Preparati

Tinktura života – tinktura za hitne slučajeve kod srčanih i moždanih udara, jak analgetik i antireumatik, analgetik, hiperemik, rubefacient, lokalni anestetik kod neuropatskih bolova.

BILJNI PREPARATI LJUTE PAPRIKE:

TINKTURA – hidroetanolni tečni ekstrakt sušenog ploda, LJUTA PAPRIKA HSS, DER 1:20  i

MATIČNA TINKTURA – hidroetanolni tečni ekstrakt sušenog ploda, LJUTA PAPRIKA TM, DER 1:10.  

Tinctura Capsici DER 1:20 (USP29)

Capsici extractum ethanolicum liquidum DER 1:10 (Fr. Ph. 2008)

 

ATC:

M02AB01, N01BX04.

– analgetik, – hiperemik, – rubefacient, – lokalni anestetik kod neuropatskih bolova.

 

MeSH klasifikacija:

agens senzornog sistema, antipruritik.

 

U skladu sa:

Eu. Ph. 08  od 01.07.2015. monografijom: 1859 ( 2336, 2337, 2529)

EMA/HMPC/674139/2013, Committee on Herbal Medicinal Products (HMPC) od 5. maja 2015.: European Union herbal monograph on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus

EMA/HMPC/674138/2013, Committee on Herbal Medicinal Products (HMPC) od 5 maja 2015.:
Assessment report on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus

Fr. Ph. 2008 ANSM: Capsicum annuum ad praeparationes homoeopathicas (Cayenne pour préparations homéopathiques)

Tinctura Capsici (U. S. P.): Tincture of Capsicum

 

a) Capsicum annuum, fructus (Cayenne pepper dried, ripe fruit) method 1.1.10 (2371), method 4a.

Biljni preparati u tečnom obliku (nerazblaženi ili razblaženi) za oralnu i lokalnu upotrebu.

 

Sastav:

a) tečni ekstrakt (DER 1:10), ekstrakcioni rastvarač etanol 90% v/v (Fr. Ph.),

b) tečni ekstrakt (DER 1:20), ekstrakcioni rastvarač etanol 95% v/v (U.S.P. – King’s American Dispensatory, 1898).

 

Capsicum annuum L., sadrži 386 *(416) istraženih hemijskih jedinjenja koja ispoljavaju 717 *(784) dejstava *(podaci ažurirani novembra 2016.).

 

Sadržaj:

a) minimalno 0,005% m/V, ukupnih kapsaicinoida (capsaicinoids), izraženih kao kapsaicin (capsaicin) (MF: C₁₈H₂₇NO₃, MW: 305,411880 g/mol⁻¹),

b) u većoj koncentraciji sadrži ACTH (najviše posle Elettaria cardamomum), alanin, α-karoten (najviše posle Daucus carota), α-tokoferol, brom, karotenoide, vit. B6,

c) više od svih biljaka sadrži kapsaicin, kapsantin, kapsiamid, kapsianozide, kapsikozide, kapsidiol, kapsantine, anteraksantin, β-kriptoksantin, dihidrokapsaicin, homokapsaicin, karpoksantin, lutein.

 

Indikacije:

Biljni preparati su namenjeni poboljšanju opšteg stanja organizma kroz razna naučno dokazana dejstva.

Upotreba kod lokomotornih, kardiovaskularnih, urogenitalnih, gastrointestinalnih, respiratornih i kožnih  tegoba.

 

Dr. Džems Djuk (Dr. James Duke) u Handbook of Medicinal Herbs, 2nd Ed. (2002). CRC Press, navodi sledeće:

 

– ima jako dejstvo kod:

grčeva, napetosti i bolova u mišićima, miozitisa, pruritisa, reumatizma, mijalgija, bolova, …

 

– delotvoran kod:

regulacije telesne težine, alkoholizma, anoreksije, artroza (bolovi), astme, ateroskleroze, bolova u leđima, bakterijskih i virusnih infekcija, bronhitisa,  bursitisa,  Ca.,  kardiopatije, poremećaja cirkulacije, klaster  glavobolja,  dijabetesa, dijabetične neuropatije, dispepsije, nazeba, kolika, kongestije, groznice, gastritisa, polenske groznice, glavobolje, herpesa, visokog holesterola i triglicerida, neuralgija, neuropatija, osteoartroza, hiperglikemije, inflamacija, lumbaga, faringitisa, psorijaze, herpes zostera, faringitisa i laringitisa, teniskog lakta, moždanog i srčanog udara, sisanja palca, zubobolje, išijalgije, promrzlina, uganuća, varikoza i ulcera, rana, malih boginja, katarakte, kod porođajnih bolova, bolesti putovanja, nadimanja, dijareje, grčeva, slabe cirkulacije, prekomernog zgrušavanja krvi, disfunkcije gutanja, hiperlipidemije, prevencije srčanih obolenja.

 

– u narodnoj medicini kod:

malarije, anoreksije, krvarenja, opekotina, Ca. (grudi, nosa, kože), drhtavice, kolere, kašlja, dijareje, hidropsije, dispneje, edema, enteroza, epitelioma, gripa, promrzlina, gasova, vrtoglavice, gihta, hemoroida, hepatitisa, promuklosti, impotencije, induracije, infekcija, anorgazmije, laringitisa, mastitisa, otitisa, kuge, respiratornih tegoba, rinitisa, morske bolesti, bolova u stomaku, infekcija urinarnog trakta (UTI), groznice, tireoiditisa, edema, tifusa, gonoreje, kod zastoja tečnosti, …

 

– spoljašnja primena (topikalno) kod:

bolova izazvanih Herpesom, osteoartritisa, reumatoidnog artritisa, post-herpetičnih neuralgija, trigeminalnih neuralgija, dijabetične neuropatije, bola u leđima, post-operativnih neuralgija, zatim kod prurigo nodularis, HIV-povezanih neuropatija,  fibromijalgije, ublažavanja spazama u mišićima, ispiranje grla kod laringitisa i kao sredstvo za odvraćanja od sisanja palca i grickanja noktiju, ujeda insekata, … Intranazalno (razblaženo 1: 1000 – 4 kapi tinkture u 100 mL fiziološkog rastvora) se koristi kod alergijskog rinitisa, perenialnog rinitisa, migrenskih glavobolja, klaster glavobolja, sinonazalnih polipoza i sinuzitisa.

 

– upotrebljava se kao: 

jak analgetik, hiperemik, rubefacient, counterirritant, zatim anestetik, antagonist Ca, antiagregant, antibakterik, antiishemik, antiinflamatik, antinitrosaminik, antioksidant, antipsoriatik, antipiretik, antikancerogenik,  antiseptik, antispasmodik, antivirotik, aperitiv, adstringent, bradikardik,  bronhokonstriktor i  bronhodilator, iritant, karminativ, katabolik, holeretik, cirkulostimulant, dekongestant, dijaforetik, digestiv, gastrogog, hemolitik, kortikosteronigenik, sialagog, protektor od zračenja, stimulant, sinergist, termogenik, tonik, ulcerogenik, uterokontraktant, vulnerar u tradicionalnoj medicini kao antidot, diuretik, fibrinolitik, hemostat, lipolitik, stomahik, vazokonstriktor, …

Monografija nemačke E komisije (Commission E Monographs), terapijski vodič za biljne lekove, preporučuje Capsicum annuum za bolove u mišićima, ruku nogu i leđa.

 

Doziranje i način primene:

1 mL (40 kapi) podeljeno u 4 i više doza.

Biljni preparat LJUTA PAPRIKA HSS i TM:

pojedinačna doza: 0,1- 0,25 mL,

preporučena dnevna doza (PDD): 1 mL.

Oralna (sat vremena pre obroka) i lokalna primena.

Upotreba na koži: aplicirati na obolelo mesto u tankom sloju ili obliku impregniranog zavoja (flastera) ne duže od dva dana, zatim napraviti pauzu najmanje pet dana.

Napraviti pauzu posle 1 nedelje neprekidne upotrebe (oralna upotreba).

Izbegavati kontakt sa sluzokožama i očima.

 

Kontraindikacije:

– preosetljivost na aktivne supstance, preosetljivost na biljke porodice (genus Capsicum, family Solanaceae).

– aktivni duodenalni ulcer, akutna dijareja, akutna holelitijaza, GE refluks (GERD – gastroesophageal reflux disease).

 

Čuvanje:

na tamnom, suvom i hladnom mestu do 20˚C, van domašaja dece i izlaganja EM zračenju,  u dobro zatvorenoj originalnoj ambalaži.

 

Rok upotrebe:

5 godina, posle prvog otvaranja 6 meseci. 

 

Pakovanje:

50 mL i 100 mL, farmaceutske braon bočice standarno, 250 mL, 500 mL, 1L i 5 L na zahtev.

 

Nutritivne informacije:

LJUTA PAPRIKA HSS i TM:

energetska vrednost u 100 mL: 2218 kJ/ 530 kcal,

u preporučenoj dnevnoj dozi (PDD) 1  mL: 22 kJ/ 5,3 kcal,

suve materije (DR) više od 0,7% (Fr. Ph.).

 

Bez konzervanasa, proteina, masti i ugljenih hidrata.

LJUTA PAPRIKA HSS i TM su rukom rađeni proizvodi. 

Analizu na teške metale, pesticide i mikrobiološku ispravnost preparata broj 4603120601 od 29.03.2016. godine izvršila ANAHEM LABORATORIJA BEOGRAD, u sklopu preparata RESPIRO 30.

CENOVNIK

TINKTURA – hidroetanolni tečni ekstrakt sušenog ploda, LJUTA PAPRIKA HSS, DER 1:20, 

RSD 500,00/ 50 mL, 1000,00/ 100 mL (US Ph.) i

MATIČNA TINKTURA – hidroetanolni tečni ekstrakt sušenog ploda, LJUTA PAPRIKA TM, DER 1:10, 

RSD 600,00/ 50 mL, 1200,00/ 100 mL (Fr. Ph.).

Podaci ažurirani novembra 2016. Poželjno pogledati sve informacije na:

http://www.biljni-preparati.com/preparati/ljuta-paprika-kajen-capsicum-annuum-l-cayenne/

Capsicum annuum (Solanaceae) Common names: Cherry Pepper; Sweet Pepper; Bell Pepper; Cone Pepper; Paprika;

 

X X X X X X

 

Axsain Last Updated on eMC 11-Apr-2014  Cephalon (UK) Limited

 

Patient Information

1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars

• 4.1 Therapeutic indications
• 4.2 Posology and method of administration
• 4.3 Contraindications
• 4.4 Special warnings and precautions for use
• 4.5 Interaction with other medicinal products and other forms of interaction
• 4.6 Fertility, pregnancy and lactation
• 4.7 Effects on ability to drive and use machines
• 4.8 Undesirable effects
• 4.9 Overdose

5. Pharmacological properties

• 5.1 Pharmacodynamic properties
• 5.2 Pharmacokinetic properties
• 5.3 Preclinical safety data

6. Pharmaceutical particulars

• 6.1 List of excipients
• 6.2 Incompatibilities
• 6.3 Shelf life
• 6.4 Special precautions for storage
• 6.5 Nature and contents of container
• 6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text

 

1. Name of the medicinal product

Axsain 0.075% w/w Cream

2. Qualitative and quantitative composition

Capsaicin 0.075% w/w

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Cream for topical application.

4. Clinical particulars

4.1 Therapeutic indications

1. For the symptomatic relief of neuralgia associated with and following Herpes Zoster infections (post-herpetic neuralgia) after open skin lesions have healed.
2. For the symptomatic management of painful diabetic peripheral polyneuropathy.

4.2 Posology and method of administration

Adults and the elderly:

For topical administration to unbroken skin. Apply only a small amount of cream (pea size) to the affected area 3 or 4 times daily. These applications should be evenly spaced throughout the waking hours and not more often than every 4 hours. The cream should be gently rubbed in, there should be no residue left on the surface. Hands should be washed immediately after application of Axsain with the fingers. Do not apply near the eyes.

Patients using Axsain for the treatment of painful diabetic peripheral polyneuropathy should only do so under the direct supervision of a hospital consultant who has access to specialist resources. The recommended duration of use in the first instance is 8 weeks, since there is no clinical trial evidence of efficacy for treatment of more than 8 weeks duration. After this time, it is recommended that the patient’s condition should be fully clinically assessed prior to continuation of treatment, and regularly re-evaluated thereafter, by the supervising consultant.

Not suitable for use in children.

4.3 Contraindications

Axsain cream is contra-indicated for use on broken or irritated skin.

Axsain Cream is contra-indicated in patients with known hypersensitivity to capsaicin or any of the excipients used in this product.

4.4 Special warnings and precautions for use

Not for use under tight bandages.

Keep away from the eyes.

Skin irritation has been reported following application of Axsain. The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.

Contact with eyes and mucous membranes should be avoided.

Patients should avoid taking a hot bath or shower just before or after applying Axsain, as it can enhance the burning sensation.

Patients and carers should avoid inhalation of vapours from the cream, as transient irritation of the mucous membranes of the eyes and respiratory tract (including exacerbation of asthma) has been reported.

If the condition worsens, seek medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

The safety of Axsain during pregnancy or lactation has not been established in either humans or animals. However, in the small amounts absorbed transdermally from Axsain Cream, it is considered unlikely that capsaicin will cause any adverse effects in humans.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Axsain may cause skin irritation or transient burning on application. This burning is observed more frequently when application schedules of less than 3-4 times daily are utilised. The burning can be enhanced if too much cream is used and if it is applied just before or after a bath or shower.

Irritation of the mucous membranes of the eyes and respiratory tract (such as nasal and throat irritation) on application of Axsain cream has been reported rarely, resulting in symptoms such as coughing, sneezing and runny eyes. These events are usually mild and self-limiting. There have been a few reports of dyspnoea, wheezing and exacerbation of asthma.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Not applicable.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents, ATC code: M02A B01.

Although the precise mechanism of action of capsaicin is not fully understood, current evidence suggests that capsaicin renders skin insensitive to pain by depleting and preventing re-accumulation of substance P in peripheral sensory neurons. Substance P is thought to be the principal chemo-mediator of pain impulses from the periphery to the Central Nervous System.

5.2 Pharmacokinetic properties

Absorption after topical application is unknown. Average consumption of dietary spice from capsicum fruit has been estimated as 2.5g/person/day in India and 5.0g/person/day in Thailand. Capsaicin content in capsicum fruit is approximately 1% therefore daily dietary intake of capsaicin may range from 0.5 – 1mg/kg/day for a 50kg person. Application of two tubes of Axsain Cream 0.075% (90g) each week results in a 9.6mg/day topical exposure. Assuming 100% absorption in a 50kg person, daily exposure would be 0.192mg/kg which is approximately one third to one quarter of the above mentioned dietary intake.

5.3 Preclinical safety data

The available animal toxicity data relating to capsicum, capsicum extracts and capsaicin do not suggest that, in usual doses, they pose any significant toxicity hazard to man. Thus, in both single and repeat dosing studies which have been reported, capsicum extracts and capsicum are generally well tolerated at many times even the highest estimated human intakes. The safety of Axsain for use in human pregnancy has not been established since no formal reproduction studies have been performed on either animals or man. However, there is no reason to suspect from human or animal studies currently available that any adverse effects in humans are likely.

Studies reported in the published literature, which relate to potential genotoxic and carcinogenic action of capsaicin have produced inconclusive and conflicting data. However, it is unlikely that capsaicin, in the quantities absorbed transdermally from Axsain Cream, will pose any significant hazard to humans.

6. Pharmaceutical particulars

6.1 List of excipients

Purified water

Sorbitol solution

Isopropyl myristate

Cetyl alcohol

White Soft Paraffin

Glyceryl stearate and PEG-100 stearate (Arlacel 165)

Benzyl alcohol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Aluminium tubes with epoxyphenolic lining and polypropylene spiked cap containing 45g Axsain Cream.

6.6 Special precautions for disposal and other handling

No special requirements for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements..

7. Marketing authorisation holder

Cephalon UK Limited

Ridings Point

Whistler Drive

Castleford

West Yorkshire

WF10 5HX

United Kingdom

8. Marketing authorisation number(s)

PL 16260/0016

9. Date of first authorisation/renewal of the authorisation

22 March 2010

10. Date of revision of the text

27/03/2014

 

X  X X  X  X

Capsicum annuum (Solanaceae)

Common names Bell Pepper; Cone Pepper; Cherry Pepper; Sweet Pepper; Green Pepper; Paprika

aktivnosti: 784 hemikalije/aktivnosti: 174 sve hemikalije: 416

jako dejstvo kao: 

Cancer-preventiv, antioksidant, antibakterik, flavor, antiinflamatik, antiseptik, antispazmodik, fungicid, Insektifug, hipoholesterolemik, antimutagenik, antitumor, perfumery, Irritant, analgesic, antiulcer, alergenik, vazodilator, antivirotik, hepatoprotektor, hipotenziv, sedativ, antiartritik, aldose-reductase-inhibitor, antidijabetik, diuretik

zatim kao: 

colorant, kardioprotektor, antifeedant, antirheumatic, antiaggregant, hypoglycemic, antihistaminic, calcium-antagonist, antiacne, antiedemic, antikatarakt, Immunomodulator, antiproliferant, antiasthmatic, antiaterosklerotik, antihypertensive, antiradikular, herbicide antiparkinsonian antidepressant, immunostimulant, antiosteoporotic, candidicide, antidementia, Lipoxygenase-Inhibitor, anticonvulsant, CNS-depresant, cytotoksik, antiherpetic, choleretic, anticancer, allelochemic, apoptotic, antinociceptive, nematicide, antihepatotoxic, antifatigue, essential, chemopreventive, antileukemic, Insecticide, ACE-Inhibitor, antiallergic, anksiolitik, anestetik, antiprostaglandin, antinitrosaminic, antitumor (breast), antiprostatitic, antisyndrome-X, antiencephalopathic, antistaphylococcic, antimaculitic, antistaphylococcic, antimaculitic, laxative, expectorant, myorelaxant, propecic, antiobesity, antitumor (lung) antiflu, antiHIV, 5-Alpha-Reductase-Inhibitor, antiepileptic, anticoronary, antimigraine, antidermatitic, antiPMS, antilithic, ubiquiot, antiarrhythmic, antiacetylcholinesterase, antitumor (prostate), antitumor (colon), antipyretic, carcinogenic, antimelanomic, antidecubitic, antilymphomic, antiperoxidant antitumor, (stomach), antimenopausal, antineuropathic, antiandrogenic, antileukotriene, antimetastatic, acaricide, prooxidant, antiLyme,transdermal antianginal, antieczemic, transdermal, antieczemic,motor-depressant, ornithine-decarboxylase-inhibitor, antiaging, antiosteoarthritic antianemic, antineuralgic, estrogenic, antiinsomniac, neurotoxic, antihangover, anticariogenic, antiangiogenic, dermatitigenic, antistroke, antisickling, antitumor-promoter, anticancer (liver), anticancer (breast), emetic, anticervicaldysplasic, antiarteriosclerotic, antiplaque, antistress, antiperiodontitic, larvicide, antigastritic, anticlimacteric, cardiotonic, antiMS, uricosuric, nephrotoxic, trichomonicide, antisunburn, antialcoholic, antiischemic, cardiodepressant, antimenorrhagic, prostaglandin-synthesis-Inhibitor, antiestrogenic, antimanic, antidandruff, antihyperthyroid, rodenticide, anticancer (Skin), antitumor (skin), xanthine-oxidase-Inhibitor, antiglaucomic, quinone-reductase-inducer, antidyskinetic, COX-2-inhibitor, antidote (lead), sweetener, antifibrotic, Insulinogenic, encephalopathic, anticheilitic, tyrosinase-Inhibitor, phytoalexin, …

Reference:

Lydon, J. & Duke, S., The potential of pesticides from plants, pp. 1-41 in Craker, L. & Simon, J., eds, Herbs, Spices & Medicinal Plants: Recent Advances in Botany, Horticulture, & Pharmacology, v. 4, Oryx Press, Phoenix, 1989, 267pp.

Ichikawa, K., et al. 1991. Isolation and Structure Determination of Aldose Reductase Inhibitors from Traditional Thai Medicine, and Syntheses of Their Derivatives. Sankyo Kenkyusho Nempo, 43: 99-110.

Challem, J., Berkson, Burt, and Smith, Melissa Dianne. 2000. Syndrome X – The complete nutritional program to prevent and reservse insulin resistance. John Wiley & Sons, New York. 272 pp. $24.95

Zheng, G-Q., Kenney, P.M., and Lam, L.K.T. Sesquiterpenes From Clove (Eugenia caryophyllata) As Potential Anticarcinogenic Agents. Journal of Natural Products 55(7): 999-1003, 1992.

Williamson, E. M. and Evans, F. J., Potter’s New Cyclopaedia of Botanical Drugs and Preparations, Revised Ed., Saffron Walden, the C. W. Daniel Co., Ltd., Essex UK, 362 pp, 1988, reprint 1989.

Borchard, R. E., Barnes, C. D., and Eltherton, L. G. 1991. Drug Dosage in Laboratory Animals: A Handbook. (3rd Ed.) The Telford Press, Inc., P. O. Box 287, Caldwell NJ 07006.

Abid Ali Khan, M.M., Jain, D.C., Bhakuni, R.S., Zaim, M., and Thakur, R.S. 1991. Occurrence of some antiviral sterols in Artemisia annua. Plant Science, 75: 161-165, 1991.

Jeffery B. Harborne and H. Baxter, eds. 1983. Phytochemical Dictionary. A Handbook of Bioactive Compounds from Plants. Taylor & Frost, London. 791 pp.

Iwu, M.M. 1993. Handbook of African Medicinal Plants. CRC Press, Boca Raton, FL 435 pp.

1986. Stored. Prod. Res., 22:141, 1986.

Keeler, R.F. and Tu, A.T. eds. 1991. Toxicology of Plant and Fungal Compounds. (Handbook of Natural Toxins Vol. 6) Marcel Dekker, Inc. NY. 665 pp.

Pizzorno, J.E. and Murray, M.T. 1985. A Textbook of Natural Medicine. John Bastyr College Publications, Seattle, Washington.

Oszmianski, J. and Lee, C.Y. 1990. Inhibitory Effect of Phenolics on Carotene Bleaching in Vegetables. J. Agric. Food Chem. 38: 688-690.

Duke, J. A. Writeups or information summaries on approximately 2,000 economic plants, USDA, ARS, Beltsville, MD 20705.

Spiller, G. A. 1996 (Spiller, G. A. Ed. 1996. CRC Handbook of Lipids in Human Nutrition. CRC Press. Boca Raton, FL. 233 pp.)

Aloe Research Council – Duke writeup of non-peer reviewd book by Coats and draft by Henry

Huang, K. C. 1993. The Pharmacology of Chinese Herbs. CRC Press, Boca Raton, FL 388 pp.

Stitt, P. A. Why George Should Eat Broccoli. Dougherty Co, Milwaukee, WI, 1990, 399 pp.

Davies, S., and Stewart, A. 1990. Nutritional Medicine. Avon Books, New York. 509pp.

Michael Castleman 1991. The Healing Herbs. Rodale Press, Emmaus, PA 436 pp.

Joseph, J., Nadeau, D. and Underwood, A. 2001. The Color Code. Hyperion, NY.

Werbach, M. 1993. Healing with Food. Harper Collins, New York, 443 pp.

Planta Medica, 57: A43, 1991.

Merck 11th Edition

Martindale’s 28th

Martindale’s 29th

jedinjenja po sadržaju

CAPSAICIN,  DIHYDROCAPSAICIN, NORDIHYDROCAPSAICIN,  LINOLEIC-ACID, NITROGEN,  ASCORBIC-ACID,  DEHYDROASCORBIC-ACID,  ASPARTIC-ACID,  GLUTAMIC-ACID, POTASSIUM,  CAROTENOIDS,  PALMITIC-ACID,  LEUCINE,  ARGININE, LYSINE,  PROLINE,  EO,  VALINE,  ALANINE,  SERINE, GLYCINE,  THREONINE,  RUTIN,  ISOLEUCINE,  OLEIC-ACID, PHENYLALANINE,  PHOSPHORUS,  ALPHA-LINOLENIC-ACID,  HOMOCAPSAICIN,

 

jedinjenja po broju dejstava

ASCORBIC-ACID,  Caffeic Acid,  TOCOPHEROL,  RUTIN,  LUTEOLIN, ZINC,  CHLOROGENIC-ACID,  Eugenol,  MAGNESIUM, SELENIUM,  LIMONENE,  LINALOOL,  BETA-CAROTENE,  BETA-SITOSTEROL, CAPSAICIN,  SCOPOLETIN, …

Izvor: dr Duke, James A.

Podaci ažurirani novembra 2016.

CAPSICUM Urtinktur D 1   DHU

X X X X X

Buttercup Original Cough Syrup Last Updated on eMC 30-Jul-2014  Omega Pharma Ltd Contact details

 

Patient Information

1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars

• 4.1 Therapeutic indications
• 4.2 Posology and method of administration
• 4.3 Contraindications
• 4.4 Special warnings and precautions for use
• 4.5 Interaction with other medicinal products and other forms of interaction
• 4.6 Fertility, pregnancy and lactation
• 4.7 Effects on ability to drive and use machines
• 4.8 Undesirable effects
• 4.9 Overdose

5. Pharmacological properties

• 5.1 Pharmacodynamic properties
• 5.2 Pharmacokinetic properties
• 5.3 Preclinical safety data

6. Pharmaceutical particulars

• 6.1 List of excipients
• 6.2 Incompatibilities
• 6.3 Shelf life
• 6.4 Special precautions for storage
• 6.5 Nature and contents of container
• 6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text

 

1. Name of the medicinal product

Buttercup Original Cough Syrup

2. Qualitative and quantitative composition

Each 5ml of syrup contains:

3.1 microlitres of extract (as liquid extract) from Squill bulb (Drimia maritima (L.) Stearn.) (1:1)

Extraction solvent: Ethanol 65% v/v

2.5 microlitres of tincture from Capsicum Oleoresin (Capsicum annuum L. var. minimum (Miller) Heiser) (1:10)

Extraction solvent: Ethanol 96% v/v

5 ml of syrup also contains 91 mg of ethanol, 4.41g of sucrose, fructose and glucose (as Partial Invert Syrup), 3.5mg of sodium methyl hydroxybenzoate (E219), 1.5 mg of sodium propyl hydroxybenzoate (E217) carmoisine E122 and Sunset Yellow E110. (See Section 4.4 ‘Special warnings and precautions for use.’)

For full list of excipients, see section 6.1

3. Pharmaceutical form

Syrup

Reddish-brown oral liquid.

4. Clinical particulars

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of coughs, colds and sore throats, based on traditional use only.

4.2 Posology and method of administration

For oral use only

Adults, the elderly and children over 12 years: Two 5 ml spoonfuls three times a day and at bedtime, if the cough is troublesome.

This product is not recommended for use in children under 12 years of age (See Section 4.4 special warnings and precautions for use.’)

Duration of use:

Do not use for more than one week.

If symptoms worsen or persist after one week, consult a doctor or qualified healthcare practitioner.

4.3 Contraindications

Hypersensitivity to any of the active ingredients, or menthol or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist after one week, consult a doctor or qualified healthcare practitioner.

If dyspnoea, fever or purulent sputum occurs, a doctor or qualified healthcare practitioner should be consulted.

This product is not recommended for use in children under 12 years of age because data are not sufficient and medical advice should be sought.

Contains sucrose, glucose and fructose (as Partial Invert Syrup). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 4.6% v/v ethanol (alcohol), i.e. up to 182 mg per 10ml dose, equivalent to 4.6 ml beer, 1.8 ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.

Contains Sunset yellow (E110 and Carmoisine E122. May cause allergic reactions.

Contains Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217). May cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

No interactions studies have been performed.

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole)

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive or operate machines have been performed.

Contains alcohol. See Section 2.

4.8 Undesirable effects

None reported.

If other adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases reported.

Very high doses of Squill would be emetic and could be cardioactive. Overdose of this product may result in alcohol intoxication and should be treated accordingly. The amount of alcohol in a full bottle is:

1.4 g in 75 ml, equivalent 34.1 ml beer or 14.2 ml wine

2.7 g in 150 ml, equivalent 68.3 ml beer or 28.4 ml wine

3.6 g in 200 ml, equivalent 91 ml beer or 37.9 ml wine

5. 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, carcinogenicity and genotoxicity have not been performed.

6. Pharmaceutical particulars

6.1 List of excipients

Acacia Powder

Caramel Colour (E150)

Ethanol

Levomenthol

Clove Oil

Peppermint Oil

Sodium methyl hydroxybenzoate (E219)

Sodium propyl hydroxybenzoate (E217)

Potassium sorbate

Aniseed Flavour

Purified Water

Carmoisine (E122)

Sunset Yellow (E110)

Strong Ginger Tincture (ginger, ethanol, water)

Acetic Acid

Saccharin Sodium

Partial Invert Syrup (sucrose, fructose and glucose)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years (unopened).

28 days (after first opening the bottle)

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container

6.5 Nature and contents of container

Clear glass bottle with aluminium tamper-evident screw-cap: 75 ml, 150 ml, 200 ml, 300 ml

Amber glass bottle with aluminium tamper-evident screw-cap: 300 ml

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

There are no special precautions for disposal.

7. Marketing authorisation holder

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

THR 02855/0011

9. Date of first authorisation/renewal of the authorisation

29/04/2013

10. Date of revision of the text

24/07/2014

Could capsaicinoids help to support weight management? A systematic review and meta-analysis of energy intake data.
Whiting, Derbyshire, Tiwari.

Abstract
OBJECTIVE:
Capsaicinoids are a group of chemicals naturally occurring in chilli peppers with bioactive properties that may help to support weight management. The aim of the present study was to conduct a meta-analysis investigating the potential effects of capsaicinoids on energy intake, to clarify previous observations and form evidence-based conclusions about possible weight management roles.

METHODS:
Medical databases (Medline, Web of Knowledge and Scopus) were systematically searched for papers. Search terms were: ‘capsaicin(*)’ or ‘red pepper’ or ‘chilli(*)’ or ‘chili(*)’ with ‘satiety’ or ‘energy intake’. Of the seventy-four clinical trials identified, 10 were included, 8 of which provided results suitable to be combined in analysis (191 participants). From the studies, 19 effect sizes were extracted and analysed using MIX meta-analysis software.

RESULTS:
Data analysis showed that capsaicinoid ingestion prior to a meal reduced ad libitum energy intake by 309.9kJ (74.0kcal) p<0.001 during the meal. Results, however, should be viewed with some caution as heterogeneity was high (I(2)=75.7%). Study findings suggest a minimum dose of 2mg of capsaicinoids is needed to contribute to reductions in ad libitum energy intake, which appears to be attributed to an altered preference for carbohydrate-rich foods over foods with a higher fat content.

CONCLUSIONS:
Meta-anlysis findings suggest that daily consumption of capsaicinoids may contribute to weight management through reductions in energy intake. Subsequently, there may be potential for capsaicinoids to be used as long-term, natural weight-loss aids. Further long-term randomised trials are now needed to investigate these effects.

X X X X X

Mechanisms and clinical uses of capsaicin.

Sharma, Vij, Sharma.

Abstract

Capsaicin is the active ingredient of chili peppers and gives them the characteristic pungent flavor. Understanding the actions of capsaicin led to the discovery of its receptor, transient receptor potential vanilloid subfamily member 1 (TRPV1). This receptor is found on key sensory afferents, and so the use of capsaicin to selectively activate pain afferents has been studied in animal and human models for various indications.

Capsaicin is unique among naturally occurring irritant compounds because the initial neuronal excitation evoked by it is followed by a long-lasting refractory period, during which the previously excited neurons are no longer responsive to a broad range of stimuli.

This process known as defunctionalisation has been exploited for therapeutic use of capsaicin in various painful conditions. We reviewed different studies on mechanisms of action of capsaicin and its utility in different clinical conditions. A beneficial role of capsaicin has been reported in obesity, cardiovascular and gastrointestinal conditions, various cancers, neurogenic bladder, and dermatologic conditions. Various theories have been put forth to explain these effects. Interestingly many of these pharmacological actions are TRPV1 independent. This review is aimed at providing an overview of these mechanisms and to also present literature which contradicts the proposed beneficial effects of capsaicin.

German Commission E Monographs (Phytotherapy)

German Commission E Monographs (Phytotherapy)

German Commission D Monographs preparation