SimAlvia 60mg/300mg, soft capsules

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

ALVERINE CITRATE; Simeticone

Disponível em:

Laboratoires Galeniques Vernin

Código ATC:

A03AX; A03AX58

DCI (Denominação Comum Internacional):

ALVERINE CITRATE; Simeticone

Dosagem:

60/300 milligram(s)

Forma farmacêutica:

Capsule, soft

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Other drugs for functional gastrointestinal disorders; alverine, combinations

Status de autorização:

Not marketed

Data de autorização:

2014-12-05

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SimAlvia 60 mg / 300 mg, soft capsules
Alverine citrate / Simeticone
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 signs of illness 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 SimAlvia, soft capsules are and what they are used for
2.
What you need to know before you take SimAlvia, soft capsules
3.
How to take SimAlvia, soft capsules
4.
Possible side effects
5.
How to store SimAlvia, soft capsules
6.
Contents of the pack and other information
1.
WHAT SIMALVIA, SOFT CAPSULES ARE AND WHAT THEY ARE USED FOR
SimAlvia, soft capsules contain two active ingredients:
•
alverine that belongs to a class of drugs called musculotropic
antispasmodics,
•
and simeticone that belongs to a class of medicines called
antiflatulents.
This medicine reduces the muscle contractions of the gut and
flatulence (gas).
It is used to relieve pain associated with contractions (spasms) of
the intestine and bloating.
This medicine is for adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMALVIA, SOFT CAPSULES
DO NOT TAKE SIMALVIA
•
if you are allergic to alverine citrate or simeticone or any of the
other ingredients of this
medicine (listed in section 6).
•
if you have had any unwanted effects after taking this medicine.
•
if you are allergic to peanut or soya, because SimAlvia, soft capsules
contains soya lecithin.
•
if you have been told by your doctor that you have paralytic ileus.
•
if you are suffering from severe constipation.
•
if you are pregnant.
•
if you are breastfeeding.
Consult your doctor if you have deve

Características técnicas

Health Products Regulatory Authority
16 March 2020
CRN009LMF
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SimAlvia 60mg/300mg, soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 60 mg alverine citrate and 300 mg
simeticone.
Excipient with known effect: soya lecithin (traces).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Soft oblong capsule, size 6, shiny opaque white, containing a thick
whitish suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of abdominal pain in irritable bowel syndrome.
SimAlvia, soft capsule is indicated in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The safety and efficacy of SimAlvia, soft capsules in children under
18 years of age have not been established.
Method of administration
For oral administration
Adults (including the elderly
1 soft capsule two to three times daily at the beginning of meals.
4.3 CONTRAINDICATIONS
Paralytic ileus
Intestinal obstruction
Use in pregnancy and lactation
History of allergic reaction or intolerance to alverine or to any of
the excipients
Hypersensitivity to peanut or soya.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Other causes of gastro intestinal pathology should be outruled, and
patients not improving after 2 weeks of treatment should
be reviewed by physician.
LIVER FUNCTION:
Health Products Regulatory Authority
16 March 2020
CRN009LMF
Page 2 of 4
Elevations in ALT (Alanine Aminotransferase) and AST (Aspartate
Aminotransferase) > twice the upper limit of normal (ULN)
have been reported in patients receiving treatment with
alverine/simeticone. These elevations may be associated with a
concomitant elevation in total serum bilirubin (see section 4.8). In
case of an elevation in hepatic aminotransferases > 3 times
the ULN and/or in the case of jaundice, treatment with
alverine/simeticone should be discontinued.
Patients should be warned to report immediately any signs and symptoms
of u