Treatment of iron deficiency without anaemia and iron deficiency anaemia. Prophylactic therapy of iron deficiency during pregnancy

Dosage and duration of therapy are dependent upon the extent of iron deficiency.

Treatment of Iron deficiency anaemia:

Children 1-11 years: 5ml 1-2 times daily.

Children above 12 years: 10ml 1-2 times daily.

Prophylactic from Iron deficiency anaemia:

Children 1-11 years: 2.5ml once daily.

Children above 12 years: 5ml once daily

Treatment should be continued for a month after return of blood values to normal, to insure complete compensation of iron stores in the body.

Pianka Syrup may cause gastrointestinal irritation if taken on empty stomach and this can reduced by giving it with or after food or by beginning therapy with a small dose and increasing gradually.

Method of administration: The daily dosage can be divided into separate doses or can be taken all at once. Pianka Syrup should be taken during or immediately after a meal. The supplied measuring Syringe is used for an exact administration of the dosage.

Known hypersensitivity or intolerance to iron(III)-hydroxide polymaltose complex or any of the excipients listed in section 6.1 Iron overload (e.g. haemochromatosis, haemosiderosis). Disturbances in iron utilisation (e.g. anaemia from lead-poisoning, sidero-achrestic anaemia, thalassaemia). Anaemia not caused by iron deficiency (e.g. haemolytic anaemia or megaloblastic anaemia due to vitamin B12 deficiency).

Infections or tumours may cause anaemia. Since iron can be utilised only after correcting the primary disease, a benefit/risk evaluation is advisable.

During treatment with Pianka Syrup, there may be dark discolouration of the faeces (stools); however this is of no clinical relevance.

Interactions of IPC (with and without folic acid) with tetracycline or aluminum hydroxide were investigated in 3 human studies (crossover design, 22 patients per study).

No significant reduction in the absorption of tetracycline was observed. The plasma tetracycline concentration did not fall below the level necessary for efficacy. Iron absorption from IPC was not reduced by aluminum hydroxide or tetracycline. Iron(III) hydroxide polymaltose complex can therefore be administered at the same time as tetracycline or other phenolic compounds, as well as aluminum hydroxide.

Studies in rats with tetracycline, aluminum hydroxide, acetylsalicyclate, sulphasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin have not shown any interactions with IPC.

Similarly, no interactions with food constituents such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soya oil and soya flour were observed in vitro studies with IPC. These results suggest that IPC can be taken during or immediately after food intake.

The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to interrupt iron therapy.

Data obtained in a limited number of pregnant women after the first trimester did not show any adverse effects on pregnancy or foetal or neonatal health. Animal studies have not shown any direct or indirect toxicity affecting pregnancy, embryo development or foetal development. Caution with use during pregnancy is necessary.

Human breast milk naturally contains iron, which is bound to lactoferrin. The amount of iron passing from iron(III)-hydroxide polymaltose complex to the mother's milk is unknown. It is unlikely that the administration of Iron III hydroxide polymaltose complex products in women who are breastfeeding causes undesirable effects to the infant. The doctor is to be consulted before Pianka Syrup products are taken during pregnancy or lactation.

Be careful driving or operating machinery until you know how Pianka Syrup affects you. However, Pianka Syrup has no or negligible influence on your ability to drive a car or operate machinery.

The safety and tolerability of Iron III hydroxide polymaltose complex has been evaluated in numerous clinical trials and published reports. The principal adverse drug reactions that have been reported in these trials occurred in the following three system organ classes: (See Table 2.)

Table 2.Adverse drug reactions (ADRs) detected in clinical trials.
System Organ Class	Very common (≥1/10)	Common (≥1/100,˂1/10)	Uncommon (≥1/1,000,˂1/100)
Gastrointestinal Disorders	Discoloured faeces 1	Diarrhoea, nausea, dyspesia	Vomiting, constipation, abdominal pain, tooth, discolouration2
Skin and Subcutaneous Tissue Disorders			Rash, pruritus
Nervous System Disorders			Headache
1 "Discoloured faeces" were very commonly reported as an adverse event (23% pf patients) and are a well-known ADR of oral iron medications. 2 "Tooth discolouration" was reported as an adverse event in 0.6% of the patients and is a known ADR of oral iron medications Notes: "Exanthema" was combined with "rash" and presented as "rash" in the table.

To reports any side effect (s):

The National Pharmacovigilance and Drug Safety Centre (NPC) • Fax: +966-11-205-7662 • Call NPC at +966-11-2038222, Exts: 2317-2356-2340. • Reporting hotline: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc

 

In cases of overdose, iron overload or intoxication is unlikely with Pianka Syrup due to the low toxicity of iron(III)-hydroxide polymaltose complex (i.e., in mice or rats: lethal dose, 50% (LD₅₀) >2,000 mg Fe/kg body weight) and controlled uptake of iron. No cases of accidental poisoning with fatal outcome have been reported.

Pharmacotherapeutic group: iron preparation
ATC Code: B03AB05.

Mechanism of action: Pianka Syrup is an iron preparation for the treatment of iron deficiency without anaemia and iron deficiency anaemia.

Pharmacodynamics

Iron is an important constituent of haemoglobin, myoglobin, and iron-containing enzymes. In general, iron deficiency can cause chronic fatigue, lack of concentration and reduced mental performance, irritability, anxiety, headache, loss of appetite, susceptibility to infection, conspicious paleness, cracks at the corners of the mouth (rhagades), dry skin and brittle hair and nails.

In iron (III)-hydroxide polymaltose complex, the polynuclear iron (III)-hydroxide core is superficially surrounded by a number of non-covalently bound polymaltose molecules resulting in an overall average molecular weight of approximately 50 kDa. Iron from IPC is taken up in the gut via an active mechanism. In contrast to iron (II) salts, IPC does not have pro-oxidative properties.

The polynuclear core of IPC has a structure similar to that of the physiological iron storage protein, ferritin. IPC is a stable complex and does not release large amounts of iron under physiological conditions. Because of its size, the extent of diffusion of IPC through the membrane of the mucosa is about 40 times less than that of the hexaquo-iron (II) complex.

Not Applicable.

Propylene glycol
Glycerol
Methyl paraben
Propyl paraben
EDTA sodium
Liquid sorbitol 70%
Orange flavor

Not applicable.

2 years

Store below 30°C.

Do not use Pianka Syrup after the bottle has been opened for more than 3 months.

Amber glass bottle typy III with Child resistance cap.

No special requirements