PACKAGE LEAFLET: INFORMATION FOR THE USER COLD RELIEF CAPSULES (Paracetamol, Caffeine, Phenylephrine Hydrochloride)

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 after 7 days.

1. What Cold Relief Capsules are and what they are used for

Cold Relief Capsules contain the following active ingredients:

•    Paracetamol - relieves pain and reduces body temperature when you have a fever

•    Caffeine - acts as a mild stimulant

•    Phenylephrine Hydrochloride - a decongestant which unblocks your nose and sinuses helping you to breathe more easily.

This medicine is used for the short term relief of the symptoms of flu, colds and chills. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh and sore throat.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you take Cold Relief Capsules DO NOT take this medicine:

•    If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);

•    If you have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart disease;

•    If you have phaeochromocytoma or glaucoma;

•    If you 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;

•    If you are taking beta blockers (e.g. atenolol).

Do not take anything else containing paracetamol while taking this medicine. Do not take with any other flu, cold or decongestant products.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

•    Have a blood vessel disease such as Raynaud’s Phenomenon;

•    Have an enlarged prostate;

•    Have a heart or circulation disease;

•    Are suffering from liver problems including liver problems due to excessive alcohol consumption;

•    Have Gilbert’s syndrome (mild jaundice);

•    Are suffering from kidney problems;

•    Have hemolytic anemia;

•    Are suffering from dehydration and chronic malnutrition;

•    Suffer from asthma and are sensitive to aspirin;

•    Are taking any other paracetamol containing medicines;

•    Have a fever that does not improve after taking this medicine;

•    Have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency).

Other medicines and Cold Relief Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially, the following:

•    Drugs for heart problems (e.g. digoxin);

•    Drugs to lower blood pressure;

•    Appetite suppressants or stimulants;

•    Drugs to thin the blood (anti-coagulant drugs e.g. Warfarin ,other coumarins);

•    Cholestyramine (reduces blood cholesterol levels)

•    Metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems)

•    Drugs to treat depression ;

•    Ergotamine or methylsergide (for migraines);

•    Probenecid (medicine used to treat high levels of uric acid in the blood stream (gout));

•    Medicine to treat fever or mild pain (Aspirin, Salicylamide);

•    Barbiturates and tricyclic antidepressants (to treat depression);

•    Medicines used to treat epilepsy (Lamotrigine);

•    Medicines to treat tuberculosis (Isoniazid).

Cold Relief Capsules with food, drink and alcohol

Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty in sleeping, shaking and an uncomfortable feeling in the chest.

You should not drink alcohol whilst you are on this medicine.

Effects of paracetamol on laboratory tests

Uric acid and blood sugar tests may be affected.

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.

Due to the caffeine content of this product it should not be used if you are pregnant or breastfeeding

Driving and using machines

This product may cause dizziness. If affected do not drive or operate machinery

3. How to take Cold Relief Capsules

Always take 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.

The recommended dose is:

Adults and children aged 16 years and over:

Swallow two capsules every 4 - 6 hours as needed. Do not take more than 12 capsules in 24 hours. Swallow each capsule with a drink of water.

Children aged 12 years to 15 years:

Two capsules every 4-6 hours as needed. Do not take more than 8 capsules in 24 hours.

-Do not take more frequently than every 4 hours;

-Do not take for more than 7 days without asking your doctor;

-Do not exceed the recommended dose;

-Do not give to children under 12 years of age.

If you do not get better, talk to your doctor.

If you take more Cold 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 Cold Relief Capsules

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking this medicine and see your doctor immediately if you experience symptoms like:

•    Very rare cases of serious skin reactions have been reported, which may cause rash, skin peeling, sores and severe blistering;

•    Visual disturbances. This is rare but is more likely in those with glaucoma;

•    Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat;

•    Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland;

•    Accumulation of fluid in the larynx including an itchy rash, throat swelling (severe allergic reaction);

•    Swelling on the face, mouth, hands (angioedema).

The following side effects may occur with Paracetamol:

Rare (may affect up to 1 in 1,000 people):

Oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin), haemorrhage (bleeding), abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, reduction of irritability or agitation (sedation), platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cell in the bone marrow), abnormal liver function, liver failure, hepatic necrosis (death of liver cells), jaundice, overdose and poisoning, tremor, headache, depression, confusion, hallucinations, sweating, pruritus (itching), feeling lousy (malaise).

Very rare (may affect up to 1 in 10,000 people):

Hepatotoxicity (damage caused to the liver), thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising), leucopenia (frequent infections due to poorly functioning white blood cells or decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (severe decrease in white blood cells which may lead to severe infections), hemolytic anemia (abnormal breakdown of red blood cells, which may cause weakness or pale skin), hypoglycemia (low levels of glucose in the blood), cloudy urine and kidney disorders.

Other adverse reactions of paracetamol whose frequency cannot be estimated from available data are:

Anaemia (decrease in red blood cells), problems with the way your liver works (liver alteration), anuresis (inability to urinate), gastrointestinal effects and vertigo.

There have been cases of difficulty breathing, wheezing, coughing, and shortness of breath with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs such as ibuprofen.

The following side effects may occur with caffeine and phenylephrine. Tell your doctor if you get them:

•    Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea or sickness;

•    Irritability, restlessness and excitability.

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

Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C. Store in the original package.

•    Do not use this medicine after the expiry date which is stated on the carton. 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 Capsules contain

•    The active substances are paracetamol 300 mg, caffeine 25 mg and phenylephrine hydrochloride 5 mg.

•    The other ingredients are modified maize starch, colloidal anhydrous silica, magnesium stearate, patent blue V (E131), titanium dioxide (E171), quinolone yellow (E104) and ferric oxide (E172).

What Cold Relief Capsules look like and contents of the pack

•    These capsules are hard, green/yellow filled with a white powder.

•    They are available in packs of 8, 12, 16, 24 or 32. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1 EG, United Kingdom Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717 Email: info@bristol-labs.co.uk

Cold Relief Capsules; PL 17907/0346

This leaflet was last revised in September 2016

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.