HeliMet (discontinued in the UK - August 2005)

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.

Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting, flatulence or abdominal pain

Dry mouth

Inflammation of the lining of the mouth (stomatitis)

Tooth or tongue discolouration

Headache

Dizziness

Fatigue

A general feeling of being unwell (malaise)

Alteration in taste

Pain in the muscles and joints

Liver or kidney disorders

Pins and needles (paraesthesia)

Reversible hearing loss

Confusion

Low blood sugar (hypoglycaemia)

Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock

Skin reactions such as rash or itching

Impotence

Blood disorders

Abnormal heart beats (arrhythmias)

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.

Due to its clarithromycin component, HeliMet should not be taken by people taking any of the following medicines:

cisapride

ergot alkaloids such as ergotamine and dihydroergotamine

pimozide

terfenadine.

Clarithromycin may increase the blood level of the following medicines and may therefore potentially increase the risk of their side effects. If you are taking any of the following medicines your doctor may want to monitor your blood level or decrease your dose while you are taking a course of HeliMet:

benzodiazepines, eg alprazolam, midazolam, triazolam

carbamazepine

ciclosporin

cilostazol

digoxin

disopyramide

methylprednisolone

phenytoin

quinidine

rifabutin

sildenafil

statins such as lovastatin or simvastatin

tacrolimus

theopylline

valproate

vinblastine.

If clarithromycin tablets are taken at the same time as the anti-HIV medicine zidovudine, they may decrease the blood level of the zidovudine thus making it less effective. If you are taking zidovudine you should take your clarithromycin dose at least two hours before or after your zidovudine dose to avoid this.

The anti-HIV medicine ritonavir can increase the level of clarithromycin in the blood. This is not normally a problem, however if you are taking ritonavir and have decreased kidney function, your doctor may need to prescribe you a lower than normal dose of clarithromycin.

Clarithromycin, metronidazole and lansoprazole may increase the anti-blood-clotting effects of anticoagulant medicines such as warfarin. If you are taking an anticoagulant your blood-clotting-time (prothrombin time or INR) should be monitored while you are taking HeliMet.

Antacids and sucralfate decrease the absorption of lansoprazole from the gut and may make it less effective. For this reason, antacids and sucralfate should not be taken within an hour of taking lansoprazole.

Phenobarbital decreases the blood level of metronidazole. If you are taking phenobarbital your doctor may need to prescribe a larger than normal dose of metronidazole.

Metronidazole may increase the blood level of the following medicines, and this may increase the risk of their side effects:

lithium (if you are taking lithium in combination with HeliMet, your lithium level and kidney function should be monitored)

fluorouracil

phenytoin.

Cimetidine may increase the blood level of metronidazole.

If you are taking a combined oral contraceptive pill there may be a very low risk that metronidazole may make it less effective at preventing pregnancy. Although the risk of this is very low, the personal and ethical consequences of an unwanted pregnancy can be very serious. For this reason the Family Planning Association recommends that women taking combined oral contraceptives should use an extra method of contraception (eg condoms) while taking a short course of broad-spectrum antibiotic, 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).

Other medicines containing the same active ingredients

There are no other products available in the UK that contain all these three medicines, however they are available separately.

Zoton contains lansoprazole.

Klaricid contains clarithromycin.

Flagyl contains metronidazole.

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