PRESCAL 2.5MG TABLETS

Active substance: ISRADIPINE

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Prescal® 2.5mg Tablets / Isradipine 2.5mg Tablets
(isradipine)
This product is available using either of the above names but will be referred to as
Prescal® 2.5mg Tablets throughout the following:
Patient Information Leaflet
What you need to know about Prescal® 2.5mg Tablets
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 Prescal® 2.5mg Tablets are and what they are used for
2. Things to consider before you start to take Prescal® 2.5mg Tablets
3. How to take Prescal® 2.5mg Tablets
4. Possible side effects
5. How to store Prescal® 2.5mg Tablets
6. Further information
1. What Prescal® 2.5mg Tablets are and what they are used for
Prescal® 2.5mg 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.
Prescal® 2.5mg Tablets are used to treat high blood pressure.
2. Things to consider before you start to take Prescal® 2.5mg Tablets
Some people MUST NOT take Prescal® 2.5mg Tablets. 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® 2.5mg Tablets. (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® 2.5mg
Tablets. 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?
Prescal® 2.5mg Tablets 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® 2.5mg Tablets
The doctor will decide what dose of Prescal® 2.5mg Tablets 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®
2.5mg Tablets 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.
Prescal® 2.5mg 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
Prescal® 2.5mg Tablets are suitable for most people, but, like all medicines, it can
sometimes cause side effects.
Some side effects can be serious
Stop taking Prescal® 2.5mg Tablets 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).
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
Visual disturbances, blurred vision
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® 2.5mg Tablets.
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.
5. How to store Prescal® 2.5mg Tablets
®
• The expiry date for these Prescal 2.5mg Tablets is given on the carton. Do not take
®
the Prescal 2.5mg Tablets after this date.
®
• Keep your Prescal 2.5mg Tablets in the original container out of the reach and sight
of children.
®
• If your doctor tells you to stop taking Prescal 2.5mg Tablets, please take any
unused tablets back to your pharmacist to be destroyed. Only keep them if the
doctor tells you to. Do not throw them away with your normal household water or
waste. This will help to protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist.
6. Further information
Each tablet contains 2.5mg isradipine.
The Prescal® 2.5mg Tablets are a pale yellow round tablet marked H breakline L on
one side and Sandoz on the reverse.
The tablets also contain the following inactive ingredients:
Sodium lauryl sulphate, magnesium stearate, povidone, maize starch and lactose.
Prescal® 2.5mg Tablets come in blister packs of 56 tablets.
This product is manufactured by Novartis Pharma SpA. Torre, Annunziata, Italy and is
procured from within the EU and repackaged by the Product Licence holder who is:
O.P.D. Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD2 4PR.
POM
PL No: 15814/0606
Leaflet issue and revision date (Ref:) 08.05.2012.
Prescal is a registered Trade Mark of Novartis AG, Basel, Switzerland.

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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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