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

PACKAGE LEAFLET

Package leaflet: Information for the user

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

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 5 days.

The name of your medicine is Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine Hydrochloride 500mg/200mg/10mg powder for oral solution. It will be referred to as Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine throughout the remainder of the leaflet.

What is in this leaflet

• 1. What Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine is and what it is used for

• 2. What you need to know before you take Perrigo

Paracetamol/Gu­aifenesin/Phe­nylephrine

• 3. How to take Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine

• 4. Possible side effects

• 5. How to store Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine

• 6. Contents of the pack and other information

1. What Perrigo Paracetamol/Guaifenesin/Phenylephrine is and what it is used for

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever
• guaifenesin which is an expectorant to help loosen phlegm
• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

These sachets are used for the short term symptomatic relief of colds and flu including aches and pains, headache, blocked nose and sore throat, chills and fever, and for relief from chesty coughs.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

2. what you need to know before you take perrigo paracetamol/guaifenesin/phenylephrine

Do not take this medicine if you:

• are allergic to paracetamol, guaifenesin, phenylephrine or any of the other ingredients of this medicine (listed in section 6)
• are pregnant or breastfeeding
• have liver or kidney problems, including alcoholic liver disease
• have a serious 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
• have diabetes
• have phaeochromocytoma
• have glaucoma, including closed angle glaucoma
• have difficulty passing urine
• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days – these are medicines such as phenelzine and isocarboxazid
• are taking tricyclic antidepressants
• are taking beta-blocking drugs
• are taking other paracetamol-containing products
• are currently taking other decongestant drugs or stimulants (e.g. ephedrine, amfetamines and xylometazoline)
• are taking a medicine to suppress a dry cough.

Warnings and precautions

Talk to your doctor or pharmacist before taking Perrigo

Paracetamol/Gu­aifenesin/Phe­nylephrine:

• if you have a very bad cough or asthma. See your doctor if your cough lasts for more than 5 days or comes back, or if you have a fever, rash or a headache which won’t go away

• have circulatory disorders such as a condition called Raynaud’s Phe­nomenon, which results from poor circulation in the fingers and toes

• if you have angina
• if you have an enlarged prostate gland, as this may cause more difficulty in passing urine
• if you have severe stomach or intestinal problems
• if you have an intolerance to some sugars
• if you suffer with phenylketonuria, a rare, inherited metabolic disorder.

Children

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

Other medicines and Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine may interact with certain medicines:

• used to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine
• used to control feeling sick or being sick such as metoclopramide or domperidone
• 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
• medicines to treat heart or circulatory problems, or to lower blood pressure, (e.g. digoxin, guanethidine, reserpine, methyldopa)
• beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
• 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)
• 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.

Other important information

• Do not use for longer than 5 days, except on medical advice
• 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
• Use medicines which will only treat the symptoms you have
• Do not take with other flu, cold or decongestant products.

Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine with alcohol

• Do not drink alcohol when using Perrigo

Paracetamol/Gu­aifenesin/Phe­nylephrine.

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.

Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine should not be used while pregnant or breast-feeding.

Driving and using machines

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

Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine contains sucrose, aspartame and sodium.

Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine:

• Contains 2.1 g 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.
• Contains aspartame (E951), a source of phenylalanine. This may be harmful for people with phenylketonuria.
• Contains 129 mg sodium per sachet. This should be taken into consideration by patients on a controlled sodium diet.

3. how to take perrigo paracetamol/guaifenesin/phenylephrine

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.

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 of the solution within IV2 hours.

The recommended dose is:

Adults, the elderly and children 12 years and over:

1 sachet every 4 hours, as required. Do not use more than 4 sachets (4 doses) in any 24 hour period.

Do not give to children under 12 years.

If you use more Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine than you should Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine contains paracetamol.

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 use Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine

Do not take more medicine than the label tells you to. If your symptoms persist for more than 5 days or worsen, you must see a doctor or pharmacist.

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.

Serious side effects

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

• allergic reactions which may be severe such as skin rash, breathing difficulties, 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.

Very rare cases of serious skin reactions have been reported.

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

Other side effects

Common: may affect up to 1 in 10 people

• 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).

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

• stomach pain or discomfort
• liver problems
• a faster or slower heart beat
• eye disorders
• problems passing water.

5. how to store perrigo paracetamol/guaifenesin/phenylephrine

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 that month.

Do not store above 30 ° C.

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 Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine contains.

The active substances are 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, lemon flavour, lemon juice flavour, quinoline yellow (E104).

What Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine looks like and contents of the pack.

The medicine is an off-white powder with a characteristic citrus/menthol odour, and is packed into individual 4.4 g sachets.

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

Marketing Authorisation holder

Omega Pharma Limited

32 Vauxhall Bridge Road

London

SW1V 2SA

UK

Manufacturer(s)

Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Omega Pharma International NV, Venecoweg 26, Nazareth, 9810, Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Perrigo Paracetamol/Gu­aifenesin/Phe­nylephrine Hydrochloride (500mg/200mg/10mg) powder for oral solution

Czech Republic: Coldrex proti chripce a kasli citron a mentol 500mg/200mg/10mg, Hungary: Rubophen Thermo Plus por belsoleges oldathoz

Italy: Bronchenolo Tosse, Influenzae Raffreddore

Poland: Coldrex Complex Grip.

This leaflet was last revised in May 2019

PL 02855/0319