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PRESCAL 2.5 MG TABLETS

Active substance(s): ISRADIPINE / ISRADIPINE / ISRADIPINE

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Prescal® 2.5 mg Tablets

2952
20.01.17[2]

(Isradipine)
PATIENT INFORMATION LEAFLET
The name of your medicine is Prescal 2.5 mg Tablets but will be referred to
as Prescal throughout this leaflet.
What you need to know about Prescal
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information. Keep the leaflet in a safe
place because you may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to be
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.

Will there be any problems with driving or using machinery?
Prescal may make you feel dizzy, lower your blood pressure too much
(hypotension), cause vision disorder or blurred vision. If you experience
these symptoms, you should not drive or use machines.
3. HOW TO TAKE PRESCAL
The doctor will decide what dose of Prescal you should take. Always take
the medicine exactly as your doctor has told you to. The dose will be on the
pharmacist’s label. Check the label carefully. It should tell you how much to
take, and how often. If you are not sure, ask your doctor or pharmacist.
Keep taking Prescal for as long as you have been told unless you have any
problems. In that case, check with your doctor.
Swallow the tablets whole with a drink of water. You can take the tablets
either before or after food. Do not take the tablets with grapefruit juice.
The usual dose for adults is:
2.5 mg twice a day.
If your blood pressure is still not controlled after three or four weeks, your
doctor may decide either to increase the dose, or to give you another
medicine to take at the same time.
For the elderly, or people with liver or kidney problems, a suitable
starting dose is:
1.25 mg (half a tablet) twice a day.

In this leaflet:
1. What Prescal is, and what it’s used for
2. Things to consider before you start to take Prescal
3. How to take Prescal
4. Possible side effects
5. How to store Prescal
6. Further information

If necessary, the tablets should be broken in half along the scored line.

1. WHAT PRESCAL IS AND WHAT IT’S USED FOR
Prescal Tablets contain 2.5 mg of the active ingredient isradipine.
Isradipine is one of a group of drugs called calcium channel blockers or
calcium antagonists. It works by relaxing the blood vessels so the heart
does not have to pump as hard.

What if you take too much?
If you accidentally take too much, tell your doctor at once or contact your
nearest hospital casualty department. Take your medicine with you so that
people can see what you have taken.

Prescal is used to treat high blood pressure.
2. THINGS TO CONSIDER BEFORE YOU START TO TAKE PRESCAL
Some people MUST NOT take Prescal. Talk to your doctor if:
- You think you may be allergic to isradipine, or other similar calcium
channel blockers (e.g. amlodipine, felodipine, lacidipine, nicardipine,
nifedipine), or to any of the other ingredients of Prescal. (These are listed
in Section 6.)
- You have recently (within the last month) had a heart attack.
- You suffer from heart, heart valve or blood vessel disorders other than
high blood pressure.
- You have unstable angina.
- You are breast feeding.
You should also ask yourself these questions before taking Prescal. If
the answer to any of these questions is YES, tell your doctor or
pharmacist.
- Do you have diabetes?
- Do you have any liver or kidney problems?
- Are you pregnant or trying to become pregnant?
- Do you suffer from episodes of irregular heart beat?
- Do you have low blood pressure?
- Are you taking drugs called beta-blockers?
- Do you have an inherited intolerance to some sugars? These tablets
contain a small amount of lactose.
Are you taking other medicines?
Some medicines can interfere with your treatment or alter blood levels of
those drugs you are currently taking. Make sure your doctor knows if you
are taking any of the following:
- Beta blockers (e.g. for heart problems or low blood pressure).
- Medicines to treat stomach ulcers such as cimetidine.
- Macrolide antibiotics (e.g. erythromycin, clarithromycin).
- Rifampicin used to treat e.g. tuberculosis or leprosy.
- Medicines for epilepsy (e.g. phenytoin, carbamazepine and
phenobarbital).
- Anti-viral drugs (e.g. ritonavir, indinavir, nelfinavir and delavirdine).
- Oral anti-fungal drugs (e.g. ketoconazole, itraconazole, voriconazole).
- Oral baclofen, a treatment for prolonged muscle spasms.
Always tell your doctor about all the medicines you are taking. This means
medicines you have bought yourself as well as medicines on prescription
from your doctor.

Prescal Tablets are not recommended for children.
What if you forget to take a dose?
If you forget to take a dose, take it as soon as you remember. Then go on
as before. Do not take a double dose.

4. POSSIBLE SIDE EFFECTS
Prescal is suitable for most people, but, like all medicines, it can sometimes
cause side effects.
Some side effects can be serious
Stop taking Prescal and tell your doctor straight away if you notice:
- Bronchospasm with wheezing or coughing and difficulty in breathing, or if
you feel faint (you might have low blood pressure), have a rash, or
experience itching or facial swelling. These symptoms might be the result
of an allergic reaction which is very rare.
- Sudden and oppressive chest pain, breathlessness, difficulty breathing
when lying down, swelling of the feet or legs, irregular heart beat (signs of
heart disorder).
- Weakness of an arm, a leg or the face, difficulty speaking, or sudden loss
of consciousness (signs of a stroke)
- Visual disturbances, blurred vision
Go and tell your doctor straight away if you notice:
- You seem to bleed or bruise more easily than usual (signs of low level of
blood platelets).
- You seem to be catching more infections such as fever, severe sore
throat or mouth ulcers than usual (signs of low level of white blood cells).
- Your skin and eyes are looking yellow, or you feel sick, have lost your
appetite or if your urine is light in colour (signs of liver disorders).
- You seem to be getting more, or worse, attacks of angina.
The side-effects listed below have also been reported.
More than 10% of people have experienced:
Headache, flushing and swollen fingers, ankles, feet or lower legs.
Up to 1 in 10 people have experienced:
Dizziness or light-headedness
Fast heart beat or palpitations
Stomach discomfort
Skin rash
Fatigue or tiredness
Passing more urine than usual.
Up to 1 in 100 people have experienced:
Low blood pressure
Weight gain.

Up to 1 in 10,000 people have experienced:
Slow heart beat
Low level of red blood cells (anaemia)
Anxiety, nervousness, depression
Feeling sleepy
Cough
Nausea, vomiting, loss of appetite
Swollen gums
Hepatitis or abnormal liver function tests
Decreased or altered skin sensitivity including pins and needles
Allergic skin reactions, itching, sweating, sensitivity to light
Back pain, muscle cramps, joint pain, pain in limbs
Inability to achieve or maintain an erection
Breast enlargement in men
Generally feeling unwell, weakness.
Some patients experienced chest pain, insomnia, dry mouth, constipation,
diarrhoea, lack of energy and fainting during treatment with Prescal.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE PRESCAL
- Keep out of the sight and reach of children.
- Do not store above 30oC.
- Do not take the medicine after the expiry date which is printed on the
outside of the pack.
- If your doctor tells you to stop taking Prescal, please take any unused
tablets back to your pharmacist to be destroyed. Only keep them if the
doctor tells you to.
- If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to
do.
- Do not throw them away with your normal household water or waste.
This will help to protect the environment.
6. FURTHER INFORMATION
Each tablet contains 2.5 mg isradipine as the active ingredient.
The tablet also contains the following inactive ingredients: sodium lauryl
sulphate, magnesium stearate, povidone, maize starch, lactose
monohydrate.
Prescal tablets are round, yellow tablets marked H scoreline L on one side
and SANDOZ on the other.
Prescal comes in pack of 56, 60 and 100 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Prescal is manufactured by Novartis Norge AS, Postboks 4284 Nydalen,
0401 Oslo Norway.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2952

Leaflet revision and issue date (Ref) 20.01.17[2]
Prescal is a trademark of Novartis AG.

Isradipine 2.5 mg Tablets

2952
20.01.17[2]

PATIENT INFORMATION LEAFLET
The name of your medicine is Isradipine 2.5 mg Tablets but will be referred
to as Isradipine throughout this leaflet.
What you need to know about Isradipine
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information. Keep the leaflet in a safe
place because you may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to be
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 Isradipine is and what it’s used for
2. Things to consider before you start to take Isradipine
3. How to take Isradipine
4. Possible side effects
5. How to store Isradipine
6. Further information
1. WHAT ISRADIPINE IS AND WHAT IT’S USED FOR
Isradipine Tablets contain 2.5 mg of the active ingredient isradipine.
Isradipine is one of a group of drugs called calcium channel blockers or
calcium antagonists. It works by relaxing the blood vessels so the heart
does not have to pump as hard.
Isradipine is used to treat high blood pressure.
2. THINGS TO CONSIDER BEFORE YOU START TO TAKE ISRADIPINE
Some people MUST NOT take Isradipine. Talk to your doctor if:
- You think you may be allergic to isradipine, or other similar calcium
channel blockers (e.g. amlodipine, felodipine, lacidipine, nicardipine,
nifedipine), or to any of the other ingredients of Isradipine. (These are
listed in Section 6.)
- You have recently (within the last month) had a heart attack.
- You suffer from heart, heart valve or blood vessel disorders other than
high blood pressure.
- You have unstable angina.
- You are breast feeding.
You should also ask yourself these questions before taking
Isradipine. If the answer to any of these questions is YES, tell your
doctor or pharmacist.
- Do you have diabetes?
- Do you have any liver or kidney problems?
- Are you pregnant or trying to become pregnant?
- Do you suffer from episodes of irregular heart beat?
- Do you have low blood pressure?
- Are you taking drugs called beta-blockers?
- Do you have an inherited intolerance to some sugars? These tablets
contain a small amount of lactose.
Are you taking other medicines?
Some medicines can interfere with your treatment or alter blood levels of
those drugs you are currently taking. Make sure your doctor knows if you
are taking any of the following:
- Beta blockers (e.g. for heart problems or low blood pressure).
- Medicines to treat stomach ulcers such as cimetidine.
- Macrolide antibiotics (e.g. erythromycin, clarithromycin).
- Rifampicin used to treat e.g. tuberculosis or leprosy.
- Medicines for epilepsy (e.g. phenytoin, carbamazepine and
phenobarbital).
- Anti-viral drugs (e.g. ritonavir, indinavir, nelfinavir and delavirdine).
- Oral anti-fungal drugs (e.g. ketoconazole, itraconazole, voriconazole).
- Oral baclofen, a treatment for prolonged muscle spasms.
Always tell your doctor about all the medicines you are taking. This means
medicines you have bought yourself as well as medicines on prescription
from your doctor.

Will there be any problems with driving or using machinery?
Isradipine may make you feel dizzy, lower your blood pressure too much
(hypotension), cause vision disorder or blurred vision. If you experience
these symptoms, you should not drive or use machines.
3. HOW TO TAKE ISRADIPINE
The doctor will decide what dose of Isradipine you should take. Always take
the medicine exactly as your doctor has told you to. The dose will be on the
pharmacist’s label. Check the label carefully. It should tell you how much to
take, and how often. If you are not sure, ask your doctor or pharmacist.
Keep taking Isradipine for as long as you have been told unless you have
any
problems. In that case, check with your doctor.
Swallow the tablets whole with a drink of water. You can take the tablets
either before or after food. Do not take the tablets with grapefruit juice.
The usual dose for adults is:
2.5 mg twice a day.
If your blood pressure is still not controlled after three or four weeks, your
doctor may decide either to increase the dose, or to give you another
medicine to take at the same time.
For the elderly, or people with liver or kidney problems, a suitable
starting dose is:
1.25 mg (half a tablet) twice a day.
If necessary, the tablets should be broken in half along the scored line.
Isradipine Tablets are not recommended for children.
What if you forget to take a dose?
If you forget to take a dose, take it as soon as you remember. Then go on
as before. Do not take a double dose.
What if you take too much?
If you accidentally take too much, tell your doctor at once or contact your
nearest hospital casualty department. Take your medicine with you so that
people can see what you have taken.
4. POSSIBLE SIDE EFFECTS
Isradipine is suitable for most people, but, like all medicines, it can
sometimes cause side effects.
Some side effects can be serious
Stop taking Isradipine and tell your doctor straight away if you notice:
- Bronchospasm with wheezing or coughing and difficulty in breathing, or if
you feel faint (you might have low blood pressure), have a rash, or
experience itching or facial swelling. These symptoms might be the result
of an allergic reaction which is very rare.
- Sudden and oppressive chest pain, breathlessness, difficulty breathing
when lying down, swelling of the feet or legs, irregular heart beat (signs of
heart disorder).
- Weakness of an arm, a leg or the face, difficulty speaking, or sudden loss
of consciousness (signs of a stroke)
- Visual disturbances, blurred vision
Go and tell your doctor straight away if you notice:
- You seem to bleed or bruise more easily than usual (signs of low level of
blood platelets).
- You seem to be catching more infections such as fever, severe sore
throat or mouth ulcers than usual (signs of low level of white blood cells).
- Your skin and eyes are looking yellow, or you feel sick, have lost your
appetite or if your urine is light in colour (signs of liver disorders).
- You seem to be getting more, or worse, attacks of angina.
The side-effects listed below have also been reported.
More than 10% of people have experienced:
Headache, flushing and swollen fingers, ankles, feet or lower legs.
Up to 1 in 10 people have experienced:
Dizziness or light-headedness
Fast heart beat or palpitations
Stomach discomfort
Skin rash
Fatigue or tiredness
Passing more urine than usual.
Up to 1 in 100 people have experienced:
Low blood pressure
Weight gain.

Up to 1 in 10,000 people have experienced:
Slow heart beat
Low level of red blood cells (anaemia)
Anxiety, nervousness, depression
Feeling sleepy
Cough
Nausea, vomiting, loss of appetite
Swollen gums
Hepatitis or abnormal liver function tests
Decreased or altered skin sensitivity including pins and needles
Allergic skin reactions, itching, sweating, sensitivity to light
Back pain, muscle cramps, joint pain, pain in limbs
Inability to achieve or maintain an erection
Breast enlargement in men
Generally feeling unwell, weakness.
Some patients experienced chest pain, insomnia, dry mouth, constipation,
diarrhoea, lack of energy and fainting during treatment with Isradipine.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ISRADIPINE
- Keep out of the sight and reach of children.
- Do not store above 30oC.
- Do not take the medicine after the expiry date which is printed on the
outside of the pack.
- If your doctor tells you to stop taking Isradipine, please take any unused
tablets back to your pharmacist to be destroyed. Only keep them if the
doctor tells you to.
- If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to
do.
- Do not throw them away with your normal household water or waste.
This will help to protect the environment.
6. FURTHER INFORMATION
Each tablet contains 2.5 mg isradipine as the active ingredient.
The tablet also contains the following inactive ingredients: sodium lauryl
sulphate, magnesium stearate, povidone, maize starch, lactose
monohydrate.
Isradipine tablets are round, yellow tablets marked H scoreline L on one
side and SANDOZ on the other.
Isradipine comes in pack of 56, 60 and 100 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Isradipine is manufactured by Novartis Norge AS, Postboks 4284 Nydalen,
0401 Oslo Norway.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2952

Leaflet revision and issue date (Ref) 20.01.17[2]

Expand Transcript

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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