Italian Medicines Agency Agenzia Italiana del Farmaco

FAQ - Ranitidine-based medicines

FAQ - Medicines containing ranitidine

September 2019

What is ranitidine?

What is ranitidine?

Ranitidine belongs to a class of medicines known as histamine H2 receptor antagonists, which reduce the production of gastric acid by blocking the histamine receptors in the stomach

What indications is it used for?

Ranitidine-based medicines are widely used to reduce the production of acid in the stomach in patients (adults and children) suffering from conditions such as gastric ulcer, gastroesophageal reflux and heartburn. Both prescription and over-the-counter medicines are available. The intake can be by mouth (tablets, syrups) or by injection.

How long is it taken and/or prescribed for?

Generally, ranitidine is not used for chronic use, but in cycles of therapy of varying duration, depending on the pathology for which it is indicated. When prescribed by the doctor, treatment does not exceed 12 weeks in most indications. In any case, the duration of therapy is always established by the doctor.

How should the patient who is being treated with drugs containing ranitidine behave?

If it is a prescription drug, you should consult your doctor as soon as possible to discuss the possibility of switching to alternative drugs that are used for the same therapeutic indications. So a new prescription may be needed.

If you are taking a non-prescription medicine, you will need to consult your pharmacist or doctor to switch to an alternative medicine used for the same therapeutic indications.

Do you have to undergo special tests?

It is not necessary to undergo any particular examination, but you must contact your doctor to discuss the therapeutic alternative that best suits your needs.

What should you do with the packages in your possession, if they are among those subject to withdrawal or if their use is prohibited?

You should not use the withdrawn ranitidine-containing medicines in your possession. Medicines that are no longer usable can be thrown into the specific containers in pharmacies. Ranitidine-based medicines that have been banned from use must not be used, however, pending the results of the analyses aimed at determining whether NDMA is present.

What is N-nitrosodimethylamine (NDMA)?

NDMA is an organic chemical that is generated as a by-product of many industrial processes. It is also present at very low levels in water supplies and in some foods (especially cooked, smoked or seasoned). It is classified as a substance probably carcinogenic to humans on the basis of studies conducted on animals. It is not expected to cause harm when ingested in very low amounts.

Based on the detected NDMA levels, is there an acute health risk?

An acute risk is not expected for the patient who has already taken withdrawn products containing ranitidine.

Which actions are the European and national authorities taking?

The EMA launched a safety review of ranitidine-based medicines upon the European Commission’s request on 13 September, after tests found the presence of NDMA in some of these medicines. In this regard, evaluations are underway by the European Medicines Agency (EMA) in collaboration with AIFA and other European and international medicines agencies.

AIFA and the other national agencies have ordered restrictive measures in their respective States and are collaborating with the EMA. AIFA has ordered the withdrawal from pharmacies and the distribution chain of all batches of medicines containing ranitidine produced at the SARACA LABORATORIES LTD pharmaceutical workshop.

It also ordered a precautionary ban on the use of all batches marketed in Italy of medicines containing ranitidine produced by other pharmaceutical companies, pending their analysis. AIFA communicated the withdrawal and prohibition of use measures to doctors and pharmacists, issued a press release and shared information on its social channels. All updated information is available on the institutional portal.

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