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FLU RELIEF CAPSULES WITH DECONGESTANT - patient leaflet, side effects, dosage

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Patient leaflet - FLU RELIEF CAPSULES WITH DECONGESTANT

FLU RELIEF CAPSULES WITH DECONGESTANT

(Phenylephrine Hydrochloride 12.2mg and Paracetamol 500mg)

PATIENT INFORMATION LEAFLET

Read this leaflet carefully because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve after 3 days.

IN THIS LEAFLET

  • 1. What this medicine is for

  • 2. Before you take the medicine

3. How to take the medicine

4. Possible side effects

  • 5. Storing the medicine

  • 6. Further information

1. WHAT THIS MEDICINE IS FOR

The capsules contain:

  • Paracetamol which relieves pain and brings down high temperatures (reduces fever)
  • Phenylephrine Hydrochloride which is a decongestant, it shrinks the blood vessels in the nose and sinuses which opens the airways helping you to breathe more easily.

Flu Relief Capsules with Decongestant are used for the relief of the symptoms of colds and flu including aches, pains and feverishness, headache, nasal congestion and sinus pain.

  • 2. BEFORE YOU TAKE THE MEDICINE

Do not take Flu Relief Capsules with Decongestant if:

  • You are allergic to Paracetamol, phenylephrine hydrochloride or to any of the other ingredients listed in section 6.
  • You are taking monoamine oxidase inhibitor medicines (MAOI’s used for depression) or have taken them within the last 14 days.
  • You are taking tricyclic antidepressants (eg. amitriptyline).
  • You are pregnant or breast feeding.
  • You have an overactive thyroid gland (hyperthyroidism).

Do not take anything else containing paracetamol while taking this medicine.

This product contains a decongestant. Do not take with other products for the relief of colds, flu or congestion.

Talk to your pharmacist or doctor before taking if:

  • you suffer from severe liver or kidney disease, including alcoholic liver disease
  • you have heart problems or high blood pressure
  • you have diabetes
  • you have prostate problems
  • you have glaucoma (increased pressure in the eye)
  • you have problems with your blood circulation (including Reynaulds Phenomenon which makes your toes and fingers numb and pale).

If you are taking other medicines

You must not take these capsules if you are taking:

  • monoamine oxidase inhibitor medicines (MAOI’s used for depression) or have taken them within the last 14 days.
  • tricyclic antidepressants (e.g. amitriptyline)

Talk to your pharmacist or doctor before taking the capsules if you are taking any of the following:

  • medicines for nausea or sickness, such as metoclopramide or domperidone
  • colestyramine for high cholesterol or high blood fats
  • warfarin (or other medicines used to thin the blood and reduce the risk of clotting). The risk of bleeding may be increased if you take paracetamol daily over a long period of time. However you can take occasional doses of paracetamol
  • any heart medicines (especially digoxin)
  • some medicines to treat high blood pressure (e.g. guanethidine or reserpine).

Pregnancy and breast feeding

Do not take the capsules if you are pregnant or breast feeding.

3. how to take the medicine

Swallow the capsules, preferably with a drink of water.

Age

Dose and how often to take

Adults and children over 12 years

Take 1 capsule every 4–6 hours as required

Do not give to children under 12 years

  • Do not take more often than every 4 hours.
  • Do not take more than 4 capsules in any 24 hours.
  • Do not continue to take for more than 3 days unless instructed by your doctor.

Do not take more medicine than the label tells you to. If you do not get better, talk to 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.

4. possible side effects

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

Side effects are rare with paracetamol and phenylephrine hydrochloride.

Stop taking the capsules and contact your doctor straight away if you notice:

  • skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat or difficulty breathing
  • unexpected bruising or bleeding, persistent tiredness, or increase in the number of infections (e.g. sore throats) which you get. These are possible signs of changes in the blood.
  • fast heart rate, changes in heart rhythm, abnormally fast heart beat (palpitations), high blood pressure, dizziness
  • feeling sick, vomiting
  • headache.

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. STORING THE MEDICINE

Do not use after the expiry date printed on the carton.

Store below 25°C in a dry place.

Keep all medicines out of the reach and sight of children.

  • 6. FURTHER INFORMATION

What is in this medicine

The active ingredients are: Paracetamol 500 mg and Phenylephrine Hydrochloride 12.2mg per capsule.

The other ingredients are: Colloidal anhydrous silica, sodium starch glycollate, magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E 171), patent blue V (E 131) and yellow iron oxide (E 172).

What this medicine looks like and the contents of the pack.

Flu Relief Capsules with Decongestant are green & white capsules which are printed „GH31“. This pack contains 8, 10, 12 or 16 capsules (not all pack sizes may be marketed)..

Marketing Authorisation Holder: Galpharm Healthcare Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Galpharm International Ltd, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

Text revised: 01/2016.