Xen Pharma Anti-Grey

Professional information for XEN PHARMA ANTI-GREY

COMPLEMENTARY MEDICINE: COMBINATION PRODUCT

(WESTERN HERBAL MEDICINE/HEALTH SUPPLEMENT)

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

SCHEDULING STATUS

S0

1. NAME OF THE MEDICINE
XEN PHARMA ANTI-GREY, tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:

3. PHARMACEUTICAL FORM
Tablets.
Light-blue, oval film-coated tablet.

4. CLINICAL PARTICULARS
4.1. Therapeutic indications
XEN PHARMA ANTI-GREY is a supplement which may reduce the effects of aging by maintaining healthy skin, hair and nails, preventing hair loss and maintaining normal hair pigmentation.

4.2. Posology and method of administration
Posology
Adults
Take one tablet after breakfast and one tablet after lunch or as directed by your health care provider.

Maintain an adequate state of hydration. Do not exceed the maximum recommended daily dosage of two tablets a day.

Paediatric population XEN PHARMA ANTI-GREY is not for use by children under the age of 18 years as the safety and efficacy has not been established.

Method of administration
For oral use.
Take with a glass of water.

4.3. Contraindications
Hypersensitivity to any of the active or inactive ingredients of XEN PHARMA ANTI-GREY (see sections 2 and 6.1).

4.4. Special warnings and precautions for use

• XEN PHARMA ANTI-GREY should not be used for longer than 3 months without advice from a relevant health care provider.
• XEN PHARMA ANTI-GREY contains iodine which may cause an allergic reaction in patients sensitive to iodine.
• Patients should be advised to discontinue XEN PHARMA ANTI-GREY at least 2 weeks prior to surgical procedures.

XEN PHARMA ANTI-GREY contains sugar alcohol
Patients with rare hereditary disorders of fructose intolerance should not take this medicine.

4.5. Interaction with other medicines and other forms of interaction
Anticoagulant/antiplatelet medicines
XEN PHARMA ANTI-GREY may enhance the effects of anticoagulant/antiplatelet medicines or herbal supplements. Concomitant use may increase the risk of bruising and bleeding.

Antidiabetic medicines
The concomitant use of XEN PHARMA ANTI-GREY with antidiabetic medicines or herbal supplements with hypoglycaemic effects may have an additive effect. Caution is advised.

Photosensitising medicines
XEN PHARMA ANTI-GREY may potentiate the effects of photosensitising medicines or herbal supplements when taken concomitantly. Caution is advised as this may sensitise the skin to sunlight.

Diuretic medicines
Co-administration of XEN PHARMA ANTI-GREY with diuretic medicines could result in an additive effect. This may increase the loss of potassium and result in hypokalaemia. Caution is advised.

4.6 Fertility, pregnancy and lactation
XEN PHARMA ANTI-GREY should not be used during pregnancy and lactation as the safety and efficacy has not been established.

4.7 Effects on ability to drive and use machines
XEN PHARMA ANTI-GREY can cause headache, drowsiness or dizziness which may affect the ability to drive a vehicle and use machines (see section 4.8). Caution is advised before driving a vehicle or operating machinery until the effects of XEN PHARMA ANTI-GREY are known.

4.8 Undesirable effects
XEN PHARMA ANTI-GREY is generally well tolerated.
Immune system disorders
Frequency unknown: hypersensitivity and/or allergic reactions.

Metabolism and nutrition disorders
Frequency unknown: anorexia.

Nervous system disorders
Frequency unknown: drowsiness, headache, dizziness.

Eye disorders
Frequency unknown: photosensitivity.

Respiratory, thoracic and mediastinal disorders
Frequency unknown: rhinitis.

Gastrointestinal disorders
Frequency unknown: nausea, vomiting, diarrhoea, abdominal pain, constipation, dyspepsia, flatulence, abdominal distension, stool discolouration.

Hepatobiliary disorders
Frequency unknown: hepatotoxicity.

Skin and subcutaneous tissue disorders
Frequency unknown: allergic skin reactions (skin rash).

Reproductive system and breast disorders
Frequency unknown: decreased libido.

General disorders and administration site conditions
Frequency unknown: tiredness.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of XEN PHARMA ANTI-GREY is important. It allows continued monitoring of the benefit/risk balance of XEN PHARMA ANTI-GREY. Health care providers are asked to report any suspected adverse reactions to the South African Health Products Regulatory Authority (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
In the event of overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). In the event of overdose, treatment should be symptomatic and supportive.

5 PHARMACOLOGICAL PROPERTIES
Category and class: D 33.7 Combination product.

The applicable part of saw palmetto is the ripe fruit. The lipid fraction contains volatile oils and fatty oils. The applicable parts of horsetail are the above ground parts. Horsetail constituents include petrosins, caffeic acid, hydroxycinnamic acid derivatives, triterpenoids, sterols, tannins, and saponins.

The applicable parts of stinging nettle are the above ground parts and root. Stinging nettle root contains polysaccharides and fatty acids, including (10E,12Z)-9-Hydroxy-10,12-octadecadienoic acid. Stinging nettle is excreted in the faeces. Chlorella contains chlorophyll, carotenoids, protein, lipids such as omega 3 and 6 fatty acids, carbohydrates, fibre, nucleic acids, vitamins including B12, B6, methylcobalamin, folate, and vitamin K, iron, trace elements such as zinc, copper, and magnesium, and minerals. It also contains sporopollein and numerous antioxidants, such as beta-carotene, ascorbic acid, alpha- tocopherol, zeaxanthin, and others. Chlorella has antioxidant properties.

The applicable parts of barley are the grain and the grass. Barley contains 3 % – 11 % beta-glucans, a soluble fibre. Barley contains varying amounts of total tocopherols, tocotrienols and vitamin E. It also contains hordenine and lunasin.

The applicable part of he shou wu is the rhizome. He shou wu root contains 40 % – 50 % starch and roughly 20 % tannin.

Constituents
of he shou wu include stilbene glucosides; anthraquinone derivatives such as chrysophanol, emodin, and physcion (emodin-3-methyl ether); a small amount of rhein, and questin, among others. These constituents contribute towards antioxidant effects.

The applicable part of black pepper is the fruit, which contains 5 % – 9 % piperine. Other constituents include chavicine, piperamine, piperidine, and other piperamides. Some of the pharmacological or clinical effects of black pepper may be due to the antioxidant effects of black pepper constituents.

L-Tyrosine is a large neutral amino acid (LNAA). Peak plasma levels of L-Tyrosine generally occur within 1,5 – 3 hours after oral intake. Acute intake of L-Tyrosine increases plasma levels of norepinephrine, epinephrine, and dopamine. L-Tyrosine crosses the blood brain barrier and is excreted in the urine.

After absorption, PABA becomes acetylated and conjugated in the liver to glycine. Its major metabolites are paraacetoamidobenzoic acid (PAABA), para-acetamidohippuric acid (PAAHA), and para-aminohippuric acid (PAHA). PABA is excreted primarily in the urine.

Plant sterols are a group of steroid compounds related to cholesterol. The main plant sterols are beta-sitosterol, campesterol, and stigmasterol. Beta-sitosterol is excreted in bile and faeces.

Vitamin B5 is required for intermediary metabolism of carbohydrates, proteins, and lipids. Vitamin B5 is a precursor of coenzyme A (CoA), which is required in the acetylation reactions in gluconeogenesis; in the release of energy from carbohydrates; in the synthesis and degradation of fatty acids; and in the synthesis of sterols, steroid hormones, porphyrins, acetylcholine, and other compounds. Vitamin B5 is excreted in the urine.

Zinc is a biologically essential trace element. It is mostly absorbed in the small intestine. More than 85 % of the total zinc in the body is in skeletal muscle and bone. Zinc is metabolised in the liver and mainly excreted in the faeces. Zinc plays a role in immune function, wound healing, reproduction, growth and development.

Vitamin B6 is absorbed passively in the upper gastrointestinal tract. It is converted to the coenzyme pyridoxal phosphate in the liver. The metabolites of vitamin B6 is excreted in the urine. Vitamin B6 has antioxidant properties.

Copper is an essential trace mineral. Copper is absorbed primarily from the small intestine. Most of the copper in the body is in the skeleton and muscles. Copper is excreted in the urine.

Lecithin is a mixture of phospholipids. Lecithin which increases choline levels is hydrolysed in the gut by phospholipase A. Selenium is an essential trace mineral found in soil, water, and some foods. Selenium functions as a cofactor for the antioxidant enzymes, including glutathione peroxidase, whose main role is to protect organisms from oxidative damage, and some thioredoxin reductases, which are essential for cell growth and survival.

The kidney accumulates the highest level of selenium. Selenium from food and supplements is excreted in the urine Synthetic folic acid is almost 100 % bioavailable. After folic acid is absorbed, it is reduced to tetrahydrofolate and then enters a methylation cycle. Folic acid is excreted mainly in the urine.

Vitamin H is an essential, water-soluble vitamin. After oral administration, vitamin H is completely absorbed and reaches peak concentration after 1 – 2 hours. Following oral absorption, the sodium-dependent multivitamin transporter (SMVT) mediates vitamin H uptake into liver and peripheral tissues. Vitamin H is excreted in the urine.

When taken orally, iodine is absorbed through the stomach and duodenum and converted to iodide. The thyroid gland concentrates about 30 % of the body's iodine. Iodine is excreted mainly in the urine, with small amounts in faeces, sweat, and saliva.

Catalase enzyme prevents cell oxidative damage by degrading hydrogen peroxide to water and oxygen.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet Core
Isomalt
Magnesium stearate
Microcrystalline cellulose
Polyethylene glycol
Silicon dioxide.

Tablet Coating
Aluminum Lake (E133)
Magnesium silicate hydroxide
Polyvinyl alcohol-polyethylene glycol copolymer
Talc
Titanium dioxide (E171).

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
2 years.
Store at or below 25 °C.

6.4 Special precautions for storage
Protect from light and moisture.

6.5 Nature and contents of container
White, 250 mL PET bottle with a white, childproof lid containing a silica sachet, foam insert and seal. Pack size: 60 tablets.

6.6 Special precautions for disposal
No special requirements.

7. HOLDER OF CERTIFICATE OF REGISTRATION
Xen Pharma (Pty) Ltd
Yarmona 12
Tzaneen, 0850
South Africa

8. REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.

9. DATE OF FIRST AUTHORISATION
Will be allocated by SAHPRA upon registration.

10. DATE OF REVISION OF THE TEXT
July 2023