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AMLODIPINE TABLETS 5MG

Active substance(s): AMLODIPINE BESILATE

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S1449-50 LEAFLET Istin 20130227

PACKAGE LEAFLET: INFORMATION FOR USER

ISTIN 5mg TABLETS
ISTIN 10mg TABLETS
(amlodipine besilate)
Your medicine is known as above but will be referred to as Istin
throughout the following patient information leaflet.
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 get 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
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 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

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)



simvastatin (a cholesterol lowering medicine)

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.
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.

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.

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’.



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).

3. HOW TO TAKE ISTIN

If you suffer from heart failure after a heart attack.

The usual initial dose is Istin 5 mg once daily. The dose can be
increased to Istin 10 mg once daily.



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.

Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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.
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. Amlodipine 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

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

Do not worry. If you forget to take a tablet, leave out that dose
completely.



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

Do not take a double dose to make up for a missed dose.



Excess sugar in blood (hyperglycaemia)

If you stop taking 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.

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



Cough, swelling of the gums



Abdominal bloating (gastritis)

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



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

4. POSSIBLE SIDE EFFECTS



Increased muscle tension

Like all medicines, Istin can cause side effects, although not
everybody gets them.



Inflammation of blood vessels, often with skin rash



Sensitivity to light

Visit your doctor immediately if you experience any of the following
very rare, severe side effects after taking this medicine.



Disorders combining rigidity, tremor, and/or movement
disorders

Take your next dose at the right time.



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

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 SIGHT AND REACH OF CHILDREN.



Istin should be stored below 30°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



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.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

Common: affects 1 to 10 users in 100


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



Palpitations (awareness of your heart beat), flushing

6. FURTHER INFORMATION



Abdominal pain, feeling sick (nausea)

What Istin contains



Ankle swelling (oedema), tiredness



Istin tablets come in two strengths, 5mg and 10mg. The 5mg
tablets contain 5mg of active substance amlodipine (as
besilate) and 10mg tablets contain 10mg of active substance
amlodipine (as besilate).



Istin also contain anhydrous dibasic calcium phosphate,
magnesium stearate, microcrystalline cellulose and sodium
starch glycolate

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

What Istin looks like and contents of the pack



Trembling, taste abnormalities, fainting, weakness



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

The 5mg tablet is octagonal and white with ‘AML’ and ‘5’ and a
breakline imprinted on one side.



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

The 10mg tablet is octagonal and white with ‘AML’ and ‘10’ and a
breakline imprinted on one side.
Istin Tablets 5mg are available as blister packs of 28 tablets.
Istin Tablets 10mg are available as blister packs of 14 & 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Heinrich Mack Nachf. GmbH & Co.
KG, Heinrich-Mack-Strasse 35, D-89257 Illertissen, Germany.
POM

PL No. 19488/1449

Istin 5mg Tablets

PL No. 19488/1450

Istin 10mg Tablets

Leaflet revision date: 27 February 2013
Rare: affects 1 to 10 users in 10,000


Istin is a registered trade mark of Pfizer Ltd, UK.

Confusion
S1449-50 LEAFLET Istin 20130227

S1449-50 LEAFLET Amlodipine 20130227

PACKAGE LEAFLET: INFORMATION FOR USER

AMLODIPINE 5mg TABLETS
AMLODIPINE 10mg TABLETS
(amlodipine besilate)
Your medicine is known as above but will be referred to as
Amlodipine throughout the following patient information leaflet.

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 may affect or be affected by other medicines, such as:


ketoconazole, itraconazole (anti-fungal medicines)



Read all of this leaflet carefully before you start taking this
medicine.

ritonavir, indinavir, nelfinavir (so called protease inhibitors used
to treat HIV)



rifampicin, erythromycin, clarithromycin (antibiotics)



Keep this leaflet. You may need to read it again.



hypericum perforatum (St. John’s Wort)



If you have any further questions, ask your doctor or
pharmacist.



verapamil, diltiazem (heart medicines)



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.



dantrolene (infusion for severe body temperature abnormalities)



simvastatin (a cholesterol lowering medicine)



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 is and what it is used for
2. Before you take Amlodipine
3. How to take Amlodipine

Amlodipine may lower your blood pressure even more if you are
already taking other medicines to treat your high blood pressure.
Taking Amlodipine with food and drink
Grapefruit juice and grapefruit should not be consumed by people
who are taking Amlodipine. 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.

4. Possible side effects
5. How to store Amlodipine

Pregnancy

6. Further information

The safety of amlodipine in human pregnancy has not been
established.

1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR

If you think you might be pregnant, or are planning to get pregnant,
you must tell your doctor before you take Amlodipine.

Amlodipine contains the active substance amlodipine which belongs
to a group of medicines called calcium antagonists.
Amlodipine 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 your medicine works by
relaxing blood vessels, so that blood passes through them more
easily. In patients with angina Amlodipine 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 AMLODIPINE

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.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Amlodipine 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.

Do not take Amlodipine


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 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.

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

If you have severe low blood pressure (hypotension).



Important information about some of the ingredients of
Amlodipine

Take special care with Amlodipine
You should inform your doctor if you have or have had any of the
following conditions:

3. HOW TO TAKE AMLODIPINE
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
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.



Recent heart attack



Heart failure

Use in children and adolescents



Severe increase in blood pressure (Hypertensive crisis)



Liver disease

For children and adolescents (6–17 years old), the recommended
usual starting dose is 2.5 mg a day.



You are elderly and your dose needs to be increased

The maximum recommended dose is 5 mg a day. Amlodipine 5 mg
tablets can be divided into halves to provide a 2.5 mg dose.

Use in children and adolescents

It is important to keep taking the tablets. Do not wait until your
tablets are finished before seeing your doctor.

Amlodipine has not been studied in children under the age of 6
years. Amlodipine should only be used for hypertension in children
and adolescents from 6 years to 17 years of age (see section 3).

If you take more Amlodipine than you should

For more information, talk to your doctor.

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

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

Do not worry. If you forget to take a tablet, leave out that dose
completely.



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

Do not take a double dose to make up for a missed dose.



Excess sugar in blood (hyperglycaemia)

If you stop taking Amlodipine



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.

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



Cough, swelling of the gums



Abdominal bloating (gastritis)

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



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

4. POSSIBLE SIDE EFFECTS



Increased muscle tension

Like all medicines, Amlodipine can cause side effects, although not
everybody gets them.



Inflammation of blood vessels, often with skin rash



Sensitivity to light

Visit your doctor immediately if you experience any of the following
very rare, severe side effects after taking this medicine.



Disorders combining rigidity, tremor, and/or movement
disorders

Take your next dose at the right time.



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

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Amlodipine should be stored below 30°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



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.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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

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

6. FURTHER INFORMATION
What Amlodipine contains


Amlodipine tablets come in two strengths, 5mg and 10mg. The
5mg tablets contain 5mg of active substance amlodipine (as
besilate) and 10mg tablets contain 10mg of active substance
amlodipine (as besilate).



Amlodipine also contain anhydrous dibasic calcium phosphate,
magnesium stearate, microcrystalline cellulose and sodium
starch glycolate

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



The 10mg tablet is octagonal and white with ‘AML’ and ‘10’ and a
breakline imprinted on one side.

Low blood pressure



Amlodipine 5mg Tablets are available as blister packs of 28 tablets.

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



Amlodipine 10mg Tablets are available as blister packs of 14 & 28
tablets.

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

What Amlodipine looks like and contents of the pack
The 5mg tablet is octagonal and white with ‘AML’ and ‘5’ and a
breakline imprinted on one side.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Heinrich Mack Nachf. GmbH & Co.
KG, Heinrich-Mack-Strasse 35, D-89257 Illertissen, Germany.
POM

PL No. 19488/1449

Amlodipine 5mg Tablets

PL No. 19488/1450

Amlodipine 10mg Tablets

Rare: affects 1 to 10 users in 10,000


Confusion

Leaflet revision date: 27 February 2013
S1449-50 LEAFLET Amlodipine 20130227

Expand view ⇕

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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