Isradipine 2.5mg Tablets
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(isradipine)
The name of your medicine is Prescal 2.5mg tablets but will be referred 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.
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
1. What Prescal is and what it’s used for
Prescal contains 2.5mg 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 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.
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:
2.5mg 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:
1.25mg (half a tablet) twice a day.
If necessary, the tablets should be broken in half along the scored line.
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.
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 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
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.
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 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.qov.uk/vellowcard 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 take your tablets after the expiry date which is stated on the carton/blisters/label after 'Exp'. The expiry date refers to the last day of that month.
Protect from light.
Return any unused medicine to your pharmacist.
6. Further information
Each tablet contains 2.5mg isradipine.
The tablets also contain the following inactive ingredients: sodium lauril sulphate, magnesium stearate, povidone, maize starch, lactose.
The yellow, circular flat bevelled edge, angle-scored tablets, which are 6mm in diameter and marked HL on one side and Sandoz on the other side they are available in packs of 56 tablets.
Manufactured by: Novartis Farma S.p.A, Torre Annunziata, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
PRESCAL® 2.5mg TABLETS
PL No: 18799/0453 POM
Leaflet date: 09.02.2015
PRESCAL is a registered trademark of Novartis.