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TANTUMGRIP LEMON-HONEY FLAVOUR 600 MG/10 MG POWDER FOR ORAL SOLUTION

Active substance(s): PHENYLEPHRINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

TANTUMGRIP lemon-honey flavour 600 mg /10 mg powder for oral solution in sachet
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
have 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 include 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 of
treatment.
What is in this leaflet:
1. What TANTUMGRIP is and what it is used for
2. What you need to know before you take TANTUMGRIP
3. How to take TANTUMGRIP
4. Possible side effects
5. How to store TANTUMGRIP
6. Contents of the pack and other information

1. WHAT TANTUMGRIP IS AND WHAT IT IS USED FOR
TANTUMGRIP contains a combination of ingredients which are effective in relieving the
symptoms associated with colds and flu, including relief of aches and pains, sore throats,
headache, nasal congestion and lowering of temperature.
Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains,
including a headache, and can also reduce a fever (antipyretic).
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passage of the
nose, relieving nasal congestion and reducing the pressure which may cause a headache.
TANTUMGRIP should be used in adults and adolescents over 12 year.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUMGRIP
As with all medicines TANTUMGRIP may not be suitable for some people.
Do not take TANTUMGRIP:
- if you are allergic to paracetamol, phenylephrine hydrochloride or any of the other
ingredients of this medicine (listed in section 6)

- if you have a serious heart condition
- if you have high blood pressure (hypertension) or an overactive thyroid
- if you are taking or have taken within the last 14 days a medicine called a monoamine
oxidase inhibitor (MAOI), usually used to treat depression
- if you are taking other nasal or eye decongestant medicines (sympathomimetics).

Warning and precautions
Do not take this medicine with any other paracetamol-containing products products because
the consumption of more than 6-8 g of paracetamol per day can damage your liver. Liver
damages could occur also at lower doses or in short-term use even if you have not hepatic
problems but you are taking alcohol or other medicine that could be toxic for the liver. Longterm alcohol abuse significantly increases the risk of paracetamol liver toxicity. The highest
risk is in chronic alcoholics with short-term abstinence (12 hours).You should not drink
alcohol whilst taking this medicine.
Talk to your doctor or pharmacist before taking TANTUMGRIP:
 If you have Raynaud’s syndrome (poor blood circulation which makes the fingers or toes
pale and numb), or diabetes mellitus
 If you have a problem with your liver or kidneys
 If you have non-cirrhotic liver disease (liver disease that is not associated with changes in
the structure of the liver)
 If you have closed angle glaucoma or prostatic enlargement

Other medicines and TANTUMGRIP
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
In particular it is important to tell your doctor or pharmacist if you are taking any of the
following medicines:
 medicines that might accelerate (e.g., metoclopramide, domperidone which are used to
treat nausea and vomiting) or reduce/delay (e.g., cholestyramine which is used to treat
blood cholesterol) the absorption of paracetamol.
 medicines used to thin the blood or to prevent blood from clotting (e.g. warfarin and other
coumarins), as paracetamol taken in high doses may lead to an increased risk of bleeding.
 medicines that contain tricyclic antidepressants (a specific class of drugs used to treat
depression), other decongestants, or barbiturates (used to treat sleep problems or epilepsy)
 medicines that contain monoamine oxidase inhibitors (see also section “Do not take
TANTUMGRIP”)
 medicines that contain beta-blockers (drugs used to treat high blood pressure), or
vasodilators (drugs used to treat high blood pressure, leg pain due to vascular problems or
Raynaud’s syndrome)
 medicines prescribed for heart failure (digoxin and cardiac glycosides).

Pregnancy and breast-feeding
The use of TANTUMGRIP is not recommended during pregnancy or breast-feeding. If you
are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
TANTUMGRIP has not been shown to affect your ability to drive or operate machinery.

TANTUMGRIP contains sucrose and sodium:
Sucrose; this medicine contains 1.8 g of sucrose per sachet. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
This should be taken into account in patients with diabetes mellitus in case of consumption of
more than 2 sachets a day (more than 5g of sucrose).
Sodium; this medicine contains 135.8 mg sodium per sachet. This should be taken into
consideration if you suffer from reduced kidney function or you are following a low sodium
diet.

3. HOW TO TAKE TANTUMGRIP POWDER FOR ORAL SOLUTION
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.
Dosage
Adults and children aged 12 years and over: 1 sachet every 4-6 hours up to a maximum of 4
sachets in a 24 hour period.
Use in children
Not to be given to children under 12.
Instructions for use
Dissolve one sachet in a glass of water (approx. 150 ml), hot or cold, and sweeten as desired.
If the symptoms of your cold or flu persist for more than three days, or worsen, consult your
doctor or pharmacist. Do not use TANTUMGRIP for more than 5 days.

If you take more TANTUMGRIP than you should
If you or someone else took too much of TANTUMGRIP, or if you think a child has
swallowed any of content of the sachets, go to your nearest hospital casualty department or
doctor immediately.
Due to the risk of delayed, serious liver damage you should go to hospital or your doctor
even if you feel well. 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.
Please take this leaflet, any remaining sachets and the container with you to the hospital or
doctor.
If you have any further questions on 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.
If you get any of the following side effects, talk to your doctor or pharmacist:



Allergic or hypersensitivity reactions (such as skin rashes)
Blood disorders, such as thrombocytopenia (reduction in blood platelets which might
mean that you bleed or bruise more easily), pancytopenia (reduction in white and red
blood cells), agranulocytosis, leucopenia or neutropenia (reduction in white blood cells
which makes infections more likely)







High blood pressure with headache
Vomiting
Palpitations (irregular or forceful heartbeat)
Acute pancreatitis (after ingestion of above normal amounts)
Difficulty in passing urine (in men only).

Very rare cases of serious skin reactions have been reported.

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 listed in Appendix V*. By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE TANTUMGRIP
Store below 25 ° C.
Store in the original package in order to protect from moisture.
Keep this medicine out of the sight and the reach of children.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.

It is important that you always have the information on the product. Please keep both the box
and the package leaflet.
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. CONTENT OF THE PACK AND OTHER INFORMATION
What TANTUMGRIP contains
Each sachet contains:
The active substances are: paracetamol 600 mg, phenylephrine hydrochloride 10 mg
(equivalent to 8.2 mg phenylephrine).
The other ingredients are: sucrose, citric acid anhydrous, sodium citrate, maize starch, sodium
cyclamate, saccharin sodium, silica colloidal anhydrous, ascorbic acid, honey flavour, lemon
flavour, caramel (E 150). See also section 2 “TANTUMGRIP contains sucrose and sodium”.

What TANTUMGRIP looks like and contents of the pack
TANTUMGRIP is a powder for oral solution in sachet.
TANTUMGRIP is available in packs containing 10 or 16 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco – ACRAF SpA
Viale Amelia 70, 00181
Roma (Italia)
Manufacturer:
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.

This leaflet was last revised in MM/YYYY
12/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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