Pbh Cold Relief Capsules
Package leaflet: Information for the user VITABIOTICS COLD AND FLU CAPSULES
Paracetamol, Caffeine, Phenylephrine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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. 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.
What is in this leaflet
1. What Vitabiotics Cold and Flu Capsules are and what they are used for
2. What you need to know before you take Vitabiotics Cold and Flu Capsules
3. How to take Vitabiotics Cold and Flu Capsules
4. Possible side effects
5. How to store Vitabiotics Cold and Flu Capsules
6. Contents of the pack and other information
1. What Vitabiotics Cold and Flu Capsules are and what they are used for
Vitabiotics Cold and Flu Capsules consist of a combination of ingredients which are effective in relieving aches, pains, headache, sore throat, fever and nasal congestion associated with colds and influenza. Paracetamol is a well-known 'analgesic' (pain killer). It is effective against aches and pains including headaches. It can also reduce fever (antipyretic). Phenylephrine hydrochloride reduces swelling in the passages of the nose (nasal decongestant) and so relieves a blocked or runny nose. Vitabiotics Cold and Flu Capsules also contain caffeine which acts as a mild stimulant.
2. What you need to know before you take Vitabiotics Cold and Flu Capsules Do not take Vitabiotics Cold and Flu Capsules:
• if you have ever had an allergic reaction to paracetamol, phenylephrine hydrochloride, caffeine or any of the other ingredients listed in Section 6
• if you have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart disease
• if you have ever had peptic ulcer
• if you have phaeochromocytoma or glaucoma
• if you are taking tricyclic antidepressants (eg., imipramine or amitriptyline) or if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (eg., moclobemide) prescribed for depression
• if you are taking beta blockers (eg., atenolol)
• if you are pregnant or breast-feeding
Warnings and precautions
Ask your doctor or pharmacist before you take this medicine:
• if you have a blood vessel disease such as Raynaud’s phenomenon
• if you have an enlarged prostate
• if you have heart or circulation disease
• if you have been an alcoholic, alcohol reduces liver capacity to deal with paracetamol
• if you have been told by your doctor you have an intolerance to some sugars
Do not take this medicine with any other paracetamol-containing products.
Do not take this medicine with other flu, cold or decongestant products.
Children under 12 years of age
Do not give this medicine to children under 12 years.
Other medicines and Vitabiotics Cold and Flu 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, particularly:
• metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick])
• ergotamine or methylsergide (for migraine)
• cholestyramine (to lower blood cholesterol)
• drugs to lower blood pressure
• appetite suppressants or stimulants
• drugs to treat depression such as tricyclic antidepressants (eg., amitriptyline)
• drugs to treat heart disease (eg., digoxin)
• anticoagulants - blood thinning drugs (eg., warfarin)
Vitabiotics Cold and Flu Capsules with alcohol
Do not consume alcohol or alcoholic drinks during treatment with this medicine.
Pregnancy and breast-feeding
Due to the phenylephrine and caffeine content of this medicine, it should not be used if you are pregnant or 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.
Driving and using machines
This medicine may cause drowsiness. Do not drive or operate machinery if you feel dizzy. Avoid alcoholic drinks.
3. How to take Vitabiotics Cold and Flu Capsules
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children over 12 years: 1 to 2 capsules to be taken up to 4 times a day, every 4 hours.
Elderly: 1 capsule every 4 hours.
It is important that you do not take more than 8 capsules in 24 hours and do not take more than 2 capsules at any one time. The capsules should be swallowed whole with a drink of water.
Do not continue taking these capsules for more than 3 days without consulting a doctor.
Avoid drinking too much tea or coffee before taking these capsules. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.
Use in children under 12 years of age
Do not give to children under 12 years of age.
If you take too many Vitabiotics Cold and Flu Capsules than you should
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
If you forget to take the Vitabiotics Cold and Flu Capsules
If you miss a dose of Vitabiotics Cold and Flu Capsules do not worry - take your next dose at the normal time. Do not take extra capsules when it is time for your next dose to make up for the capsules you have missed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you experience:
• Serious allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or throat or shortness of breath
• Serious illness with blistering of the skin, mouth, eyes and genitals
• Skin rash or peeling, or mouth ulcers
• Reduction in red blood cells, which can make the skin pale and cause weakness
• Reduction in blood platelets, which increases risk of bleeding or bruising
• Bluish colouring of the skin
• Reduction in white blood cells, which causes increased risk of infections
• Breathing problems, these are more likely if you have experienced them before when taking other painkillers
• Nausea, sudden weight loss and yellowing of the eyes and skin
• Inflammation of pancreas which causes severe abdominal and back pain
• Visual disturbances, this is rare but is more likely in those with glaucoma
• Prolonged abnormal dilation of the pupil of the eye
• Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat
• Perforation of the nasal septum, which causes whistling noise when breathing or combination of crusting, blood discharge, difficulty breathing, nasal pressure and discomfort
• Difficulty and pain during passing water, this is more likely to occur in men with an enlarged prostate gland
• Elevated white blood cells in the urine which may be a sign of bacterial tract infection
• High levels of nitrogenous waste products (urea) in the blood that are usually excreted in the urine, which causes loss of appetite and lack of energy
The following side effects may occur. Tell your doctor if you get them
Most common effects
• Raised blood pressure
• Headache, dizziness, difficulty sleeping, nervousness, anxiety
• Diarrhoea or sickness
Frequency not known
• Feelings of distress, anxiety, irritability, excitement or anger
• Muscle twitching
• Ringing in the ears
• Stomach ulcers, indigestion
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: 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 Vitabiotics Cold and Flu Capsules
Do not take this medicine after the expiry date printed on the pack. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the blisters in the carton in order to protect from light.
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 Vitabiotics Cold and Flu Capsules contain
• Each capsule contains 300 mg paracetamol, 25 mg caffeine and 5 mg phenylephrine hydrochloride.
• The other inactive ingredients are maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, patent blue V (E131), iron oxide (E172), quinoline yellow (E104) and titanium dioxide (E171).
What Vitabiotics Cold and Flu Capsules look like and contents of the pack
Vitabiotics Cold and Flu Capsules are in the form of green and yellow hard gelatin capsules.
They are available in packs of 10, 12, 16 and 24 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Max Remedies Ltd,
William Nadin Way, Swadlincote,
Derbyshire, DE11 0BB, UK