Sunday, October 23, 2016

Cafergot Tablets






Cafergot tablets 1 mg


ergotamine tartrate and caffeine



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 Cafergot tablets are and what they are taken for


  • 2. Check before you take Cafergot tablets


  • 3. How to take Cafergot tablets


  • 4. Possible side effects


  • 5. How to store Cafergot tablets


  • 6. Further information




What Cafergot tablets are and what they are taken for


Cafergot tablets belong to a group of medicines called antimigraine drugs.


Cafergot tablets are used to treat migraines which have not responded to simple painkillers. They are used at the first sign of a migraine attack to relieve the symptoms and to stop the attack getting worse.


Do not use Cafergot tablets to prevent migraine attacks.




Check before you take Cafergot tablets



Do not take Cafergot tablets if you:


  • are allergic (hypersensitive) to ergotamine tartrate, caffeine or any of the ingredients of Cafergot tablets (see section 6 Further information)

  • have poor blood circulation to your arms and legs

  • suffer from heart problems

  • have high blood pressure which has not been controlled by treatment

  • are suffering from a severe infection (septic shock)

  • suffer from kidney problems

  • suffer from liver disease

  • suffer from a condition known as giant cell arteritis or temporal arteritis (the symptoms of which can include severe headache, a tender scalp and problems with your vision)

  • suffer from a specific type of migraine called a basilar migraine (symptoms of which include giddiness, double vision, unsteadiness, fainting or loss of consciousness) or a hemiplegic migraine (symptoms of which include temporary paralysis down one side of the body, hearing impairment, numbness around the mouth leading to trouble speaking or swallowing)

  • are pregnant or breast-feeding

  • are taking a certain type of antibiotics (called macrolides) for example, erythromycin, clarithromycin, azithromycin

  • are taking medicines to treat HIV or AIDS (called HIV-protease or reverse-transcriptase inhibitors) for example, amprenavir, indinavir

  • are taking certain types of antifungals (called azole antifungals) for example, ketoconazole, miconazole

  • are taking other anti-migraine drugs (including ergot alkaloids or drugs that end in ‘triptan’ such as sumatriptan, almotriptan, rizatriptan).

Do not give Cafergot tablets to children under 12 years old.


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




Take special care with Cafergot tablets


Before you take Cafergot tablets tell your doctor if:


  • you have taken a triptan (such as almotriptan, rizatriptan, sumatriptan or zolmitriptan) in the last 6 hours

  • you are a smoker.

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


If you attend hospital, or are about to have an operation or medical procedure tell the medical staff that you take Cafergot tablets.




Taking other medicines


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




  • antibiotics: used to treat bacterial infections such as macrolides (for example, erythromycin, azithromycin, clarithromycin, spiramycin, telithromycin), quinupristin, dalfopristin, tetracycline


  • antifungals: used to treat fungal infections such as, ketoconazole, miconazole, itraconazole, posaconazole, voriconazole


  • antivirals: used to treat HIV infection such as amprenavir, indinavir, nelfinavir, ritonavir, saquinavir, atazanavir, efavirenz


  • 5HT1 agonists (triptans): used to treat migraines such as almotriptan, rizatriptan, sumatriptan, zolmitriptan, eletriptan, frovatriptan


  • cimetidine: used to treat stomach ulcers and heartburn

  • treatments for low blood pressure: for example ephedrine hydrochloride, metaraminol


  • beta-blockers: used to treat heart disease, angina and other heart disorders such as propranolol, oxprenolol, atenolol


  • nicotine: for example from smoking or nicotine replacement therapy (nicotine patches or gum)

  • certain general anaesthetics: for example halothane

  • certain antidepressants: for example reboxetine.

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




Taking with food and drink


Cafergot tablets should be swallowed whole with a glass of water.




Pregnancy and breast-feeding


Do not take Cafergot tablets if you are pregnant or breast-feeding. Cafergot tablets can be passed into breast milk and may cause vomiting, diarrhoea, changes in blood pressure and a weak heartbeat in your baby. If you become pregnant whilst taking Cafergot tablets tell your doctor immediately.


Ask your doctor or pharmacist for advice before taking any medicine.




Driving and using machines


Cafergot tablets may make you dizzy or anxious. If you are affected do not drive or operate machinery until these effects have worn off.




Important information about some of the ingredients of Cafergot tablets


Cafergot tablets contain sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.





How to take Cafergot tablets


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


Your doctor will decide on the right dose of Cafergot tablets for you. Cafergot tablets should be swallowed whole with a glass of water.



Adults and the Elderly


The usual dose is 1 or 2 tablets taken at the first sign of a migraine. Your doctor may increase your dose up to 4 tablets in 24 hours, however it is important to use the lowest dose which is effective.


Keep a record of how many tablets you take.


It is important that you:


  • do not take more than 4 Cafergot tablets in 24 hours

  • do not take Cafergot tablets every day to prevent migraines

  • do not take Cafergot tablets if you have already taken a course of treatment within the last 4 days

  • do not take more than 8 Cafergot tablets in a week.

If you are not getting relief from your migraine do not take more tablets, tell your doctor.




Children


Do not give Cafergot tablets to children under 12 years old.




What to do if you take more Cafergot tablets than you should


If you accidentally take too many Cafergot tablets or someone else takes any of your medicine, you should tell your doctor at once or contact your nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.


Symptoms of an overdose include feeling or being sick, drowsiness, dizziness or confusion, having a slow or fast heartbeat, difficulty breathing, convulsions, tingling or numbness in your fingers or toes, your fingers turning blue, difficulty in passing urine or severe headache.




If you forget to take Cafergot tablets


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. 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.




Cafergot Tablets Side Effects


Do not worry. Like all medicines, Cafergot tablets can cause side effects, although not everyone gets them.


If you experience severe numbness or tingling in your hands or feet, nausea, vomiting, pains in your chest or are passing less urine than normal stop taking Cafergot tablets and contact a doctor or go to the nearest hospital straight away as you may need urgent medical attention.



Common side effects (that affect less than 1 person in 10):


  • feeling or actually being sick

  • stomach pain

  • dizziness



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


  • poor circulation in your hands or feet which can make them feel cold or painful and look pale or blue

  • pain or weakness in your arms, hands, legs or feet

  • tingling or numbness in your hands or feet

  • diarrhoea.



Rare side effects (that affect less than 1 person in 1000):


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

  • slow or fast heartbeat

  • high blood pressure

  • muscle pain

  • headache

  • stroke (causing sudden weakness or numbness, dizziness or severe headache)

  • changes in blood tests which show how the kidneys are working.



Very rare side effects (that affect less than 1 person in 10 000):


  • angina or heart attack (causing pain in the chest)

  • gangrene (when the blood supply to extremities such as toes or fingers is cut off).



The caffeine in Cafergot tablets may cause the following unwanted side effects:


  • feeling of anxiety

  • trembling

  • sweating

  • fast heartbeat.


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 Cafergot tablets


Keep out of the reach and sight of children.


Do not take Cafergot tablets after the expiry date which is stated on the carton (EXPIRY). 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 Cafergot tablets?


The active ingredients in this medicine are ergotamine tartrate and caffeine.


The other ingredients are:


tartaric acid, gelatin, stearic acid, lactose, starch, talc, gum acacia, sugar and carnauba wax.




What Cafergot tablets look like and contents of the pack


Cafergot tablets come in cartons of 30 tablets in an opaque aluminium/PVdC blister pack.




Marketing Authorisation Holder and Manufacturer


The product licence holder is:



Alliance Pharmaceuticals Ltd

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

UK


Cafergot tablets are manufactured by:



Novartis Pharmaceuticals Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK



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




This leaflet was last approved: 30th March 2009


Alliance and associated devices are registered Trademarks of Alliance Pharmaceuticals Limited.


Cafergot is a registered trademark of Novartis Pharmaceuticals Limited and is used under licence by Alliance Pharmaceuticals Limited.


© Alliance Pharmaceuticals Ltd 2009.


UK PIL 006






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