DILATAM 120 SR

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

DILTIAZEM HYDROCHLORIDE

Διαθέσιμο από:

ABIC LTD.

Φαρμακολογική κατηγορία (ATC):

C08DB01

Φαρμακοτεχνική μορφή:

TABLETS SLOW RELEASE

Σύνθεση:

DILTIAZEM HYDROCHLORIDE 120 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Θεραπευτική ομάδα:

DILTIAZEM

Θεραπευτική περιοχή:

DILTIAZEM

Θεραπευτικές ενδείξεις:

Hypertension: either as monotherapy or with other antihypertensive medications such as diuretics. Angina pectoris: chronic stable angina, angina due to coronary artery spasm.

Ημερομηνία της άδειας:

2012-05-31

Φύλλο οδηγιών χρήσης

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
DILATAM 120 SR
SLOW-RELEASE TABLETS
COMPOSITION
Each tablet contains:
Diltiazem (as hydrochloride) 120 mg
For
information
about
inactive
ingredients
see
section
6
–
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have additional questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for your treatment. Do not
pass it on to others. It may harm them even if it seems to you that
their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treatment of hypertension and angina pectoris.
THERAPEUTIC CLASS: calcium channel blockers.
These tablets have been prescribed for you for treatment of
angina pectoris (chest pain caused by insufficient amount of
oxygen reaching the heart) or for treatment of high blood pressure
(hypertension). The tablets contain the active ingredient diltiazem,
which helps more blood reach the heart and reduces blood
pressure.
DILATAM 120 SR TABLETS WERE DESIGNED TO WORK WELL FOR 12
HOURS. IF THE TABLETS ARE CRUSHED OR CHEWED, THE DOSAGE THAT
WAS SUPPOSED TO LAST FOR 12 HOURS MAY BE ABSORBED RAPIDLY
IN YOUR BODY. THIS MAY BE DANGEROUS AND CAUSE SERIOUS
PROBLEMS, SUCH AS AN OVERDOSE.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to
any of the other ingredients this medicine contains (see
section 6 – “Additional information”).
•
You are pregnant or there is a possibility that you might
become pregnant.
•
You
have
an
irregular
or
severely
slow
heartbeat
(slowing of the heartbeat to less than 40 beats per
minute).
•
You have heart failure (a condition that may cause
shortness of breath and swollen ankles) or problems
with blood flow to the lungs.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE TREATMENT

Αρχείο Π.Χ.Π.

Dilatam_120_SR_LC+KL_Notification_SPC_12/2021
SUMMARY OF PRODUCT CHARACTERISTICS
DILATAM 120 SR
TABLETS SLOW RELEASE
1. NAME OF THE MEDICINAL PRODUCT
Dilatam 120 SR
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 120 mg diltiazem hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet slow release
White to off-white, round tablet, debossed "120" on one side and "D"
on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
either as monotherapy or with other antihypertensive medications such
as diuretics.
Angina pectoris:
Chronic stable angina.
Angina due to coronary artery spasm.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Note: Dilatam 120 SR Tablets are not suitable for use in patients who
require less than 120 mg per
dose, since the tablet is not divisible.
Hypertension
The usual recommended dosage of Dilatam 120 SR Tablets is one tablet
twice daily. The dosage
should be individualized and adjusted to the patient's needs.
The maximum antihypertensive effect is achieved usually by 14 days of
chronic therapy. The usual
optimum dosage range reported in clinical trials was 240-360 mg/day.
Angina Pectoris
The usual recommended dosage of Dilatam 120 SR Tablets is one tablet
twice daily. The dosage
should be individualized and adjusted to the patient's needs.
Concomitant Drug Therapy
An additive antihypertensive effect occurs when diltiazem is
coadministered with other
antihypertensives. Adjust the dose of Dilatam 120 SR or the
concomitant antihypertensive
accordingly.
Sublingual nitroglycerin may be taken as required to abort acute
anginal attacks during Dilatam 120
SR therapy. Dilatam 120 SR may be also coadministered with
prophylactic nitrate therapy.
Dilatam_120_SR_LC+KL_Notification_SPC_12/2021
4.3 CONTRAINDICATIONS
Hypersensitivity to diltiazem or to any of the excipients
listed in section 6.1.
Pregnancy and in women of child bearing capacity.
Patients with severe bradycardia (less than 40 bpm), second or third
degree heart block, sick