Prescal Tablets 2.5mg
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Isradipine 2.5 mg Tablets
(isradipine)
This medicine will be referred to simply as Isradipine in 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.
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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
Store the tablets below 30°C. Keep the tablets in the original pack to protect them from light.
Keep all medicines out of the reach and sight of children.
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. Do not throw them away with your normal household water or waste.
This will help to protect the environment.
Isradipine comes in packs of 56 or 60 tablets. Some of the pack sizes might not be available.
The product licence holder is Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England.
Isradipine is made by Novartis Pharmaceuticals UK Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom or Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
Distrbuted by:
Sandoz Limited,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.
This leaflet was revised in April 2014.
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
6. Further information
Isradipine tablets are round, yellow tablets marked HL on one side and SANDOZ on the other. They contain 2.5 mg of the active ingredient, isradipine. The tablets also contain the inactive ingredients sodium lauryl sulphate, magnesium stearate, povidone, maize starch and lactose.
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