Patient leaflet - SAINSBURYS HEALTHCARE MAX STRENGTH COLD & FLU RELIEF BLACKCURRANT FLAVOUR POWDER FOR ORAL SOLUTION, BOOTS MAX STRENGTH COLD & FLU RELIEF BLACKCURRANT FLAVOUR POWDER FOR ORAL SOLUTION, TESCO HEALTH MAX STRENGTH COLD & FLU RELIEF BLACKCURRANT FLAVOUR POWDER
Illllllllll
Package leaflet: Information for the user
Paracetamol, 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 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 this medicine is 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 this medicine 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
- 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 relief of the symptoms of colds and flu, including headache, aches and pains, sore throat, nasal congestion (blocked nose) and feverishness (high temperature).
2. what you need to know before you take this medicine
Do not use in children under 16 years of age.
Do not take this medicine if you:
- are allergic to paracetamol, phenylephrine or any of the other ingredients (see section 6 for further information)
- have a serious heart condition
- 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 and isocarboxazid
- you are taking other decongestants such as ephedrine or xylometazoline
- have an over active thyroid gland
I* have an enlarged pro state or prostate pro blems
- have phaeochromocytoma (rare tumor of the adrenal gland tissue)
- have high blood pressure (hypertension).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- are pregnant or breast-feeding
- suffer from kidney or liver problems, including alcoholic liver disease
- have non-cirrhotic liver disease (liver disease that is not associated with changes in the structure of the liver)
- have circulatory disorders such as a condition called Raynaud's Phenomenon, which results from poor circulation in the fingers and toes
- suffer with phenylketonuria, a rare, inherited metabolic disorder
- have diabetes mellitus
- have closed angle glaucoma.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
- medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as cholestyramine
- 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
- antidepressant drugs called monoamine oxidase inhibitors (MAOI's) or have taken them within the last 14 days – these are medicines such as moclobemide, phenelzine and isocarboxazid
- medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (e.g. atenolol), vasodilators (e.g. hydralazine) or cardiac glycosides (e.g. digoxin)
- other decongestant drugs such as ephedrine or xylometazoline.
Contains paracetamol.
Do not take anything else containing paracetamol while taking this medicine.
This medicine with food and alcohol
Do not drink alcohol (beer, wine, spirits etc) while taking this product.
___ ___ ___ ___ ___ Pleas e tu rn ov er
Pregnancy, breast-feeding andTertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should not use this product. This product should not be used in women with a history of Ipre-eclampsia (high blood pressure in pregnancy which can lead to seizures). Always ask your doctor or pharmacist for advice before taking this medicine.
This medicine contains sucrose, aspartame (E951), sodium and carmoisine
[contains 2.4 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 medicine contains 53 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 118 mg sodium (the main bomponent of cooking/table salt) in each sachet. This is equivalent to 6% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains carmoisine which may cause allergic reactions.
3. how to take this medicine
Pour the contents of 1 sachet into a standard Imug. 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.
Adults, the elderly and children 16 years and over:
-
1 sachet every 4 to 6 hours as required. Do not take more than 4 sachets (4 doses) in any 24 hour period. Leave at least 4 to 6 hours between doses.
Do not give to children under 16 years.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
Do not take for longer than 3 days, unless your doctor agrees.
If you take more of this medicine 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. You may experience symptoms of dizziness, palpitations (irregular or forceful heartbeat), stomach pain, high blood pressure with headache, unhealthy pale appearance (pallor), feeling sick (nausea) or vomiting if you take too much of this medicine. If ^ou forget to take this medicine:
Do not take a double dose to make up for a forgotten dose. If you forget a dose, take it as soon as you remember it and then take the next dose at least 4 hours later.
L _ _ _ _ _ _ _
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
- Serious skin reactions
- Allergic reactions (such as skin rashes).
Other side effects:
Not known (frequency cannot be estimated from the available data):
- Blood disorders, such as thrombocytopenia (reduction in blood platelets which might mean that you bleed or bruise more easily), pancytopenia (reduction in white and red blood cells), agranulocytosis, leucopenia or neutropenia (reduction in white blood cells which makes infections more likely)
- Stomach and gut disorder, such as vomiting, nausea or abdominal discomfort
- Difficulty in passing urine (especially in males).
5. how to store this medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the pack.
Do not store above 25°C.
6. contents of the pack and other information
What this medicine contains
The active ingredients are paracetamol and phenylephrine hydrochloride. Each 5 g sachet contains paracetamol 1000 mg and phenylephrine hydrochloride 12.2 mg.
The other ingredients are: sucrose, sodium citrate, citric acid, ascorbic acid (Vitamin C), acesulfame potassium (E950), aspartame (E951), blackcurrantl flavour, carmoisine (E122) and brilliant blue (E133).
What this medicine looks like and contents of the pack
Each 5 g sachet contains purple powder.
This pack contains 5 or 10 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.
Text revised: April 2020.
PL 12063/0070 D8P46FVJ2]