PALUDRINE Tablet Ref.[9545] Active ingredients: Proguanil

Renal Impairment

Haematological changes in patients with severe renal impairment have been reported (see section 4.8).

Paludrine should be used with caution in patients with severe renal impairment (See also Section 4.2).

In any locality where drug-resistant malaria is known or suspected, it is essential to take local medical advice on what prophylactic regimen is appropriate. Prophylactic use of Paludrine alone may not be sufficient.

Antacids

Antacids may reduce the absorption of proguanil, so should be taken at least 2-3 hours apart.

Anticoagulants

Proguanil can potentiate the anticoagulant effect of warfarin and related anticoagulants through a possible interference with their metabolic pathways. Caution is advised when initiating or withdrawing malaria prophylaxis with Paludrine in patients on continuous treatment with anticoagulants.

Live oral typhoid vaccination (Ty21a strain)

Proguanil should be stopped 3 days before and should not be started until 3 days after receiving live oral typhoid vaccination (Ty21a strain).

Boosted protease-inhibitors

When given with boosted protease-inhibitors, reduction in proguanil exposure has been observed. This combination should be avoided when possible.

Pregnancy

There are limited data available from the use of proguanil in pregnant women.

Paludrine should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs the risk.

Malaria in pregnant women increases the risk of maternal death, miscarriage, still-birth and low birth weight with the associated risk of neonatal death. Although travel to malarious areas should be avoided during pregnancy, if this is unavoidable effective prophylaxis is therefore strongly advised in pregnant women.

Proguanil is a dihydrofolate reductase inhibitor (see section 5.1) and adequate folate supplements should be given to pregnant women taking proguanil.

Lactation

Although Paludrine is excreted in breast milk, the amount is insufficient to confer any benefit on the infant. Separate chemoprophylaxis for the infant is required.

There is no evidence to suggest that Paludrine causes sedation or is likely to affect concentration.

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

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

* usually subsides as treatment is continued.
** reversible alopecia

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

None known.