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FUERTE TABLETS

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Package Leaflet: Information for The User

Fuerte® Tablets
Wild indigo root,
Echinacea purpurea root,
Echinacea pallida root,
White cedar tips and leaves

Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without a prescription. However, you still need to
take Fuerte® carefully to get the best results from it.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 You must contact a doctor, if your symptoms worsen or do not improve
after 10 days.
 If any of the side effects become serious, or you notice any side effects not
listed in this leaflet, please tell your doctor, pharmacist or qualified
healthcare practitioner.
In this leaflet:
1. What Fuerte® is and what it is used for
2. Before you take Fuerte®
3. How to take Fuerte®
4. Possible side effects
5. How to store Fuerte®
6. Further information

1. What Fuerte® is and what it is
used for
Fuerte® is a traditional herbal medicinal
product used to relieve the symptoms of the
common cold, such as cough, catarrh, sore
throat, runny or blocked nose, based on
traditional use only.

2. Before you take Fuerte®
Fuerte®

2.1 Do not take
if you
 are allergic to any of the active
ingredients or plants of the Asteraceae/
Compositae such as daisies, marigolds or
artichokes
 are allergic to any of the other ingredients
(see section 6)
 are under 12 years of age
 suffer from frequent allergic reactions
such as hives (urticaria), eczema, asthma
 suffer from the infection tuberculosis
 suffer from connective tissue disease with
formation of clumps of cells (sarcoidosis)
mainly occurring in the lymph nodes,
lungs and liver
 suffer from auto-immune diseases such
as inflammation of the connective tissues
(collagenosis) or multiple sclerosis
 suffer from conditions which decrease
your natural response to infection (e.g.
HIV infection or AIDS)
 suffer from blood disorders involving the
white blood cell system such as low white
cell count due to bone marrow disorders
(agranulocytosis) or blood cell cancer
(leukemias)

 are already taking immunosuppressant
medication such as ciclosporin or
methotrexate
 are on therapy to reduce your natural
response to infection
(immunosuppression e.g. chemotherapy
or radiotherapy for cancer, history of
organ or bone marrow transplant
While you take this medicine, see your
doctor if you experience shortness of
breath, high temperature or yellow, green
or blood-stained sputum.
Tell your doctor before you take this
product if you have an intolerance to some
sugars (see section 6).
2.2 Take special care with Fuerte®
 if there is a family history of allergic
reactions
 because Echinacea can trigger autoimmune diseases
If your symptoms last for more than 10
days or get worse you must see your
doctor.
2.3 Taking other medicines
Please tell your doctor, pharmacist or
qualified healthcare practitioner if you are
taking, or have recently taken any other
medicines. This includes any medicines
which you have bought without
prescription.

2.4 Pregnancy and breast feeding
Do not take this product if you are pregnant
or breast feeding because there is no
evidence that it is safe to do so.

 Shrinking of the airways of the lungs with
obstruction (bronchospasm)
 Asthma and life threatening allergic
reactions (anaphylactic shock)

2.5 Driving and using machines
This product is not likely to affect your
ability to drive or use machines.

Echinacea can trigger allergic reactions in
patients who have a tendency to allergic
reactions. Stop taking the product
immediately if you experience an allergic
reaction.

2.6 Important information about some of
the ingredients of Fuerte®
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this product. Each
tablet contains 170.6 mg lactose
monohydrate and 91.5 mg of sucrose.

3. How to take Fuerte®
Remember to always take this medicine
with a glass of water. The tablets should be
swallowed whole and not chewed. You
should check with your doctor, pharmacist or
qualified healthcare practitioner if you are
not sure.
3.1 How much Fuerte® to take
The usual treatment time is 10 days. If your
symptoms worsen or persist for more than
10 days, see your doctor or pharmacist.
3.2 Adults, the elderly and children over
12 years
Take 5 tablets three times a day.
The tablets should be taken at regular
intervals, in the morning, in the middle of the
day and in the evening. You do not need to
take the tablets with meals.
Do not give to children under 12 years of
age. Do not exceed the stated dose.
3.3 If you take more Fuerte® than you
should
This usually will not have any side effects.
Continue to take the usual dose at the usual
time.
If you have accidentally taken a lot of this
medicine you may get more side effects or
any side effects may get worse. You must
talk to your doctor.
3.4 If you forget to take Fuerte®
Continue to take your usual dose at the
usual time. Never take a double dose to
make up for a missed dose.
If you have any further questions about
taking this medicine, please ask your doctor,
pharmacist or qualified healthcare
practitioner.

4. Possible side effects
Like all medicines, Fuerte® can cause side
effects, although not everybody gets them.
The frequency is not known. Possible side
effects are:
 Allergic reactions such as swelling, hives
or rashes
 Swelling of the skin due to fluid
 Swelling of the facial area (Quincke's
oedema)

Association with auto-immune diseases
has been reported such as:
 inflammation of the brain and spinal cord
(disseminated encephalitis)
 painful lumps on the shins (erythema
nodosum)
 low blood platelet count
(immunothrombocytopenia)
 destruction of blood cells by antibodies
(Evans syndrome)
 Dryness in the mouth and eye with kidney
tubular dysfunction (Sjogren Syndrome).
A decrease in the number of white blood
cells (leucopenia) may occur in long term
use (more than 8 weeks).
Stop taking this product immediately if you
experience allergic reactions. If any of the
side effects become serious, or you notice
any side effects not listed in this leaflet, tell
your doctor or pharmacist.

5. How to store Fuerte®
Keep out of the reach and the sight of
children.
Do not use the tablets after the expiry date
on the carton and the blister strip. The expiry
date is the last day of that month. Store the
tablets in a cool, dry place below 30° C.
Keep them in the blister package until it is
time to take them.
Medicines should not be thrown away in
waste water or in household waste. Please
ask your pharmacist how to throw away any
medicine you do not need anymore. If you
do this you will help protect the environment.

6. Further Information
What Fuerte® contains
Each tablet contains:
3.2 mg of extract (as dry extract) (4-9:1) from
Wild indigo root (Baptisia tinctoria (L.) R.Br.),
Echinacea purpurea root (Echinacea
purpurea (L.) Moench), Echinacea pallida
root (Echinacea pallida (Nutt.) Nutt. White
cedar tips and leaves (Thuja occidentalis L.)
(4.92:1.85:1.85:1). Extraction solvent:
ethanol 30 % v/v.
The other ingredients are:
Lactose monohydrate, Magnesium stearate,
Macrogol 6000, Sucrose

What Fuerte® looks like and contents of
the pack
Fuerte® is a beige-brown, round tablet.
Fuerte® comes in blister packs of 60, 100 or
200 tablets.
Not all pack sizes may be marketed.
Traditional Herbal Registration Holder
and Manufacturer
Traditional Herbal Registration Holder:
Schaper & Brümmer GmbH & Co. KG,
Bahnhofstr. 35, 38259 Salzgitter, Germany
Manufacturer: Schaper & Brümmer GmbH
& Co. KG, Bahnhofstr. 35, 38259 Salzgitter,
Germany

You can help to make medicines safer by
reporting any side effects to the YellowCard
Scheme at www.mhra.gov.uk/yellowcard.
Alternatively you can get a paper
YellowCard form from your GP’s surgery or
pharmacy, or call freephone 0808 100 3352
(available 10am-2pm Monday-Friday).

For a large print, Braille or audio
version of this leaflet, please
contact: Schaper & Brümmer
GmbH & Co. KG, Bahnhofstr. 35,
38259 Salzgitter, Germany
This leaflet was last revised in April 2013.
®

Registered Trade Mark

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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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