Salmodil Syrup: What Is in This Leaflet

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Consumer Medication Information Leaflet (RiMUP)

SALMODIL SYRUP
Salbutamol sulphate/Bromhexine hydrochloride (2mg/4mg per 5ml)

What is in this leaflet As salbutamol is probably found in Hypokalaemia (deficiency of potassium


1. What SALMODIL is used for breast milk, its use in nursing mother is in the blood stream) may occur following
2. How SALMODIL works not recommended unless the expected over dosage with salbutamol.
3. Before you use SALMODIL benefit outweighs any potential risk.
4. How to use SALMODIL While you are using it
5. While you are using it -Before you start to use it -Things you must do
6. Side effects -Use with caution if you have acute
7. Storage and Disposal of severe asthma. - Take your medicine exactly as your
SALMODIL doctor has told you.
8. Product Description -Taking other medicines - Tell all the doctors, dentists and
9. Manufacturer and Product It is important to tell your doctor or pharmacists treating you that you are
Registration Holder pharmacist about all the medicines that taking SALMODIL.
10. Date of revision you are taking, including those obtained - Tell your doctor immediately if you
without doctor’s prescription. You become pregnant while taking this
What SALMODIL is used for should talk to you doctor or pharmacist if medication.
SALMODIL is a bronchodilator (helps you are on the following:-
open the airways in the lungs) with - Xanthine derivatives -Things you must not do
mucolytic (to breakdown mucus) - Steroids
expectorant for clearance of viscid - Non selective beta-blockers such as - Do not stop taking the medicine
purulent mucus in acute and chronic propranolol or water tablets unless advised by your doctor.
bronchiectasis (abnormal widening of the (diuretics), used to treat high blood - Do not take any new medicines
airways) and whooping cough. pressure or heart condition. without consulting your doctor or
pharmacist.
How SALMODIL works - Do not give SALMODIL to anyone
It contains salbutamol, which works by How to use SALMODIL else, even if they have the same
relaxing the muscles of the airways of -How much to use symptoms or condition as you.
the lungs, and facilitates in breathing. It
also contain bromhexine, which works Children: -Things to be careful of
by thinning the mucus in the airways, Below 6 year-old: It either the usual relief with salbutamol
thus making the mucus less sticky and it 1.25 to 2.5 ml, 3 to 4 times daily is diminished, or the usual duration of
also facilitates the removal of the mucus. action reduced, you should not increase
Older children: the dose or its frequency of medicine, but
Before you use SALMODIL 2.5 to 5 ml, 3 to 4 times daily should seek medical advice.
-When you must not use it Or as directed by physician.
Tell your doctor before using Side effects
SALMODIL if you -How long to use it
- Are allergic to Salbutamol or Like all medicines, SALMODIL can
Bromhexine or any other ingredients Do not stop taking this medicine even cause side effects, although not
listed at the end of this leaflet. when you feel better, unless being everybody gets them.
- have thyrotoxicosis (excessive advised by your doctor. Some of the side effects are listed below:
amount of thyroid hormone). - Tachycardia (increase heart
- have severe cardiovascular disease -If you forget to use it rate)
(disease of the heart or blood - Palpitation (strong pounding of
vessels). If you miss a dose of SALMODIL, take heart beat)
- have angina (chest pain). it as soon as possible. However, if its due - Precordial pain (chest pain)
- have peptic ulcer (ulcers in the for the next dose, skip the missed dose - Potentially serious
lining of the stomach or first part of and continue with your regular dosing hypokalaemia may result from
the small intestine. schedule. Do not double up the doses. beta-2 agonist therapy.
- Nervousness
-Pregnancy and breastfeeding -If you use too much (overdose) - Tremors in few people
- Nausea
Tell your doctor or pharmacist if you are Contact your doctor immediately or go to - Vomiting
pregnant, planning to get pregnant or are the Emergency Department of your Visit your doctor or pharmacist
breastfeeding. SALMODIL should only nearest hospital, if you think you or immediately if you experience any side
be used during pregnancy if the expected anyone else may have taken too much of effects after taking this medicine.
benefit to mother is greater than any this medicine. Do this even if there are
possible risk to fetus. no signs of discomfort or poisoning. You You may report any side effects or
may need urgent medical attention. adverse drug reactions directly to the
1
Consumer Medication Information Leaflet (RiMUP)

National Centre for Adverse Drug Date of revision


Reaction Monitoring by calling Tel: 03- 25/09/2017
78835550, or visiting the website
npra.moh.gov.my (Public Reporting
Medicine Problem/ Side Effect/ AEFI/ Serial Number
Vaccine Safety). NPRA(R4/1)190917/00249

Storage and Disposal of SALMODIL


SYRUP
- Storage

Store in dry place below 30 °C.

- Disposal

Medicines should not be disposed of


via wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

Product Description
- What it looks like

Clear, pink colored syrup having a sweet


and slightly bitter taste, with cooling
effect.

- Ingredients
- Active ingredient(s)

Salbutamol Sulphate, Bromhexine


Hydrochloride

- Inactive ingredients

Sugar, Sodium Benzoate, Sorbitol


Solution, Hydrochloric Acid, Propylene
Glycol, Carmoisine, Cherry Sweet,
Menthol and Purified Water.

-MAL number(s):
MAL19871056AZ

Manufacturer
FDC Limited
At: B-8 M.I.D.C. Waluj
Dist. Aurangabad 431 136 India.

Product Registration Holder


Unimed Sdn. Bhd.
No.53 Jalan Tembaga SD 5/2B,
Bandar Sri Damansara,
52200 Kuala Lumpur.

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