficacy *

Products » Items » Irbavel Plus 300mg/12.5mg

Contraindicated
Foetotoxicity

Not recommended
Can inhibit the milk production

Irbavel Plus 300mg/12.5mg :
Type	Medicine Authorised
Originator	CoAprovel 300mg/12.5mg
Agent	Benta Trading Co
Distributor	Benta Trading Co
Laboratory	Benta Laboratories
Manufacturer	Benta SAL
Manufacturing Type	G
Origin	Lebanon
ATC	C09DA04

Irbavel Plus 300mg/12.5mg :

Oral

Irbavel Plus 300mg/12.5mg :

C Cardiovascular system

C09 Agents acting on the renin-angiotensin system

C09D Angiotensin II receptor blockers, combinations

C09DA Angiotensin II receptor blockers and diuretics

C09DA04 Irbesartan and diuretics

Irbavel Plus 300mg/12.5mg :

Hydrochlorothiazide : 12.5mg

Irbesartan : 300mg

Irbavel Plus 300mg/12.5mg :

Adults : Hypertension 1 tablet per day

Irbavel Plus 300mg/12.5mg :

Hypromellose (Hydroxypropylmethyl cellulose) (HPMC) (E464)

Lactose *

Magnesium stearate (E470b)

Microcrystalline cellulose (E460(i)) (Avicel PH-102)

PEG (Polyethylene glycol) (Macrogol) Digestive disorders

Povidone (E1201)

Red Iron Oxide (E172ii) CI77491

Sodium starch glycolate (primojel)

Titanium dioxide (E171) (CI 77891)

Yellow iron oxide (E172iii) (Opadry 85F32004) CI 77492

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Irbavel Plus 300mg/12.5mg :

Revision Date : 28/06/2012

Frequency	Percentage
Very Common	≥ 1/10
Common	≥ 1/100 - < 1/10
Uncommon	≥ 1/1,000 - < 1/100
Rare	≥ 1/10,000 - < 1/1,000
Very Rare	< 1/10,000
Unknown	Cannot be Estimated

Effect	Frequency
Agranulocytosis	Not known
Anaphylactic reactions	Not known
Angioedema (Angioneurotic oedema) (Quincke oedema)	Not known
Angle closure glaucoma	Not known
Aplastic anemia	Not known
Arrhythmia	Not known
Arthralgia (Pain joint) (Joint ache)	Not known
Asthenia	Not known
Blood cholesterol increased	Not known
Blood creatine phosphokinase increased	Common
Blood creatinine increased	Common
Blood potassium decreased	Uncommon
Blood sodium decreased	Uncommon
Blood triglycerides increased	Not known
Blood urea increased	Common
Bone marrow failure	Not known
Chest pain	Uncommon
Constipation	Not known
Cough	Not known
Cutaneous lupus erythematosus	Not known
Cutaneous vasculitis	Not known
Decreased appetite	Not known
Depression	Not known
Diarrhoea (Diarrhea)	Uncommon
Dizziness	Common
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance)	Not known
Dyspepsia	Not known
Electrolyte imbalance	Not known
Epigastric discomfort	Not known
Fatigue	Common
Flushing	Uncommon
Glucosuria (Glycosuria)	Not known
Haemolytic anemia	Not known
Headache	Not known
Hepatic function abnormal	Not known
Hepatitis	Not known
Hyperglycaemia	Not known
Hyperkalaemia	Not known
Hypersensitivity	Not known
Hyperuricaemia	Not known
Hypokalaemia	Not known
Hyponatraemia (Hyponatremia)	Not known
Hypotension	Uncommon
Jaundice	Uncommon
Jaundice cholestatic (Cholestatic icterus)	Not known
Leucopenia (Leukopenia)	Not known
Libido disorder	Uncommon
Lyell Syndrome (Toxic epidermal necrolysis)	Not known
Micturition disorder	Common
Muscle spasms	Not known
Myalgia	Not known
Myopia	Not known
Nausea	Common
Necrotizing vasculitis	Not known
Neutropenia	Not known
Oedema	Uncommon
Oedema peripheral	Uncommon
Orthostatic dizziness	Uncommon
Orthostatic hypotension	Not known
Pancreatitis	Not known
Paraesthesia (paresthesia)	Not known
Photosensitivity reaction	Not known
Pneumonitis	Not known
Pulmonary oedema	Not known
Pyrexia	Not known
Renal failure	Not known
Renal impairment	Not known
Respiratory distress	Not known
Restlessness	Not known
Sexual dysfunction	Uncommon
Sialadenitis	Not known
Skin rash	Not known
Sleep disorder (Sleep disturbance)	Not known
Syncope	Uncommon
Tachycardia	Uncommon
Thrombocytopenia (Thrombopenia)	Not known
Tinnitus	Not known
Tubulointerstitial nephritis	Not known
Urticaria	Not known
Vasculitis	Not known
Vertigo	Not known
Vision blurred	Not known
Vomiting	Common
Xanthopsia	Not known

Irbavel Plus 300mg/12.5mg :

Lebanon

Form	Tablet, Film-Coated
Package Size	Box of 30
Strength	300mg/12.5mg
Storage Condition	<30°C protect from humidity & light
Public Price	559294,45 L.L.
Stratum	A1
NSSF	✔
Quarantine	✘
Reg. Number	17621/1
Submission date	2021
Registration Year	2021

● Country:	Lebanon
● Form:	Tablet, Film-Coated
● Package Size:	Box of 30
● Public Price:	559294.45 LBP	( 559,294.45 LBP )
● Pack size unit used:	30
● Cost/Unit:	18643,15 LBP	( 18,643.00 LBP )
● Pricing Date:	03/10/2025

P.P. =	Public Price
P/U =	Price Per Unit

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