Thursday, October 20, 2016

Biorphen






Biorphen
Liquid 25mg/5ml


orphenadrine 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 gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.



The information in this leaflet has been divided into the following sections:



  • 1. What Biorphen is and what it is taken for


  • 2. Before you take Biorphen


  • 3. How to take Biorphen


  • 4. Possible side effects


  • 5. How to store Biorphen


  • 6. Further information




What Biorphen is and what it is taken for


Biorphen belongs to a group of medicines called antimuscarinics.


Biorphen is used to treat some of the symptoms of Parkinson's disease such as shakiness or stiffness of the muscles which can cause difficulty moving.


Some medicines can cause side effects which are like the symptoms of Parkinson’s disease and Biorphen is also used to reduce these side effects.




Before you take Biorphen



Do not take Biorphen:


  • if you are allergic to orphenadrine hydrochloride or similar medicines such as trihexyphenidyl hydrochloride or procycline hydrochloride, or if you are allergic to any of the other ingredients in Biorphen (see Section 6 Further information)

  • if you have glaucoma (increased pressure in the eye)

  • if you suffer from prostate problems which cause difficulty in passing urine

  • if you have porphyria (a disease which causes stomach pain, constipation, changes in the colour of urine, skin rashes and disturbed behaviour).

Do not give Biorphen to children.




Take special care with Biorphen


Tell your doctor if:


  • you have a fast heart beat – Biorphen may make this worse

  • you suffer from kidney or liver problems

  • you experience unusual movements of the face and tongue as this may be a sign of a serious condition known as tardive dyskinesia.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Biorphen.




Taking other medicines


Tell your doctor or pharmacist if you are taking or have taken any of the following medicines as they may interfere with Biorphen:


  • antihistamines - (used to treat allergies)

  • antiarrythmics such as disopyramide - (used to treat an irregular heartbeat)

  • phenothiazines - (used to treat psychoses), for example chlorpromazine or thioridazine

  • tricyclic antidepressants - (used to treat depression), for example amitriptyline

  • amantadine - (used to treat Parkinson’ s disease and some viral infections)

  • antispasmodics - (used to treat stomach pain), for example atropine sulphate, dicycloverine hydrochloride or propantheline bromide.

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




Pregnancy and breast-feeding


Do not take Biorphen if you are breast-feeding.


Tell your doctor if you are pregnant, trying to become pregnant or are breast-feeding.




Driving and using machines


Taking Biorphen may make your vision blurred. If you are affected you should not drive or use machines until the effect has worn off.




Important information about some of the ingredients of Biorphen


Biorphen contains:


  • glycerol - which can be harmful in high doses. It can cause headaches, stomach upsets and diarrhoea.

  • sorbitol - which may have a mild laxative effect. There is 1.75g of sorbitol in every 5ml of Biorphen. The maximum dose of Biorphen supplies 28g of sorbitol. The calorific value of sorbitol is 2.6kcal/g. Biorphen is therefore unsuitable for patients with hereditary fructose intolerance.




How to take Biorphen


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



Adults and the elderly: the usual starting dose is 150mg (six 5ml spoonfuls) a day. This is usually divided into three separate doses of 50mg ( two 5ml spoonfuls) three times a day.


If necessary, this may be increased by your doctor gradually until your symptoms are controlled. The dose is usually increased every 2-3 days by adding 50mg (two 5ml spoonfuls) to the total daily dose each time.


The usual dose range is between 150-300mg (a total of six - twelve 5ml spoonfuls) per day. The maximum dose is 400mg (a total of sixteen 5ml spoonfuls) per day.



Children: Do not give Biorphen to children.


Do not stop taking this medicine suddenly as your symptoms may get worse.


If you want to stop taking Biorphen ask your doctor who will tell you how to reduce the dose gradually.



What to do if you take more Biorphen than you should


If you accidentally take too much Biorphen, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest accident & emergency department. Show any left-over medicines or the empty container to the doctor.




If you forget to take a dose of Biorphen


Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose (within 1-2 hours). DO NOT take a double dose. Then go on as before.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Biorphen Side Effects


Like all medicines, Biorphen can have side effects although not everyone gets them. Biorphen sometimes causes the following side effects in some people:


  • dry mouth

  • blurred vision

  • upset stomach

  • dizziness

  • difficulty in passing water.

Uncommon side effects (that affect less than 1 person in 100):


  • fast heart beat

  • allergic reactions that may include itchy rash, swelling of the face, difficulty breathing, nettle rash

  • mood changes

  • nervousness

  • hallucinations

  • feeling optimistic

  • difficulty sleeping

  • inability to coordinate movements

  • confusion.

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




How to store Biorphen


Keep Biorphen out of the reach and sight of children.


Do not use Biorphen after the expiry date which is given on the carton and bottle label after EXP. The expiry date refers to the last day of that month.


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




Further information



What is in Biorphen?


The active ingredient in this medicine is orphenadrine hydrochloride.


The other ingredients are sorbitol, glycerol, anise water condensed, saccharin sodium, Tween 20, benzoic acid solution and water.




What Biorphen looks like and contents of the pack


Biorphen is a clear colourless liquid available in 200ml bottles.




Marketing Authorisation Holder and Manufacturer


The product licence holder is:



Alliance Pharmaceuticals Ltd

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

UK


Biorphen is manufactured by:



Pharmasol Ltd

North Way

Walworth Industrial Estate

Andover

Hampshire

SP10 5AZ

UK



The information in this leaflet applies only to Biorphen. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.




This leaflet was last approved in: 23rd July 2009


Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks.


Biorphen is a registered trademark of Alliance Pharmaceuticals Limited.


© Alliance Pharmaceuticals Ltd 2009.


PIL UK 008 v3






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