TANTUM FLU orange x 10 sach
TANTUM FLU WITH ORANGE FLAVOR sachet * 10
LEAFLET: INFORMATION FOR THE USER
TANTUM FLU with orange flavor 600 mg / 10 mg powder for oral solution in
sachet
TANTUM FLU orange taste 600 mg / 10 mg powder for oral solution in sachet
paracetamol, phenylephrine hydrochloride
paracetamol, phenylephrine hydrochloride
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.
If you need further information or advice, ask your doctor or 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 after 3 days of treatment you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains:
1. What TANTUM FLU is and what it is used for
2. What you need to know before you take TANTUM FLU
3. How to take TANTUM FLU
4. Possible side effects
5. How to store TANTUM FLU
6. Contents of the package and other information
1. What TANTUM FLU is and what it is used for
TANTUM FLU contains a combination of ingredients that effectively relieve cold and flu symptoms, including joint pain, sore throat, headache, stuffy nose and reduce high fever.
Paracetamol is a well-known pain reliever (analgesic). It works effectively against various pains, including headaches, and reduces fever (antipyretic).
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the nasal cavity, relieves nasal congestion, and reduces pressure that can cause headaches.
TANTUM FLU can be used by adults and adolescents over 12 years of age.
If after 3 days you do not feel better or your condition worsens, you should consult a doctor.
2. What you need to know before you take TANTUM FLU
Like all medicines TANTUM FLU may not be suitable for everyone.
Do not take TANTUM FLU:
if you are allergic to paracetamol, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
if you have severe heart disease
if you have high blood pressure (hypertension) or an overactive thyroid gland.
if you are taking or have taken in the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), which is usually used to treat depression
if you are taking other medicines to unblock the nose or eyes (sympathomimetics).
Warnings and precautions
Do not take this medicine with other products containing paracetamol, as using more than 6-8 grams of paracetamol per day can damage your liver. Liver damage can also occur at lower doses or with short-term use, even if you do not have liver problems but are taking alcohol or another drug that can be toxic to the liver. Long-term alcohol abuse greatly increases the risk of liver toxicity from paracetamol. The greatest risk is found in chronic alcoholics with short-term abstinence (12 hours). You should not drink alcohol while taking this medicine.
Talk to your doctor or pharmacist before you start taking TANTUM FLU:
If you suffer from Raynaud's syndrome (poor blood circulation that causes the fingers and toes to turn white and numb) or diabetes mellitus
If you have a liver or kidney problem
If you have non-cirrhotic liver disease (disease not associated with structural changes in the liver)
If you have angle-closure glaucoma or an enlarged prostate.
Other medicines and TANTUM FLU
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:
medicines that can speed up (eg metoclopramide, domperidone, used to treat nausea and vomiting) or reduce/slow down (eg cholestyramine to regulate blood cholesterol) the absorption of paracetamol
medicines to thin the blood or prevent clotting (eg warfarin and other coumarins), as high doses of paracetamol may increase the risk of bleeding
medicines that contain tricyclic antidepressants (a specific class of medicines to treat depression), others that reduce inflammation of the nasal mucosa or barbiturates (used to treat sleep disorders or epilepsy)
drugs that contain monoamide oxidase inhibitors (see also the section "Do not take TANTUM FLU")
medicines that contain beta-blockers (to treat high blood pressure) or vasodilators (used to treat high blood pressure, leg pain caused by vascular problems or Raynaud's syndrome)
medicines prescribed for heart failure (digoxin and cardio-glycosides).
Pregnancy and breastfeeding
The use of TANTUM FLU is not recommended during pregnancy and breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
TANTUM FLU has not been shown to affect your ability to drive or use machines.
TANTUM FLU contains sucrose, sodium and glucose:
Sucrose: each sachet of this medicine contains 2 g of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
This should be considered in patients with diabetes, when taking more than 2 sachets daily (more than 5 g of sucrose).
Sodium: each sachet of this medicine contains 135.8 mg of sodium. This should be taken into account if you suffer from reduced kidney function or follow a low sodium diet.
Glucose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take TANTUM FLU powder for oral solution
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.
Dosage
Adults and children 12 years and older: 1 sachet every 4-6 hours, up to a maximum of 4 sachets in a 24-hour period.
Use in children
Do not give to children under 12 years of age.
Instructions for use
Dissolve 1 sachet in a glass of water (about 150 ml), hot or cold, and sweeten as desired.
If cold or flu symptoms persist for more than three days or worsen, consult your doctor or pharmacist. Do not use TANTUM FLU for more than 5 days.
If you have taken more than the required dose of TANTUM FLU
If you or someone else has taken too much TANTUM FLU, or if you suspect that a child has swallowed some of the contents of the sachet, go to the nearest hospital or doctor immediately.
Because of the risk of delayed serious liver damage, you should go to hospital or your doctor, even if you feel well. Take this leaflet, the rest of the sachets and the packaging with you to the hospital or doctor.
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.
Very rare: may affect 1 to 10,000 people
Skin reactions
Frequency not known: no estimate can be made from the available data
Allergic or hypersensitivity reaction (such as skin rash)
Disorders of the circulatory system, such as thrombocytopenia (a decrease in the number of platelets, which may mean that you bleed or bruise more easily), pancytopenia (a decrease in the number of red and white blood cells), agranulocytosis, leukopenia or neutropenia (a decrease in the number of white blood cells, making you more susceptible to infections)
High blood pressure
Headache
Vomiting
Palpitations (irregular or rapid heartbeat)
Acute pancreatitis (inflammation of the pancreas characterized by sudden onset of abdominal pain)
Difficulty urinating (men only).
Reporting adverse reactions
If you get side effects, tell your doctor or pharmacist. This also applies to side effects not described in this leaflet. You can report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
phone: +359 2 8903417
website: www.bda.bg.
By reporting side effects you are helping to gather more information about the safety of this medicine.
5. How to store TANTUM FLU
To be stored at temperatures below 25°C.
Store in the original package to protect from moisture and light.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiration date corresponds to the last day of the specified month.
It is important to have product information available at all times. Therefore, keep both the box and the leaflet.
Do not dispose of medicines down the drain or in household waste containers. 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 other information
What TANTUM FLU contains
Each sachet contains:
The active substances are: paracetamol 600 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg phenylephrine).
Excipients: sucrose, anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, sodium saccharin, ascorbic acid, colloidal anhydrous silica, red orange flavor, curcumin powder 5% P-WD (curcumin E100 + dried glucose syrup) . See also item 2 "TANTUM FLU contains sucrose, sodium and glucose".
What TANTUM FLU looks like and contents of the pack
TANTUM FLU is a powder for oral solution in a sachet.
TANTUM FLU is sold in packs of 10 or 16 sachets.
Not all packages may be available in the market.
Marketing Authorization Holder:
Angelini Pharma Bulgaria EOOD, Bulgaria.
Manufacturer:
ACRAFSpA, Italy.
Leaflet last updated: May 2017.
