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GALPHARM FLU-MAX 4-IN-ONE RELIEF POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - GALPHARM FLU-MAX 4-IN-ONE RELIEF POWDER FOR ORAL SOLUTION

Particulars to appear on the outer packaging

Package leaflet: Information for the patient

Galpharm Flu-Max 4-In-One Relief powder for oral solution Paracetamol, Guaifenesin, Phenylephrine, Cetylpyridinium

Read all of this leaflet carefully before you start taking this medicine because it contains important information.

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 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 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
  • cetylpyridinium chloride which is an antibacterial, and relieves sore throats.

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

2. what you need to know before you take this medicine do not take this medicine if you:

  • 1.3 PRODUCT INFORMATION

  • are allergic to paracetamol, guaifenesin, phenylephrine, cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6)
  • have a serious heart condition or cardiovascular disorder(s)
  • have high blood pressure (hypertension)
  • have an overactive thyroid
  • have 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, isocarboxazid and tranylcypromine
  • 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

  • are pregnant or breastfeeding
  • suffer from kidney or liver problems, including alcoholic liver disease
  • have diabetes
  • have circulatory disorders such as a condition called Raynaud’s Phe­nomenon, which results from poor circulation in the fingers and toes
  • have angina
  • have an enlarged prostate gland, as this may cause more difficulty in passing urine
  • suffer from phenylketonuria, a rare, inherited metabolic disorder.

Other medicines and Galpharm Flu-Max 4-In-One Relief powder for oral solution

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

  • 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
  • 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)
  • phenothiazines used as sedatives (e.g. chlorpromazine, pericyazine and fluphenazine)
  • if you are going to have a general anaesthetic as this may cause changes in heart rhythm.

Contains paracetamol.

Other important information:

If you are taking medication or are under medical care , consult your doctor before using this medicine.

Long term use of this product is not recommended.

Information about some of the ingredients in this medicine:

Contains aspartame (E951), a source of phenylalanine equivalent to 20 mg per sachet.

Each sachet contains 117 mg sodium. To be taken into consideration by people on a controlled sodium diet.

3) how to take this medicine

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.

Adults, the elderly and children 16 years and over:

  • 1 sachet every 4 to 6 hours, as necessary, up to a maximum of 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 of age.

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 advised by your doctor.

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.

4) possible side effects

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.

  • 1.3 PRODUCT INFORMATION

Rare side effects are:

  • allergic reactions such as skin rash
  • stomach upsets, diarrhoea
  • dizziness
  • tingling and coolness of the skin
  • difficulty sleeping (insomnia)
  • nervousness, tremors or convulsions
  • a rise in body temperature
  • a rise in blood pressure with headache, vomiting (being sick) and fast, slow or irregular heart beat (palpitations).

More rarely, the following side effects can happen

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

Very rare cases of serious skin reactions have been reported.

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:

By reporting side effects you can help provide more information on the safety of this medicine.

5) how to store this medicinedo 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 25°C.

6) contents of the pack and other informationeach 4.1 g sachet of off-white powder, taken as a hot drink, contains the active ingredients: paracetamol 1000 mg, guaifenesin 200 mg, phenylephrine hydrochloride 12.2 mg and cetylpyridinium chloride 3 mg.

The other ingredients are: maltodextrin, citric acid (anhydrous), tartaric acid, sodium citrate, acesulfame potassium (E950), aspartame (E951), sucralose, powdered menthol flavour, lemon flavour and the colour curcumin (E100).

This product is available in pack sizes of 5 or 10 sachets.

1.3



PRODUCT INFORMATION


  • 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET

Sources: Original (products.mhra.gov.uk)