ATOVAQUONE GLENMARK

Posology The importance of taking the full prescribed dose of Atovaquone Glenmark 750 mg/5 ml oral suspension with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.

Dosage in adults Pneumocystis pneumonia:

The recommended oral dose is 750 mg twice a day (1 x 5 ml morning and evening) administered with food each day for 21 days. 2). Dosage in Children Clinical efficacy has not been studied. 4). 2 for pharmacokinetics in adults). If it is necessary to treat such patients with Atovaquone Glenmark 750 mg/5 ml oral suspension, caution is advised and administration should be closely monitored.

4).

Patients participating in clinical trials with atovaquone have often experienced undesirable effects consistent with the course of advanced Human Immunodeficiency Virus (HIV) disease or of concomitant therapy. The following adverse reactions have been observed and reported to have a suspected (at least possible) causal relationship to treatment with atovaquone with the following frequencies: The following convention is used for frequencies: 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 the available data).

Blood and the lymphatic system disorders Common: anaemia, neutropenia Metabolism and nutrition disorders Common: hyponatraemia Psychiatric disorders Common: insomnia Nervous system disorders Common: headache Gastrointestinal disorders Very common: nausea Common: diarrhoea, vomiting Hepatobiliary disorders Common: elevated liver enzymes levels Immune System Disorders Common: hypersensitivity reactions including angioedema, bronchospasm and throat tightness Skin and subcutaneous tissue disorders Very common: rash, pruritus Common: urticaria Not known: erythema multiforme, Stevens-Johnson Syndrome General disorders and administration site conditions Common: fever Investigations Uncommon: elevated amylase levels 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.

Diarrhoea at the start of treatment has been shown to be associated with significantly lower atovaquone plasma levels. These in turn correlated with a higher incidence of therapy failures and a lower survival rate. Therefore, alternative therapies should be considered for such patients and for patients who have difficulty taking Atovaquone Glenmark 750 mg/5 ml oral suspension with food.

5). 5). 5). Concurrent use of metoclopramide is not recommended. 5). 5). The efficacy of Atovaquone Glenmark 750 mg/5 ml oral suspension has not been systematically evaluated i) in patients failing other PCP therapy, including co- trimoxazole, ii) for treatment of severe episodes of PCP [(A-a) DO2 > 45 mmHg (6kPa)], iii) as a prophylactic agent for PCP, or iv) versus intravenous pentamidine for treatment of PCP.

No data are available in non-HIV immuno-compromised patients suffering with PCP. No clinical experience of atovaquone treatment has been gained in elderly patients. Therefore use in the elderly should be closely monitored. Patients with pulmonary disease should be carefully evaluated for causes of disease other than PCP and treated with additional agents as appropriate.

Atovaquone Glenmark 750 mg/5 ml oral suspension is not expected to be effective therapy for other fungal, bacterial, mycobacterial or viral diseases. Benzyl alcohol Atovaquone Glenmark contains benzyl alcohol which may cause allergic reactions.

Benzyl alcohol is associated with the risk of accumulation in newborn babies (up to 4 weeks old) due to metabolic immaturity. Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”).

The minimum amount of benzyl alcohol at which toxicity may occur is not known. Should not be used for more than a week in young children (less than 3 years old) due to increased risk of accumulation. Should be used with caution and only if necessary, especially in pregnant or breast- feeding patients or in patients with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

Sodium This medicine contains less than 1 mmol sodium (23 mg) in each 5 ml, that is to say essentially 'sodium free'.

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