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PAVACOL-D

Active substance: PHOLCODINE

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14-019 Pavacol-D 150 ml PIL.13-02-14_Layout 1 13/02/2014 13:23 Page 1

Artwork Information
Product Title:

Pavacol-D 150mg PIL

Date:

13.02.14

Product Size:

180 x 245mm

Label Number:

14-019

Colours Used:

Black

Fonts Used:

Gill Sans

Font size:

8.5pt

Magenta text, keylines and shading are NOT to be printed

14-019 Pavacol-D 150 ml PIL.13-02-14_Layout 1 13/02/2014 13:23 Page 2

PAVACOL-D®
pholcodine
Patient Information Leaflet
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet.You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do
not improve after 5 days.
• If you notice any side effects (see section 4) or any side
effects not mentioned in this leaflet, talk to your doctor or
pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Pavacol-D is and what it is used for
Before you take Pavacol-D
How you take Pavacol-D
Possible side effects
How to store Pavacol-D
Further information

1. What Pavacol-D is and what it is used for
Pavacol-D is a dark brown liquid that contains the active
ingredient pholcodine. Pholcodine is one of a group of
medicines called anti-tussives (help to prevent coughing).
Pavacol-D is a cough suppressant for relief of acute non-productive
cough associated with upper respiratory tract infection.
For children aged 6 to 12 years: simple treatments should be
tried first before you give this medicine. Further information on
treating coughs and colds in children can be found at the end of
this leaflet.

2. Before you take Pavacol-D
Do not give to children under 6 years of age.
You should not take Pavacol-D if you:
• are allergic to pholcodine or any other ingredients of
Pavacol-D (these are listed in Section 6).
• have liver disease
• have a very serious breathing problem (ventilatory failure)
• have chronic bronchitis (inflammation of the airways)
• have bronchiectasis (abnormal widening of one or
more airways)
• have or may have any problems with your airways such
as chronic obstructive pulmonary disease (COPD), or
other breathing problems
• are taking or have taken MAOIs in the last 2 weeks
(MAOIs [monoamine oxidase inhibitors] are a type
of antidepressant such as phenelzine, isocarboxazid,
tranylcypromine or moclebemide).
Take special care with Pavacol-D and tell your doctor if
you have any of the following conditions:
• kidney disease
• a history of drug abuse
• if you suffer from a chronic or persistent cough
Tell your doctor if you still have a cough after 5 days.

Ask a doctor before use if you suffer from a chronic or persistent
cough, if you have asthma, are suffering from an acute asthma
attack or where the cough is accompanied by excessive secretions.
Taking other medicines/alcohol
Do not take Pavacol-D if you are taking any other cough or
cold medicines.
Tell you doctor or pharmacist about any other medicines,
including medicines you are taking at the same time, particularly
the following:
Antidepressants, antihistamines, sleeping tablets or sedatives
strong painkillers, medicines to treat epilepsy, as Pavacol-D may
make you feel more sleepy.
Avoid consumption of alcohol as this may also increase
drowsiness if taken with Pavacol-D.
Also tell your doctor or pharmacist if you are taking any of the
following medicines:
Diuretics (water tablets), antihypertensives (blood pressure
tablets) as Pavacol-D can lower your blood pressure.
Tell your doctor or pharmacist if you are due to have or have
recently had a general anaesthetic.
Pregnancy and breast-feeding
You should not take Pavacol-D during the first three months of
pregnancy unless you doctor tells you to. Always speak to your
doctor or pharmacist for advice before taking any medication.
Driving and using machines
Pavacol-D may cause sleepiness. Make sure you are not affected
before you drive or operate machinery.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how
it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
– The medicine has been prescribed to treat a medical or
dental problem and
– You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
– It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether
it is safe for you to drive while taking this medicine.
Important information about some of the ingredients
of Pavacol-D
• If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking Pavacol-D.
• May have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.
• Pavacol-D also contains small amounts of ethanol (alcohol),
less than 100 mg per 5 ml.
• The propyl and methyl hydroxybenzoates in Pavacol-D may
cause allergic reactions (possibly delayed).

14-019 Pavacol-D 150 ml PIL.13-02-14_Layout 1 13/02/2014 13:23 Page 3

3. How you take Pavacol-D
Dosage
Adults and the elderly
One or two 5 ml spoonfuls as required. The dose may be
increased to three 5 ml spoonfuls if necessary. No more than
60 ml (12 x 5 ml spoonfuls) should be taken in 24 hours.
Children
From 6 to 12 years: one 5 ml spoonful four to five times daily.
No more than 25 ml (5 x 5 ml spoonfuls) should be taken in
24 hours.
Do not use for more than 5 days without the advice
of a doctor.
Seek medical attention if the child’s condition gets
worse during treatment.
Do not give to children under 6 years of age.
Do not exceed the stated dose.

Medicines should not be disposed of via waste-water or with
household waste. Ask your pharmacist what you should do with
medications you no longer need. These measures will help
protect the environment.

6. Further information
What Pavacol-D contains
The active substance is pholcodine 5 mg in 5 ml. The other
ingredients are:
Tolu balsam, ethanol 96%, star anise oil, clove oil, peppermint oil,
capsicum tincture, strong ginger tincture, sorbitol solution,
saccharin, sodium hydroxyethylcellulose, treacle flavour, caramel,
levomenthol, methyl hydroxybenzoate, propyl hydroxybenzoate,
and purified water.
What Pavacol-D looks like and contents of the pack
Pavacol-D is available as 50 ml, 100 ml, 150 ml, 250 ml, 300 ml,
and 1000 ml round amber glass bottles with a child resistant cap.
Not all pack sizes may be marketed.

If you take more Pavacol-D than you should
Contact your doctor or go to your nearest hospital
immediately. Symptoms of overdose include feeling sick,
sleepiness, restlessness, excitement, co-ordination problems, and
shallow breathing.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects

Treating cough and cold in children
It's normal for children to get 8 or more colds in a year.
Gradually they build up immunity and get fewer colds. Most
colds will get better within a few days and you may not need to
do more than keep your child comfortable until they get over it.
Because colds are caused by viruses, not bacteria, antibiotics
don't help. Here are some simple steps to help your child who
has a cough or cold:

Like all medicines, Pavacol-D can cause side-effects, although
these do not affect everyone. If you experience any of the
following stop taking Pavacol-D immediately and talk to your
doctor or pharmacist.

1. If they are hot/feverish:
Increase the amount of fluid your child normally drinks. Lower
their temperature with a paracetamol or ibuprofen medicine
which has doses for children. (Paracetamol is not for children
under 2 months. Ibuprofen is not for children under 3 months).

• sudden wheeziness
• difficulty in breathing
• severe allergic reactions including swelling of the
eyelids, face or lips, rash or itching, especially affecting
your whole body

2. For coughs:
Although it is distressing to hear your child cough, in fact
coughing serves a purpose. It helps clear phlegm on the chest or
mucus from the nose. Give the child plenty of warm clear fluids
to drink.

The following side effects have also been reported occasionally:

3.To help with breathing:
Plain saline nose drops, available from your pharmacy, can help
babies with blocked noses who are having trouble feeding.











feeling sick (nausea)
congestion (sputum retention)
constipation
mild laxative effect
drowsiness
dizziness
excitation
confusion
vomiting

If any of the side effects becomes severe, or if you
notice any side effects not listed in this leaflet, please
tell you doctor or pharmacist.

5. How to store Pavacol-D

Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, United Kingdom.
Pavacol-D is manufactured by:
Pharmaserve (North West) Limited, 9 Arkwright Road, Astmoor
Industrial Estate, Runcorn, Cheshire, WA7 1NU.
This leaflet was last revised in February 2014
Pavacol-D is a registered trademark of Alliance Pharmaceuticals
Limited. Alliance and associated devices are registered
trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2014.

Pavacol-D should be kept out of the reach and sight of children.
Do not store above 25ºC and protect from light.
Do not use Pavacol-D after the expiry date as indicated on the
box after “EXP”. The expiry date refers to the last day of the
month.

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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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