Thursday, September 22, 2016

Ultramol Soluble






ULTRAMOL SOLUBLE



Paracetamol, Codeine phosphate 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 further questions, please ask your doctor or pharmacist


Do not pass this medicine 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.




In this leaflet:


  • 1. What Ultramol Soluble is and what it is used for

  • 2. Before you take Ultramol Soluble

  • 3. How to take Ultramol Soluble

  • 4. Possible side effects

  • 5. How to store Ultramol Soluble

  • 6. Further information




What Ultramol Soluble Is And What It Is Used For


The name of your medicine is Ultramol Soluble. Ultramol Soluble contains three different medicines called paracetamol, codeine phosphate and caffeine. It belongs to a group of medicines called analgesics (painkillers) and is used to relieve migraines, headaches, rheumatic pain, period pains, toothache, neuralgia (nerve pain), sore throats and the symptoms of cold and flu.




Before You Take Ultramol Soluble



Important things you should know about Ultramol Soluble



  • If you need to use this medicine for more than three days at a time, see your doctor


  • Taking Ultramol Soluble regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets


  • Taking a painkiller for headaches too often or for too long can make them worse



Do not take Ultramol Soluble and tell your doctor if:


  • You are allergic (hypersensitive) to paracetamol, codeine phosphate, caffeine or any of the other ingredients in your medicine (listed in Section 6: Further information).
    Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue.

Do not take Ultramol Soluble if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ultramol Soluble.




Take special care and check with your doctor before taking Ultramol Soluble if:


  • You have severe kidney or liver problems

  • You have non-cirrhotic alcoholic liver disease

  • The person going to take the tablets is under 12 years of age. Ultramol Soluble should not be given to children under 12 years of age.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Ultramol Soluble can affect the way some other medicines work. Also, some other medicines can affect the way Ultramol Soluble works.



While taking Ultramol Soluble you should not take any other medicines which contain paracetamol.


This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.



Do not take this medicine and tell your doctor or pharmacist if you are taking the following:


  • Medicines used to thin the blood such as warfarin

  • Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting)

  • Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ultramol Soluble.




Taking Ultramol Soluble with food and drink


Drinking too much coffee, or other drinks containing caffeine, whilst taking these tablets may make you tense and irritable.




Pregnancy and breast-feeding


Talk to your doctor before taking these tablets if:


  • You are pregnant, think you may be pregnant or plan to get pregnant

  • You are breast-feeding or planning to breast-feed



Driving and using machines


You may feel dizzy or sleepy while taking Ultramol Soluble. If this happens, do not drive or use any tools or machines.




Important information about some of the ingredients of your Ultramol Soluble tablets



  • Sodium: There is 362mg of sodium per effervescent tablet. This may be harmful to people on a low sodium or low salt diet.


  • Sorbitol: This is a type of sugar. If you have been told by you doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.



Changing or stopping treatment


Chronic usage of Ultramol Soluble may lead to tolerance and dependence. If you have taken regular daily doses of Ultramol Soluble for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor.





How To Take Ultramol Soluble


Always take Ultramol Soluble exactly as instructed on this leaflet. You should check with your doctor or pharmacist if you are not sure.



  • Do not take more than the recommended dose


  • If you need to use this medicine for more than three days at a time, see your doctor


Adults and children over 12


  • The usual dose of Ultramol Soluble is 2 effervescent tablets, taken together

  • Dissolve the effervescent tablets in a full glass of water before taking

  • Wait at least 4 hours before taking another dose

  • Do not take more than 8 tablets in any 24-hour period



Children


Ultramol Soluble should not be given to children under 12 years of age.




If you take more Ultramol Soluble than you should


  • Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage

  • Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken



If you have forgotten to take Ultramol Soluble


If you forget to take a dose at the right time, take it as soon as you remember.


However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.





Ultramol Soluble Side Effects


As with all medicines, Ultramol Soluble can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:



Important side-effects you should know about Ultramol Soluble


  • Taking a painkiller for headaches too often or for too long can make them worse.

  • Taking Ultramol Soluble regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.



Stop taking Ultramol Soluble and see a doctor or go to a hospital straight away if:


  • You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
    This may mean you are having an allergic reaction to Ultramol Soluble



Talk to your doctor straight away if you notice the following serious side effect:


  • Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect



Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:


  • Constipation

  • Feeling sick (nausea), being sick (vomiting)

  • Dizziness, light-headedness, drowsiness, confusion

  • Difficulty in passing water

  • Becoming dependent on paracetamol

  • You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)

  • Stomach pain, indigestion, nausea or vomiting. These can be signs that the caffeine is irritating your stomach.

  • Headaches

  • Tremor

  • Nervousness

  • Irritability

  • Sleeplessness

  • Palpitations


If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Ultramol Soluble


Keep this medicine in a safe place out of the reach and sight of children.


Do not use this medicine after the expiry date shown on the pack.


Store your medicine in the original packaging in order to protect from moisture.


Do not store above 30°C.


Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.




Further Information



What Ultramol Soluble Tablets contain


  • The active substances of Ultramol Soluble are paracetamol, codeine phosphate and caffeine. Each tablet contains 500mg of paracetamol, 8mg of codeine and 30mg of caffeine.

  • The other ingredients are, sodium bicarbonate, citric acid, sodium carbonate, sorbitol, saccharin sodium, povidone, dimeticone, and sodium lauryl sulphate.



Contents of pack


Ultramol Soluble are flat white tablets with bevelled edges, plain on one side and scored on the other. Each pack contains 32 tablets.




The Marketing Authorisation Holder is



Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK




The Manufacturer is



Fawdon Manufacturing Centre

Edgefield Avenue

Fawdon

Newcastle upon Tyne

NE3 3TT

UK




This leaflet was last updated in January 2008


‘Winthrop’ is a registered trademark. © 2008 Winthrop Pharmaceuticals.





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