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2. Napiers Herbal Heartburn Relief

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Herbal Heartburn Relief Box's Herbals Indigestion Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: -

25 mg of Ginger rhizome (Zingiber officinale Roscoe)

25 mg of extract (as dry extract) from Milk Thistle fruits (Silybum marianum L. Gaertner) (20:1) Extraction Solvent: Ethanol 90% v/v

40 mg of extract (as dry extract) from Holy Thistle herb (Cnicus benedictus L.) (20:1) Extraction solvent: Water

25 mg of Valerian root (Valeriana officinalis L.)

75 mg of extract (as dry extract) from Dandelion root (Taraxacum officinale Weber ex Wigg.) (2:1) Extraction solvent: Ethanol 70 % v/v

25mg of Myrrh resin (Commiphora myrrha Engl.)

Each tablet contains 70mg of sucrose (see section 4.4. ‘Special warnings and precautions for use’).

For a full list of excipients, see section 6.1

PHARMACEUTICAL FORM

Tablets, pink biconvex

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of heartburn, stomach ache, indigestion, flatulence and dyspepsia, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the Elderly: One or two tablets to be taken after meals three times a day.

The use in children and adolescents under 18 years of age is not recommended. (see section 4.4 ‘Special warnings and precautions for use’).

If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or to plants of the Asteraceae (Compositae) family or to any of the excipients.

Peptic or duodenal ulcer.

Obstruction of the bile duct, cholangitis, liver diseases, gall stones or any other biliary diseases.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.

The use in patients with renal failure and/or diabetes, and/or heart failure should be avoided because of possible risks due to hyperkalemia.

If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.

Ginger may inhibit platelet aggregation and may decrease platelet thromboxane production thus theoretically may increase the risk of bleeding. The product should be discontinued at least 2 weeks prior to elective surgery due to the potential increased risk of bleeding and for potential interactions with medicinal products used during general and regional anaesthesia (see Section 4.5)

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

In vitro, Milk Thistle extract resulted in inhibition of CYP isoenzymes. However the clinical relevance of these findings is not established.

Only limited data on pharmacological interactions of Valerian with other medicinal products are available.Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.

Combination with synthetic sedatives is not recommended. The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

Ginger may increase the risk of bleeding when taken with drugs that affect coagulation and bleeding e.g. aspirin, anticoagulants such as warfarin, phenprocoumon, heparin, antiplatelet drugs such as clopidogrel, and non steroidal anti-inflammatory drugs such as aspirin, ibuprofen and naproxen.

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.

Studies on the effect on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.

In some cases patients have experienced drowsiness while taking ginger. Affected patients should not drive or operate machines.

4.8 Undesirable effects

Epigastric pain and hyperacidity may occur with dandelion root. Allergic reactions may occur. The frequency is not known.

Minor gastrointestinal complaints, particularly stomach upset, eructation, dyspepsia and nausea have been reported with ginger. Frequency: common (>1/100 and <1/10). Drowsiness has been reported.

There is one case report of inhibition of platelet aggregation following chronic consumption of large quantities of ginger marmalade.

Allergic skin reactions have been reported with myrrh. The frequency is not known.

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.

Gastrointestinal reactions (nausea,, upset stomach, diarrhea), headache, allergic reactions (urticaria, skin rash, pruritis, anaphylaxis) have been reported with milk thistle. The frequency is not known.

If other adverse reaction not mentioned above occurs, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 800 tablets of Napiers Herbal Heartburn Tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g of the drug) withdrawal symptoms (delirium) have been reported.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose

Sodium starch glycolate Talc

Magnesium stearate Spearmint oil Kaolin light Sucrose syrup Beetrot powder Gum Arabic Maltodextrin

Incompatibilities

Not applicable.

DATE OF REVISION OF THE TEXT

20/01/2015