How To Know If A Medicine Has Gluten?

To find out if a drug has gluten, we have current regulations, which require us to declare whether a drug has this component. Starch is used as an excipient in the manufacture of some medicines, especially in tablets and capsules.

This starch generally comes from wheat, corn, potato or rice flour. However, patients with celiac disease can only be affected by wheat starch, which is the one that can contain gluten.

Celiac disease is a global health problem. The only treatment for this disease is to eliminate gluten from your diet. For this reason, it is especially important to identify both foods and medications that may contain gluten in their composition.

What is celiac disease?

It is a chronic disease that affects the small intestine, causing inflammation of the mucosa and loss of microvilli. This makes it difficult to absorb the vitamins, minerals, and nutrients in food.

People with this disease can not tolerate a set of small proteins called gluten. These proteins are present in the flour of many cereals, such as wheat, barley, rye, oats, spelled, triticale, kamut and their derivatives, including starches.

Gluten and medications

One of the most used excipients in the preparation of medicines is starch, which can come from wheat, corn, potatoes or rice . Among these, the problem for celiacs would be wheat starch, since it may contain gluten.

The amount of gluten that a tablet can contain is very small. The gluten contained in a 1 gram tablet can be even less than 100 grams of bread labeled ‘suitable for celiacs’.

In the list of excipients that may contain gluten, it is important to bear in mind that gluten does not usually appear as such, but with the name of the excipient that may contain it.

Rice, corn or potato starch and its derivatives is one of the most widely used excipients as a diluent or disintegrant in the manufacture of tablets and capsules. The information that should appear depends on the starch content:

• Gluten content less than 20 parts per million (20 μg / g).
• Gluten content greater than 20 parts per million (20 μg / g).

Information to know if a medicine has gluten

In Spain, it is mandatory since 2008 that medicines declare if they contain starch in their composition, its origin and the amount of gluten they contain, if any. To know if a medicine has gluten, you have to look at the composition section in its leaflet. 

Here are the possible excipients that may contain gluten :

• Oat, barley, rye or wheat starch.
• Triticale.
• Carboxymethylstarch.
• Starch syrup.
• Type C sodium or sodium carboxymethyl starch.
• Carboxymethyl starch ether.
• Other derivatives of wheat, oat or rye starch.
• Oat or wheat flour.
• Wheat bran.
• Wheat germ dry extract.

What tools do we have to know if a drug has gluten?

We currently have a series of tools to obtain information, linked to the drug information center, CIMA.

CIMA general search engine

In this search engine we obtain a summary of the drugs that meet the selected search criteria, in which the excipients ‘susceptible’ of mandatory declaration are included.

Advanced search by CIMA data sheet

Another tool that CIMA makes available to users is the advanced search engine by technical sheet. Since 2016, the AEMPS has enabled a tool that allows the division by sections of the technical sheet and the drug leaflet. This division allows the operation of the advanced search engine by technical sheet.

Prescription gazetteer and drug tree

From CIMA, the possibility of downloading a drug database designed to provide basic prescription information, the prescription gazette and the drug tree is offered .

The prescription gazette includes for all authorized and marketed, financed and non-financed medicines, the data related to their identification and technical information. Among the fields offered, excipients that can be declared mandatory are included.

Conclusion:  how to tell if a drug has gluten

Remember that it is very important to tell your doctor and pharmacist that you have celiac disease. In this way, you ensure a correct prescription and dispensing of medications.