NAFTIDROFURYL Capsules Ref.[9627] Active ingredients: Naftidrofuryl

The administration of Naftidrofuryl may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones (the oxalate content is 19mg per 100mg of active ingredient).

Should be used with caution in patients with renal or hepatic disorders as the drug is metabolised in the liver and excreted mainly in the urine.

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

The administration of Naftidrofuryl without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water.

None known.

Pregnancy

In the absence of any relevant clinical data, the use of Naftidrofuryl is not advisable during pregnancy.

Lactation

In the absence of specific data concerning the excretion of the drug in human milk, Naftidrofuryl should not be used by breast-feeding women.

As Naftidrofuryl can cause dizziness patient should make sure they are not affected before driving or operating machinery.

According to information collected during clinical trials and spontaneous reports since marketing authorisation, the following undesirable effects may occur under treatment with Naftidrofuryl.

The following definitions apply to the frequency terminology used hereafter: very common ≥1/10, common ≥1/100, <1/10, uncommon ≥1/1,000, <1/100, rare ≥1/10,000, <1/1,000, very rare <1/10,000, frequency not known: cannot be estimated from the available data.

Gastro-intestinal disorders

Uncommon: Diarrhoea, nausea, vomiting and epigastric pain.

Frequency not known: In some patients who took the medicinal product without liquid before going to bed, the capsule being stuck in the throat led to local oesophagitis.

Renal and urinary disorders

Very rare: Calcium oxalate kidney stones (see section 4.4).

Skin and subcutaneous tissue disorders

Uncommon: Skin rash.

Hepatobiliary disorders

Rare: Liver damage.

Frequency not known: Hepatitis and hepatic failure.

Central Nervous System

Frequency not known: Dizziness, headache, agitation and sleep disorders.

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

None known.