TEVETEN PLUS 600/12.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE
Dosage:
600/12.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN PLUS 600 MG/12.5 MG, FILM-COATED TABLETS
Eprosartan and hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS INFORMATION
FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• 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).
The full name of your medicine is Teveten Plus 600 mg/12.5
mg, film-coated tablets. In this leaflet the
shorter name Teveten Plus is used.
WHAT IS IN THIS LEAFLET:
1.
What Teveten Plus is and what it is used for
2.
What you need to know before you take Teveten Plus
3.
How to take Teveten Plus
4.
Possible side effects
5.
How to store Teveten Plus
6.
Contents of the pack and other information
1.
WHAT TEVETEN PLUS IS AND WHAT IT IS USED FOR
Teveten Plus is used:
• to treat high blood pressure.
Teveten Plus contains two active ingredients: eprosartan
and hydrochlorothiazide.
• EPROSARTAN belongs to
a group of medicines called “angiotensin II receptor antagonists”. It blocks the
action of a substance in your body called ‘angiotensin
II’. This substance causes your blood vessels to
narrow. This makes it
more difficult for the blood to flow through the vessels and so your blood
pressure increases. By blocking this substance, the vessels
relax and your blood pressure decreases.
• HYDROCHLOROTHIAZIDE belongs to a group
of medicines called
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten Plus 600 mg/12.5 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 600 mg eprosartan and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Butterscotch-coloured, capsule-shaped film-coated tablets
The inscription of the tablet is “5147” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension. Teveten Plus 600 mg/12.5 mg is indicated in patients whose blood pressure is not adequately
controlled on eprosartan alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is one tablet Teveten Plus 600 mg/12.5 mg once daily, which should be taken in the morning.
The switch from eprosartan monotherapy to the fixed combination can be considered after 8 weeks of blood pressure
stabilization. Teveten Plus 600 mg/12.5 mg can be taken with or without food.
Elderly
No dose adjustment is required in the elderly, although limited information is available in this population.
Paediatric Population
As safety and efficacy of administration to children have not been established, treatment of children and adolescents <
18 years with Teveten Plus 600 mg/12.5 mg is not recommended.
Hepatic Impairment
The use of Teveten Plus in patients with mild to moderate hepatic impairment is not recommended since there is
currently only limited experience of eprosartan mesylate in this patient group. In patients with severe hepatic
impairment Teveten Plus is contraindicated (see section 4.3).
Renal Impairment
In patients with mild to moderate renal impairment (creatinine clearance
30 ml/min) dose adjustment is not
necessary. Teveten Plus is contraindi
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