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WOCKHARDT SINUS DUAL RELIEF CAPSULES

Active substance(s): CAFFEINE ANHYDROUS / PHENYLEPHRINE HYDROCHLORIDE / CAFFEINE ANHYDROUS / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the user
Health Essentials Cold relief with decongestant Capsules
Paracetamol, Caffeine and Phenylephrine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you. This medicine is available without prescription. However you still need to take
Health Essentials Cold relief with decongestant Capsules carefully to get the best results from them.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
The name of your medicine is Health Essentials Cold relief with decongestant Capsules. In the rest of this leaflet it
is called Cold Relief with Decongestant Capsules.
What is in this leaflet
1. What Cold Relief with Decongestant Capsules are and what they are used for
2. What you need to know before you take Cold Relief with Decongestant Capsules
3. How to take Cold Relief with Decongestant Capsules
4. Possible side effects
5. How to store Cold Relief with Decongestant Capsules
6. Contents of the pack and other information
1. What Cold relief with Decongestant Capsules are and what they are used for
Cold Relief with Decongestant Capsules contain a combination of paracetamol (a painkiller), caffeine (a mild
stimulant) and phenylephrine hydrochloride (a decongestant).
Cold Relief with Decongestant Capsules are used to relieve the symptoms of the common cold, flu, nasal
congestion, blocked nose and sinuses.
2. What you need to know before you take Cold Relief with Decongestant Capsules
Do not take Cold Relief with Decongestant Capsules if you:
• are allergic to paracetamol, caffeine, phenylephrine hydrochloride or any of the other ingredients of this
medicine (listed in section 6)
• are hypersusceptible to phenylephrine
• have had ulcers of the stomach or small intestine (peptic ulcer disease)
• have an overactive thyroid
• have narrowing of blood vessels or swelling of blood vessels (aneurysms)
• suffer from heart disease, including high blood pressure
• suffer from a tumour called a phaeochromocytoma
• suffer from an enlarged prostate
• are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or if you are taking or have taken within the
last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression.
• suffer from diabetes
• suffer from an eye condition called closed angle glaucoma
• are taking sympathomimetic decongestants
• are taking beta blockers e.g. atenolol (used to treat high blood pressure)
Warnings and precautions
Talk to your doctor or pharmacist before taking Cold Relief with Decongestant Capsules if you:
• suffer from severe kidney disease or liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• have a blood vessel disease such as Raynaud’s Phenomenon
• have heart or circulation disease
This medicine contains paracetamol; do not take with any other paracetamol-containing products at the
same time.
Do not take with any other flu, cold or decongestant products.
Other medicines and Cold Relief with Decongestant Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription. The following medicines can affect or be affected by treatment with
Cold Relief with Decongestant Capsules:
• medicines used to treat bacterial infections (e.g. quinolone antibiotics such as enoxacin, pipemidic acid,
ciprofloxacin and isoniazid used to treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, lamotrigine, phenytoin and primodone)
• medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as amitriptyline or
imipramine, reversible inhibitors of monoamine oxidase (RIMAs) such as moclobemide and monoamine
oxidase inhibitors (MAOIs) or if you have taken MAOIs within the past 14 days)
• digoxin (used to treat heart disease) and cardiac glycosides (used to treat heart failure)
• 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) as there is an increased risk of bleeding
• 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)
• disulfiram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexiletine (used to treat abnormal heart rhythms)
• phenylpropanolamine (a decongestant)
• theophylline (used in the treatment of asthma)
• alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)
• beta-blockers (used to treat high blood pressure)
• medicines used to decrease appetite
• amphetamine-like psychostimulants also known as ‘uppers’ or ‘speed’
• atropine (used in anaesthesia or to increases the heart rate)
• ergot alkaloids (used in the treatment of migraines e.g. ergotamine and methysergide)
• oxytocin (used to induce childbirth)
• sympathomimetics (used to maintain blood pressure in critically ill patients)
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

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Cold Relief Capsules with Decongestant - 16 Capsules (Aldi)
Wockhardt UK
UK supply
(w)130mm x (h)300mm
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Cold Relief Capsules_Leaflet_107568-2.ai
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22nd July, 2016
R 1st PDF sent on - 9TH AUG. 2016
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Changes in detail: • New regulatory text

Non-Regulatory

Cold Relief with Decongestant Capsules with alcohol
Do not drink alcohol while taking this medicine
Driving and using machines
It is possible that Cold Relief with Decongestant Capsules may cause dizziness. Do not drive or
operate machinery if affected.
3. How to take Cold Relief with Decongestant Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure. 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 with Decongestant 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 Cold Relief with Decongestant 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. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may develop side effects. 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, mouth ulcers, swollen
red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.
• restlessness
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers
such as ibuprofen or aspirin.
• Unexplained bruising or bleeding
• Nervousness, Dizziness, Headache, Diarrhoea
• Reoccuring fevers or infections
• Visual disturbances. This is more likely in those with glaucoma.
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
• Unusually fast pulse rate or a sensation of unusually fast or irregular heartbeat
• Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.
Side effects that have been reported with Cold Relief with Decongestant Capsules are:
• high blood pressure
• feeling sick
• worsening of asthma
• irritability
• excitement
• insomnia
• anxiety
• 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 with Decongestant Capsules
Keep this medicine out of the sight and reach of children.
• Cold Relief with Decongestant 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
• Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cold Relief with Decongestant Capsules contain
The active ingredients are: paracetamol 300mg, caffeine 25mg and phenylephrine hydrochloride 5mg. The other
ingredients are: starch, colloidal anhydrous silica, magnesium stearate, gelatin and colours; quinolone yellow
(E104), patent blue V (E131), titanium dioxide (E171) and black iron oxide (E172).
What Cold Relief with Decongestant Capsules look like and contents of the pack
Cold Relief with Decongestant Capsules are hard, green and yellow, gelatine capsules. The medicine is supplied
in a blister pack and outer cardboard carton.
Cold Relief with Decongestant 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.
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
Health Essentials Cold Relief with Decongestant Capsules
29831/0173
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in February 2017.
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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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