AMLODIPINE 5MG TABLETS

Active substance: AMLODIPINE MESILATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ISTIN® 5mg TABLETS
(amlodipine besilate)

The name of your medicine is Istin 5mg Tablets but will be
referred to as Istin throughout this leaflet. This medicine is
available in other strengths.
Read all of this leaflet carefully before you start taking this
medicine.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

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
pharmacist.
In this leaflet:
1. What Istin is and what it is used for
2. Before you take Istin
3. How to take Istin
4. Possible side effects
5. How to store Istin
6. Further information
1) WHAT ISTIN IS AND WHAT IT IS USED FOR

Taking other medicines
Please 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)
Istin may lower your blood pressure even more if you are already
taking other medicines to treat your high blood pressure.
Taking 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
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.

Istin contains the active substance amlodipine which belongs to a
group of medicines called calcium antagonists.

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.

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.

Ask your doctor or pharmacist for advice before taking any
medicine.

In patients with high blood pressure your 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. Your medicine does not
provide immediate relief of chest pain from angina.
2) BEFORE YOU TAKE ISTIN
Do not take Istin

If you are allergic (hypersensitive) to Amlodipine, or any of
the other ingredients of your 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
Take special care with 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
Use in 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.

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.
Important information about some of the ingredients of Istin
This medicine contains less than 1 mmol sodium (23 mg) per
tablet, which means it is essentially ‘sodium-free
3) HOW TO TAKE ISTIN
The usual initial dose is Istin 5mg once daily. The dose can be
increased to Istin 10mg once daily.
Your medicine can be used before or after food and drinks. You
should take your medicine at the same time each day with a drink
of water. Do not take Istin with grapefruit juice.
Always take your medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended
usual starting dose is 2.5mg a day. The maximum recommended
dose is 5mg a day.
Amlodipine 2.5mg is not currently available and the 2.5mg dose
cannot be obtained with Istin 5mg tablets as these tablets are not
manufactured to break into two equal halves.
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 missed dose.
If you stop using Istin
Your doctor will advise you how long to take your medicine. Your
condition may return if you stop using your medicine before you
are advised.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Istin can cause side effects, although not
everybody gets them.
Visit your doctor immediately if you experience any of the
following very rare, severe 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 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: affects 1 to 10 users in 100

Headache, dizziness, sleepiness (especially at the beginning
of treatment)

Palpitations (awareness of your heart beat), flushing

Abdominal pain, feeling sick (nausea)

Ankle swelling (oedema), tiredness
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: affects 1 to 10 users in 1,000

Mood changes, anxiety, depression, sleeplessness

Trembling, taste abnormalities, fainting, weakness

Numbness or tingling sensation in your limbs; loss of pain
sensation

Visual disturbances, double vision, ringing in the ears

Low blood pressure

Sneezing/running nose caused by inflammation of the lining
of the nose (rhinitis)

Altered bowel habits, diarrhoea, constipation, indigestion, 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

Weakness, pain, feeling unwell




Joint or muscle pain, muscle cramps, back pain
Weight increase or decrease

Rare: affects 1 to 10 users in 10,000

Confusion
Very rare: affects less than 1 user in 10,000

Decreased numbers of white blood cells, decrease in blood
platelets which may result in unusual bruising or easy
bleeding (red blood cell damage)

Excess sugar in blood (hyperglycaemia)

A disorder of the nerves which can cause weakness, tingling
or numbness

Cough, 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
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
pharmacist.
5) HOW TO STORE ISTIN
Keep out of the reach and sight of children.
Keep your medicine in a dry place.
Do not use your medicine after the expiry date which is stamped
on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater of household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.
6) FURTHER INFORMATION
What Istin contains

The active substance is Amlodipine (as amlodipine besilate)

The other ingredients are calcium hydrogen phosphate,
magnesium stearate, microcrystalline cellulose and sodium
starch glycollate.
What Istin looks like and contents of the pack
The 5mg tablets are white, marked AML5 on one side and Pfizer
on the other. They contain 5mg amlodipine besilate.
Istin comes in packs of 28 and 30 tablets.
Manufacturer
Your tablets are manufactured by Pfizer Manufacturing
Deutschland GmbH, Heinrich-Mack-Str.35, 89257 Illertissen and
are procured from within the EU by the Product Licence Holder,
BR Pharma International Limited, Unit 3 Manor Point, Manor
Way, Borehamwood, Herts., WD6 1EE.
PL 16782/0090 – Istin 5mg Tablets
The Istin trademark belongs to Pfizer
st

Date of preparation: 31 May 2012

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMLODIPINE 5mg TABLETS
(amlodipine besilate)
The name of your medicine is Amlodipine 5mg Tablets but will be
referred to as Amlodipine Tablets throughout this leaflet. This
medicine is available in other strengths.
Read all of this leaflet carefully before you start taking this
medicine.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

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
pharmacist.
In this leaflet:
1. What Amlodipine Tablets is and what it is used for
2. Before you take Amlodipine Tablets
3. How to take Amlodipine Tablets
4. Possible side effects
5. How to store Amlodipine Tablets
6. Further information
1) WHAT AMLODIPINE TABLETS ARE AND WHAT THEY
ARE USED FOR
Amlodipine Tablets is one of a group of medicines called calcium
antagonists.
Amlodipine Tablets are 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 your medicine works by
relaxing blood vessels, so that blood passes through them more
easily. In patients with angina Amlodipine Tablets work by
improving blood supply to the heart muscle which then receives
more oxygen and as a result chest pain is prevented. Your
medicine does not provide immediate relief of chest pain from
angina.
2) BEFORE YOU TAKE AMLODIPINE TABLETS
Do not take Amlodipine Tablets

If you are allergic (hypersensitive) to Amlodipine, or any of
the other ingredients of your 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
Take special care with Amlodipine Tablets
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
Use in children and adolescents
Amlodipine Tablets has not been studied in children under the
age of 6 years. Amlodipine Tablets 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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Amlodipine Tablets 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)
Amlodipine Tablets may lower your blood pressure even more if
you are already taking other medicines to treat your high blood
pressure.
Taking Amlodipine Tablets with food and drink
Grapefruit juice and grapefruit should not be consumed by people
who are taking Amlodipine Tablets. 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
Amlodipine.
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
Amlodipine Tablets.
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 Amlodipine Tablets.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Amlodipine Tablets 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.
Important information about some of the ingredients of
Amlodipine Tablets
This medicine contains less than 1 mmol sodium (23 mg) per
tablet, which means it is essentially ‘sodium-free’.
3) HOW TO TAKE AMLODIPINE TABLETS
The usual initial dose is Amlodipine 5 mg once daily. The dose
can be increased to Amlodipine 10 mg once daily.
Your medicine can be used before or after food and drinks. You
should take your medicine at the same time each day with a drink
of water. Do not take Amlodipine with grapefruit juice.
Always take your medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended
usual starting dose is 2.5mg a day. The maximum recommended
dose is 5mg a day.
Amlodipine 2.5mg is not currently available and the 2.5mg dose
cannot be obtained with Amlodipine 5mg tablets as these tablets
are not manufactured to break into two equal halves.


It is important to keep taking the tablets. Do not wait until your
tablets are finished before seeing your doctor.
If you take more Amlodipine Tablets 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 Amlodipine tablets.
If you forget to take Amlodipine Tablets
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 missed dose.
If you stop using Amlodipine Tablets
Your doctor will advise you how long to take your medicine. Your
condition may return if you stop using your medicine before you
are advised.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine Tablets can cause side effects,
although not everybody gets them.
Visit your doctor immediately if you experience any of the
following very rare, severe 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 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: affects 1 to 10 users in 100

Headache, dizziness, sleepiness (especially at the beginning
of treatment)

Palpitations (awareness of your heart beat), flushing

Abdominal pain, feeling sick (nausea)

Ankle swelling (oedema), tiredness
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: affects 1 to 10 users in 1,000

Mood changes, anxiety, depression, sleeplessness

Trembling, taste abnormalities, fainting, weakness

Numbness or tingling sensation in your limbs; loss of pain
sensation

Visual disturbances, double vision, ringing in the ears

Low blood pressure

Sneezing/running nose caused by inflammation of the lining
of the nose (rhinitis)

Altered bowel habits, diarrhoea, constipation, indigestion, 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 passing urine





Inability to obtain an erection, discomfort or enlargement of
the breasts in men
Weakness, pain, feeling unwell
Joint or muscle pain, muscle cramps, back pain
Weight increase or decrease

Rare: affects 1 to 10 users in 10,000

Confusion
Very rare: affects less than 1 user in 10,000

Decreased numbers of white blood cells, decrease in blood
platelets which may result in unusual bruising or easy
bleeding (red blood cell damage)

Excess sugar in blood (hyperglycaemia)

A disorder of the nerves which can cause weakness, tingling
or numbness

Cough, 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
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
pharmacist.
5) HOW TO STORE AMLODIPINE TABLETS
Keep out of the reach and sight of children.
Keep your medicine in a dry place.
Do not use your medicine after the expiry date which is stamped
on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater of household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.
6) FURTHER INFORMATION
What Amlodipine Tablets contains

The active substance is Amlodipine (as Amlodipine besilate)

The other ingredients are calcium hydrogen phosphate,
magnesium stearate, microcrystalline cellulose and sodium
starch glycollate.
What Amlodipine Tablets look like and contents of the pack
The 5mg tablets are white, marked AML5 on one side and Pfizer
on the other. They contain 5mg Amlodipine besilate.
Amlodipine Tablets come in packs of 28 and 30 tablets.
Manufacturer
Your tablets are manufactured by Pfizer Manufacturing
Deutschland GmbH, Heinrich-Mack-Str.35, 89257 Illertissen and
are procured from within the EU by the Product Licence Holder,
BR Pharma International Limited, Unit 3 Manor Point, Manor
Way, Borehamwood, Herts., WD6 1EE.
PL 16782/0090 – Amlodipine 5mg Tablets
st

Date of preparation: 31 May 2012

POM

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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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