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ISTIN 5MG TABLETS

Active substance(s): AMLODIPINE BESILATE / AMLODIPINE BESYLATE

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Package leaflet: Information for the user
ISTIN™ 5 mg and 10 mg tablets
Amlodipine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- 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
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.
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:

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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.
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, sirolimus, temsirolimus, and everolimus (medicines 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.
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
Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding
or about to start breast-feeding you must tell your doctor before taking Istin.

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

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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, toxic epidermal necrolysis) 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.
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)

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 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
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 or search for MHRA Yellow Card in the Google Play or

Apple App Store.
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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.
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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. 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
Or
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
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Mooswaldallee 1
79090 Freiburg,
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
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 02/2018.
Ref: IS 29_0

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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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