RIAMET

e. total of 24 tablets, given over a period of 60 hours as follows: the first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Children and infants weighing 5 kg to less than 35 kg A six-dose regimen is recommended with 1 to 3 tablets per dose, depending on bodyweight: 5 to less than 15 kg bodyweight: the first dose of one tablet, given at the time of initial diagnosis, should be followed by five further doses of one tablet given at 8, 24, 36, 48 and 60 hours thereafter.

15 to less than 25 kg bodyweight: the first dose of two tablets, given at the time of initial diagnosis, should be followed by five further doses of two tablets given at 8, 24, 36, 48 and 60 hours thereafter. 25 to less than 35 kg bodyweight: the first dose of three tablets, given at the time of initial diagnosis, should be followed by five further doses of three tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Infants weighing less than 5 kg The safety and efficacy of Riamet tablets have not been established in infants weighing less than 5 kg and no dosing recommendations can be made. 2. Older people There is no information suggesting that the dosage in patients over 65 years of age should be different than in younger adults.

Method of administration Tablets for oral administration. 2). If patients are unable to tolerate food, Riamet should be administered with water, but the systemic exposure may be reduced. Patients who vomit within 1 hour of taking the medication should repeat the dose.

For administration to small children and infants, the tablet/s may be crushed.

The safety of Riamet has been evaluated in 20 clinical trials with more than 3500 patients. A total of 1810 adults and adolescents above 12 years of age as well as 1788 infants and children of 12 years of age and below have received Riamet in clinical trials.

Adverse reactions reported from clinical studies and post-marketing experience are listed below according to system organ class. Adverse reactions are ranked under headings of frequency using the MedDRA frequency 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) Not known (cannot be estimated from available data).

2 %) Gait disturbance Common -- *: These adverse reactions were reported during post-marketing experience. Because these spontaneously reported events are from a population of uncertain size, it is difficult to estimate their frequency.

#: Has been reported up to a few weeks after treatment has been stopped. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6). Riamet has not been evaluated for the treatment of severe malaria, including cases of cerebral malaria or other severe manifestations such as pulmonary oedema or renal failure. 5) unless there is no other treatment option. If a patient deteriorates whilst taking Riamet, alternative treatment for malaria should be started without delay.

In such cases, monitoring of the ECG is recommended and steps should be taken to correct any electrolyte disturbances. The long elimination half-life of lumefantrine must be taken into account when administering quinine in patients previously treated with Riamet.

5). 5). In patients previously treated with halofantrine, Riamet should not be administered earlier than one month after the last halofantrine dose. Riamet is not indicated and has not been evaluated for prophylaxis of malaria. 5). g. 1).

Caution is recommended when combining Riamet with drugs exhibiting variable patterns of inhibition, moderate induction or competition for CYP3A4 as the therapeutic effects of some drugs could be altered. 2). Caution is recommended when combining Riamet with hormonal contraceptives.

Riamet may reduce the effectiveness of hormonal contraceptives. 5). Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be greater. Renal impairment No specific studies have been carried out in this group of patients.

There is no significant renal excretion of lumefantrine, artemether and dihydroartemisinin in studies conducted in healthy volunteers and clinical experience is limited. No dose adjustment for the use of Riamet in patients with renal impairment is recommended.

Caution is advised when administering Riamet to patients with severe renal impairment. In these patients, ECG and blood potassium monitoring is advised. Hepatic impairment No specific studies have been carried out in this group of patients.

In patients with severe hepatic impairment, a clinically relevant increase of exposure to artemether and lumefantrine and/or their metabolites cannot be ruled out. 2). In these patients, ECG and blood potassium monitoring is advised.

No dose adjustment is recommended for patients with mild to moderate hepatic impairment. New infections Data for a limited number of patients in a malaria endemic area show that new infections can be treated with a second course of Riamet.

In the absence of carcinogenicity study data, and due to lack of clinical experience, more than two courses of Riamet cannot be recommended. e. ”

1. • patients with severe malaria according to WHO definition*. g. metoprolol, imipramine, amitryptyline, clomipramine). • patients with a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.

• patients taking drugs that are known to prolong the QTc interval (proarrythmic). These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride.

- flecainide • patients with a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction. g. hypokalemia or hypomagnesemia.

• patients taking drugs that are strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum). (*Presence of one or more of the following clinical or laboratory features: Clinical manifestation: Prostration; impaired consciousness or unarousable coma; failure to feed; deep breathing, respiratory distress (acidotic breathing); multiple convulsions; circulatory collapse or shock; pulmonary edema (radiological); abnormal bleeding; clinical jaundice; hemoglobinuria Laboratory test: Severe normocytic anemia; hemoglobuniuria; hypoglycemia; metabolic acidosis; renal impairment; hyperlactatemia; hyperparasitemia)