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ISTIN 10MG TABLETS

Active substance(s): AMLODIPINE BESILATE / AMLODIPINE BESYLATE

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11.1. 2016

Package leaflet: Information for the user

ISTIN 5 mg and 10 mg tablets
TM

Amlodipine

– Keep this leaflet. You may need to
read it again.
– If you have any further questions,
ask your doctor or pharmacist.
– This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
– If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Istin is and what it is used for
2. What you need to know before you
take Istin
3. How to take Istin
4. Possible side effects
5. How to store Istin
6. Contents of the pack and other
information

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1. What Istin is and
what it is used for

Istin contains the active substance
amlodipine which belongs to a group of
medicines called calcium antagonists.
Istin is used to treat high blood
pressure (hypertension) or a certain
type of chest pain called angina,
a rare form of which is Prinzmetal’s
or variant angina.
In patients with high blood pressure
this medicine works by relaxing blood
vessels, so that blood passes through
them more easily. In patients with
angina Istin works by improving blood
supply to the heart muscle which then
receives more oxygen and as a result
chest pain is prevented. This medicine
does not provide immediate relief of
chest pain from angina.

UNITED KINGDOM

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2. What you need to
know before you
take Istin

Do not take Istin
• If you are allergic (hypersensitive)
to amlodipine, or any of the other
ingredients of this medicine listed in
section 6, or to any other calcium
antagonists. This may be itching,
reddening of the skin or difficulty in
breathing.
• If you have severe low blood pressure
(hypotension).
• If you have narrowing of the aortic
heart valve (aortic stenosis) or
cardiogenic shock (a condition where
your heart is unable to supply enough
blood to the body).
• If you suffer from heart failure after a
heart attack.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Istin.
You should inform your doctor if you
have or have had any of the following
conditions:
• Recent heart attack
• Heart failure
• Severe increase in blood pressure
(Hypertensive crisis)
• Liver disease
• You are elderly and your dose needs
to be increased
Children and adolescents
Istin has not been studied in children
under the age of 6 years. Istin should
only be used for hypertension in
children and adolescents from 6 years
to 17 years of age (see section 3).
For more information, talk to your
doctor.
Other medicines and Istin
Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.

YOU WILL FIND MORE ABOUT
ISTIN ON THE BACK OF THIS LEAFLET

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Read all of this leaflet
carefully before you start
taking this medicine because
it contains important
information for you.

MORE INFORMATION ON ISTIN

Istin with food and drink
Grapefruit juice and grapefruit should
not be consumed by people who are
taking Istin. This is because grapefruit
and grapefruit juice can lead to an
increase in the blood levels of the
active ingredient amlodipine, which can
cause an unpredictable increase in the
blood pressure lowering effect of Istin.
Pregnancy and breast-feeding
Pregnancy
The safety of amlodipine in human
pregnancy has not been established.
If you think you might be pregnant, or
are planning to get pregnant, you must
tell your doctor before you take Istin.
Breast-feeding
It is not known whether amlodipine
is passed into breast milk. If you are
breast-feeding or about to start
breast-feeding you must tell your
doctor before taking Istin.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Istin may affect your ability to drive or
use machines. If the tablets make you
feel sick, dizzy or tired, or give you a
headache, do not drive or use machines
and contact your doctor immediately.

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3. How to take
Istin

Use in children and adolescents
For children and adolescents
(6 –17 years old), the recommended
usual starting dose is 2.5 mg a day.
The maximum recommended dose is
5 mg a day. Istin 5 mg tablets can
be divided into halves to provide
a 2.5 mg dose.
It is important to keep taking the
tablets. Do not wait until your tablets
are finished before seeing your doctor.
If you take more Istin
than you should
Taking too many tablets may cause
your blood pressure to become low or
even dangerously low. You may feel
dizzy, lightheaded, faint or weak. If
blood pressure drop is severe enough
shock can occur. Your skin could feel
cool and clammy and you could lose
consciousness. Seek immediate medical
attention if you take too many Istin
tablets.
If you forget to take Istin
Do not worry. If you forget to take a
tablet, leave out that dose completely.
Take your next dose at the right time.
Do not take a double dose to make up
for a forgotten dose.
If you stop taking Istin
Your doctor will advise you how long
to take this medicine. Your condition
may return if you stop using this
medicine before you are advised.
If you have any further questions
on the use of this medicine, ask your
doctor or pharmacist.

Istin contains sodium
This medicine contains less than 1 mmol
sodium (23 mg) per tablet, which means
it is essentially ‘sodium-free’.

UNITED KINGDOM

YOU WILL FIND MORE ABOUT
ISTIN ON THE BACK OF THIS LEAFLET

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Always take this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
The recommended initial dose is
Istin 5 mg once daily. The dose can be
increased to Istin 10 mg once daily.
This medicine can be used before or
after food and drinks. You should take
this medicine at the same time each day
with a drink of water. Do not take Istin
with grapefruit juice.
en checked completely,

Istin may affect or be affected by other
medicines, such as:
• ketoconazole, itraconazole
(anti-fungal medicines)
• ritonavir, indinavir, nelfinavir (so called
protease inhibitors used to treat HIV)
• rifampicin, erythromycin,
clarithromycin (antibiotics)
• hypericum perforatum (St. John’s
Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body
temperature abnormalities)
• tacrolimus (medicine used to alter
the way your immune system works)
• simvastatin (cholesterol lowering
medicine)
• cyclosporine (an immunosuppressant)
Istin may lower your blood pressure
even more if you are already taking
other medicines to treat your high
blood pressure.

MORE INFORMATION ON ISTIN

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4. Possible side
effects

Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Visit your doctor immediately if you
experience any of the following side
effects after taking this medicine.
• Sudden wheeziness, chest pain,
shortness of breath or difficulty in
breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat
which causes great difficulty breathing
• Severe skin reactions including
intense skin rash, hives, reddening
of the skin over your whole body,
severe itching, blistering, peeling and
swelling of the skin, inflammation of
mucous membranes (Stevens Johnson
Syndrome) or other allergic reactions
• Heart attack, abnormal heart beat
• Inflamed pancreas which may cause
severe abdominal and back pain
accompanied with feeling very unwell
The following very common side
effect has been reported. If this causes
you problems or if it lasts for more
than one week, you should contact
your doctor.
Very common: may affect more
than 1 in 10 people
• Oedema (fluid retention)
The following common side effects
have been reported. If any of these
cause you problems or if they last for
more than one week, you should
contact your doctor.
Common: may affect up to
1 in 10 people
• Headache, dizziness, sleepiness
(especially at the beginning of
treatment)
• Palpitations (awareness of your heart
beat), flushing
• Abdominal pain, feeling sick (nausea)
• Altered bowel habits, diarrhoea,
constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling
Other side effects that have been
reported include the following list. If
any of these get serious, or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

UNITED KINGDOM

Uncommon: may affect up to
1 in 100 people
• Mood changes, anxiety, depression,
sleeplessness
• Trembling, taste abnormalities,
fainting
• Numbness or tingling sensation in
your limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by
inflammation of the lining of the nose
(rhinitis)
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating,
itchy skin, red patches on skin,
skin discolouration
• Disorder in passing urine, increased
need to urinate at night, increased
number of times of passing urine
• Inability to obtain an erection,
discomfort or enlargement of the
breasts in men
• Pain, feeling unwell
• Joint or muscle pain, back pain
• Weight increase or decrease
Rare: may affect up to
1 in 1,000 people
• Confusion
Very rare: may affect up to
1 in 10,000 people
• Decreased numbers of white blood
cells, decrease in blood platelets
which may result in unusual bruising
or easy bleeding
• Excess sugar in blood
(hyperglycaemia)
• A disorder of the nerves which
can cause muscular weakness, tingling
or numbness
• Swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation
of the liver (hepatitis), yellowing of
the skin (jaundice), liver enzyme
increase which may have an effect on
some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often
with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor,
and/or movement disorders

YOU WILL FIND MORE ABOUT
ISTIN ON THE BACK OF THIS LEAFLET

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MORE INFORMATION ON ISTIN
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly (see details below).
By reporting side effects you can help
provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard.
Malta
ADR Reporting
Website: www.medicinesauthority.
gov.mt/adrportal

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5. How to store
Istin

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the pack
after ‘EXP’. The expiry date refers to
the last day of that month.
Tablets
Do not store above 25°C.
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.

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6. Contents of the
pack and other
information

What Istin contains
The active substance in Istin 5 mg
tablets is amlodipine (as besilate).
The active substance in Istin 10 mg
tablets is amlodipine (as besilate).
The other ingredients are calcium
hydrogen phosphate anhydrous,
magnesium stearate, microcrystalline
cellulose and sodium starch glycolate
Type A.
What Istin looks like and
contents of the pack
5 mg tablets: White to off-white,
emerald-shaped tablets engraved
AML 5 and breaker score on one side
and Pfizer logo on the other side.

10 mg tablets: White to off-white,
emerald-shaped tablets engraved
AML-10 on one side and Pfizer logo
on the other side.
Istin 5 mg tablets are available in
blisters containing 4, 10, 14, 20, 28,
30, 50, 60, 98, 100, 300, 500 tablets,
calendar packs containing 28 and
98 tablets and in unit dose blister strips
containing 50x1 and 500x1 tablets.
Istin 10 mg tablets are available in
blisters containing 4, 10, 14, 20, 28, 30,
50, 60, 90, 98, 100, 300, 500 tablets,
calendar packs containing 28 and
98 tablets and in unit dose blister strips
containing 50x1 and 500x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen
Germany
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
Tablets:
Austria, Bulgaria, Denmark, Estonia,
Finland, Germany, Hungary, Iceland,
Italy, Latvia, Lithuania, Netherlands,
Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Sweden: Norvasc
Czech Republic: Zorem
Denmark: Amlodipin Pfizer
Ireland, Malta, United Kingdom: Istin
Ireland: Amlodipine Pfizer 5 mg tablets,
Amlodipine Pfizer 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg comprimidos,
Norvas 10 mg comprimidos
United Kingdom: Amlodipine 5 mg
tablets, Amlodipine 10 mg tablets
This leaflet was last revised in 01/2016.
Ref: IS 24_2

Pfizer Limited
Sandwich, England

580110

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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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