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AQUALETTE FILM-COATED TABLETS

Active substance(s): DANDELION ROOT AND HERB / HORSETAIL QUANTIFIED DRY EXTRACT

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12-05-03

13.59

Package leaflet:
Information for the user

Aqualette
film-coated tablets
Extracts of horsetail herb and dandelion
herb with root

Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However, you still need to
take Aqualette 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 or a qualified
healthcare practitioner if your symptoms
worsen or do not improve after one
week.
• If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
qualified healthcare practitioner.

In this leaflet:
1. What Aqualette is and what it is used for
2. Before you take Aqualette
3. How to take Aqualette
4. Possible side effects
5. How to store Aqualette
6. Further information

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Sida 1

1. What Aqualette is and
what it is used for
Aqualette is a traditional herbal medicinal
product used to relieve bloating associated
with premenstrual water retention. This
usage is based on traditional use only.

2. Before you take
Aqualette
Do not take Aqualette if you
are allergic (hypersensitive) to:
• horsetail, dandelion or plants from
the same plant family (Asteraceae
/Compositae) such as daisies,
marigolds or artichokes
• any of the other ingredients of Aqualette
(listed in Section 6 below)

Or if you:
• have a blockage of the bile duct
• have an inflammation of the bile duct
(cholangitis)
• have gall stones or any other problems
with the bile duct
• have liver disease
• have an ulcer in the stomach or gut
• are under 18 years of age

Take special care and consult
your doctor or qualified
healthcare practitioner if you:
• develop symptoms such as fever, spasm,
burning or stinging sensation when
going to the toilet or blood in your urine
• have kidney failure
• have diabetes
• have heart failure

Taking other medicines

Adults

Do not take Aqualette with other water
tablets such as bendroflumethiazide,
furosemide and amiloride.

Take 2 to 3 tablets 3 times a day.
The tablets should be taken before you
expect your period to start.

Please tell your doctor or qualified
healthcare practitioner if you are taking or
have recently taken any other medicines,
including medicines obtained without
a prescription or other herbal remedies.
This is just in case any of them interfere
with how Aqualette works.

Pregnancy and breast-feeding
Do not take Aqualette if you are pregnant,
think you might be pregnant or are breastfeeding. Ask your doctor or qualified
healthcare practitioner for advice before
taking any medicine.

Important information about
some of the ingredients of
Aqualette
This product contains lactose monohydrate.
If you have been told by your doctor that
you have an intolerance to some sugars,
do not take Aqualette.

Contact your doctor or qualified healthcare
practitioner if your symptoms worsen or do
not improve after one week.

If you take more Aqualette than
you should
If you take more than the recommended
dose, speak to a doctor or qualified
healthcare practitioner and take this leaflet
with you.

If you forget to take Aqualette
Continue to take your usual dose at the
usual time. Do not take a double dose to
make up for forgotten tablets.
If you have any further questions on the
use of this product, ask your doctor or
qualified healthcare practitioner.

3. How to take Aqualette
For oral short term use only. Take Aqualette
as advised in this leaflet. You should check
with your doctor or qualified healthcare
practitioner if you are not sure.
Do not exceed the stated dose. Swallow
the tablet whole with water.

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4. Possible side effects
Like all medicines, Aqualette can cause
side effects, although not everybody gets
them.
Stop taking Aqualette and contact
your doctor if you experience any of the
following:
• Rash, swallowing or breathing
problems, swelling of your lips,
face,throat and tongue, feeling faint.
These could be signs of an allergic
(hypersensitive) reaction.
Other side effects include
• Stomach or gut problems including
indigestion.
If any of the side effects gets serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
qualified healthcare practitioner.
You can help to make medicines safer by
reporting any side-effects to the Yellow
Card Scheme at
www.mhra.gov.uk/yellowcard
Alternatively you can get a paper
Yellow Card form from your GP’s surgery
or pharmacy, or call freephone
0808 100 3352 (available 10 am–2 pm
Monday–Friday).

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5. How to store Aqualette
Do not store above 25°C. Keep in original
package.

What Aqualette looks like and
contents of the pack

Keep out of the reach and sight of
children.

The film-coated tablets are round and
white.
Pack sizes: 40, 60, 80 tablets in blisters.
Not all pack sizes may be marketed.

Do not use Aqualette after the expiry date
which is stated on the carton. The expiry
date refers to the last day of that month.

Traditional Herbal Registration
Holder

Medicines should not be disposed of via
wastewater or household waste. Take the
medicines no longer required to your
pharmacist who will dispose of them.
These measures will help to protect the
environment.

6. Further information
What Aqualette contains
• Each film-coated tablet contains:
60.75 mg of extract (as dry extract)
from Horsetail herb (equivalent to
407– 674.3 mg Equisetum arvense
L. herb).
Extraction solvent: Ethanol 70% V/V.
84 mg of extract (as dry extract) from
Dandelion herb and root (equivalent to
479–722 mg Taraxacum officinale
Weber herb and root).
Extraction solvent: Ethanol 20% V/V.
• The other ingredients are 231–245
mg of lactose monohydrate, potato
starch, magnesium oxide, colloidal
silica dioxide, magnesium stearate,
hypromellose, titanium dioxide (E171)
and macrogol 6000.

Pharbio Medical International AB,
Box 715, 194 27 Upplands Väsby,
Sweden.
Telephone: +46 8 590 963 00
E-mail: regulatory@cederroth.com

Manufacturer
Cederroth International Production
Paramedical A/S,
Vassingerødvej 3-7, DK-3540 Lynge,
Denmark.

Some suggestions to promote
a normal water balance and to
feel less bloated
• Exercise: like cycling, swimming or
taking a brisk walk can help.
• Healthy eating: a whole food diet
with as few pre-packaged, processed
foods as possible will help you keep
your salt intake down. Excessive salt can
cause water retention. Also aim to eat
fresh fruit and vegetables every day.
• Clothing: wear loose, comfortable
clothes rather than ones that can feel
tight around the middle.
• Resting: on a bed can help redistribute
water particularly from the legs and
ankles.
• Relax: try to put your feet up whenever
possible, e.g. sit down with your feet
resting on a stool.

This leaflet was last revised in
May 2012.

CERTIFICATION 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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