SIMPLE LINCTUS PAEDIATRIC BP

Active substance: CITRIC ACID MONOHYDRATE

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B/N:

EXP:

SIMPLE LINCTUS
PAEDIATRIC
B
A
R
C
O
D
E

Citric Acid

200 ml
Clonmel, Ireland.

Leaflet is assumed to utilise pages of 72mm x 52mm
Except for the front page, this is 80mm x 52mm.

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In this leaflet:
1. What Simple Linctus Paediatric is and what it is used for
2. Before you give Simple Linctus Paediatric
3. How to give Simple Linctus Paediatric
4. Possible side effects
5. How to store Simple Linctus Paediatric
6. Further information

SIMPLE LINCTUS PAEDIATRIC BP
Citric Acid Monohydrate 31.25 mg/5 ml

3. HOW TO GIVE SIMPLE LINCTUS PAEDIATRIC
Always give the product to the child exactly as advised. You
should check with your doctor or pharmacist if you are not sure.
Only to be taken by mouth.
The usual dose is:
Children: One or two 5 ml spoonfuls taken 3-4 times daily.
Adults:
Simple Linctus Paediatric is not recommended.
A different formulation of Simple Linctus is
available for adults; please see your pharmacist.
DO NOT EXCEED THE STATED DOSE
If your child takes more Simple Linctus Paediatric than
they should:
Contact your doctor or pharmacist. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
If you forget to give this medicine:
If you miss a dose, give it as soon as you remember and take
any remaining doses for that day at evenly spaced times. Do
not take a double dose to make up for the missed dose.

6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
What Simple Linctus Paediatric contains:
Like all medicines, Simple Linctus Paediatric can cause side
effects, although not everybody gets them.
• The active substance is Citric Acid Monohydrate
31.25 mg/5 ml equivalent to 28.57 mg/5 ml Anhydrous
If your child takes too much Simple Linctus Paediatric over a long
Citric Acid.
period of time it may cause erosion of the teeth or stomach irritation.
• The other ingredients are colour 1508 Red (Anstead)
(E123), glycerol, chloroform, ethanol, sugar (M.W.G.)
If any of the side effects gets serious, or if you notice any
and aniseed oil.
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
What Simple Linctus Paediatric looks like and contents
5. HOW TO STORE SIMPLE LINCTUS PAEDIATRIC
of the pack
Keep out of the reach and sight of children. Do not store
Simple Linctus Paediatric is an oral solution, available in
above 25˚C. Do not use Simple Linctus Paediatric after the
500 ml, 1 L and 2 L plastic (HDPE) bottles, or in 100 ml,
expiry date which is stated on the label. The expiry date refers
200 ml and 500 ml amber glass bottles.
to the last day of that month.
Marketing Authorisation Holder and Manufacturer
Medicines should not be disposed of via wastewater or
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel,
household waste. Ask your pharmacist how to dispose
Co. Tipperary, Ireland. PL 04917/0012
of medicines no longer required. These measures will help
This leaflet was last revised 05/2010.
to protect the environment.

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Take special care with Simple Linctus Paediatric if the child: Driving and using machines
• has diabetes mellitus.
This medicine is intended for use in children. However, Simple
Linctus Paediatric has no known effect on your ability to drive
Taking other medicines
or use machines.
Please tell your doctor or pharmacist if your child is taking or has
recently taken any other medicines, including medicines obtained Important information about some of the other
Read all of this leaflet carefully because it contains
without a prescription.
ingredients of Simple Linctus Paediatric
important information for you.
Simple Linctus Paediatric contains:
This medicine is available without prescription, however, you still
Citric acid (the active substance) may interact with potassium
• small amounts of ethanol (alcohol), less than 100 mg
1. WHAT SIMPLE LINCTUS PAEDIATRIC IS AND WHAT IT IS
need to give Simple Linctus Paediatric carefully to your child to
tartrate, carbonates and bicarbonates, therefore do not give
per 5 ml dose.
USED FOR
get the best results from it.
other medicines containing these ingredients at the same time
• sucrose: contains up to 4.5 g of sucrose per 5 ml dose.
Simple Linctus Paediatric is a medicine which helps to stop a
- Keep this leaflet. You may need to read it again.
as Simple Linctus Paediatric.
Tell your doctor before taking this medicine if your child
- Ask your pharmacist if you need more information or advice. mild non-specific cough in children.
has an intolerance to some sugars or diabetes mellitus.
- You must contact a doctor if your symptoms worsen or do
Pregnancy and breast-feeding
• Colour 1508 Red (E123): may cause allergic reaction.
2. BEFORE YOU GIVE SIMPLE LINCTUS PAEDIATRIC
not improve after a few days.
This medicine is intended for use in children. However, ask your
DO NOT give Simple Linctus Paediatric if the child:
doctor or pharmacist for advice before taking Simple Linctus
- If any of the side effects gets serious, or if you notice any
• is allergic to citric acid or any of the other ingredients in this Paediatric during pregnancy, or if you are breast-feeding.
side effects not listed in this leaflet, please tell your doctor
medicine (see Section 6 and end of Section 2).
or pharmacist.
• has an hereditary intolerance to some sugars.

Leaflet Back Face

Leaflet Front Face

PATIENT INFORMATION LEAFLET

Each 5 ml contains the active ingredient
Citric Acid Monohydrate 31.25 mg/5 ml
(equivalent to 28.57 mg/5 ml Anhydrous
Citric Acid). Also contains: ethanol,
sucrose and colour 1508 red (E123).
See leaflet for further information.
Dosage: For oral use only.
Children: one or two 5 ml spoonfuls
3-4 times daily. Not recommended
for use in adults.
DO NOT EXCEED THE STATED DOSE.
If you have any questions on the use
of this product, ask your doctor or
pharmacist. Keep out of the reach
and sight of children. Do not store
above 25˚C. Do not use after the
expiry date.
MA Holder and Manufacturer:
Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel, Co. Tipperary,
Ireland. PL 04917/0012 23LL

SIMPLE LINCTUS PAEDIATRIC BP
SIMPLE LINCTUS PAEDIATRIC BP

SIMPLE LINCTUS
PAEDIATRIC
Citric Acid

Each 5 ml contains the active ingredient
Citric Acid Monohydrate 31.25 mg/5 ml
(equivalent to 28.57 mg/5 ml Anhydrous
Citric Acid). Also contains: ethanol,
sucrose and colour 1508 red (E123).
See leaflet for further information.
Dosage: For oral use only.
Children: one or two 5 ml spoonfuls
3-4 times daily. Not recommended
for use in adults.
DO NOT EXCEED THE STATED DOSE.
If you have any questions on the use
of this product, ask your doctor or
pharmacist. Keep out of the reach
and sight of children. Do not store
above 25˚C. Do not use after the
expiry date.
MA Holder and Manufacturer:
Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel, Co. Tipperary,
Ireland. PL 04917/0012 23LL

SIMPLE
LINCTUS
200 ml
PAEDIATRIC BP
Clonmel, Ireland.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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