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Consumer Medication Information Leaflet (RiMUP)

RHINATHIOL® 2% CHILDREN SYRUP


Carbocisteine (2gm/ 100ml)

What is in this leaflet  If you (or your child) have a fever - How long to use it
or are coughing up "greenish" Do not use for more than 8 to 10 days.
1. What Rhinathiol is used for mucus. Talk to your doctor if symptoms
2. How Rhinathiol works  If you (or your child) suffer from worsen or persist after 10 days of
3. Before you use Rhinathiol chronic (long term) bronchial or treatment.
4. How to use Rhinathiol pulmonary disease.
5. While you are using it  If you (or your child) have a - If you forget to use it
6. Side effects history of gastroduodenal ulcers Do not take a double dose to make up
7. Storage and disposal of Rhinathiol (affecting the stomach or for a forgotten dose.
8. Product description intestine).
9. Manufacturer and Product  If you are elderly. - If you use too much (overdose)
Registration Holder  If you are also taking medicines Stop the treatment and contact your
10. Date of revision that are likely to cause bleeding in doctor or pharmacist immediately.
the stomach or intestine.

What Rhinathiol is used for Treatment should be stopped if While you are using it
Rhinathiol thins bronchial secretions bleeding in the stomach or intestine - Things you must do
(mucus) and makes them easier to occurs. Always take this medicine exactly as
cough up (expectorate). described in this leaflet or as your
- Taking other medicines doctor or pharmacist has told you.
Tell your doctor or pharmacist if you
How Rhinathiol works (or your child) are taking or have You must talk to a doctor if you do not
Rhinathiol belongs to a group of recently taken any other medicines, feel better or if you feel worse.
medicines called mucolytics. It including medicines obtained without a
contains an active substance called prescription. - Things you must not do
carbocisteine. Rhinathiol thins Do not give this medicine to anyone
bronchial secretions (mucus) and else, even if they have the same
makes them easier to cough up. How to use Rhinathiol condition.
Always take Rhinathiol exactly as the
doctor has told you. You should check
Do not use this medicine to treat any
Before you use Rhinathiol with your doctor or pharmacist if you
other complaints unless your doctor
- When you must not use it are not sure.
tells you to.
Do not take Rhinathiol if:
 You (or your child) are allergic to This medicine should be taken by
- Things to be careful of
carbocisteine or any of the other mouth.
Pregnancy and breast-feeding
ingredients of this medicine If you are pregnant or breast-feeding,
(particularly methyl Use the measuring spoon provided to
think you may be pregnant or are
parahydroxybenzoate), listed at the measure the quantity of syrup for one
planning to have a baby, ask your
end of this leaflet. dose (5 ml).
doctor or pharmacist for advice before
 You (or your child) have a taking this medicine.
stomach or intestinal ulcer Rinse the measuring spoon thoroughly
 Your child is under 2 years of age, after each use. Close the bottle tightly
Pregnancy
as bronchial congestion may after use.
There are no available data on
become worse. carbocisteine use in pregnant women.
- How much to use
- Before you start to use it Children aged 2 to 5 years: The usual
If you are pregnant, the use of
You (or your child) must not use dose is one 5 ml measuring spoon 2
carbocisteine is not recommended.
medicines which suppress cough times a day (i.e. 200 mg per day,
(cough suppressants) or which dry out divided into 2 doses).
This medicine should only be used
bronchial secretions when taking during pregnancy on your doctor’s
Rhinathiol. This is because Rhinathiol Children aged over 5 years: The
advice.
thins secretions, making them easier to usual dose is one 5 ml measuring
cough up. Coughing is a useful spoon 3 times a day (i.e. 300 mg per
If you discover that you are pregnant
mechanism for expectoration. day, divided into 3 doses).
during treatment, talk to your doctor.
Only your doctor can decide whether it
Talk to your doctor or pharmacist - When to use it
is necessary to continue treatment.
before using Rhinathiol: Give Rhinathiol at about the same time
each day to your child unless your
Ask your doctor or pharmacist for
doctor tells you otherwise.
advice before taking any medicine.

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Consumer Medication Information Leaflet (RiMUP)

Breast-feeding breathing and be life-threatening Red syrupy liquid with an odour of


There are no available data on the (angioedema). In this case, you raspberry and cherry. It is available in
presence of carbocisteine in human should stop treatment and see your 125ml bottle and comes with a 5ml
milk. doctor immediately. measuring spoon.
 Brown or purple plaques which
Breast-feeding your child is not can cause skin discoloration (fixed - Ingredients
recommended if you are taking this drug eruption). In this case, you - Active ingredient
medicine. should see your doctor One 5 ml measuring spoon contains
immediately. 100 mg of carbocisteine.
Ask your doctor or pharmacist for  Appearance of spots, sometimes
advice before taking any medicine. with blisters, on the skin that can - Inactive ingredients
also affect the mouth (erythema Sucrose, methyl parahydroxybenzoate
Rhinathiol contains sodium, methyl multiforme), appearance of blisters (E218), vanillin, cochineal red A
parahydroxybenzoate (E218), with detachment of the skin that (E124), raspberry flavoring, cherry
cochineal red A (E124) and sucrose: can spread over the whole body flavoring, sodium hydroxide, purified
 This medicine contains 13 mg of and may be life-threatening water
sodium in each measuring spoon (Stevens-Johnson syndrome).
(5 ml). This should be taken into - MAL Numbers
account if you are on a no-sodium Rhinathiol may cause severe allergy Rhinathiol 2% Children Syrup
or low-sodium diet. and serious skin reactions. Stop using MAL19910914X
 This medicine contains methyl Rhinathiol and seek medical assistance
parahydroxybenzoate (E218) and immediately if you experience any of
cochineal red A (E124). These can the following symptoms: Manufacturer
cause allergic reactions.  Severe allergy: breathing Unither Liquid Manufacturing
 This medicine contains sucrose: difficulties, light headedness, skin 1-3 allée de la Neste
o Patients with rare hereditary swellings or rash. Z.I. d’En Sigal
problems of fructose  Severe skin reaction: skin 31770 Colomiers, France.
intolerance, glucose-galactose reddening, blisters, rash, fever,
malabsorption or sucrase- sore throat or eye irritation.
isomaltase insufficiency should Product Registration Holder
not take this medicine You may report any side effects or Sanofi-aventis (Malaysia) Sdn. Bhd.
o If you have been told by your adverse drug reactions directly to the Unit TB-18-1,
doctor that you have an National Centre for Adverse Drug Level 18-1, Tower B, Plaza 33
intolerance to some sugars, Reaction Monitoring by visiting the No.1 Jalan Kemajuan,
contact your doctor before website npra.gov.my (Consumer → Seksyen 13,
taking this medicinal product. Reporting Side Effects to Medicines 46200 Petaling Jaya,
o Each measuring spoon contains (ConSERF or Vaccines (AEFI)). Selangor Darul Ehsan,
3.5 g of sucrose. This should be Malaysia.
taken into account if you are on
a no-sugar or low-sugar diet. Storage and disposal of Rhinathiol
- Storage Date of revision
Keep this medicine out of the sight and 14/09/2020 (based on FR PIL Dec19)
Side Effect reach of children.
Like all medicines, Rhinathiol can Do not use this medicine after the
expiry date which is stated on the box. Serial Number
cause side effects, although not NPRA(R2/1)190903/235
everyone gets them. The expiry date refers to the last day of
 Possible worsening of bronchial that month.
congestion in infants. Do not store above 25°C.
 Gastrointestinal disorders, such as
stomach pain, nausea, vomiting - Disposal
and diarrhea. If these occur, the Do not throw away any medicines via
dosage should be reduced. wastewater or household waste. Ask
 Bleeding in the stomach or your pharmacist how to throw away
intestine. Treatment should be medicines you no longer use. These
stopped. measures will help protect the
 Allergic skin eruptions and environment.
anaphylactic reactions, such as
hives, itching, appearance of
plaques or spots on the skin, and Product Description
swelling of the face and/or neck - What it looks like
that can lead to difficulty

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