Spasmin

Main information

  • Trade name:
  • Spasmin Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Spasmin Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19930132
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet(RiMUP)

SPASMIN TABLET

Dicyclomine hydrochloride (20mg)

1

What is in this leaflet

1. What Spasmin is used for

2. How Spasmin works

3. Before you use Spasmin

4. How to use Spasmin

5. While you are using it

6. Side effects

7. Storage and Disposal of Spasmin

8. Product description

9. Manufacturer and Product Registration

holder

10.Date of revision

What Spasmin is used for

For treatment of irritable bowel syndrome,

spasm related constipation, colon

inflammation, pyloric sphincter and biliary

movement disorder.

How Spasmin works

Dicyclomine is a medicine which has a

direct action in reducing spasm and pain of

the gastrointestinal tract.

Before you use Spasmin

- When you must not use it

- Do not take Spasmin if allergic to

dicyclomine or to other ingredients in

the product.

- Not recommended for use in:

- enlargement of the prostate gland

- intestinal obstruction due to paralysis of

the intestinal muscles

- pyloric stenosis (blockage of stomach to

the intestines).

- in infants under the age of six months.

- Before you start to use it

Be careful when using:

- in the elderly

- glaucoma (increased eye pressure)

- urinary retention, obstructive uropathy

(blocking of normal urine flow)

- fever

- heart disease, increased heart rate

- over active thyroid gland

- histal hernia (displacement of stomach)

with back flow of stomach contents into

the esophagus, intestinal obstruction

- acute bleeding with unstable heart and

blood status

- kidney or liver function impairment

- myasthenia gravis (muscle weakness)

- colon ulcer and inflammation

- Taking other medicines

Tell the doctor if you are taking:

- narcotic analgesics (for pain)

- antimuscarinic medicine

- amantadine (antiviral)

- monoamine oxidase (MAO) inhibitors

- phenothiazines or tricyclic antidepressant

- antacid or antidiarrhoeal

- antihistamine

How to use Spasmin

- How much to use

Adults: oral, 10 – 20mg

the dosage being

adjusted as needed and tolerated up to

160mg daily.

Children over 2 years: oral, 10mg, the

dosage being adjusted as needed and

tolerated, or as directed by physician.

Follow all directions given by your doctor

and pharmacist carefully. They may differ

from the information contained in this

leaflet. If you do not understand the

instructions on the label, ask your doctor

or pharmacist for help.

- When to use it

Use three or four times a day or as directed

by the doctor or pharmacist.

- How long to use it

Continue medication as directed by doctor.

- If you forget to use it

Consult your doctor or pharmacist on

what you should do if you forget to use it.

Take the missed dose as soon as you

remember. If it is almost time for your

next dose, wait until then to take the

medicine and skip the missed dose. Do

not take a double dose to make up for

the missed dose.

- If you use too much (overdose)

Contact your doctor immediately or go

to the Emergency Department of your

nearest hospital, if you think you or

anyone else may have taken too much

of this medicine. Do this even if there

are no signs of discomfort or poisoning.

You may need urgent medical attention.

Signs of overdose include increased heart

rate, rapid breathing, increased body

temperature, restlessness, confusion and

excitement, hallucinations (hear, smell,

taste or feel things that do not exist)

leading to delirium (confused state), rash

on face and upper body, central nervous

system depression and circulatory failure.

While you are using Spasmin

- Things you must do

Take your medicine exactly as the doctor

has told you.

Tell the doctor, dentist and pharmacist

treating you that you are taking Spasmin.

Tell the doctor immediately if you are

pregnant while taking this medication.

- Things you must not do

Do not stop taking the medicine unless

advised by your doctor.

Do not take any new medicines without

consulting your doctor or pharmacist.

Do not give Spasmin to anyone else,

even if they have the same symptoms

or condition as you.

- Things to be careful of

Safety for use in pregnancy and breast

feeding has not been established.

Side effects

Spasmin can cause side effects. Visit your

doctor or pharmacist immediately if you

experience dryness of mouth, thirst,

dilatation of the eye pupils, flushing and

dryness of skin, feeling pounding of

heartbeats, difficulty urinating, constipation,

vomiting, blurred vision, giddiness and

staggering.

You may report any side effects or adverse

drug reactions directly to the National

Centre for Adverse Drug Reaction

Monitoring by calling Tel: 03-78835550, or

visiting the website npra.moh.gov.my

(Public

Reporting Medicinal Problems /

Side Effects / AEFI / Vaccine Safety).

Storage and Disposal of Spasmin

- Storage

Store in a cool, dry place below 30

Protect from light. Keep out of reach of

children.

- Disposal

Medicines should not be disposed of via

wastewater or household waste. Ask your

pharmacist how to dispose of medicines no

longer required.

Product description

- What it looks like

Blue, oblong and top-scored tablet.

- Ingredients

- Active ingredient: dicyclomine

hydrochloride

- Inactive ingredients: lactose monohydrate,

cornstarch, indigo carmine lake,

polyvinylpyrrolidone and magnesium

stearate

- MAL number:

MAL19930132AZ

Manufacturer and Product Registration

Holder

Prime Pharmaceutical Sdn. Bhd.

1505, Lorong Perusahaan Utama 1

Taman Perindustrian Bukit Tengah

14000 Bukit Mertajam, Penang, Malaysia.

Date of revision

16/08/2017

Serial number

NPRA(R4/1)160817/00215