Pectikon 30 mL Suspension

As an adjunct to rest, fluids and appropriate diet in the symptomatic (relating to symptoms) treatment of mild to moderate acute non-infective diarrhoea.

Posology
General information
If the symptoms persist for longer than 48 hours or the condition of the patient deteriorates, the product must be discontinued and a doctor consulted. In the treatment of diarrhoea, it is important that hydration be maintained by administering adequate fluids and electrolytes.

Adults
15 mL to 30 mL three to four times daily.

Children
12 years and over
15 mL to 30 mL three to four times daily.
6 to 12 years
12,5 mL to 25 mL three to four times daily.
3 to 6 years
5 mL to 12,5 mL three to four times daily.

Method of administration
PECTIKON suspension is for oral administration. SHAKE THE BOTTLE BEFORE USE.

• Hypersensitivity to the active substances or any excipients listed in section 6.1.
• Patients with intestinal obstruction and patients with spastic bowel conditions.

Alcohol
The concomitant use of alcohol should be avoided.

Medicine absorption
The adsorbent properties of kaolin, as in PECTIKON may reduce the gastrointestinal absorption of other medicines (see section 4.5).

Gastrointestinal disorders
Pectin, as in PECTIKON should not be given to patients with intestinal obstruction (see section 4,8).

Excipients
Tartrazine
PECTIKON contains tartrazine ( FD & C Yellow No 5 ), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

Sorbitol
This medicine contains 140 mg sorbitol in each 5 mL suspension. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicines for oral use may affect the bioavailability of other medicines for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given PECTIKON.

Alcohol
This medicine contains 22,8 mg of alcohol (ethanol) in each 5 mL of suspension. The amount in 5 mL of this medicine is equivalent to less than 12 mL beer or 5 mL wine. The small amount of alcohol in this medicine is not likely to have an effect on adults and adolescents, and its effect in children are not likely to be noticeable. It may have some effects in younger children, for example drowsiness.

Reduced gastrointestinal absorption
Pectin, as in PECTIKON may lower the transit time through the gut and may affect the absorption of other medicines when administered concomitantly. Pectin, used with a lipid-lowering diet and lovastatin, a lipid regulating medicine, has resulted in a paradoxical increase in low-density lipoprotein (LDL)-cholesterol in patients with hypercholesterolaemia. It was believed the pectin reduced the absorption of lovastatin from the gut. Kaolin, as in PECTIKON, can form insoluble complexes with some medicines in the gastrointestinal tract and reduce their absorption resulting in a reduced serum concentration and potentially a decrease in efficacy (see section 4.4); oral doses should not be taken at the same time as PECTIKON.

Pregnancy
The safety of PECTIKON in pregnancy has not been established.

Breastfeeding
The safety of PECTIKON in lactation has not been established.

The active ingredients in PECTIKON are not absorbed into the body and should have no or negligible influence on the ability to drive and use machines (see sections 4.4 and 4.8).

a. Summary of the safety profile
Constipation may occur. Pectin, as in PECTIKON may temporarily increase flatulence and distension, and intestinal obstruction has been reported after administration (see section 4.4).

b. Tabulated list of adverse reactions
System Organ Class Frequency Adverse reactions
Gastrointestinal disorders Frequency unknown Constipation, flatulence, distension, intestinal obstruction (see section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Alternately you can contact Gulf Drug Company (Pty) Ltd at +27 31 538 8700 or per [email protected].

Symptoms and signs
Gastrointestinal symptoms such as constipation and intestinal obstruction may be evident (see section 4.8).

Treatment
Gastrointestinal symptoms may be treated symptomatically.