NORMITEN 100

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ATENOLOL

MAH:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC_code:

C07AB03

pharmaceutical_form:

TABLETS

composition:

ATENOLOL 100 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

therapeutic_group:

ATENOLOL

therapeutic_area:

ATENOLOL

therapeutic_indication:

Management of angina pectoris and hypertension,including hypertension of renal origin. Late intervention after acute myocardial infarction.

authorization_date:

2010-04-30

PIL

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
NORMITEN
® 25 MG
TABLETS
COMPOSITION
Each tablet contains atenolol as follows:
Atenolol 25 mg
NORMITEN
® 50 MG
TABLETS
COMPOSITION
Each tablet contains atenolol as follows:
Atenolol 50 mg
NORMITEN
® 100 MG
TABLETS
COMPOSITION
Each tablet contains atenolol as follows:
Atenolol 100 mg
For the list of inactive ingredients in the
preparation, see section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT
ON TO OTHERS. IT MAY HARM THEM EVEN IF IT
SEEMS TO YOU THAT THEIR MEDICAL CONDITION
IS SIMILAR.
THIS MEDICINE IS NOT INTENDED FOR USE IN
CHILDREN.
1. WHAT IS THE MEDICINE INTENDED
FOR?
A preparation from the beta-adrenergic receptor
blocker group (beta blockers), for the treatment
of angina pectoris, acute myocardial infarction
(after a heart attack) and hypertension.
THERAPEUTIC GROUP
Selective beta 1 receptor blocker.
2. BEFORE USING THE MEDICINE DO NOT USE NORMITEN IF:
∙ you are sensitive (allergic) to atenolol
or any of the other ingredients of the
medicine (see section 6).
∙ you have suffered in the past from heart
problems, especially uncontrollable heart
failure (which usually causes shortness
of breath and swelling of the ankles),
second- or third-degree heart block (a
condition which can be treated by a
pacemaker), very slow or irregular heart
beats/rate, very low blood pressure or
severe disturbances in blood circulation.
∙ you are suffering from cardiogenic shock,
manifested by a significant reduction
in blood pressure, pallor, restlessness,
fast and weak heartbeat, clammy skin,
stupor.
∙ you have low blood pressure.
∙ you are being treated with intravenous
verapamil or diltiazem

SPC

This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked approved on March 2016
1. Name of the medicinal product
Normiten 25, 50, 100
2. Qualitative and quantitative composition
Atenolol 25, 50, 100 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
4. Clinical particulars
4.1 Therapeutic indications
Normiten is indicated in the treatment of:
• Hypertension.
• Angina pectoris.
• Myocardial infarction.
4.2 Posology and method of administration
Posology
The dose must always be adjusted to individual requirements of the
patients, with the lowest
possible starting dosage.
The following are guidelines:
Adults
_Hypertension _
Initially 25-50 mg once a day, the dosage being increased gradually to
100 mg a day
after two weeks, as needed and tolerated.
_ _
_Angina _
Initially 50 mg once a day, the dosage being increased gradually to
100 mg after
1 week, as needed and tolerated.
_Myocardial infarction _
_ _
For patients who present some days after suffering an acute myocardial
infarction, an
oral dose of Normiten 100 mg daily is recommended for long-term
prophylaxis of
myocardial infarction
.
Older population
Dosage requirements may be reduced, especially in patients with
impaired renal function.
Paediatric population
There is no paediatric experience with Atenolol and for this reason
Normiten is not recommended
for use in children.
Renal failure
Since Atenolol is excreted via the kidneys, the dosage should be
adjusted in cases of severe
impairment of renal function.
No significant accumulation of Atenolol occurs in patients who have a
creatinine clearance greater
than 35 ml/min/1.73 m
2
(normal range is 100–150 ml/min/1.73 m
2
).
For patients with a creatinine clearance of 15–35 ml/min/1.73 m
2
(equivalent to serum creatinine of
300–600 micromol/litre), the oral dose should be 50 mg daily.
For patients with a creatinine clearance of less than 15 ml/min/1.73 m
2
(equivalent to serum
creatinine of greater than 600 micromol/litre