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WOCKHARDT COLD RELIEF CAPSULES WITH DECONGESTANT

Active substance(s): CAFFEINE ANHYDROUS / PHENYLEPHRINE HYDROCHLORIDE

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20000XXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER
Wockhardt Cold Relief Capsules with Decongestant
Paracetamol, Caffeine and Phenylephrine hydrochloride

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Wockhardt
Cold Relief Capsules with Decongestant carefully to get the best results from them.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Wockhardt Cold Relief Capsules with Decongestant. In the rest of this
leaflet it is called Cold Relief Capsules with Decongestant.
In this leaflet:
1. What Cold Relief Capsules with Decongestant are and what they are used for
2. Before you take Cold Relief Capsules with Decongestant
3. How to take Cold Relief Capsules with Decongestant
4. Possible side effects
5. How to store Cold Relief Capsules with Decongestant
6. Further information
1. What Cold Relief Capsules with Decongestant are and what they are used for
The name of your medicine is Cold Relief Capsules with Decongestant. These capsules contain a
combination of paracetamol (a painkiller), caffeine (a mild stimulant) and phenylephrine (a
decongestant).
Cold Relief Capsules with Decongestant are used to relieve the symptoms of the common cold, flu,
nasal congestion, blocked nose and sinuses.
2. Before you take Cold Relief Capsules with Decongestant
You should not take Cold Relief Capsules with Decongestant if you:
• are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine or any of the other
ingredients in Cold Relief Capsules with Decongestant (see section 6, Further information)
• have had ulcers of the stomach or small intestine (peptic ulcer disease)
• have an overactive thyroid
• have swelling of blood vessels (aneurysms)
• have very high blood pressure
• have narrowing of blood vessels
• suffer from a tumour called a phaeochromocytoma
• suffer from an enlarged prostate
• are taking antidepressants called monoamine oxidase inhibitors (MAOIs) such as moclobemide.
Talk to your doctor or pharmacist before taking Cold Relief Capsules with Decongestant if you:
• are elderly
• suffer from kidney disease
• suffer from liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• suffer from heart disease such as high blood pressure, prinzmetal angina (chest pain) or
thromboembolic disorders following myocardial infarction (reduced blood supply in veins or
arteries following a heart attack) or a history of ischemic heart disease.
Caution should be exercised when taking paracetamol products prior to (less than 72 hours before)
or at the same time as intravenous busulfan.
This medicine contains paracetamol; do not take with any other paracetamol-containing
products at the same time.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. The following medicines can affect or be
affected by treatment with Cold Relief Capsules with Decongestant:
• general anaesthetics such as halothane and cyclopropane
• medicines used to treat bacterial infections (e.g. quinolone antibiotics such as enoxacin, pipemidic
acid and ciprofloxacin and isoniazid used to treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, phenytoin, primodone)
• medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as
imipramine and monoamine oxidase inhibitors (MAOIs) such as moclobemide)
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• warfarin and other coumarin medicines (used to thin the blood)
• probenecid (used to treat gout)
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)
• benzodiazepine medicines (sedatives e.g. diazepam)
• disulfaram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• phenylpropanolamine (a decongestant)
• fluconazole or terbinafine (used to treat fungal infections)
• clozapine (an antipsychotic used to treat schizophrenia)
• diuretics such as hydrochlorothiazide
• ephedrine, a stimulant used in dietary supplements such as Ma Huang
• theophylline (used in the treatment of asthma)
• alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)
• atropine (used in anaesthesia or to increases the heart rate)
• ergot alkaloids (used in the treatment of migraines)
• oxytocin (used to induce childbirth)
• sympathomimetics (used to maintain blood pressure in critically ill patients)
• intravenous busulfan (used in chemotherapy to treat cancer).

pg1/2
ART WORK CHECK BOX
PRODUCT :

Process
Black

CUSTOMER :
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Wockhardt Cold Relief Capsules with Decongestant
- 16 Capsules
Wockhardt UK

Indswift
(w)130 x (h)320mm
Dummy
– N.A. –
9 pt. (15% condensed)
Cold Relief Capsules_Lit_104588-2.ai
Adobe Illustrator CS5
Arial Regular / Bold
10th February, 2015
R 1st PDF sent on - 12TH FEB. 2015

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • Regulatory text amends

Non-Regulatory

Pregnancy and breast-feeding
If you are pregnant or are breast-feeding you should only take this medicine if your doctor
has specifically recommended it.
Driving and using machinery
It is possible that Cold Relief Capsules with Decongestant may cause dizziness. Do not
drive or operate machinery if affected.
3. How to take Cold Relief Capsules with Decongestant
Always follow the instructions on the label. If you are not sure then ask your doctor or pharmacist for
advice. Swallow capsules whole with a glass of water.
Adults and children over 12 years
• 1 to 2 capsules every 4 hours as required
• do not take more than 8 capsules in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your doctor.
Children under 12 years
• do not give to children under 12 years unless your doctor tells you to.
If you take more Cold Relief Capsules with Decongestant than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because
too much paracetamol can cause delayed, serious liver damage.
If you forget to take Cold Relief Capsules with Decongestant
If you forget a dose, take another as soon as you remember. If it is almost time for your next dose,
then do not take the missed dose at all. NEVER take a double dose to make up for the one missed
4. Possible side effects
Like all medicines, Cold Relief Capsules with Decongestant can cause side effects, although not
everybody gets them.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience
any of the following, stop taking this medicine immediately, and see your doctor or pharmacist:
• allergic reactions which may be severe such as skin rash, peeling of the skin, itching, swollen red areas
of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.
Side effects that have been reported with Cold Relief Capsules are:
• rash
• worsening of asthma
• tremor
• anxiety
• sleep disturbance
• restlessness
• excitement
• palpitations
• high blood pressure
• muscle weakness
• acidosis (increased
• piloerection
• narrowing of
• irritability
acid concentration
(bristling of
blood vessels
• acid reflux
in the blood)
hairs on the
• feeling sick
• bowel irritation
• insomnia
skin)
• increased frequency
• changes in blood
• very rare cases of
• lumps (cysts)
to urinate
cells
serious skin reactions
in the breasts
• problems passing water
• irregular heart beat
have been reported
• vomiting
The use of this medicine over a long time can cause kidney problems. If you experience any side
effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Cold Relief Capsules with Decongestant
Keep out of the sight and reach of children.
• Cold Relief Capsules with Decongestant should be stored in a dry place below 25°C.
• Store in the original container to protect from light; do not transfer to another container.
• Cold Relief Capsules with Decongestant should not be taken after the expiry date on the label; the
expiry date refers to the last day of the month.
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 protect the environment.
6. Further information
What Cold Relief Capsules with Decongestant contain
The active ingredients are: paracetamol 300mg, caffeine 25mg and phenylephrine 5mg.
The other ingredients are: starch, colloidal anhydrous silica, magnesium stearate, gelatin and colours;
quinoline yellow (E104), patent blue V (E131), titanium dioxide (E171) and black iron oxide (E172).
What Cold Relief Capsules with Decongestant look like and the contents of the pack
Cold Relief Capsules with Decongestant are hard, green and yellow, gelatine capsules. The
medicine is supplied in a blister pack and outer cardboard carton.
Cold Relief Capsules with Decongestant are available on general sale in pack sizes of 8, 10, 12 and
16 capsules. Or in larger pack sizes (20, 24, 28, 30 and 32 capsules) from the pharmacy.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name
Reference number
Cold Relief Capsules with Decongestant
29831/0173
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: February 2015
104588/2

pg2/2

20000XXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER
Wockhardt Sinus Dual Relief Capsules
Paracetamol, Caffeine and Phenylephrine hydrochloride

Read all of this leaflet carefully because it • suffer from heart disease,
high blood pressure such as
contains important information for you.
prinzmetal angina (chest
This medicine is available without
pain) or thromboembolic
prescription. However, you still need to
disorders following myocardial
take Wockhardt Sinus Dual Relief
infarction(reduced blood supply in
Capsules carefully to get the best results
veins or arteries following a heart
from them.
attack) or a history of ischemic heart
- Keep this leaflet. You may need to read
disease.
it again while you are receiving your
Caution
should be exercised when taking
treatment.
paracetamol
products prior to (less than
- If you have any further questions,
72 hours before) or at the same time as
please ask your pharmacist.
intravenous busulfan.
- You must contact a doctor if your
This medicine contains paracetamol;
symptoms worsen or do not improve
do not take with any other
after 3 days.
- If any of the side effects get serious, or paracetamol-containing products at
the same time.
if you notice any side effects not listed
in this leaflet, please tell your doctor or Taking other medicines
pharmacist.
Please tell your doctor or pharmacist if

you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription. The
following medicines can affect or be
affected by treatment with Sinus Dual
In this leaflet:
Relief Capsules:
1. What Sinus Dual Relief Capsules are
• general anaesthetics such as
and what they are used for
halothane and cyclopropane
2. Before you take Sinus Dual Relief

medicines used to treat bacterial
Capsules
infections (e.g. quinolone antibiotics
3. How to take Sinus Dual Relief
such as enoxacin, pipemidic acid and
Capsules
ciprofloxacin and isoniazid used to treat
4. Possible side effects
tuberculosis)
5. How to store Sinus Dual Relief Capsules
• medicines used to treat epilepsy (fits)
6. Further information
(e.g. carbamazepine, phenobarbital,
phenytoin, primodone)
1. What Sinus Dual Relief Capsules are
• medicines used to treat depression
and what they are used for
(e.g. fluvoxamine, tricyclic
antidepressants such as imipramine
The name of your medicine is Sinus Dual
and monoamine oxidase inhibitors
Relief Capsules. These capsules contain
(MAOIs) such as moclobemide)
a combination of paracetamol (a
painkiller), caffeine (a mild stimulant) and • metoclopramide and domperidone
(used to treat sickness and nausea)
phenylephrine hydrochloride (a
• oral contraceptives (“The Pill”,
decongestant).
mini-pill), hormonal implants and HRT
Sinus Dual Relief Capsules are used to

warfarin and other coumarin medicines
relieve the symptoms of the common
(used to thin the blood) as there is an
cold, flu, nasal congestion (blocked nose
increased risk of bleeding
and sinuses).
• probenecid (used to treat gout)
• diflunisal (an anti-inflammatory
2. Before you take Sinus Dual Relief
painkiller)
Capsules
• colestyramine (used to treat high
cholesterol and in diseases of the
You should not take Sinus Dual Relief
intestine and liver)
Capsules if you:
• benzodiazepine medicines (sedatives
• are allergic (hypersensitive) to
e.g. diazepam)
paracetamol, caffeine, phenylephrine
• fluconazole or terbinafine (used to treat
hydrochloride or any of the other
fungal infections)
ingredients in Sinus Dual Relief
• clozapine (an antipsychotic used to
Capsules (see section 6, Further
treat schizophrenia)
information)
• diuretics such as hydrochlorothiazide
• have had ulcers of the stomach or
• ephedrine, a stimulant used in dietary
small intestine (peptic ulcer disease)
supplements such as Ma Huang
• have an overactive thyroid
• disulfaram (used to treat alcoholism)
• have swelling of blood vessels
• lithium (used to treat manic
(aneurysms)
depression/bipolar disorder)
• have very high blood pressure
• mexilitine (used to treat abnormal heart
• have narrowing of blood vessels
rhythms)
• suffer from a tumour called a
• phenylpropanolamine (a decongestant)
phaeochromocytoma
• theophylline (used in the treatment of
• suffer from an enlarged prostate
asthma)
• are taking antidepressants called
monoamine oxidase inhibitors (MAOIs) • alpha-blockers (used in high blood
pressure and problems associated with
such as moclobemide.
enlarged prostate)
Talk to your doctor or pharmacist

atropine (used in anaesthesia or to
before taking Sinus Dual Relief
increase the heart rate)
Capsules if you:

ergot alkaloids (used in the treatment
• are elderly
of migraines)
• suffer from severe kidney disease
• oxytocin (used to induce childbirth)
• suffer from severe liver disease,
• sympathomimetics (used to maintain
particularly if caused by alcohol
blood pressure in critically ill patients)
• suffer from alcoholism

intravenous busulfan (used in
• suffer from asthma, particularly if your
chemotherapy to treat cancer).
asthma is worsened by aspirin
The name of your medicine is Wockhardt
Sinus Dual Relief Capsules. In the rest of
this leaflet it is called Sinus Dual Relief
Capsules.

ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Process
Black

Wockhardt Sinus Dual Relief Capsules - 16 Capsules
Wockhardt UK

Indswift
(w)130 x (h)320mm
Dummy
– N.A. –
9 pt.
Sinus Dual Relief Capsule_Lit_105611-2.ai
Adobe Illustrator CS5
Arial Regular / Bold
12th June, 2013
R 1st PDF sent on
R 2nd PDF sent on
R 3rd PDF sent on
R 4th PDF sent on
R 5th PDF sent on
R 6th PDF sent on

- 2ND JULY 2013
- 17TH JAN. 2014
- 8TH OCT. 2014
- 21ST NOV. 2014
- 28TH JAN. 2015
- 12TH FEB. 2015

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Updated new Wockhardt logo
• Text font size increased to 9pt.
• Dimensions changed to 130 x 320mm
(Dimensions changed to accomodate bigger text font size)

pg1/2

Pregnancy and breast-feeding
If you are pregnant or are breast-feeding
you should only take this medicine if your
doctor has specifically recommended it.
Driving and using machinery
It is possible that Sinus Dual Relief
Capsules may cause dizziness. Do not
drive or operate machinery if affected.
3. How to take Sinus Dual Relief
Capsules
Always follow the instructions on the
pack. If you are not sure then ask your
doctor or pharmacist for advice. Swallow
capsules whole with a glass of water.
Adults and children over 12 years
• 1 to 2 capsules every 4 hours as
required
• do not take more than 8 capsules in 24
hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days
unless you have been told to do so by
your doctor.
Children under 12 years
• do not give to children under 12 years
unless your doctor tells you to.
If you take more Sinus Dual Relief
Capsules than you should
Talk to a doctor at once if you take too
much of this medicine even if you feel
well. This is because too much
paracetamol can cause delayed, serious
liver damage.
If you forget to take Sinus Dual Relief
Capsules
If you forget a dose, take another as
soon as you remember. If it is almost
time for your next dose, then do not take
the missed dose at all. NEVER take a
double dose to make up for the one
missed.

The use of this medicine over a
long time can cause kidney
problems. If you experience any
side effects or feel that the
medicine is affecting you badly
tell your doctor or pharmacist
immediately.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Sinus Dual Relief Capsules
Keep out of the sight and reach of
children.
• Sinus Dual Relief Capsules should be
stored in a dry place below 25°C.
• Store in the original container to
protect from light; do not transfer to
another container.
• Sinus Dual Relief Capsules should not
be taken after the expiry date on the
pack; the expiry date refers to the last
day of the month.
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 protect the environment.
6. Further information
What Sinus Dual Relief Capsules
contain
The active ingredients are: paracetamol
300mg, caffeine 25mg and phenylephrine
hydrochloride 5mg.

Like all medicines, Sinus Dual Relief
Capsules can cause side effects,
although not everybody gets them.

The other ingredients are: starch,
colloidal anhydrous silica, magnesium
stearate, gelatine, and colours; quinoline
yellow (E104), patent blue V (E131),
titanium dioxide (E171) and black Iron
oxide (E172).

As can happen with any medicine, a few
people may develop an allergic reaction.
If you experience any of the following,
stop taking this medicine immediately,
and see your doctor or pharmacist:
• allergic reactions which may be severe
such as skin rash, peeling of the skin,
itching, swollen red areas of the skin,
sometimes with shortness of breath or
swelling of the mouth, lips, tongue,
throat or face.

What Sinus Dual Relief Capsules look
like and the contents of the pack
Sinus Dual Relief Capsules are hard,
green and yellow, gelatine capsules. The
medicine is supplied in a blister pack and
outer cardboard carton.
Sinus Dual Relief Capsules are available
on general sale in pack sizes of 8, 10, 12
and 16 capsules or in larger pack sizes
(20, 24, 28, 30 and 32 capsules) from the
pharmacy.

Side effects that have been reported with
Sinus Dual Relief Capsules are:
• rash
• worsening of
asthma
• tremor
• anxiety
• sleep disturbance • restlessness
• excitement
• palpitations
• high blood pressure • muscle weakness
• acidosis (increased • piloerection
acid concentration
(bristling of hairs
in the blood)
on the skin)
• narrowing of
• irritability
blood vessels
• feeling sick
• acid reflux
• bowel irritation
• insomnia
• increased frequency • lumps (cysts)
to urinate
in the breasts
• irregular heart beat • vomiting
• problems passing • changes in blood
water
cells
• very rare cases of
serious skin reactions
have been reported

Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham LL13 9UF, UK.

4. Possible side effects

Other formats:
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:
Product name

Reference
number

Wockhardt
Sinus Dual Relief Capsules 29831/0173
This is a service provided by the Royal
National Institute of Blind People.
Leaflet Prepared: February 2015
105611/2

pg2/2

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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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