Alverine citrate 120mg capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALVERINE CITRATE

Available from:

Blackrock Pharmaceuticals Limited

ATC code:

A03AX; A03AX08

INN (International Name):

ALVERINE CITRATE

Dosage:

120 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other drugs for functional gastrointestinal disorders; alverine

Authorization status:

Authorised

Authorization date:

2016-03-11

Patient Information leaflet

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, please ask your doctor or
pharmacist.
- This medicine is 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 Alverine Citrate Capsules are and what it is used for
2. What you need to know before you take Alverine Citrate
Capsules
3. How to take Alverine Citrate Capsules
4. Possible side effects
5. How to store Alverine Citrate Capsules
6. Contents of the pack and other information
The name of your medicine is Alverine Citrate Capsules. The
capsules contain a medicine called alverine citrate. Alverine
Citrate Capsules belong to a group of medicines called
anti-spasmodics. It relaxes the muscles in the intestine (gut) and
uterus (womb). This helps stop the pain you feel when the
muscles become tense.
It is used to help people aged 12 and above who have Irritable
Bowel Syndrome (IBS). Some of the symptoms of IBS are:
• Abdominal pains like cramp, which come and go
• Diarrhoea
• Constipation
• Feeling full and bloated
• Wanting to go to the toilet urgently.
Sometimes these symptoms are worse if you are worried or
under stress.
Alverine Citrate Capsules can also be used for a condition of the
large intestine called painful diverticular disease of the colon, and
to relieve period pains.
DO NOT TAKE ALVERINE CITRATE CAPSULES IF:
• you are ALLERGIC (HYPERSENSITIVE) to alverine citrate or any
other ingredient in this medicine (see section 6)
• your doctor has told you that you have OBSTRUCTION OF THE GUT or that your SMALL BOWEL IS NOT WORKING PROPERLY
• you are pregnant and/or breast- feeding.
You should not take Alverine Citrate Capsules if an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alverine citrate 120mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains alverine citrate equivalent to 120mg alverine
citrate.
Excipients with known effect:
Carmoisine (E122): 0.0420 mg/Capsule.
Tartrazine (E102): 0.0180 mg/Capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Gelatin capsule shell size #1, with blue cap (marked as ALV) and white
body (marked as 120), filled with white to off-
white granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alverine citrate is indicated for the relief of smooth muscle spasm,
in conditions such as irritable bowel syndrome,
painful diverticular disease of the colon and primary dysmenorrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
For oral administration.
Capsules should be swallowed whole.
Posology
Recommended dose and dosage schedules:
ADULTS (INCLUDING THE ELDERLY): 1 capsule one to three times daily.
CHILDREN BELOW THE AGE OF 12 YEARS: not recommended.
4.3 CONTRAINDICATIONS
Paralytic ileus, intestinal obstruction, hypersensitivity to the
active substance or to any of the excipients listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Additional warnings to be included in the Patient Information Leaflet:
If this is the first time you have had these symptoms, consult your
doctor before using any treatment.
If any of the following apply do not use Alverine Citrate 120 mg; it
may not be the right treatment for you. See your
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___