In the area of self-medication, it is not necessary for patients to be treated with maximum dose and maximum efficacy. Patients who self-medicate with drugs from the pharmacy are characterized by the fact that the symptoms of their migraine attacks are in the mild or moderate range. It is therefore appropriate that the lowest effective dose is made available for self-medication and that the focus is on tolerability and safety.

Naratriptan 5 mg is also more effective than the 2.5-mg dose. However, only the dose of 2.5 mg was authorised from the onset. This means that the efficacy of naratriptan 2.5 mg is in the lower range compared to the other triptans. On the other hand, this results in better tolerability. From a clinical point of view, it therefore seems appropriate that this substance in the dose of 2.5 mg was the first to be made available in pharmacies for self-medication.

With regard to long-term clinical experience and clinical studies, it is also evident for rizatriptan 5 mg that this dose has no increased side effect potential compared to placebo. It is therefore justified that rizatriptan 5 mg should also be made available in pharmacies for self-medication and that patients should be provided with a further treatment option.

It follows on from this, that for patients with severe migraine attacks who do not respond to treatment with rizatriptan 5 mg as part of self-medication, physician consultation will be arranged and here it may be considered whether a higher dose of 10 mg is required. In the clinical context of migraine treatment, but also regarding development of medication overuse headache, early and higher doses are suggested to achieve effective attack therapy [27]. Therefore, if 5 mg is not sufficiently effective, 10 mg should be used.

The finding of altered pharmacokinetics of rizatriptan 5 mg when pretreated with propranolol is of no further clinical relevance in the event of a switch of rizatriptan 5 mg from prescription to pharmacy-only status. As rizatriptan 5 mg is provided as a single dose, concomitant prophylactic treatment of migraine with propranolol and the altered pharmacokinetics are already taken into account ex ante. This also applies to the group of patients with renal or hepatic disease.

To date, there is no known clinical relevance for the increase in plasma concentrations of rizatriptan with concomitant use of propranolol. In other countries, such as the United States, a corresponding restriction on the use of rizatriptan 10 mg with concomitant pre-treatment with propranolol is not listed in the prescribing information. There is no indication in the literature regarding a clinical relevance for the safety and tolerability of pretreatment with propranolol during treatment with rizatriptan 5 or 10 mg. These are studies in healthy subjects and theoretical precautionary measures in the context of initial drug approval. However, after more than 20 years of experience, no clinically relevant effects on the tolerability or safety of rizatriptan 5 mg or rizatriptan 10 mg were found in the clinical use in the acute treatment of migraine attacks.

On average, migraine patients suffer 1.6 attacks per month [10]. From a clinical point of view, it is appropriate for migraine patients with an average or even lower frequency of migraine attacks per month to self-medicate from the pharmacy. This applies all the more if patients can thereby achieve effective treatment. It is appropriate for this group of patients to have various treatment options from different groups of active ingredients at their disposal. It is therefore necessary that further substances with a comparable or even better risk–benefit profile are transferred from the prescription-only to the pharmacy-only status. As the study situation proves this for rizatriptan 5 mg, it is appropriate from a clinical standpoint that rizatriptan 5 mg should be transferred from prescription-only to pharmacy-only status.

When headaches occur for the very first time, there is always diagnostic uncertainty as to which type of headache is present. As a result, patients experiencing headaches for the first time with a relevant degree of suffering should always be examined and advised by a doctor. The requirement for self-medication should therefore be that this should only take place after an initial diagnosis of the headache by a doctor.

As primary headache disorders such as migraine can persist for several decades of life, self-medication can then be carried out responsibly in the further course of the disease if the headache phenotype remains constant and the occurrence of attacks is known, and if it is effective and well tolerated. However, if the medication is not effective, if adverse events occur or if the headache phenotype changes, patients should be informed that they should be seen by a doctor again during the course of the disease.

Patients should be informed at the pharmacy about what to do if a recurrent headache occurs. Patients should also be told what to do if rizatriptan 5 mg is not initially effective during an acute migraine attack.

If there is a significant improvement in the migraine attack after taking Rizatriptan 5 mg (reduction from severe or moderate headache to mild or no headache) and the headache recurs after this reduction, this is referred to as a recurrence headache. In this case, it is appropriate to take a second dose. A renewed improvement in the headache is then to be expected according to the clinical study situation. It is therefore also appropriate that two tablets are available in one packaging unit for self-medication.

However, if there is no initial improvement after taking Rizatriptan 5 mg, there is a primary inefficacy in the context of this attack. This does not necessarily mean that there will be no efficacy in the event of another attack at a different time. In the current attack, however, it is not practical to take the second dose. According to study data, it cannot be expected that a repeated dose will be effective during this attack in the event of primary inefficacy. Instead, a backup medication with a different active ingredient should be used.