Alverine 60mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Alverine citrate

Inapatikana kutoka:

NorthStar Healthcare Unlimited Company

ATC kanuni:

A03AX08

INN (Jina la Kimataifa):

Alverine citrate

Kipimo:

60mg

Dawa fomu:

Oral capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01020000; GTIN: 05051089990343

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPASMONAL
® 60MG CAPSULES
(ALVERINE CITRATE)
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.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
•
The name of this medicine is Spasmonal
®
60mg Capsules but will be
referred to as Spasmonal throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET:
1) What Spasmonal is and what it is used for
2) What you need to know before you take Spasmonal
3) How to take Spasmonal
4) Possible side effects
5) How to store Spasmonal
6) Contents of the pack and other information
1) WHAT SPASMONAL IS AND WHAT IT IS USED FOR
Spasmonal is an “anti-spasmodic” medicine. 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 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.
Spasmonal can also be used for a condition of the large intestine
called
painful diverticular disease of the colon and to relieve period pains.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SPASMONAL
DO NOT TAKE SPASMONAL IF:
•
You are allergic (hypersensitive) to alverine citrate or any other
ingredients of Spasmonal.
•
Your doctor has told you that you have obstruction of the gut or that
your small bowel is not working properly.
WARNINGS AND PRECAUTIONS
If this is the first time you have had these symptoms, consult your
doctor
before using any treatment.
Do

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alverine Citrate 60mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60mg alverine citrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsules
Hard gelatin capsules, size 3 with opaque blue colour body and opaque
grey colour
cap marked ‘I 64’ containing white to off-white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
Posology
_ADULTS AND THE ELDERLY _
1 or 2 capsules of 60mg or 1 capsule of 120mg, one to three times
daily.
_CHILDREN BELOW THE AGE OF 12 YEARS _
Not recommended.
Method of administration
For oral use.
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 Hard
Capsules, it may not be
the right treatment for you. See your doctor as soon as possible if:
•
you are aged 40 years or over
•
you have passed blood from the bowel
•
you are feeling sick or vomiting
•
you have lost your appetite or lost weight
•
you are looking pale and feeling tired
•
you are suffering from severe constipation
•
you have a fever
•
you have recently travelled abroad
•
you are or may be pregnant
•
you have abnormal vaginal bleeding or discharge
•
you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms or if your
symptoms
worsen, or if they do not improve after 2 weeks treatment.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTER