Spasmalvex 60 mg/300 mg, soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALVERINE CITRATE; Simeticone

Available from:

Laboratoires Galeniques Vernin

ATC code:

A03AX58

INN (International Name):

ALVERINE CITRATE; Simeticone

Dosage:

60/300 milligram(s)

Pharmaceutical form:

Capsule, soft

Therapeutic area:

alverine, combinations

Authorization status:

Not marketed

Authorization date:

2021-03-12

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Spasmalvex 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 Spasmalvex, soft capsules are and what they are used for
2.
What you need to know before you take Spasmalvex, soft capsules
3.
How to take Spasmalvex, soft capsules
4.
Possible side effects
5.
How to store Spasmalvex, soft capsules
6.
Contents of the pack and other information
1.
WHAT SPASMALVEX, SOFT CAPSULES ARE AND WHAT THEY ARE USED FOR
Spasmalvex, soft capsules contain two active ingredients:
•
Alverine citrate 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 SPASMALVEX, SOFT CAPSULES
DO NOT TAKE SPASMALVEX
•
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 Spasmalvex 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.
Consul

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2021
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spasmalvex 60 mg/300 mg, 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.
Spasmalvex, soft capsule is indicated in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
_ _
The safety and efficacy of Spasmalvex, 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:
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
Health Products Regulatory Authority
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Page 2 of 4
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