Nizoral tablets (ketoconazole)

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Nausea and vomiting.

Itching (pruritus).

Abdominal pain.

Diarrhoea.

Headache.

Dizziness.

Sleepiness.

Rash.

Menstrual disorders - very rare.

Erectile dysfunction - very rare.

Abnormal enlargement of breasts in men (gynaecomastia) - very rare.

Decreased numbers of blood cells called platelets in the blood (thrombocytopenia) - very rare.

Hair loss (alopecia) - very rare.

Raised pressure inside the skull - very rare.

Severe swelling of lips, face or tongue (angioedema) - very rare.

Serious liver damage that may be fatal - very rare.

Underactivity of the adrenal glands - very rare.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Nizoral tablets must not be taken in combination with any of the following medicines. This is because when ketoconazole is taken by mouth it can raise the blood levels of these medicines, resulting in an increased risk of serious side effects:

cilostazol

cisapride

darifenacin

disopyramide

eletriptan

eplerenone

ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine and methysergide

ivabradine

lovastatin

midazolam taken by mouth

mizolastine

nisoldipine

pimozide

quinidine

sertindole

simvastatin

sirolimus

terfenadine

triazolam

vardenafil.

Ketoconazole may also increase the blood levels of various other medicines and could increase the risk of their side effects. Other medicines affected in this way include the following:

almotriptan

alprazolam

aprepitant

aripiprazole

buprenorphine

buspirone

calcium channel blockers, eg felodipine

carbamazepine

ciclosporin

docetaxel

domperidone (not recommended in combination with ketoconazole tablets)

erlotinib

galantamine

imatinib

indinavir

loratadine

methlyprednisolone and possibly other corticosteroids

mirtazapine

reboxetine

repaglinide

rimonabant

ritonavir (ritonavir may also increase the blood level of ketoconazole)

saquinavir

sildenafil

solifenacin

sunitinib

tacrolimus

tadalafil

theophylline

tolterodine.

Ketoconazole may enhance the anti-blood-clotting effect of anticoagulant medicines such as warfarin. If you are taking this medicine in combination with an anticoagulant your blood clotting time (INR) should be monitored more frequently.

When there is a low level of acidity in the stomach, the absorption of ketoconazole is decreased. This could make it less effective at treating infection. For this reason, you should not take antacid medicines (eg for indigestion or heartburn) for at least two hours after taking Nizoral tablets. If you are taking regular medicines that decrease the acidity in the stomach (for example H2-antagonists such as ranitidine or cimetidine, or proton pump inhibitors such as lansoprazole or omeprazole), the manufacturer recommends that you take your Nizoral tablets with a cola drink.

The following medicines may reduce the amount of ketoconazole in the blood and could make it less effective at treating infection:

carbamazepine

isoniazid

nevirapine

phenytoin

rifabutin

rifampicin (ketoconazole may also reduce the blood level of rifampicin).

If you are taking the contraceptive pill there may be a very low risk that ketoconazole tablets may make it less effective at preventing pregnancy. The personal and ethical consequences of an unwanted pregnancy can be very serious and for this reason, it is recommended that women taking the pill should use an extra method of contraception (eg condoms) while taking a course of this medicine and for seven days after finishing the course. If the seven days run beyond the end of a pill packet, a new packet should be started without a break (in the case of ED pills the inactive tablets should be omitted). Ask your doctor or pharmacist for more advice.

Other medicines containing the same active ingredient

Daktarin gold cream	Dandrazol anti-dandruff shampoo	Dandrazol shampoo
Ketopine shampoo	Nizoral anti-dandruff shampoo	Nizoral cream
Nizoral dandruff shampoo	Nizoral shampoo

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