Theraflu Cold And Cough Syrup
PACKAGE LEAFLET
December 22, 2014
Package leaflet: Information for the user Theraflu Cold and Cough Syrup
Paracetamol 500 mg/30 ml, Phenylephrine Hydrochloride 10 mg/30 ml, Guaifenesin 200 mg/30 ml
For adults
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 Theraflu Cold and Cough is and what it is used for
2. What you need to know before you take Theraflu Cold and Cough
3. How to take Theraflu Cold and Cough
4. Possible side effects
5. How to store Theraflu Cold and Cough
6. Contents of the pack and other information
1. What Theraflu Cold and Cough is and what it is used for
of colds, chills and sore throat, fever, has an expectorant
Theraflu Cold and Cough is used for the short term relief of the symptoms influenza. These symptoms include shivers, aches and pain, headache, blocked nose and a chesty, productive cough. Theraflu Cold and Cough also effect on a chesty cough (it loosens phlegm).
Theraflu Cold and Cough is only for use in adults.
Theraflu Cold and Cough is ONLY to be taken if you are suffering from ALL of the following symptoms: pain and/or fever, stuffy nose and chesty cough.
How Theraflu Cold and Cough works
Theraflu Cold and Cough contains three active ingredients:
paracetamol is a pain killer (analgesic) and fever reducer (reduces your temperature when you have a fever)
phenylephrine 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 phlegm and relieves a chesty, productive cough.
You must talk to a doctor 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.
2. What you need to know before you take Theraflu Cold and Cough
Do NOT take Theraflu Cold and Cough if you:
are allergic to paracetamol, phenylephrine hydrochloride, guaifenesin or any of the other ingredients of this medicine (listed in section 6 and end of section 2)
• 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.
Warning and precautions
It is important that Theraflu Cold and Cough 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. 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.
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 Cold and Cough if you have:
kidney problems liver problems cardiovascular problems
• an enlarged prostate, as you may have urine retention or difficult discharge of urine
• a blood circulation problem (such as Raynaud’s syndrome)
• mild jaundice (Gilbert’s syndrome)
• glucose-6-phosphatedehydrogenase 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 18 years of age.
Other medicines and Theraflu Cold and Cough
Do not use Theraflu Cold and Cough 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 containing paracetamol or decongestants for colds and flu
medicines used to treat fever or mild pain (salicylates/salicylamide)
halogenated anesthetics used in anesthesia before surgery
tell your doctor that you are taking this medicine if you are having urine tests.
Taking Theraflu Cold and Cough 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 Cold and Cough if you are pregnant or breast-feeding.
Driving and using machines
This product may cause dizziness. If you are affected, do not drive or operate machinery.
Theraflu Cold and Cough contains
• Maltitol liquid (E965) 9.5 g per 30 ml dose. If you have been told by your doctor that you have intolerance to some sugars, ask your doctor before use. May have a mild laxative effect
• Ethanol. This medicinal product contains 10.15% v/v ethanol (alcohol), i.e. 2.4 g of ethanol per 30 ml dose, equivalent to 61 ml beer or 26 ml wine. This is harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy
• Propylene glycol 5.4 g per 30 ml dose.This may cause alcohol-like symptoms
• Sodium 0.68 mmol (or 15 mg) per 30 ml dose: to be taken into account if you are on a controlled or low sodium diet
• Potassium 17.27 mg per 30 ml dose: to be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet
• Sunset yellow (E110), an azo colouring agent which may cause allergic reactions.
3. How to take Theraflu Cold and Cough
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.
For adults:
The recommended dose is one 30 ml measured dose every four to six hours as needed. Do not take more than 4 doses in any 24 hour period (corresponding to 2000 mg of paracetamol, 40 mg of phenylephrine hydrochloride and 800 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.
Do not exceed the stated dose.
Use in children and adolescents
Do not give to children and adolescents below 18 years of age.
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.
Patients with severe renal disease
In patients with severe renal insufficiency, the dosing interval must be prolonged. Ask your doctor for advice before using this medicine.
How to take Theraflu Cold and Cough
For oral use.
Fill the measuring cup to the 30 ml mark. Wash and dry the measuring cup after each use.
If you take more Theraflu Cold and Cough than you should
If you accidentally take too much, seek medical attention immediately, even if you feel well, because of the risk of delayed, serious liver damage.
If you forget to take Theraflu Cold and Cough
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 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 Cold and Cough can cause side effects, although not everybody gets them.
STOP taking Theraflu Cold and Cough 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.
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 your doctor: headache or dizziness
stomach pain or discomfort (diarrhoea, nausea, vomiting) high blood pressure, palpitations or 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 the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Theraflu Cold and Cough
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 bottle and pack after {abbreviation used for expiry date}. The expiry date refers to the last day of that month.
Store below 25°C.
Once the bottle is opened, Theraflu Cold and Cough Syrup should be used within 6 months.
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 Cold and Cough contains
The active substances are paracetamol, phenylephrine hydrochloride and guaifenesin. 30 ml syrup contains paracetamol 500 mg, phenylephrine hydrochloride 10 mg, guaifenesin 200 mg.
The other ingredients are: maltitol liquid (E965), Flavor 316282 (propylene glycol, artificial and natural flavors), Orange Flavour Natural (propylene glycol, ethyl alcohol and natural flavors), propylene glycol, ethanol 96%, acesulfame potassium (E950), citric acid anhydrous, sodium benzoate (E211), disodium edetate, sodium citrate, Sunset Yellow (E110), purified water (see also end of Section 2 for information on some of these ingredients).
What Theraflu Cold and Cough looks like and contents of the pack
Theraflu Cold and Cough is a clear, orange to dark orange syrup with a characteristic citrus odour. Theraflu Cold and Cough is available in a 240 ml bottle, accompanied by a 30ml measuring cup.
Marketing Authorisation Holder
Novartis Consumer Health UK Ltd Park View, Riverside Way Watchmoor Park Camberley, Surrey GU15 3YL
United KingdomTel: +44 (0) 1276 687269
Manufacturer
Novartis Consumer Health S.A. Route de l'Etraz, CH-1260 Prangins, Nyon,
Switzerland
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Bulgaria Czech Republic Estonia Germany Hungary Italy Latvia Poland Portugal Slovakia Slovenia |
Theraflu Cold and Cough 500 mg/ 10 mg/ 200 mg Syrup Theraflu nachlazeni a kasel, sirup Theraflu Theracomplex Erkaltung & Husten Sirup Neo Citran Cold and Cough szirup Termainflu Aroma arancia 500 mg/30 ml +10 mg/30 ml+200 mg/30 ml sciroppo Theraflu 500 mg/200 mg/10 mg/ 30 ml sirups Theraflu Complex Grip 500 mg + 200 mg + 10 mg, syrop Theraflu Gripe e Constipa^ao 500mg + 10mg + 200mg, xarope Theraflu prechladnutie a kasel’ sirup Theraflu 500 mg/10 mg/200 mg v 30 ml sirup |
United Kingdom Theraflu Cold and Cough Syrup This leaflet was last approved in September 2014