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«PACKAGE LEAFLET: INFORMATION FOR THE USER Sporanox®-Pulse Itraconazole Sporanox is a registered trademark Read all of this leaflet carefully before ...»

-- [ Page 2 ] --

• Week 1: take 2 capsules of Sporanox-Pulse twice a day for this week

• Weeks 2, 3 and 4: do not take Sporanox-Pulse for these next 3 weeks

• Week 5: take 2 capsules of Sporanox-Pulse twice a day for this week

• Weeks 6, 7 and 8: do not take Sporanox-Pulse for these next 3 weeks

• Week 9: take 2 capsules of Sporanox-Pulse twice a day for this week.

This completes the treatment course

–  –  –

If you take too much of your medicine If you take more Sporanox-Pulse than you were told to, talk to your doctor or go to the nearest hospital casualty department straight away.

If you forget to take Sporanox-Pulse

• If you forget to take your capsules, take them as soon as you remember.

However, if it is nearly time for the next capsules, skip the missed capsules

• Do not take a double dose to make up for a forgotten dose When to stop using Sporanox-Pulse Keep taking Sporanox-Pulse for as long as your doctor has told you. Do not stop your treatment just because your skin or nails have improved.

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

4. Possible side effects Like all medicines, Sporanox-Pulse can cause side effects, although not everybody gets them.

Stop using Sporanox-Pulse and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

• Sudden signs of allergy such as rash, hives (also known as nettle rash or urticaria), severe irritation of your skin, swelling of the face, lips, tongue or other parts of the body. These may be signs of a severe allergic reaction.

This only happens in a small number of people

• Severe skin disorders with peeling and/or rashes with small pustules (with a fever) or blistering of the skin, mouth, eyes and genitals, with fever, chills, aching muscles and generally feeling unwell. (This occurs rarely)

• A tingling sensation, numbness or weakness in your limbs. (This occurs rarely)

• Severe lack of appetite, feeling sick (nausea), being sick (vomiting), unusual tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of your eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a liver problem. (This only happens in a small number of people)

• Shortness of breath, unexpected weight gain, swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night. These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs. (This occurs rarely) Tell your doctor or pharmacist if you notice any of the following side

effects:

Common (affects less than 1 in 10 people)

• Stomach ache, feeling sick (nausea)

• Headache Uncommon (affects less than 1 in 100 people)

• Problems with periods

• Sinusitis, runny nose, coughs and colds

• Constipation, diarrhoea, wind, being sick (vomiting), indigestion Rare (affects less than 1 in 1000 people)

• Increases in liver function tests (shown by blood tests)

• Unexpected passing of urine or need to urinate (pass water) more often

• Problems with sight including blurred vision and double vision

• Change in taste

• Certain blood disorders which may increase the risk of infections

• Ringing in your ears

• Hearing loss (may be permanent)

• Severe upper stomach pain, often with nausea and vomiting (inflammation of the pancreas)

• Swelling due to fluid under the skin

• Unusual hair loss or thinning (alopecia)

• High levels of triglycerides in the blood (shown by blood tests)

• Red, itchy, flaking or peeling skin

• Sensitivity of the skin to light

• Erection difficulties If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Sporanox-Pulse Keep out of the reach and sight of children.

• Store the capsules in their carton

• Keep the carton in a dry place out of strong sunlight Do not store above 30oC •

• Do not use Sporanox-Pulse after the expiry date which is stated on the label.

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 how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information The active substance in Sporanox-Pulse is itraconazole. Each capsule contains 100 mg of itraconazole.

The other ingredients are sugar spheres, hypromellose and macrogol. The capsule is made of gelatin and the colours titanium dioxide (E171), indigotin disulphonate sodium (E132) and erythrosine (E127).

What Sporanox-Pulse looks like and contents of the pack Sporanox-Pulse capsules are pink and blue. They are supplied in blister packs of 28 capsules.

The product licence is held by:

JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK

Sporanox-Pulse is made by:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium OR Janssen-Cilag SpA, Via C Janssen, 04100 Borgo San Michele, Latina, Italy For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last revised in May 2015



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