Friday, September 23, 2016

Univer Capsules 120, 180 and 240mg hard-capsules






UNIVER 120 mg, 180 mg 240 mg Prolonged Release Hard Capsules


(Verapamil hydrochloride)



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What UNIVER is and what it is used for.

  • 2. Before you use UNIVER.

  • 3. How to use UNIVER.

  • 4. Possible side effects.

  • 5. How to store UNIVER.

  • 6. Further information.




What Univer Is And What It Is Used For


The name of this medicine is UNIVER prolonged release hard capsules and it comes in three strengths (120 mg, 180 mg and 240 mg).


The active ingredient in them is verapamil hydrochloride which belongs to a group of medicines called calcium channel blockers.


UNIVER is used to treat high blood pressure (hypertension) and chest pains caused by lack of oxygen getting to the heart (angina pectoris).




Before You Take Univer



Do not take UNIVER if you:


  • Are allergic (hypersensitive) to verapamil hydrochloride or any of the other ingredients of UNIVER.

  • Have had a heart attack which has been followed by a slow heart rate, low blood pressure or breathlessness.

  • Have a slow heart rate which is not controlled by a pacemaker.

  • Have low blood pressure.

  • Suffer from sick sinus syndrome (causing a slow heart rate).

  • Have a weak heart (causing breathlessness and tiredness).

  • Suffer with Lown-Ganong-Levine or Wolff-Parkinson-White syndrome (causing palpitations).

  • Suffer from porphyria (a rare inherited disease affecting the blood).

  • Have been given a muscle relaxant called dantrolene by injection.

  • Have been given a type of medicine called a Beta-blocker by injection.

Do not drink grapefruit juice whilst taking UNIVER as this may affect how your medicine works.


This medicine is not suitable for anyone under the age of 18 years old.


Talk to your doctor before taking this product if any of the above apply to you.




Take special care with UNIVER if you:


  • Are pregnant or breast-feeding.

  • Have any liver problems.

  • Have any kidney problems.

  • Have low blood pressure.

  • Have any heart conditions.

  • Have myasthenia gravis (a nervous condition which causes muscle weakness).

If any of the above apply to you, you should speak to your doctor before taking this medicine.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including those medicines obtained without a prescription.


It is especially important if you are taking any of the following:


  • Dantrolene (a muscle relaxant).

  • Theophylline (to help breathing).

  • Ciclosporin (to prevent organ transplant rejection).

  • Rifampicin (to treat tuberculosis).

  • Midazolam (to induce sleepiness before surgery).

  • Lithium (to treat mood swings).

  • An antibiotic called erythromycin.

  • Protease inhibitors (eg ritonavir).

  • Medicines as part of a general anaesthetic.

Or if you are taking medicines to treat:


  • High blood pressure.

  • Irregular heart rates (e.g digoxin).

  • Heart conditions (eg beta-blockers).

  • Epilepsy (eg phenytoin, phenobarbitone, carbamazepine).

  • Fungal infections (eg ketoconazole).

  • High cholesterol.



Taking with food and drink


You can drink alcohol while taking this medicine, however, the effects of alcohol may be increased when taken together with UNIVER.


If you are concerned about how much alcohol you can drink while you are taking this medicine discuss this with your doctor.



Grapefruit juice can increase the effects of UNIVER and should be avoided while taking this medicine.




Pregnancy and breast-feeding


If you are pregnant, think you might be pregnant, or are breast-feeding you should ask you doctor or pharmacist for advice before taking UNIVER.




Driving or operating machinery


UNIVER may cause dizziness or fatigue, particularly when you first start taking it. If you are affected you should not drive or operate machinery.





How To Take Univer


Always take UNIVER exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Mild to moderate high blood pressure


Initially the dose will be 120 mg once a day, but this may be increased to 240 mg once a day or to a maximum of 480 mg once a day.



Angina


The usual dose is 360 mg once a day. This may be increased to 480 mg once a day.


The capsules should be swallowed whole with water (not chewed or sucked).


You may be prescribed a different dose if you have liver or kidney problems or are elderly.



If you take more UNIVER than you should


If you take too much UNIVER you should go to the nearest hospital casualty department immediately. Take the packet and this leaflet with you so that the doctor will know what you have taken.




If you forget to take UNIVER


If you forget to take your dose, take it as soon as you remember. If it is almost time for the next dose (up to 8 hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose.





Possible Side Effects


Like all medicines, UNIVER can cause side effects, although not everybody gets them.



Stop taking this medicine and tell your doctor immediately if you have difficulty breathing or your mouth or throat begins to swell or if you start suffering from a severe rash, itching or other skin reactions, as these may be signs of a serious allergic reaction.


Other side effects seen include:


  • Constipation.

  • Flushing of the face.

  • Headaches.

  • Tiredness.

  • Low blood pressure.

  • Feeling sick or being sick.

  • Dizziness.

  • Ankle swelling.

  • Slow or irregular pulse.

  • Muscle weakness.

Rarely, UNIVER may cause breast growth or milk production in men, stopping of menstrual periods in women, cause gum over growth, pins and needles, or an increase in levels of a hormone called prolactin. It may also cause sudden severe pain, reddening or sweating of the hands and/or feet.


If any of the side effects become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Univer


Keep out of the reach and sight of children.


Keep the tablets in the pack and do not store above 25ÂșC.


Do not use after the expiry date shown on the carton and blister pack.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What UNIVER contains


The active ingredient is verapamil hydrochloride. The capsules contain either 120 mg, 180 mg or 240 mg of the active ingredient.


In addition the capsules also contain fumaric acid, sugar spheres (containing sucrose and maize starch), talc, povidone, shellac, gelatine, titanium dioxide (E171), yellow iron oxide (E172), erythrosine (E127), indigotine (E132), black iron oxide (E172) and propylene glycol (E1520) as inactive ingredients.




What UNIVER looks like and the contents of the pack


The 120 mg capsules are blue and yellow and marked V120. The 180 mg capsules are yellow and marked V180 and the 240 mg capsules are blue and yellow and marked V240.


The capsules are available in blister packs containing 28 or 56 capsules.




Marketing Authorisation Holder



Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

UK




Manufacturer



Elan Pharma International Ltd

Monksland

Athlone

Co. Westmeath

Ireland


And




Manufacturer



APS Berk

Eastbourne

BN22 9AG

UK





This leaflet was last approved in March 2010


For more information please call free on 0800 783 4869 or e-mail: UKMedInfo@cephalon.com



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