TANTUM 600 mg + 10 Mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Tantum Flu orange flavor, 600 mg + 10 mg,
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Tantum Flu orange flavor and what is it used for
4. Important information before taking Tantum Flu orange flavor
   1. When not to take Tantum Flu orange flavor:
   2. Warnings and precautions
   3. Tantum Flu orange flavor and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Tantum Flu orange flavor contains sucrose, sodium, and glucose:
5. How to take Tantum Flu orange flavor
   1. Dosage
   2. Method of administration
   3. Taking a higher dose of Tantum Flu orange flavor than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Tantum Flu orange flavor
8. Package contents and other information
   1. What Tantum Flu orange flavor contains
   2. What Tantum Flu orange flavor looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 22.07.2022

Leaflet attached to the packaging: patient information

Tantum Flu orange flavor, 600 mg + 10 mg,

powder for oral solution preparation, in a sachet
Paracetamol + Phenylephrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet, or according to
the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Tantum Flu orange flavor and what is it used for
• 2. Important information before taking Tantum Flu orange flavor
• 3. How to take Tantum Flu orange flavor
• 4. Possible side effects
• 5. How to store Tantum Flu orange flavor
• 6. Package contents and other information

1. What is Tantum Flu orange flavor and what is it used for

Tantum Flu orange flavor contains a combination of active substances that are effective in
relieving symptoms associated with colds and flu, including painful conditions (such as throat and headache), swelling and congestion of the nasal mucosa, and reducing fever.
Paracetamol is a well-known pain reliever (analgesic). It is effective in various pains, including headache, and also reduces fever (antipyretic).
Phenylephrine hydrochloride is a medicine that facilitates breathing by constricting the blood vessels of the nasal mucosa. It reduces swelling of the nasal passages, relieving their congestion and reducing pressure in the nasal sinuses, which can cause headache.
Tantum Flu orange flavor should be used in adults and adolescents over 12 years old.
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Tantum Flu orange flavor

Like any medicine, Tantum Flu orange flavor may not be suitable for everyone.

When not to take Tantum Flu orange flavor:

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe heart disease;
• if the patient has high blood pressure (hypertension) or hyperthyroidism;
• if the patient is taking or has taken in the last 14 days monoamine oxidase inhibitors (MAOIs), usually used to treat depression;
• if the patient is taking other medicines that reduce nasal congestion and eye redness (sympathomimetics).

Warnings and precautions

This medicine should not be taken simultaneously with other medicines containing paracetamol, as taking more than 6-8 grams of paracetamol per day may damage the liver. Liver damage can also occur after taking smaller doses of the medicine or after short-term use of paracetamol by patients without previous liver function disorders, but who consume alcohol or other liver-toxic substances at the same time.
Long-term excessive alcohol consumption significantly increases the risk of liver damage from paracetamol.
The highest risk of liver damage occurs in chronic alcoholics with a short period of abstinence (12 hours).
Alcohol should not be consumed while taking this medicine.
Before starting to take Tantum Flu orange flavor, the patient should discuss it with their doctor or pharmacist:

• If the patient has Raynaud's syndrome (insufficient blood circulation causing paleness and numbness of the fingers) or diabetes.
• If the patient has liver or kidney problems.
• If the patient has liver disease without cirrhosis (i.e., not related to changes in liver cells).
• If the patient has glaucoma or prostate enlargement.

Tantum Flu orange flavor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.
It is especially important to inform the doctor or pharmacist if the patient is taking any of the following medicines:

• medicines that may increase paracetamol absorption (e.g., metoclopramide and domperidone, used for nausea and vomiting) or may decrease or delay it (e.g., cholestyramine, used when there is too high a cholesterol level in the blood);
• blood-thinning medicines and medicines that prevent blood clots (e.g., warfarin and other coumarin derivatives), as paracetamol taken in high doses may increase the risk of bleeding;
• tricyclic antidepressants (used to treat depression), other medicines that facilitate breathing by clearing nasal passages, or barbiturates (used to treat sleep disorders or epilepsy);
• medicines containing monoamine oxidase inhibitors (see also section "When not to take Tantum Flu orange flavor");
• medicines containing beta-blockers (used to treat high blood pressure) and medicines that dilate blood vessels (used to treat high blood pressure, leg pain caused by vascular problems, or Raynaud's syndrome);
• medicines used to treat heart failure (digoxin and cardiac glycosides);
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney function disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking the maximum daily doses of paracetamol.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

Tantum Flu orange flavor is not recommended during pregnancy and breastfeeding. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

It has not been shown that Tantum Flu orange flavor affects the ability to drive or use machines.

Tantum Flu orange flavor contains sucrose, sodium, and glucose:

Sucrose: if the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Sodium: the medicine contains 135.8 mg of sodium (the main component of table salt) in each sachet. This corresponds to 6.8% of the maximum recommended daily intake of sodium in the diet for adults.
Glucose: if the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Tantum Flu orange flavor

This medicine should always be taken exactly as described in the patient leaflet, or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

Adults and children over 12 years old: 1 sachet every 4-6 hours. A maximum of 4 sachets can be taken per day.
Use in children
This medicine should not be taken by children under 12 years old.

Method of administration

Dissolve the contents of 1 sachet in a glass of hot or cold water (approx. 150 ml), optionally sweeten to taste.
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor or pharmacist. Tantum Flu orange flavor should not be taken for more than 5 days.

Taking a higher dose of Tantum Flu orange flavor than recommended

If the patient or someone else has taken a higher dose of Tantum Flu orange flavor than recommended, or if there is a suspicion that a child has swallowed the contents of a sachet, they should immediately go to the emergency room of the nearest hospital or see a doctor. Due to the risk of late symptoms of liver damage, this should be done even if the patient feels well. The patient should take this leaflet, any remaining sachets, and the medicine packaging with them.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like any medicine, Tantum Flu orange flavor can cause side effects, although not everyone will experience them.
Very rare: may occur less frequently than in 1 in 10,000 people

• Skin reactions

Frequency not known: cannot be estimated from available data

• allergic reactions or hypersensitivity reactions (such as skin rash),
• blood changes, such as thrombocytopenia (reduced platelet count, which can cause bleeding and bruising), pancytopenia (reduced white and red blood cell count), agranulocytosis, leukopenia, or neutropenia (reduced white blood cell count, which increases the risk of infection),
• high blood pressure,
• headache,
• vomiting,
• palpitations (irregular or rapid heartbeat),
• acute pancreatitis (inflammation of the pancreas characterized by sudden abdominal pain),
• urination difficulties (only in men).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: +48 (22) 49 21 301, fax: +48 (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tantum Flu orange flavor

Store at a temperature below 25°C.
Store in the original packaging to protect from moisture and light.
The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
It is important to keep the leaflet and packaging to ensure constant access to product information.
Medicines should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Tantum Flu orange flavor contains

The active substances of the medicine are paracetamol and phenylephrine hydrochloride. Each sachet contains 600 mg of paracetamol and 10 mg of phenylephrine hydrochloride (which corresponds to 8.2 mg of phenylephrine).
The other ingredients are: sucrose, anhydrous citric acid, sodium citrate, cornstarch, sodium cyclamate, sodium saccharin, ascorbic acid, colloidal silica anhydrous, orange flavor, curcuma powder 5% P-WD (curcuma E 100 + dried glucose syrup). See also section 2 "Tantum Flu orange flavor contains sucrose, sodium, and glucose".

What Tantum Flu orange flavor looks like and what the packaging contains

Tantum Flu orange flavor is a powder for oral solution preparation, in a sachet.
Tantum Flu orange flavor is available in packages containing 10 or 16 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
phone: (22) 702 82 00
fax: (22) 702 82 02
e-mail: [email protected]

Manufacturer

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona, Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: TANTUMGRIP orange flavour 600 mg/10 mg powder for oral solution
Austria: Tantum Grip Orangengeschmack Paracetamol/Phenylephrinhydrochlorid 600 mg/10 mg Pulver im Beutel zur Herstellung einer Lösung zum Einnehmen
Bulgaria: Тантум Флу с вкус на портокал 600 mg/10mg прах за перорален разтвор в саше
Czech Republic: TANTOGRIP pomeranč
Greece: TANTOGRIP 600mg/10mg κόνις για πόσιμο διάλυμα με γευση πορτοκάλι σε φακελίσκο
Hungary: TANTOGRIP narancs 600mg/10mg por belsőleges oldathoz
Poland: TANTUM FLU o smaku pomarańczowym
Portugal: TANTUMGRIP sabor a laranja 600 mg+10 mg pó para solução oral
Romania: TANTUMGRIP cu gust de portocală 600 mg /10 mg pulbere pentru soluție orală în plic
Slovakia: TANTUMGRIP 600 mg/10 mg prášok na perorálny roztok s pomarančovou príchuťou
A leaflet in a format suitable for the blind or visually impaired is available at the marketing authorization holder's headquarters.

Date of last revision of the leaflet: 22.07.2022