TACHIFENE 500mg/150mg 16 film-coated tablets is a drug sold by Angelini S.p.A. "for the temporary treatment of pain associated with: headache, migraine, back pain, menstrual pain, toothache, muscle pain, flu and cold symptoms, sore throat and fever".

Ingredients

Active ingredients: paracetamol, ibuprofen

Other components: pregelatinized corn starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and white Opadry (containing HMPC-hydroxypropyl methylcellulose/ipromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol/PEG 4000 and sodium citrate dihydrate (E331))

First of all, an analysis that I never see anyone do: the analysis of the ingredients of the capsule coating and excipients. Nobody pays you much attention, yet there are ingredients that we take constantly and several times a day.

I am not convinced by the composition of the outer shell of these capsules. I agree that the quantities are minimal, I prefer to avoid E171 titanium dioxide on which there is a lot of literature regarding safety and Talc, for the reasons I will explain later.

So let's examine all the ingredients to see what we put in our stomachs.

Paracetamolo Paracetamol (500mg per tablet). It is an active ingredient, analgesic and antipyretic, used for the treatment of flu and cold, present the hundreds of drugs that can be sold without prescription.

Ibuprofene  (150mg per tablet) Ibuprofen is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. According to scientific literature it produces the same effects as paracetamol by lowering fever and playing the role of anti-inflammatory, but is more effective than paracetamol. Among other things, ibuprofen also develops a neuroprotective action.

L'amido di mais Corn starch is obtained by grinding corn or maize, usually from its central part or kernel, unlike corn flour where the whole corn cob is ground and is commonly used in food and cosmetics. Thickener and binder. Pregelatinized corn starch. It is a modified corn starch. Modified starches are substances modified with physical or chemical properties to improve the conditions of the starch when it is processed. With these modifications, corn starch will be better able to withstand cooking, cold, sterilization.

Cellulosa microcristallina Microcrystalline cellulose is becoming in high demand due to the growing demand for alternatives to non-renewable and poorly available fossil materials. Although it still suffers from some drawbacks, microcrystalline cellulose has recently gained more interest for its renewability, non-toxicity, economic value, biodegradability, high mechanical properties, high surface area and biocompatibility.

Croscarmellosa sodica (E468, Sodium CNC) Croscarmellose sodium is an emulsifying chemical compound consisting of crude cellulose treated with sodium compounds. It serves to improve and accelerate the release of the drug into the intestine.

Magnesio stearato Magnesium stearate is used as an essential lubricant in tablet production and has effects on tablet dissolution, disintegration and hardness.

Talco. Talc. Used in several fields, cosmetic, pharmaceutical, industrial as tablet coating, filling agent and anti-caking agent. It's dangerous if inhaled.

Idrossipropilmetilcellulosa Hydroxypropylmethylcellulose is used as a coating in capsules by the pharmaceutical industry and can prevent the precipitation of the drug caused by magnesium stearate.

Lattosio monoidrato Lactose monohydrate is a disaccharide sugar that is extracted from milk. Industrially it is a chemical compound in the form of a white powder commonly used as a binding excipient, filling binder and compression aid in pharmaceutical mixtures. It is used in oral administration drugs as a spray-dried carrier.

Biossido di titanio (TiO2) or Titanium dioxide, is a chemical compound, a white pigment that creates a white or opaque coloration. A study conducted by 19 researchers at the University of Toulon notes with concern that the daily intake of TiO2 nanoparticles, as they overcome the normal defenses of the human body, is associated with an increased risk of chronic intestinal inflammation and carcinogenesis.

Macrogol 4000 is a PEG, a biologically inert mixture of ethylene glycol polymers is inserted into tablets usually with hydroxypropyl methylcellulose where it acts as a stabilizing excipient to prevent particles from aggregating and clogging the spray nozzle that forms the coating.

Sodio citrato diidrato Sodium citrate dihydrate labelled with the number E331 in the list of food additives has the function of acidity regulator to bring the pH to normal values.

Conclusion

These tablets have done their job very well and in two days they have restored my health. However, I will not buy them again because of the presence of titanium dioxide and talc. I will also get advice from my doctor about other tablets that only have ibuprofen.

Frankly, the presence of a decidedly "unhealthy" ingredient that could therefore cause health problems in a medicine is surprising. The only explanation maybe is the dated formulation and not updated with recent studies. On the other hand, unfortunately, until the ingredient (Titanium Dioxide is banned in some European countries but not yet in Italy and yet it is present in many medicines) will not be banned also in Italy, there is nothing to do. Pharmaceutical companies answer: excipient approved by the competent Authority.

18-4-2021 Today I wrote these comments to the EMA (European Medicines Agency) and to Europe Direct Contact Center asking for a written response.

4-6-2021 Answer: : 

Regarding titanium dioxide, the European Food Safety Authority published its opinion on May 6, 2021 and concluded that, based on all available evidence, a concern for genotoxicity cannot be ruled out, and given the many uncertainties, E 171 can no longer be considered safe when used as a food additive. As mentioned in a tweet on the same day, following EFSA's new scientific opinion on the food additive E171, we will propose to ban its use in the EU. https://twitter.com/food_eu/status/1390347410476523521

Regarding medicinal products, the Commission has asked the European Medicines Agency to assess the effect on the use of TiO2 in medicinal products and the feasibility of alternatives to replace TiO2, if possible, without impact on the quality, safety and efficacy of medicinal products. A decision will be made by the Commission based on the analysis provided by the Agency."

All we can do is hope and wait (how much?).