Cariban 10 mg/10 mg modified-release hard capsules

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

DOXYLAMINE SUCCINATE; Pyridoxine hydrochloride

Inapatikana kutoka:

Italfarmaco S.p.A.

ATC kanuni:

R06AA59

INN (Jina la Kimataifa):

DOXYLAMINE SUCCINATE; Pyridoxine hydrochloride

Dawa fomu:

Modified-release capsule, hard

Eneo la matibabu:

doxylamine, combinations

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2020-05-15

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAVALEM 10 MG/10 MG MODIFIED-RELEASE CAPSULES, HARD
Doxylamine Succinate / Pyridoxine Hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important
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 symptoms 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.
WHAT IS IN THIS LEAFLET:
1.
What Navalem is and what it is used for
2.
What you need to know before you take Navalem
3.
How to take Navalem
4.
Possible side effects
5.
How to store Navalem
6.
Contents of the pack and other information
1. WHAT NAVALEM IS AND WHAT IT IS USED FOR
This medicine belongs to a group of medicines called antiemetics and
antinauseants and is indicated for
symptomatic treatment of nausea and vomiting during pregnancy in
adults.
Navalem contains two medicines (‘active substances’) called:
‘doxylamine succinate’ and ‘pyridoxine
hydrochloride’. Doxylamine succinate belongs to a group of medicines
called ‘antihistamines’. Pyridoxine
hydrochloride is another name for Vitamin B6”
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAVALEM
DO NOT TAKE NAVALEM:
-
If you are allergic to doxylamine, pyridoxine, or any of the other
ingredients of this medicine listed
in section 6.
-
If you are hypersensitive to antihistamines (allergy medications)
derived from ethanolamine (such
as diphenhydramine or carbinoxamine).
-
If you are taking antidepressants such as monoamine oxidase inhibitors
(MAOIS) since XXXX can
intensify and extend the adverse effects on the nervous system.
-
If you are taking potent inhibitors of the CYP450 isoenzymes.
-
If you suffer from porphyria (a very rare metabolic disorder)
-
If you have problems of hered

Tabia za bidhaa

Health Products Regulatory Authority
01 March 2024
CRN00DKXR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cariban 10 mg/10 mg modified-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Doxylamine succinate ……………….. 10 mg
Pyridoxine hydrochloride ……………. 10 mg
Excipient with known effect: Sucrose (79.5 mg per capsule).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release hard capsule.
Green capsule, size 3, containing two types of modified-release
pellets one for each active ingredient, one containing
Pyridoxine hydrochloride and the other containing Doxylamine
succinate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cariban is indicated for the symptomatic treatment of nausea and
vomiting during pregnancy in adults who do not respond to
conservative management.
Limitations of use: The combination doxylamine/pyridoxine has not been
studied in case of hyperemesis gravidarum (see
section 4.4.).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is:
If nauseas are in the morning take 2 capsules at bedtime (Day 1). If
this dose controls symptoms the next day, continue taking
two capsules daily at bedtime. However, if symptoms persist into the
afternoon of Day 2, the patient should continue the usual
dose of two capsules at bedtime (Day 2) and on Day 3 take three
capsules (one capsule in the morning and two capsules at
bedtime). If these three capsules do not adequately control symptoms
on Day 3, the patient can take four capsules starting on
Day 4 (one capsule in the morning, one capsule mid-afternoon and two
capsules at bedtime).
The maximum recommended dose is four capsules (one in the morning, one
in the mid-afternoon and two at bedtime) daily.
_Special populations_
_ _
_Hepatic impairment_
No pharmacokinetic studies have been conducted in hepatic impaired
patients.
No data is available on differences in the pharmacokinetics of the
combination of doxylamine succi