TRIFLUNEX 200/500/10MG PULVERIS N10 (WICK)

ATC code: R05XU 

Active substances: Paracetamolum, Guaifenesinum, Phenylephrini Hydrochloridum

Vendor, principal: Procter & Gamble Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

TRIFLUNEX 500MG/+200MG/+10MG N5

PACKAGE LEAFLET: INFORMATION FOR THE USER
TriFlunex
Paracetamol 500mg, Guaifenesin 200mg, Phenylephrine HCl 10mg. Powder for oral solution
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Triflunex carefully to get the best results from it.
-   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
-   If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.   What Triflunex is and what it is used for
2.   Before you take Triflunex
3.   How to take Triflunex
4.   Possible side effects
5.   How to store Triflunex
6.   Further information
1.   WHAT VICKS COLD & FLU CARE DAYMED COMPLETE HOT DRINK IS AND WHAT IT IS USED FOR
Triflunex is designed for the relief of symptoms of colds and flu.
It contains three active ingredients:
•   Paracetamol is a well known pain killer (analgesic). It is effective against aches and pains including headache and sore throat and can also reduce fever (antipyretic).
•   Guaifenesin (an expectorant) loosens phlegm which helps relieve chesty coughs.
•   Phenylephrine hydrochloride (a nasal decongestant) reduces swelling in the passages of the nose and so relieves a blocked nose.
You should only use Triflunex if you have pain/or fever, nasal congestion and chesty cough.
2.   BEFORE YOU TAKE TRIFLUNEX Do not take Triflunex if you:
•   are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride, or to any of the ingredients (see section 6)
•   have heart disease
•   have high blood pressure (hypertension)
•   have a problem with your liver or severe kidney disease
•   have overactivity of the thyroid gland
•   are diabetic
•   have glaucoma (increased pressure in the eye) of the narrow-angle type
•   have porphyria, which is a hereditary disorder of characterised by excessive amounts of pigments in the urine
•   are taking tricyclic antidepressants
•   are taking beta blockers
•   are taking monoamine oxidase inhibitors (MAOIs) - used in treatment of depression or Parkinson’s disease or have taken them in the last 14 days
•   are taking medicines to lower your blood pressure or treat angina.
Do not give Triflunex to children under 12 years of age
Important: Contains Paracetamol. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Do not take with any other flu, cold or decongestant products.
Ask your doctor or pharmacist before taking Triflunex if you:
•have a problem with your liver functions
•are male and have an enlarged prostate gland, as you may have more difficulty passing water •have a blood circulation problem (including Raynaud’s syndrome)
•have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Taking other medicines

Please inform your doctor or pharmacist before you take Triflunex if you are taking:
•   medicine containing paracetamol or other decongestants for colds and flu.
If you are taking these, do not take Triflunex.
•   monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson’s disease. Do not take Triflunex if you have taken MAOIs in the last 14 days.
•   tricyclic antidepressants for depression, such as amitriptyline or imipramine.
•   medicine for high blood pressure (antihypertensives), including beta-blockers, or for improving heart function or correcting abnormal heart rhythms (digoxin, lanoxin, digitoxin).
•   phenothiazines (which are used either as antipsychotic drugs to treat conditions such as schizophrenia or paranoia, or to prevent nausea and vomiting).
•   medicine for nausea and vomiting( such as metoclopramide or domperidone)
•   medicine for thinning the blood (anticoagulants), such as warfarin or other coumarins
•   medicine for high cholesterol (such as cholestyramine)
•   sedatives (barbiturates)
•   probenecid or AZT (zidovudine)
•   isoniazid (used to treat or prevent tuberculosis)

Taking Triflunex with food and drink

Do not take this product with alcoholic drinks.

Pregnancy and breast- feeding

Taking Triflunex during pregnancy or breast feeding is not recommended: you should ask your doctor or pharmacist for advice before use.
Driving and using machines
This product may cause dizziness or confusion. If you are affected do not drive or operate machinery.

Important information about some of the ingredients of Triflunex

This product contains:
•   Aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.
•   Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
•   Sodium (157 mg per dose). To be taken into consideration by patients on a controlled sodium diet

3. HOW TO TAKE TRIFLUNEX

Always take Triflunex exactly as your doctor or pharmacist has told you; check with them if you are not sure about anything.

Dosage

This medicine is a powder to be dissolved in water and taken as a hot drink.
Pour one sachet of powder into a mug of standard size and fill with hot, but not boiling water (approx 250ml). Allow to cool to a drinkable temperature.
Adults and children over 12 years:
1 sachet every 4-6 hours as required. Do not take more than 4 sachets in any 24 hour period.

Do not give to children under 12 years of age Do not exceed the stated dose.

Do not take this medicine with alcoholic drinks.
Long term use of the product is not recommended.
If symptoms persist for more than 3 days or worsen, consult your doctor.

If you take more Triflunex than you should:

Seek medical advice immediately if you accidentally take more than you should or give a child more than is recommended, even if you/the child feel well because of the risk of delayed, serious liver damage.
If you have any further questions on the use of this product, ask your pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Triflunex can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine immediately and seek for urgent medical advice:
•   Very rare cases of serious skin reactions have been reported. Severe allergic reactions (anaphylaxis), wheezing or breathing difficulties may occur rarely.
(Rare: affects less than 1 in 1000 people, but more than 1 in 10,000 people; Very rare: affects less than 1 in 10,000 people ).
•   Certain disorders of the blood cells and pancreatitis (inflammation of the pancreas) may occur very rarely with paracetamol (affect less than 1 in 10,000 people).

Other side effects

Frequency Side effect Common (affect less than 1 in 10 people, but more than 1 in 100 people). Loss of appetite, nausea or vomiting Rare (affect less than 1 in 1000 people, but more than 1 in 10,000 people). Mild allergic reactions (such as skin rashes or hives) Stomach ache, diarrhoea Headache, dizziness Rapid heartbeat (palpitations); High blood pressure Difficulty sleeping (insomnia), nervousness, shaking (tremor), irritability, restlessness, confusion or anxiety.

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

5. HOW TO STORE TRIFLUNEX

Keep out of the reach and sight of children

Store below 25 C.
Do not take Triflunex after the expiry date which is printed on the sachet or carton. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Triflunex contains

Each sachet of this medicine provides a single dose containing the active ingredients: paracetamol 500mg, guaifenesin 200mg and phenylephrine hydrochloride 10 mg.
The other ingredients are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E951), acesulfame potassium (E950), powdered menthol, lemon flavour, lemon juice flavour, quinoline Yellow (E104). See end of section 2.

What Triflunex looks like and contents of the pack

Triflunex is an off-white coloured powder which is packed in laminated sachets in a carton box. The product is available in cartons of 5 and 10 sachets.
Not all pack sizes may be marketed

Marketing Authorisation Holder

Wick Pharma
Sulzbacher Strasse 40, 65824 Schwalbach am Taunus Germany

Manufacturer

Wrafton Laboratories Limited Braunton,
Devon,
EX33 2DL UK

This leaflet was approved in 05-2017

4