THERAFLU 500MG/6.1MG/100MG CIETĀS N16

ATC code: N02BE51 

Active substances: Paracetamolum, Phenylephrini Hydrochloridum, Guaifenesinum

Vendor, principal: Glaxosmithkline Dungarvan Limited. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

THERAFLU 500MG/+100MG/+6.1MG N16

Package leaflet: Information for the patient

Theraflu 500 mg / 6.1 mg / 100 mg, capsules hard

Paracetamol, Phenylephrine hydrochloride, Guaifenesin
For adults and adolescents aged 16 years and over

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 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 after 3 days.
What is in this leaflet
1.   What Therafluis and what it is used for
2.   What you need to know before you take Theraflu
3.   How to take Theraflu
4.   Possible side effects
5.   How to store Theraflu
6.   Contents of the pack and other information

1.   What Theraflu is and what it is used for

Theraflu is used for the short term relief of the symptoms of colds, chills and flu. These symptoms include mild and moderate pains, fever, nasal congestion (blocked nose) and chesty cough.
Theraflu is only for use in adults, the elderly and adolescents aged 16 years and over.
Theraflu is ONLY to be taken if you are suffering from all of the following symptoms: pain and/or fever, blocked nose and a chesty, productive cough. You must talk to a doctor or pharmacist if you do not feel better or if you feel worse after 3 days or if coughing is accompanied by high fever, skin rash or persistent headache.
How Theraflu works
Theraflu contains three active substances:
•   Paracetamol is a pain killer (analgesic) and fever reducer (reduces your temperature when you have a fever).
•   Phenylephrine hydrochloride is a nasal decongestant. It unblocks your stuffy nose and helps you breathe more easily by reducing the swelling in the nasal passages.
•   Guaifenesin is an expectorant which loosens mucus (phlegm) and relieves a chesty, productive cough.

2.   What you need to know before you take Theraflu Cold an Cough Do NOT take Theraflu if you:

•   you are allergic to paracetamol, phenylephrine hydrochloride, guaifenesin or to any of the other ingredients of this medicine (listed in section 6)
•   have heart disease or high blood pressure (hypertension)
•   have diabetes
•   have an overactive thyroid
•   have closed-angle glaucoma (increased pressure in the eye)
•   have phaeochromocytoma (a type of tumour of the adrenal glands located near the kidneys)
•   are taking, or have taken in the last 14 days, monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression or Parkinson’s disease)
•   are taking tricyclic antidepressants
•   are taking beta blockers (medicines used in the treatment of high blood pressure and heart problems)
•   are taking other sympathomimetic drugs such as decongestants, appetite suppressants and amphetamine-like psychostimulants
Warnings and precautions
It is important that Theraflu is ONLY taken if you are suffering from ALL of the following symptoms: pain and/or fever, stuffy nose and chesty cough.
Contains paracetamol. Do NOT take with any other paracetamol-containing products.
Severe liver damage may occur if you exceed the maximum daily dose of paracetamol.
In general, habitual intake of painkillers, particularly a combination of several analgesic substances, can lead to permanent renal damage with the risk of renal failure.
Do not take alcoholic beverages while using this medicine.
Do not take with any other cough, cold or decongestant product.
Consult a doctor if symptoms persist for more than 3 days, worsen or if your coughing is accompanied by high fever, skin rash or persistent headache.
Talk to your doctor or pharmacist before taking Theraflu if you have:
•   cardiovascular problems
•   liver problems
•   kidney problems
•   an enlarged prostate, as you may have urine retention or difficulty passing urine
•   a blood circulation problem (such as Raynaud’s syndrome)
•   mild jaundice (Gilbert’s syndrome)
•   glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency)
•   abnormal breakdown of red blood cells (haemolytic anaemia)
•   dehydration or chronic malnutrition
•   chronic cough, asthma or emphysema (disease of the lungs)
Children and adolescents
Do not give this medicine to children and adolescents below 16 years of age or to adolescents aged 16 to 18 years who weigh less than 50 kg.
Other medicines and Theraflu
Do not use Theraflu if you are taking:
•   or have taken within 14 days monoamine oxidase inhibitors (MAOIs), used to treat depression and Parkinson’s disease
•   tricyclic antidepressants used to treat depression
•   high blood pressure medicines, such as beta-blockers
•   medicines containing sympathomimetic drugs such as decongestants, appetite suppressants and amphetamine like psychostimulants
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular:
•   medicines used to treat heart failure and abnormal heart rhythms (digoxin and other cardiac glycosides)
•   medicines for thinning the blood (anticoagulants), such as warfarin or other coumarins
•   medicines for nausea and vomiting, such as metoclopramide or domperidone
•   medicines for tuberculosis (rifampicin and isoniazid), for bacterial infections (chloramphenicol)
•   medicines used to treat seizures, such as lamotrigine, phenytoin, phenobarbital and carbamazepine
•   cholestyramine, used to lower cholesterol
•   zidovudine (AZT), used for the treatment of HIV infection (AIDS)
•   probenecid, used to treat gout
•   ergotamine and methylsergide, used for migraine
•   medicines used to treat fever or mild pain (salicylates, salicylamide)
•   medicines containing paracetamol or decongestants for colds and flu
•   halogenated anaesthetics used in anesthesia before surgery
•   tell your doctor that you are taking this medicine if you are having urine tests
Theraflu with food, drink and alcohol
Do not drink alcohol while using this medicine This medicine can be taken with or without food.
Pregnancy and breast-feeding
Do not take Theraflu if you are pregnant or breast-feeding.
Driving and using machines
This medicine may cause dizziness. If you are affected, do not drive or operate machinery.
3. How to take Theraflu
Always take 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.
The recommended dose is
For adults, the elderly and adolescents aged 16 years and over, who weigh more than 50 kg:
•   Swallow 2 capsules with water every 4 to 6 hours as needed.
•   Do not take more than 6 capsules (3 doses of 2 capsules) in any 24 hour period (corresponding to 3000 mg of paracetamol, 36.6 mg of phenylephrine hydrochloride and 600 mg of guaifenesin).
•   Do not use for more than 3 days. Tell your doctor if symptoms persist after 3 days or worsen or if coughing is accompanied by high fever, skin rash or persistent headache.
Theraflu capsules should not be used in adults, the elderly and adolescents aged 16 years and over, who weigh less than 50 kg.
Do not exceed the stated dose.
Use in children and adolescents
Do not give to children below 16 years of age. Do not give to adolescents aged 16 to 18 years who weigh less than 50 kg.
Patients with hepatic disease
In patients with impaired liver, the dose must be reduced or the dosing interval prolonged. Ask your doctor for advice before using this medicine. The total daily dose should not exceed 4 capsules over 24 hour period (with a minimum interval of 8 hours between capsules).
Patients with renal disease
In patients with renal impairment, the dosing interval must be prolonged. Ask your doctor for advice before using this medicine. More appropriate pharmaceutical forms are available in the market for use.
Method of administration:
For oral use.
Swallow the whole capsule with water. Do not chew the capsule.
If you take more Theraflu than you should:
If you accidentally take too many capsules, seek medical attention immediately, even if you feel well, because of the risk of delayed, serious liver damage.
If you forget to take Theraflu If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Then continue treatment as recommended. Always leave an interval of at least 4 hours between two doses. Never take a double dose (4 capsules) 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, Theraflu can cause side effects, although not everybody gets them.
STOP taking Theraflu and tell a doctor straight away if you experience:
•   allergic reactions, including wheezing, shortness of breath, swelling of the face or mouth
•   skin rash (including hives, itching), redness of the skin
•   skin peeling, blisters, sores, mouth ulcers
•   blood problems including unusual bleeding or bruising
•   yellowing of the skin or eyes (jaundice). These are signs of liver problems
The above side effects are rare (may affect up to 1 in 1,000 people) or very rare. In particular, serious skin reactions are very rare (may affect up to 1 in 10,000 people).
The following side effects may occur in rare or very rare cases (may affect up to 1 in 1,000 or 1 in 10,000 people). If you experience any of the following tell you doctor:
•   stomach pain or discomfort (diarrhoea, nausea, vomiting)
•   headache, dizziness
•   high blood pressure, palpitations, fast heartbeat
•   sleep disturbance, restlessness, nervousness, irritability or confusion
•   difficulty in breathing
•   dilation of the pupil, increased pressure in the eye
Results (or values) of liver function tests may be abnormal in rare cases.

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 Theraflu

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 blister and the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°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 Theraflu contain

The active substances are paracetamol, phenylephrine hydrochloride and guaifenesin. Each capsule contains paracetamol 500 mg, phenylephrine hydrochloride 6.1 mg (corresponding to 5 mg phenylephrine base) and guaifenesin 100 mg.
The other ingredients are: croscarmellose sodium, maize starch, sodium laurilsulfate, talc and magnesium stearate.
The capsule shell contains: gelatin, purified water, indigo carmine (E132), titanium dioxide (E171), quinoline yellow (E104), sodium laurilsulfate, erythrosine (E127).
What Theraflu looks like and contents of the pack
Theraflu is gelatin capsules, hard with a translucent green body and opaque blue cap, size 0, filled with an off-white powder, free from large aggregates and particulate contamination.
Theraflu is available in packs of 8 or 16 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline Consumer HealthCare (UK) Trading Ltd.
980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom
Manufacturer
Novartis Consumer Health GmbH Zielstattstrasse 40 81379 München Germany
Wrafton Laboratories Limited Exeter Road, Wrafton Braunton, Devon EX33 2DL United Kingdom
GSK Consumer Healthcare GmbH & Co. KG Barthstraße 4 80339 München Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
GlaxoSmithKline Eesti OÜ Phone: +372 6676 900 [email protected]

This leaflet was last revised in October 2016.