PANMIGROL MIGRAINE AND HEADACHE RELIEF

Posology Adults (18 years and older) For headache:

The usual recommended dosage is 1 tablet; an additional tablet can be taken, with 4 to 6 hours between doses. In case of more intense pain, it is possible to take 2 tablets. If needed, additional 2 tablets can be taken, with 4 to 6 hours between doses.

Panmigrol Migraine and Headache Relief is intended for episodic use, up to 4 days for headache.

For migraine:

Take 2 tablets when symptoms appear. If needed additional 2 tablets can be taken, with 4 to 6 hours between doses. Panmigrol Migraine and Headache Relief is intended for episodic use, up to 3 days for migraine. For both headache and migraine, intake must be limited to 6 tablets in 24 hours.

The medicinal product must not be used for a longer period or at a higher dosage without first consulting a doctor. 4). Drink a full glass of water with each dose. Children and adolescents (under 18 years of age) Safety and efficacy of Panmigrol Migraine and Headache Relief in children and adolescents have not been evaluated.

4). Elderly Based on general medical considerations, caution should be exercised in the elderly, particularly in elderly patients with low body weight. Hepatic and renal impairment The effect of hepatic or renal disease on the pharmacokinetics of Panmigrol Migraine and Headache Relief has not been evaluated.

Due to the mechanism of action of acetylsalicylic acid and paracetamol, this could enhance the renal or hepatic impairment. g. 4).

Many of the following adverse reactions are clearly dose-dependent and variable from one person to another. Table 4-4 provides a listing of adverse reactions from 16 single-dose clinical studies on the efficacy and safety of Panmigrol Migraine and Headache Relief in the treatment of migraine, headache or dental pain associated with tooth extraction, involving 4809 Panmigrol Migraine and Headache Relief-treated subjects, and from post- marketing spontaneous reports.

The adverse reactions included in the table were those regarded as at least possibly related to the administration of Panmigrol Migraine and Headache Relief and are listed in descending order of frequency within MedDRA System Organ Classification.

For adverse reactions from the spontaneous reporting system, the frequencies cannot be reliably determined and therefore, is not known. Adverse reactions are listed below by system organ class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), including isolated reports and not known (cannot be estimated from the available data).

Table 4-4 Adverse reactions reported from clinical studies and from post- marketing spontaneous reports System Organ Class Frequency Preferred Term Infections and infestations Rare Pharyngitis Blood and lymphatic system disorders Not known Prolonged bleeding time, thrombocytopenia, ecchymosis Immune system disorders Not Known Hypersensitivity*, anaphylactic reaction, Stevens Johnson syndrome, toxic epidermal necroysis Metabolism and nutrition disorders Rare Not known Decreased appetite Sodium and fluid retention, high anion gap metabolic acidosis** Common Nervousness Uncommon Insomnia Psychiatric disorders Rare Anxiety, euphoric mood, tension Not Known Restlessness Common Dizziness Uncommon Tremor, paraesthesia, headache Rare Dysgeusia, disturbance in attention, amnesia, coordination abnormal, hyperaesthesia, sinus headache Nervous system disorders Not Known Migraine, somnolence Eye disorders Rare Eye pain, visual disturbance Uncommon TinnitusEar and labyrinth disorders Not known Temporary hearing loss.

General: • Panmigrol Migraine and Headache Relief should not be taken together with other products containing acetylsalicylic acid or paracetamol. • As with other acute migraine therapies, before treating a suspected migraine in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

• Patients who experience vomiting with > 20% of their migraine attacks or who require bedrest with >50% of their migraine attacks should not use Panmigrol Migraine and Headache Relief. • If the patient gets no migraine relief from the first 2-tablet dose of Panmigrol Migraine and Headache Relief, the patient should seek the advice of a physician.

• Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have chronic headaches (15 days or more per month) with concurrent overuse of headache medications for more than 3 months.

Therefore, this product should not be used on more than 10 days per month for more than 3 months. g. by sickness, diarrhoea, or before or after major surgery). • Panmigrol Migraine and Headache Relief may mask the signs and symptoms of infection due to its pharmacodynamic properties.

5). • Panmigrol Migraine and Headache Relief should be used with caution in patients suffering from gout, impaired renal or hepatic function, dehydration, uncontrolled hypertension, and diabetes mellitus. • Acetylsalicylic acid in low doses reduces uric acid excretion.

Due to this fact, patients who tend to have reduced uric acid excretion may experience gout attacks. • Acetylsalicylic acid is known to cause sodium and water retention which may exacerbate hypertension, congestive heart failure and renal impairment.

1. Patients in whom attacks of asthma, bronchospasm, angioedema, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs such as diclofenac or ibuprofen. • Active gastric or intestinal ulcer, gastrointestinal bleeding or perforation and in patients with a history of peptic ulceration.

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