Isodur 25XL capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Isosorbide mononitrate

Commercializzato da:

Galen Ltd

Codice ATC:

C01DA14

INN (Nome Internazionale):

Isosorbide mononitrate

Dosaggio:

25mg

Forma farmaceutica:

Modified-release capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02060100; GTIN: 5016298060676

Foglio illustrativo

- if you suffer from an under-active thyroid gland (a condition
known as hypothyroidism)
- if you suffer from hypothermia (very low body temperature)
- if you suffer from malnutrition (severe lack of food)
- if you suffer from very poor circulation
- if you have slower than normal bowel movements
If any of the above apply to you, it is important that you tell
your doctor or pharmacist before taking Isodur and they will
decide what to do. It may still be safe for you to take Isodur.
CHILDREN
Isodur Capsules should not be taken by children.
OTHER MEDICINES AND ISODUR CAPSULES
Do not take Viagra (sildenafil – for male erectile dysfunction)
or other phosphodiesterase type-5 inhibitors while you are
taking Isodur. Taking these medicines while you are taking
Isodur could cause a severe and possibly dangerous fall in
blood pressure. This could result in collapse, unconsciousness
and could be fatal. You must not stop taking Isodur to take
these medicines as this will increase your chances of having an
angina attack.
Do not take Isodur with products that contain riociguat, a
medicine used in treating pulmonary hypertension.
It is important that you inform your doctor or pharmacist if you
are taking any of the following medicines:
- Medicines that can lower your blood pressure
- Tricyclic antidepressants (used to treat depression) and
neur
oleptics (used to treat anxiety)
- Ergotamine used for migraine
- Sapropterin used for phenylketonuria (PKU)
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
ISODUR CAPSULES WITH ALCOHOL
Do not drink alcohol while taking Isodur Capsules. Alcohol
could increase the effect of Isodur and lower your blood
pressure too much. If this happens, you may feel dizzy or faint.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. You should
not use Is

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isotard 25XL Capsules/Isodur 25XL Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide-5-mononitrate 25mg per capsule.
Excipient(s) with known effect
Not more than 56mg of sucrose per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard prolonged-release capsule.
Hard gelatin capsule (size 3) with a brown cap and a white body; the
cap is
marked in white ink with “ISM 25”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylactic treatment of angina pectoris.
Isotard 25XL Capsules/Isodur 25XL Capsules are indicated in adults,
including the elderly.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS:
One capsule to be taken in the morning. For patients with higher
nitrate
requirements, the dose may be increased to two capsules taken
simultaneously.
The lowest effective dose should be used.
Attenuation of effect has occurred in some patients being treated with
prolonged-release preparations. In such patients intermittent therapy
may be
more appropriate (see section 4.4).
Treatment with Isotard 25XL Capsules/Isodur 25XL Capsules, as with any
other nitrate, should not be stopped suddenly. Both dosage and
frequency
should be tapered gradually (see section 4.4).
ELDERLY POPULATION:
There is no evidence of a need for routine dosage adjustment in the
elderly,
but special care may be needed in those with increased susceptibility
to
hypotension.
PAEDIATRIC POPULATION:
This product is not recommended for use in children. The safety and
efficacy
of these capsules in children has not yet been established.
Method of administration
For oral use.
The capsules must be swallowed whole and can be taken with water. They
must not be chewed or crushed (see section 5.2).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
This product should not be used in cases of acute myocardial
infarction with
low filling pressure, acute circulatory fail