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KALTEN CAPSULES

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Kalten® Capsules
(atenolol, hydrochlorothiazide and amiloride hydrochloride)
Your medicine is known by the above name, but will be referred to as Kalten
throughout this:

Patient Information Leaflet
Please read this leaflet carefully before you take your medicine. This leaflet only
gives a summary of the information available on your capsules. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.

WHAT YOU SHOULD KNOW ABOUT YOUR CAPSULES
Your medicine is called Kalten. Each capsule contains the active ingredients,
atenolol 50mg, amiloride hydrochloride (dihydrate) 2.84mg equivalent to
amiloride hydrochloride 2.5mg and hydrochlorothiazide 25mg. The hard gelatine
capsules has a reddish brown cap and a cream body.
Kalten also contain the following inactive ingredients:
gelatin, red and yellow iron oxide (E172), lactose, magnesium stearate, maize
starch, sodium lauryl sulphate, sodium starch glycollate and titanium dioxide
(E171).
Kalten is available as calendar packs of 28 capsules.
Atenolol is one of a group of drugs called beta blockers. It affects the heart and
circulation. Hydrochlorothiazide and amiloride belong to a group of drugs called
diuretics. They increase the amount of urine produced by the kidneys.

WHAT YOUR CAPSULES ARE USED FOR
Kalten is used to treat hypertension (high blood pressure).

BEFORE TAKING YOUR CAPSULES
Do not take Kalten if,
• You have previously had an allergic reaction to it or to atenolol,
hydrochlorothiazide or amiloride.
• You have heart failure which is not under control or with certain other
conditions such as heart block, very slow or very irregular heart beats, very
low blood pressure or very poor circulation.
• You have phaeochromocytoma which is not being treated or by people who
have metabolic acidosis.Your doctor will know about these conditions.
Are you taking any other medicines?
• If you are taking any other medicines tell your doctor. Kalten can interfere
with the action of some other drugs and some drugs can have an effect on
Kalten.
• The drugs which can cause some problems when taken together with
Kalten are verapamil, diltiazem, nifedipine (which are used to treat
hypertension or angina), disopyramide (for irregular heart beats), digoxin
(for heart failure), adrenaline (a heart stimulant), ibuprofen and
indomethacin (for pain and inflammation), lithium (for depression), certain
other diuretics (medicines which increase the amount of urine produced by
the kidneys), potassium supplements, insulin and oral antidiabetic drugs (for
diabetes).
• Are you taking a drug called clonidine (for hypertension or migraine)? If you
are taking clonidine and Kalten together, you must not stop taking clonidine
unless your doctor tells you to do so. If it becomes necessary for you to stop
taking clonidine, your doctor will give you careful instructions on how to do
it.
Tell your doctor if,
• You have ever had asthma or wheezing, you should not take this medicine
unless you have discussed these symptoms with the prescribing doctor.
• You have a particular type of chest pain called Prinzmetal's angina
• You get allergic reactions to such things as insect stings.
• You have diabetes Kalten may change your normal response to low blood
sugar, which usually involves an increase in heart rate.
• You have thyrotoxicosis? Kalten may hide the symptoms of thyrotoxicosis.
• You have kidney or liver problems or stomach or gut problems. Talk to your
doctor because you may need to have some check ups during your
treatment.
This product contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking your
medicine.
Driving and using machinery
Your medicine is unlikely to affect your ability to drive or to operate machinery.
However, some people may occasionally feel dizzy or tired when taking Kalten.
If this happens to you, ask your doctor for advice.
If you are pregnant or breast feeding
Do not take Kalten if you are pregnant or if you are breast feeding a baby.

TAKING YOUR CAPSULES
Kalten capsules should be swallowed. Follow your doctor's instructions about
when and how to take your medicine. Also read the label.Your pharmacist can
also help if you are not sure.
The translation of the days of the week on the blister strip is as follows:
MON
TUE
WED
THU FRI
SAT
SUN
LUN
MAR
MIER
JUE
VIER
SAB
DOM
Dosage
Your doctor will have decided what dose you should take each day depending
on your condition.The usual daily dose for an adult is one capsule.
If you take more capsules than you should
If you accidentally take an overdose of your medicine, either call your doctor
straight away, or go to your nearest hospital casualty department. Always take
any remaining capsules, the container and the label with you, so that the
medicine can be identified.
If you forget to take a dose
If you forget to take your medicine, take your dose when you remember and
then take your next dose at the usual time. Don't take two doses at the same
time. If you are worried, ask your doctor or pharmacist for advice.
If you stop taking your medicine
Do not stop taking your medicine without talking to your doctor first. In some
cases, it may be necessary to stop taking the medicine gradually.

AFTER TAKING YOUR CAPSULES
As with all medicines, side effects can sometimes be experienced with Kalten. If
you get any side effects or if you think your medicine is causing any problems,
tell your doctor or pharmacist. Do not be alarmed by this list of possible side
effects.You may not have any of them.
Possible side effects:
Occasionally, a few people can suffer from cold hands and feet, tiredness, slow
heart beat, headache, dry mouth, nausea, diarrhoea, disturbed sleep, thinning
of the hair, mood changes, confusion, psychoses or hallucinations, bruising
more easily or purplish marks on the skin, tingling of the hands, dry eyes,
disturbances of vision, skin rashes, worsening of psoriasis, dizziness
particularly when standing up or impotence.
Other possible side effects which may occur in susceptible people are
numbness and spasm in the fingers (Raynaud's phenomenon), heart block
(which can cause dizziness or fainting), worsening of heart failure in people with
heart failure, worsening of breathing difficulties in people with asthma or
breathing problems or worsening of the circulation in people with poor
circulation.
Some other possible side effects include constipation, vomiting, thirst, fever,
loss of appetite, restlessness, muscle cramps and pain, skin rashes caused by
exposure to sunlight, severe abdominal pain (which may indicate inflammation
of the pancreas), sore mouth (salivary gland inflammation) and jaundice (yellow
skin or eyes). .
..
Possible allergic reactions: If you suffer from allergic reactions while taking
your medicine, which may include raised lumps (weals), swelling of the skin and
swelling around the mouth, you may need urgent medical attention.
Having an operation: If you go into hospital to have an operation, tell the
anaesthetist or the medical staff that you are taking Kalten.

HOW TO STORE YOUR CAPSULES






Do not use after the expiry date printed on the carton label or blister strip.
Kalten should be stored at room temperature below 25°C and protected
from light and moisture. Store in original pack.
Keep all medicines out of the reach and sight of children.
If your doctor tells you to stop taking the capsules, please take them back to
the pharmacist for safe disposal. Only keep the capsules if your doctor tells
you to.
If the capsules become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist before taking them.

WHO HAS MADE YOUR CAPSULES
PL 10383/0406

POM

Your medicine is manufactured by Teofarma S.r.l. Via F. Lli Cervi, 8, 27010
Valle Salimbene (PV), Italy. Procured from within the EU and repackaged by the
Product Licence holder: Primecrown Ltd., Unit 28, Sarum Complex, Uxbridge,
Middlesex UB8 2RZ

FURTHER INFORMATION
This leaflet does not contain all the information that is available about Kalten. If
you have any questions, or are not sure about anything, ask your doctor or a
pharmacist.
These capsules are for you. Only a doctor can prescribe them for you. Never
give it to someone else. It may harm them even if their symptoms are the same
as yours.
The information applies only to Kalten.
Leaflet date: 28.09.2011.
®

Kalten is a registered trade mark of BPC 100 Ltd, UK.

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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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