THERAFLU EXTRA for colds and flu x 14 sachets
Teraflu
TERAFLU COLD AND FLU ENHANCED FORMULA
650 mg/10 mg/20 mg Powder for oral solution
Paracetamol / Phenylephrine hydrochloride / Pheniramine maleate
THERAFLU COLD AMD FLU EXTRA STRENGTH
650 mg/10 mg/20 mg Powder for oral solution
Paracetamol / Phenylephrine hydrochloride / Pheniramine maleate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use 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.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If you do not feel better within 5 days or your condition worsens, as well as if the high temperature lasts more than 3 days, you should seek medical help.
What this leaflet contains
1. What TERAFLU COLD & FLU ENHANCED FORMULA is and what it is used for
2. What you need to know before you use TERAFLU COLD AND FLU ENHANCED FORMULA
3. How to use TERAFLU COLD AND FLU ENHANCED FORMULA
4. Possible side effects
5. How to store TERAFLU COLD & FLU ENHANCED FORMULA
6. Contents of the package and additional information
1. What TERAFLU COLD & FLU ENHANCED FORMULA is and what it is used for
TERAFLU COLD AND FLU ENHANCED FORMULA contains three active ingredients that affect cold and flu symptoms:
Paracetamol has a pain-relieving effect (analgesic) and a temperature-lowering effect (lowers the temperature in case of fever).
Phenylephrine hydrochloride is a nasal and sinus decongestant. It relieves nasal congestion and sinus tension.
Pheniramine maleate is an antihistamine. It helps relieve allergy symptoms.
TERAFLU COLD & FLU STRENGTHENED FORMULA is used to relieve cold and flu symptoms by temporarily lowering high fever and affecting chills, body aches, headache, nasal and sinus congestion, runny nose and sneezing.
2. What you need to know before you use TERAFLU COLD AND FLU ENHANCED FORMULA
Do not use TERAFLU COLD AND FLU ENHANCED FORMULA if:
you are allergic to paracetamol, phenylephrine, pheniramine or any of the other ingredients of this medicine (listed in section 6 and the end of section 2);
you are taking or have taken in the last 14 days monoamine oxidase inhibitors (MAOIs are medicines used to treat depression or Parkinson's disease). If you do not know whether your prescribed medicines contain MAOIs, ask your doctor or pharmacist before taking this product;
if you suffer from severe heart disease or high blood pressure (hypertension);
if you have an overproduction of the thyroid gland (hyperthyroidism);
if you have glaucoma (increased intraocular pressure);
if you have a pheochromocytoma (a type of tumor of the adrenal glands located near the kidneys, which is responsible for an increase in blood pressure);
if you are taking tricyclic antidepressants;
if you are taking beta-blockers (medicines used to treat high blood pressure and heart problems);
if you are taking other sympathomimetic drugs by mouth, such as nasal decongestants, appetite suppressants, etc.
Warnings and precautions
Talk to your doctor or pharmacist before taking TERAFLU COLD AND FLU ENHANCED FORMULA if:
you have liver or kidney disease;
you suffer from hemolytic anemia;
you suffer from an inherited disease called glucose-6-phosphate dehydrogenase deficiency;
suffer from dehydration or chronic malnutrition;
you have heart disease;
you have diabetes;
you have an enlarged prostate, as you may retain urine;
you have a blockage in the intestinal tract;
you have a stomach ulcer;
you have epilepsy
The medicinal product contains paracetamol. Do NOT take at the same time as other paracetamol-containing products. Severe liver damage may occur if the maximum daily dose of paracetamol is exceeded.
Consult your doctor if:
you have respiratory diseases such as asthma, emphysema or chronic bronchitis;
the fever worsened or lasted more than 3 days;
pain or nasal congestion worsens or lasts more than 5 days, or is accompanied by a high fever, skin rash, or persistent headache.
Other medicines and TERAFLU COLD AND FLU ENHANCED FORMULA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular:
Monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease: DO NOT use TERAFLU COLD AND FLU STRENGTHENED FORMULA if you are taking or have taken an MAOI in the past 14 days;
Antidepressants used to treat depression, eg tricyclic antidepressants;
Medicines for high blood pressure, for example beta-blockers;
Medicines to treat heart failure or irregular heart rhythm (digoxin or other cardiac glycosides);
Medicines to reduce blood clotting (anticoagulants), eg warfarin or other coumarins;
Medicines containing paracetamol or decongestants for colds and flu;
Medicines for nausea and vomiting, for example metoclopramide or domperidone;
Medicines for tuberculosis (rifampicin and isoniazid), for bacterial infections (chloramphenicol);
Medicines to treat seizures, eg phenytoin, phenobarbital, carbamazepine and lamotrigine;
Cholestyramine, used to lower cholesterol;
Zidovudine (AZT), used to treat HIV infections;
Probenecid, used to treat gout;
Ergotamine and methysergide, used for migraine;
Central nervous system (CNS) depressants - alcohol and tranquilizers, drugs to treat depression or Parkinson's disease, tricyclic antidepressants, barbiturates or narcotics;
Medicines against blood clotting.
Laboratory Interactions:
This medicine may affect the results of a uric acid phosphate test, which is done to determine the level of uric acid in the blood, especially in patients with or diagnosed with gout.
TERAFLU COLD AND FLU STRENGTHENED FORMULA and alcohol
Do not drink alcohol while using TERAFLU COLD & FLU ENHANCED FORMULA.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant.
Do not use this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
TERAFLU COLD & FLU STRENGTHENED FORMULA may cause drowsiness. Caution is required when driving, operating machinery, or performing other tasks that require attention.
Important information about some of the other ingredients in TERAFLU COLD & FLU ENHANCED FORMULA
TERAFLU COLD AND FLU ENHANCED FORMULA contains:
Sucrose 12.6 g in a sachet. This should be considered in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.
FD&C Yellow No 6 (Sunset Yellow FCF) (EEC): May cause an allergic reaction.
Sodium 42.2 mg per sachet. This should be considered in patients on a controlled sodium diet.
3. How to use TERAFLU COLD AND FLU ENHANCED FORMULA
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Use in adults and adolescents over 12 years of age:
One sachet every 4 to 6 hours as needed. Up to 3-4 sachets per 24 hour period.
Do not use for a period longer than 5 days. Consult your doctor if symptoms last more than 5 days or worsen, and if fever lasts more than 3 days.
Do not exceed the recommended dose.
Not to be taken by children under 12 years of age.
How to take TERAFLU COLD AND FLU ENHANCED FORMULA
Dissolve the contents of one sachet in a standard glass of hot but not boiling water (approximately 250 ml). Drink it after it has cooled to an acceptable temperature.
If you take more TERAFLU COLD & FLU ENHANCED FORMULA than you should
In case of overdose or accidental ingestion, consult a doctor immediately. Prompt medical intervention is important, even if you feel well, because of the risk of delayed, serious liver damage.
If you forget to take TERAFLU COLD AND FLU ENHANCED FORMULA
Do not take a double dose to make up for a missed dose.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking this medicine and consult a doctor immediately if you experience:
allergic reactions, including wheezing, difficulty breathing, swelling of the face, lips, tongue, or throat;
skin rash (including urticaria, itching), redness of the skin;
peeling skin, blisters, inflammation, mouth sores;
unusual bleeding or clotting (blood problems).
The side effects listed above are rare or very rare (may affect 1 to 10 in 10,000 people) or their frequency cannot be estimated from the available data. For example, very rare cases of serious skin reactions have been reported.
The following side effects are common (may affect up to 1 in 10 people):
nausea;
vomiting;
drowsiness.
Other side effects may occur in rare cases (may affect up to 1 in 1,000 people):
restlessness, insomnia;
dizziness, headache;
fast heart rate, palpitations, increased blood pressure;
constipation, indigestion, abdominal pain;
dry mouth;
a feeling of general discomfort or physical unwellness.
Liver function test results (or values) may be abnormal in rare cases.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system in Bulgaria:
Medicines Executive Agency,
St. "Damyan Gruev" No. 8,
1303 Sofia,
Phone: +359 2 8903417,
Website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store TERAFLU COLD & FLU ENHANCED FORMULA
Keep out of the reach of children.
To be stored below 25°C.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date corresponds to the last day of the specified month.
Store in the original packaging.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What TERAFLU COLD & FLU ENHANCED FORMULA contains
The active substances are: paracetamol, phenylephrine hydrochloride, pheniramine maleate.
The other ingredients (excipients) are: sucrose, acesulfame potassium, quinoline yellow (E104), sunset yellow FCF (E110), maltodextrin, silicon dioxide, natural lemon WONF, citric acid (anhydrous), sodium citrate (dihydrate), calcium phosphate ( tribasic).
What TERAFLU COLD & FLU ENHANCED FORMULA looks like and contents of the pack
TERAFLU COLD AND FLU ENHANCED FORMULA is available as a powder for oral solution in sachets. The powder is coarse, loose, consisting of white and yellow granules and may contain soft lumps.
Package contents: 10 or 14 sachets per package
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Dungarvan Limited, Ireland.
Manufacturers:
Novartis Consumer Health GmbH, Germany;
Famar Orleans, France;
GlaxoSmithKline Consumer Healthcare GmbH & Co., Germany.
