Wednesday, October 26, 2016

Celiprolol Hydrochloride 200MG AND 400MG Tablets






CELIPROLOL HYDROCHLORIDE TABLETS



KEEP ALL MEDICATION OUT OF THE REACH OF CHILDREN



Please read this leaflet carefully BEFORE you start to take your tablets. This leaflet is a summary of the important information about your medicine. Keep it in a safe place, as you may want to refer to it again. If you have any questions or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.




What Is In Celiprolol Hydrochloride Tablets ?


The active ingredient is Celiprolol Hydrochloride.


Celiprolol Hydrochloride 200 mg Tablets contain celiprolol hydrochloride 200 mg and Celiprolol Hydrochloride 400 mg Tablets contain celiprolol hydrochloride 400 mg.


Celiprolol Hydrochloride 200 mg Tablets are white, heart shaped and engraved with an 'S' shape on one side and 200 and a break line on the other. Celiprolol Hydrochloride 400 mg Tablets are white, heart shaped and engraved with an 'S' shape on one side, and 400 on the other.


The tablets also contain the following inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.


The film coating contains: 200 mg strength: Opadry Y-IR-7000 and Opadry YS-I-7006 (E464, E171, polyethylene glycol 400 and polyethylene glycol 6000).


400 mg strength: Opadry Y-1-7000 and Opadry YS-I-7006 (E464, E171, polyethylene glycol 400 and polyethylene glycol 6000).


Celiprolol Hydrochloride 200 mg and 400 mg Tablets are available in packs containing 28 tablets. Celiprolol hydrochloride is one of a group of medicines called beta-blockers.


Beta-blockers are used to treat disorders of the heart and blood circulation.



MA Holder:



Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK




The product is made by



Aventis Intercontinental

56, route de Choisy au Bac 60200 Compiègne

France





Why Have You Been Prescribed Celiprolol Hydrochloride Tablets ?


Celiprolol Hydrochloride Tablets are used to treat high blood pressure (hypertension).


If you need any further information on your condition, please ask your doctor.




Before Taking Your Medicine


Tell your doctor or pharmacist if any of the following apply:


  • If you are sensitive or allergic to celiprolol or any other beta-blockers.

  • If you are sensitive or allergic to any of the inactive ingredients.

  • If you suffer from a slow heart beat (bradycardia).

  • If your heart is not pumping blood as well as it should (heart failure).

  • If you have low blood pressure (hypotension).

  • If you suffer from a type of chest pain called Prinzmetal's angina.

  • If you suffer from very poor circulation in the hands and feet (Raynaud's disease).

  • If you suffer from any other problems with your heart or blood circulation.

  • If you have any liver problems.

  • If you have any kidney problems, in particular kidney failure.

  • If you have phaeochromocytoma (high blood pressure caused by a tumour, usually near the kidney) which is not being treated.

  • If you have metabolic acidosis (abnormal levels of acid in your blood).

  • If you have a history of wheezing, asthma, bronchitis, emphysema or other breathing problems.

  • If you have ever suffered from psoriasis.

  • If you have previously suffered from allergic reactions (e.g. to insect stings).

  • If you have diabetes, or an overactive thyroid gland.

  • If you are pregnant or think you might be pregnant.

  • If you are breast feeding.

  • If the patient is under 12 years of age.

  • If you are taking any other medicines.

Some medicines may change the way celiprolol hydrochloride works, or should not be taken with it. If you are taking any of the following, tell your doctor: amiodarone, digitalis, diltiazem, disopyramide, nifedipine, quinidine, verapamil (may be used to treat heart problems), non steroidal anti inflammatory drugs such as ibuprofen or indomethacin (used for treating pain and inflammation), theophylline (may be used to treat asthma), chlorthalidone, hydrochlorothiazide, clonidine (and other drugs used to lower blood pressure), insulin (or other drugs used to treat diabetes), tricyclic antidepressants, monoamine oxidase inhibitors (for treating depression), chlorpromazine or other phenothiazines (used for treating certain psychiatric disorders), adrenaline (used as a heart stimulant), medicines bought from the chemist (especially cough and cold remedies).


If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking celiprolol hydrochloride. This is especially important if you are likely to be given an anaesthetic.




How To Take Your Medicine


The usual adult dosage is 200 mg to 400 mg first thing in the morning, half an hour before food. The tablets should be swallowed with water. It is important to take your tablets at the right time. If your doctor decides to stop or change your treatment, you may be asked to reduce the number of tablets you are taking. Always take the number of tablets your doctor has told you. The pharmacist’s label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.



What If You Forget To Take Your Medicine ?


Do not worry, just take your tablets as soon as you remember, then go on as before.



Do not take double the dose on the same day.




What If You Or A Child Takes Too Much ?


If you accidentally take too many tablets or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.




Driving And Operating Machinery


Celiprolol hydrochloride is unlikely to affect your ability to drive or to operate machinery.


However, some people may occasionally feel dizzy or drowsy when taking a beta-blocker.


If this happens to you, ask your doctor for advice.





Does Celiprolol Hydrochloride Have Side Effects ?


As well as benefits, all medicines may occasionally have unwanted effects in some patients.


These are called side effects. Side effects of celiprolol hydrochloride that are well known are headache, dizziness, light-headedness, slow heart beat (bradycardia) or other heart effects, tiredness or fatigue, nausea or feeling sick, vomiting, diarrhoea, sleepiness and insomnia (sleep disturbances).


Patients with an overactive thyroid gland or diabetes should be aware that the symptoms of thyrotoxicosis or hypoglycaemia may be hidden by celiprolol hydrochloride. Rarer effects are nightmares, hallucinations, confusion and loss of sex drive.You do not need to worry about them unless they become troublesome - in which case, you should contact your doctor.


Some side effects may be more serious and you should tell your doctor immediately if you have any of the following: skin rashes, any changes in your eyesight, breathlessness, wheezing or coughing, depression, shakiness, palpitations (fast heart rate), coldness, numbness or tingling in the hands and feet.



Do not be alarmed by this list of possible events. Most people take celiprolol hydrochloride without any problems.


All medicines may have unwanted effects which are not mentioned in the product leaflet.


If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.




Expiry Date


You must not take these tablets after the expiry date. This can be found on the carton and blister. It is given as ‘EXP’ followed by the month and year. The tablets should not be used after the end of that month. If you are not sure when this is, check with your doctor or pharmacist.




Storage Of Your Celiprolol Hydrochloride Tablets


Your tablets should be stored in the pack in which you are given them. Do not store above 25°C.



Keep your tablets in a safe place, out of reach and sight of children.


Do not keep the tablets if your doctor decides to stop treatment. Return them to your pharmacist who will arrange for their safe destruction.



REMEMBER: These tablets are for you. Only a doctor may prescribe them for you. Never give your tablets to other people. They may harm other people even if their symptoms appear to be the same as yours.



This leaflet was revised in September 2008.


R755370





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