SCHEDULING STATUS: S0

 

Professional Information

 

1. NAME OF THE MEDICINE:

Mega Ulcer

 

2. QUALITATIVE AND QUANTITATIVECOMPOSITION

Each serving size (5 ml) of Mega Ulcer Oral Suspension contains:

Active Ingredients:      5ml serving size

Sucralfate                     1000 mg

 

Inactive Ingredients:

Water, Glycerine, Strawberry Flavour J1183 TSL, Xanthan Gum, Methyl Paraben (0,072 % m/v), Propyl Paraben (0,038 % m/v) and Strawberry colourant.

 

Preservatives:

Methyl Paraben (0,072 % m/v), Propyl Paraben (0,038 % m/v).

 

PHARMACEUTICALFORM

Liquid.

 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

* Effective treatment and relief of gastric ulcer, duodenal ulcer, chronic gastritis and reflux oesophagitis.

* Relief of subjective symptoms of peptic ulceration e.g. epigastric pain, hyperchlorhydria, vomiting.

               

4.2 Posology and method of administration

Take 5 ml (one medicine measure) of Mega Ulcer suspension three to four times a day between meals and at bedtime.

               

Do not exceed daily dose without consulting a relevant healthcare provider.

               

4.3 Contraindications

Hypersensitivity to sucralfate or to any of the excipients or residues from the manufacturing process.

 

See section “4.4 Special warnings and precautions for use”.

               

4.4 Special warnings and precautions for use

Mega Ulcer should be administered with caution in patients with renal impairment or on

dialysis. This is due to the possibility of increased aluminium absorption. In patients with renal failure, absorption of aluminium may cause adverse effects. Aluminium accumulation and toxicity (aluminium osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Blood levels of aluminium, phosphate, calcium, alkaline phosphatase, should be periodically measured in these patients.

 

Caution is advised when Mega Ulcer is administered in patients with phosphate deficiencies as aluminium binds to phosphate in the gastrointestinal tract, inhibiting its absorption.

Occasional cases of bezoar (an insoluble mass formed within the gastric lumen) have been reported in patients using products similar (sucralfate) to Mega Ulcer. Bezoars have been described in patients after administration of sucralfate products in severely ill patients in Intensive Care Units, and especially in premature infants in whom the use of Mega Ulcer is not recommended. Caution should be used in patients with delayed gastric emptying or receiving concomitant enteral feeds.

As the elderly often have reduced physiological function, the dosage should be adjusted with care.

 

See Section 4.8 Undesirable effects.

4.5 Interaction with other medicines and other forms of interaction

If you are taking prescription medication, consult a relevant health care provider prior to use.

               

Sucralfate may interfere with the absorption of other medicines and it has been suggested that there should be an interval of 2 hours between the administration of Mega Ulcer and other concurrent non-antacid medication.

Some of the medicines reported to be affected by Mega Ulcer include medicines containing citrates or aluminium, cimetidine, ranitidine, digoxin, ketoconazole, phenytoin,

fluoroquinoloneantibacterial, tetracycline(antibiotics), sulpiride containing medicines (Eglonyl), evothyroxine, quinidine, theophylline andpossibly warfarin.

 

It is recommended that a 30 minute interval between administration of Mega Ulcer and other antacids be taken.

               

Interactions with food and drink

Cases of bezoar formation has been reported when sucralfate has been administered concomitantly with enteral feeds. An one hour interval should separate Mega Ulcer administration and enteral feeding.

 

See “4.4 Special warnings and precautions”.

See “4.8 Undesirable effects”.

               

4.6 Fertility, pregnancy and lactation

The safety of Mega Ulcer in pregnant and or lactating women has not been established.

               

4.7 Effects on ability to drive and use machines

Mega Ulcer may cause drowsiness or dizziness. Caution should be practiced in patients operating hazardous machinery including driving a motor vehicle until they are reasonably certain that Mega Ulcer does not adversely affect them.

               

4.8 Undesirable effects

The frequencies of adverse reactions are ranked according to the following:

frequent > 1/100 

less frequent< 1/100

               

Immune disorders:

Frequency unknown:

Hypersensitivity.

               

Nervous system disorders:

Less Frequent:

Dizziness, drowsiness.

Frequency unknown:

Vertigo.

                .

Skin and subcutaneous tissue disorders:

Less frequent:

Skin rashes, pruritus.

               

Gastrointestinal disorders:

Frequent:

Constipation Less frequent: Diarrhoea, nausea, dry mouth, gastric discomfort. A few cases of bezoar have been reported in patients with the administration of sucralfate equivalents and enteral feeds by nasogastric tube.

See 4.5 “Interactions”

 

General disorders and administrative site conditions:

Frequency unknown:

Back pain.

               

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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8

               

4.9 Overdose

Risks associated with sucralfate overdosing are minimal as sucralfate has minimal absorption from the gastrointestinal system; many patients that overdosed on sucralfate remained asymptomatic.

               

Treatment is symptomatic and supportive.

               

5. PHARMACOLOGICAL PROPERTIES

Category A: Allopathic Medicine

Classification: 11.4.3 Medicines acting on the gastrointestinal tract: Other

               

5.2 Pharmacodynamic properties

Sucralfate is therapeutically anti-ulcerogenic and capable of inhibiting the proteolytic action of pepsin. Sucralfate forms a protective film over the mucosa in ulcerated or inflamed areas of the stomach and protects the gastric mucosa, and can absorb pepsin, trypsin, and bile acids.

               

5.2 Pharmacokinetic properties

Sucralfate, a complex of aluminium hydroxide with sulfatedsucrose, forms a strong

gastrointestinal tract (GIT) mucosal barrier with excellent anti-ulcer property. Because sucralfate does not undergo any significant oral absorption, sucralfate resides in the GIT for a considerable length of time.

               

5.3 Preclinical safety data

The safety of sucralfate, an aluminum salt of sucrose octasulfate that is used to treat peptic ulcer disease, is based on data from clinical trials in over 2,000 patients. In vitro, animal, and clinical studies have shown that sucralfate does not have anticoagulant effects, in contrast to other sulfated polysaccharides. Sucralfate was well tolerated by healthy volunteers in a

multiple-dose study, in which the drug was administered in doses two and three times higher than the normal treatment dose, for 14 and 28 days, respectively. In open-label trials conducted in Japan, France, and Latin America in 1,600 subjects, side effects were reported in only 44 subjects, with the most common complaint being constipation (in 23 subjects). In the United States, safety evaluations of sucralfate were similar to those obtained in other

countries, with only 12.9% of subjects treated with sucralfate (232) reporting side effects. The incidence of side effects in the placebo-treated group was about 12.1%. Furthermore, sucralfate has been shown to heal ulcers comparable to antacids and cimetidine. Its therapeutic efficacy, combined with the fact that it is well tolerated and free of serious systemic effects, enhances sucralfate’s therapeutic clinical usefulness in the treatment of peptic ulcer disease.

               

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water, Glycerine, Strawberry Flavour J1183 TSL, Xanthan Gum, Methyl Paraben (0,072 % m/v), Propyl Paraben (0,038 % m/v) and Strawberry colourant.

               

Preservatives:

Methyl Paraben (0,072 % m/v), Propyl Paraben (0,038 % m/v).

               

6.2 Incompatibilities

Not applicable.

               

6.3 Shelf life

24 months.

               

6.4 Special precautions for storage

Store in a dry place at or below 25 °C. Protect from light. Keep in original packaging.

               

6.5 Nature and contents of the container

100 ml, white bottle comprised of high-density polyethylene (HDPE) with a white snap-on cap.

               

6.6 Special precautions for disposal

No special requirements.

               

7. BUSINESS ADDRESS:

TALA Health and Wellness

454 Koedoesnek Street
Waterkloof Ridge
012 347 8497

               

8. REGISTRATION NUMBER:

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Not applicable.

               

10. DATE OF REVISION OF TEXT

Not applicable.