PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500 MG / 200 MG / 10 MG POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

Package Leaflet: Information for the user

Paracetamol/Gu­aifenesin/Phe­nylephrine Hydrochloride 500mg/200mg/10mg Powder for oral solution

Paracetamol, Guaifenesin, 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 have 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 3 days.

What is in this leaflet

• 1. What is this medicine and what it is used for

• 2. What you need to know before you take this medicine

• 3. How to take this medicine

• 4. Possible side effects

• 5. How to store this medicine

• 6. Contents of the pack and other information

1. what is this medicine and what it is used for

This medicine contains the following active substances:

• Paracetamol which is a pain reliever (analgesic) effective against aches and pains including headache and sore throat, and also helps reduce your temperature when you have a fever (antipyretic).
• Guaifenesin which is an expectorant to help loosen mucus (phlegm) when you have a chesty cough.
• Phenylephrine hydrochloride which is a decongestant used to reduce swelling in the passages of the nose to help you breathe more easily.

This medicine is used for the short-term relief of the symptoms of colds and flu, including aches and pains, such as headache and sore throat, nasal congestion, chills and feverishness (high temperature). Loosens stubborn mucus (phlegm) and provides relief from chesty coughs, in adults and children aged 12 years and over.

This medicine should only be used if you have all of the following symptoms – pain and/or fever, a blocked nose and a chesty cough.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before you take this medicine

• are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• have liver or severe kidney disease
• have a heart condition or cardiovascular disorder(s) or blood problems such as anaemia (low red blood cell count).
• have high blood pressure (hypertension).
• have an overactive thyroid (hyperthyroidism).
• have diabetes.
• have phaeochromocytoma (a rare tumour of adrenal gland tissue).
• are taking tricyclic antidepressants such as imipramine or amitriptyline.
• are taking beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine), used to treat high blood pressure (hypertension).
• are taking other paracetamol-containing products.
• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days – these are medicines such as moclobemide, phenelzine, isocarboxazid and tranylcypromine.
• have closed angle glaucoma (high pressure inside the eyes).
• have difficulty passing urine, an enlarged prostate or other prostate problems.
• are currently taking other decongestant drugs (e.g. ephedrine and xylometazoline) or stimulants (e.g. dexamfetamine).

Warnings and precautions

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

• have a very bad cough or asthma, or is accompanied by a fever, rash or persistent headache. See your doctor if your cough lasts for more than 5 days or comes back.
• have circulatory disorders such as a condition called Raynaud’s Phe­nomenon, which results from poor circulation in the fingers and toes.
• have angina or other cardiovascular disease(s).
• have an autoimmune disorder called myasthenia gravis where muscles become easily tired and weak.
• have an enlarged prostate gland, as this may cause more difficulty in passing urine.
• have severe stomach or intestinal problems.
• have liver or kidney disease.
• are taking a cough suppressant.
• have difficulties in sleeping (insomnia), nervousness, increased body temperature, tremors and/or convulsions.
• have an intolerance to some sugars.
• suffer with phenylketonuria, a rare, inherited metabolic disorder.

You should see your doctor if:

• you develop a high fever;
• you develop signs of other infection such as feeling unwell, night sweats, tiredness, pain, or swelling;
• your symptoms do not get better after three days.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and this medicine

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

If you are taking any of the following medicines, please see your doctor before taking this medicine

• If you are taking probenecid speak to your doctor as the dose of this medicine may need to be reduced.
• Medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine.
• Medicines to control feeling sick or being sick such as metoclopramide or domperidone.
• Medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins – you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis.
• Barbiturates (for epilepsy or to help you sleep), such as phenobarbitones.
• Tricyclic antidepressants such as imipramine, amitriptyline.
• Monoamine oxidase inhibitors (MAOI’s) such as moclobemide, phenelzine, isocarboxazid and tranylcypromine, used to treat depression.
• Medicines to treat heart or circulatory problems, or to lower blood pressure, (e.g. digoxin, guanethidine, reserpine, methyldopa).
• Aspirin or other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
• Medicines to treat migraine (e.g. ergotamine and methylsergide).
• Zidovudine as this might cause blood problems (low white blood cell count).
• Phenothiazines used as sedatives (e.g. chlorpromazine, pericyazine and fluphenazine).
• Other flu, cold or decongestant products containing sympathomimetic amines.
• If you are going to have blood or urine tests as taking this medicine may affect the results.
• If you are going to have a general anaesthetic, as this may cause changes in heart rhythm.

This medicine with alcohol

Do not drink alcohol when using this medicine.

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.

This product should not be used during pregnancy or breast-feeding without medical advice.

Driving and using machines

This product could cause dizziness. If you are affected do not drive or operate machinery.

This medicine contains sucrose

Contains 2.1 g of sucrose (sugar) per sachet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account in patients with diabetes.

This medicine contains aspartame (E951)

This medicine contains 12 mg aspartame in each sachet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains sodium

This medicine contains 129 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 6.5% of the recommended maximum daily dietary intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

3. how to take this medicine

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

For oral use.

Adults, the elderly and children 12 years and over

The recommended dose is 1 sachet every 4 to 6 hours, as required. Do not take more than

• 4 sachets (4 doses) in any 24-hour period.

Use in children and adolescents

Do not give to children under 12 years.

Pour the contents of 1 sachet into a standard mug. Fill the mug to below the brim with approximately 250 ml (8 fluid oz) of hot, but not boiling, water. Stir until dissolved, and allow to cool to a drinkable temperature. Drink all the yellow solution within m hours.

Do not exceed the stated dose. If your symptoms persist for more than 3 days or worsen, you must see a doctor or pharmacist.

If you take more medicine than you should

Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage. 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.

Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

If you forget to take this medicine

Do not take a double dose to make up for a forgotten dose.

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.

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

The following adverse events may represent the most commonly occurring adverse events, though actual frequencies are not available:

• Difficulty sleeping (insomnia),
• diarrhoea, nausea (feeling sick),
• nervousness, tremors, irritability, restlessness or excitability,
• a rise in blood pressure with headache, dizziness, vomiting (being sick) and irregular heart beat (palpitations).

The frequency of the events below is unknown but considered likely to be rare:

• 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.
• Breathing problems, these are more likely if you have experienced them before when taking other painkillers such as aspirin or ibuprofen.
• Stomach upsets (pain or discomfort), nausea, vomiting, diarrhoea,
• tingling or coolness of the skin,
• liver problems,
• a faster or irregular heartbeat,
• an acute increase of the pressure inside the eye, enlarged eye pupil.
• Problems or pain passing water.

The frequency of the events below is unknown but considered likely to be very rare:

• You may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

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 the Yellow Card Scheme Website: By reporting side effects, you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of the month.

Do not store above 25°C.

After reconstitution with hot water the solution is stable for IV2 hours.

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 informationeach sachet contains the active ingredients: paracetamol (500 mg), guaifenesin (200 mg) and phenylephrine hydrochloride (10 mg).

The other ingredients are: sucrose, citric acid (E330), tartaric acid (E334), sodium cyclamate (E952), sodium citrate (E331), acesulfame potassium (E950), aspartame (E951), powdered menthol flavour [contains natural menthol, corn maltodextrin and arabic gum (E414) ], lemon flavour [contains flavouring preparation, natural flavouring substance, corn maltodextrin, arabic gum E414, sodium citrate E331, citric acid E330 and butylated hydroxyanisole E320 (0.01%)], lemon juice flavour [contains flavouring preparation, natural flavouring substance(s), maltodextrin, modified starch E1450 and butylated hydroxyanisole E320 (0.03%)], quinoline yellow (E104).

What this medicine looks like and contents of the pack

This medicine is a powder for oral solution, with an off-white colour and a characteristic citrus/menthol odour, in sachets.

The reconstituted solution is opalescent yellow with a characteristic citrus/menthol o­dour.

This medicine is available in pack sizes of 5, 6, 10, 14, 15 or 20 sachets although not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer(s) :

Wrafton Laboratories Limited

Braunton, Devon, EX33 2DL

United Kingdom

Omega Pharma International NV,

Venecoweg 26,

Nazareth, 9810,

Belgium

Marketing Authorisation Holder :

Omega Pharma Ltd

32 Vauxhall Bridge Road, London

SW1V 2SA, United Kingdom

This leaflet was last revised in May 2020