NORMOPRESAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLONIDINE HYDROCHLORIDE

Available from:

RAFA LABORATORIES LTD

ATC code:

C02AC01

Pharmaceutical form:

TABLETS

Composition:

CLONIDINE HYDROCHLORIDE 150 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

CLONIDINE

Therapeutic area:

CLONIDINE

Therapeutic indications:

Antihypertensive.

Authorization date:

2014-06-30

Patient Information leaflet

1
Patient Leaflet According to the Pharmacists' Regulations
(Preparations) - 1986
This medicine is sold with a doctor's prescription only
Normopresan
Tablets
Active ingredient:
Each tablet contains: 150 mcg (microgram) Clonidine hydrochloride.
For a list of inactive ingredients, please see section 6. See also
'Important information about some of
the medicine's ingredients' in section 2.
Read this entire leaflet carefully before using this medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
What is the medicine intended for?
The medicine is intended for the treatment of high blood pressure
(Hypertension).
Therapeutic group:
Centrally acting alpha-2 (α
2
) adrenergic agonist and imidazoline receptor agonist.
2.
Before using the medicine
Do not use the medicine if:
•
Do not use if you are sensitive
(allergic) to the active ingredient or to any of the other ingredients
this medicine contains (for a list of inactive ingredients, please see
section 6).
•
Do not use this medicine if you suffer from slow heart rate
(Bradycardia).
Special warnings regarding the use of this medicine:
•
If you are taking additional medicines that affect the heart rate such
as digoxin, calcium channel
blockers or beta blockers, your heart rate should be monitored (see
also 'Tests and follow up' in
section 3).
•
Using this medicine may cause dryness in the eyes; this may be a
problem for patients wearing
contact lenses.
•
Inform your doctor about taking this medicine if you are scheduled to
undergo any surgery (including
dental surgery).
•
Dizziness or faintness may occur while taking the medicine, especially
when getting up from a lying
or sitting position, when standing for a long period of time, during
physical exercise or in hot
weather.
•
Elderly patients may be

Summary of Product characteristics

Normopresan
-DL-Aug 2023-03
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Normopresan
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mcg (microgram) of clonidine hydrochloride.
Excipients with known effect:
Each tablet contains 36 mg of lactose.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Pale blue scored tablets marked N/150.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antihypertensive
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Normopresan Tablets are for oral administration only.
ADULTS:
Treatment of hypertension requires regular medical supervision. The
dose of
Normopresan must be individualized according to the patient's blood
pressure
response.
As an initial daily dose in mild to moderate forms of hypertension, 75
mcg (half a
tablet) to 150 mcg (one tablet) twice daily are sufficient in most
cases. After a
period of 2-4 weeks the dose may be increased if necessary until the
desired
response is achieved.
Usually doses above 600 mcg per day do not result in a further marked
drop in
blood pressure. In severe hypertension it might be necessary to
increase the
single dose further to 300 mcg; this could be repeated up to three
times daily
(900 mcg).
Patients changing to treatment with Normopresan should have their
existing
therapy reduced gradually, while Normopresan is added to the regimen.
Although concurrent use of a thiazide diuretic may be a valuable
adjuvant in
many hypertensive patients, when administered alone, Normopresan will,
in
many cases, provide full control of blood pressure. Nevertheless, the
use of a
diuretic may aid in overcoming tolerance to clonidine and permit
reduction of
2
clonidine dosage.
Normopresan may be added to an existing antihypertensive regimen where
blood pressure control has not been satisfactorily achieved. If
side-effects with
existing therapy are troublesome the concomitant use of Normopresan
may
allow a lower dose of the established regimen to be employed. Patients
changing trea