ANTIMETIL

the best ginger supplement in the world

Ilias ZOIDAKIS
Pharmacist (University of Lieges),
MBA (University of Strathclyde, Glasgow)
Medical Affairs Director BELGIUM, TILMAN
Say Stop
to Nausea
TRUST
Antimetil
NAUSEA AND VOMITING / ANTIEMETICS

 Vomiting is a protective action against food overload, toxic or indigestible

products
 Vomiting exists in all species except …
NAUSEA AND VOMITING / ANTIEMETICS

 Vomiting is a protective action against food overload, toxic or indigestible products

 Vomiting exists in all species except the rat - mice, rabbit and horse

néophobie
NAUSEA AND VOMITING / ANTIEMETICS

• Digestive discomfort
• Motion sickness
• Post-operative
• Chemotherapy and other medications
• Gastroenteritis
• Pregnancy
• …
GINGER MODE OF ACTION
 GINGER
MODE OF ACTION

Receptors:
Acetylcholine = Muscarinic (=)
Serotonin
Substance P = same receptors
than Neurokinin)

No Action on:
X H1 = histamine
X D2 = Dopamine

No sedation vs. antihistamines

No extrapyramidal symptoms vs. metochlopramide
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING
Digestive discomfort
Motion sickness
Post-operative
Chemotherapy and other medications
Gastroenteritis
Pregnancy
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Digestive discomfort
 Ginger DIGESTIVE DISCOMFORT

Digestion – functional dyspepsia

Hu et al. [2011] World Journal of Gastroenterology

Effect of ginger on gastric motility and symptoms of functional dyspepsia.

11 patients suffering from functional dyspepsia

Double-blind vs. placebo
3 ginger caps: 1200mg vs. Placebo
Then after 1h, meal of 500ml soup
Results
• Gastric emptying was more rapid after ginger than placebo
(half-emptying time 12,3 min vs. 16,1 min (P≤0.05)
• Positive trend for more antral contractions in ginger group (P = 0.06)

Ginger stimulates gastric emptying and antral contractions

in patients with functional dyspepsia.
 Ginger
Digestion – Functional dyspepsia - Gastroparesis

Ginger can be considered for digestive discomfort:

 Overeating
 “Overdrinking”
 Dyspepsia
 Functional dyspepsia
 postprandial heaviness,
 early satiety: fullness and bloating, and an inability to finish meals
 Nausea & vomiting
 Gastroparesis (lazy stomach)
 Stomach's motility works poorly
 Feeling of fullness after eating just a few bites
 Abdominal bloating and pain
Cisaprid – Prepulisid a medicine for
 Nausea & vomiting
functional dyspepsia and gastroparesis
in many countries, has been withdrawn
because of side-effects (arrhythmias)
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Motion sickness
MOTION SICKNESS

Randomized clinical study

• Sea safari
• 1475 participants
• 203 in the ginger group

Dosage:
500 mg of ginger powder 2 hours before departure and
500 mg after 4 hours as needed
Results:
 Ginger is as effective as reference products:
Cinnarizine, Cinnarizine + Domperidone, Cyclizine,
Dimenhydrinate + Caffeine, Meclozine + Caffeine and
Scopoalmine transdermal

Ginger is effective in 8 / 10 patients

Schmid et al. 1994
MOTION SICKNESS

Randomized clinical study

• 28 children 4 to 8 years old suffering from motion sickness
• travel by car, boat and plane
Dosage:
250 or 500 mg of ginger powder 30 minutes before departure and every 4
hours during the trip

Results:
Ginger is more effective (faster and more potent) than Dimenhydrinate
No side effects vs, sedation in 2/3 of children in dimenhydrinate group

Careddu 1999
MOTION SICKNESS
NEW STUDY 2020 Car
Ferry
Subway
Open label clinical study Bus
N = 185 travellers (134 women) suffering from motion sickness Train

Treatment:
15’ before travel: 160 mg ginger extract standardised at 8 mg gingerols
vs. Baseline (before treatment)

2 visits: before and after treatment

4 everyday trips with duration > 15’: 1 control trip, 3 trips with ginger 15’ before

Physician assessment: 10-point scale (1 worst possible evaluation) visit 1 and 2

+ Evaluation of treatment from patients with the Motion Sickness Assessment
Questionnaire (MSAQ) score

Nunes 2020
MOTION SICKNESS
NEW STUDY 2020 Car
Ferry
Subway
RESULTS Bus
Train

Significant decrease in motion sickness scores (MSAQ questionnaire) p <0.0001

Reproducibility of results on 3 trips with treatment - consistent effect of treatment
Significant improvement in physician assessment scores at Visit 2 (p <.0001)

> 50% of travellers want to continue treatment

96% of patients find the treatment well tolerated

Confirmation of the VERY FAST onset of action of ginger, with efficacy when used
only 15 ’ before travel

Nunes 2020
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Gastroenteritis
 VOMITING IN CHILDREN WITH ACUTE GASTROENTERITIS
Randomized double-blind, placebo-controlled trial
• 141 children 1 to 10 years old with acute gastroenteritis
and mild-moderate state of dehydration
1. Ginger 10 mg of ginger (20 drops) at start and every 8
hours until needed (oral solution 1% on ginger)
2. Placebo
All children <3 years expected to suffer
30 min after intake children started oral rehydration
from acute gastroenteritis

Results: 3 to 5 billion cases / year

 Ginger significantly decreases vomiting episodes 75% of children report vomiting

by an absolute of 20% vs. placebo
 Children in Ginger group consumed 3 x more oral
rehydration solution (ORS) vs. placebo
 Ginger decreased by 28% the number of children missing
school
Every year in Europe: 87,000 hospital
visits and 700,000 outpatient visits
= 1.34 million childhood deaths / year
worldwide.

 No child presented adverse events. Nocerino 2020

GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Post-operative nausea & vomiting

19
POST OPERATIVE NAUSEA AND VOMITING

Meta-analysis of 5 clinical trials out of a total of 59:

• 5 randomised, double-blind, vs. placebo, 363 patients:
Laparoscopic gynaecological surgery
• 1 g powdered ginger 1 h before anaesthesia.

Results
 the effect on vomiting is quite significant::
the risk ratio (95%) = 0.62 (0.46-0.84)
 the effect on vomiting and nausea is also quite significant:
the risk ratio (95%) = 0.65 (0.51-0.84)

Use of ginger is an effective means for reducing postoperative

nausea and vomiting
Safety is also optimal with a single case of side effects mentioned
(digestive discomfort).
Chaiyakunapruk 2006, Am J Obstet
Gynecol.
20
POST OPERATIVE NAUSEA AND VOMITING
GINGER VS. METOCLOPRAMIDE IV
Double blind placebo controlled trial
60 women undergoing gynaecological surgery
• 1 g powdered ginger + placebo injection 1,5 h before surgery.
• placebo capsules + 10mg metoclopramide iv injection
• placebo capsules + placebo injection

Results
 significantly fewer episodes of nausea at the
assessment 4 hours postoperatively in Ginger group
and metoclopramide iv group compared to placebo

Ginger had the same effect as iv metoclopramide

“Ginger has the major advantage over other substances

in that it does not have any recorded side effects”
Bone et all. 1990

21
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Chemotherapy and other medications

Induced nausea and vomiting

22
 CHEMOTHERAPY INDUCED
NAUSEA AND VOMITING

5-HT3 antagonist (sertrans)

cortisone

Ryan et al. 2012 Support Care Cance

23
 CHEMOTHERAPY INDUCED
NAUSEA AND VOMITING
Randomized double blind, placebo-controlled clinical trial
576 cancer patients, randomised in 4 groups
1) placebo
2) 500 mg powdered ginger/day
3) 1 g powdered ginger/day
4) 1.5 g powdered ginger/day
Treatment duration of 6 days (3 days prior to chemotherapy and 3 days after):
All patients in the 4 groups received antiemetic treatment with 5-HT3 antagonist at each day of chemotherapy
(corresponding to 1 cycle).
Study assessed over 3 cycles.

Results:
• all ginger doses showed a significant decrease in nausea vs. placebo (p<0,003)
• the largest reduction in nausea (40%) at a dose of 1 g of ginger
• Ginger best when administered before chemotherapy
Ryan et al. 2012 Support Care Cance

24
GINGER FOR PREVENTION OF
ANTIRETROVIRAL-INDUCED NAUSEA AND
VOMITING: A RANDOMIZED CLINICAL TRIAL
102 HIV positive patients, 2 groups of 51 individuals that randomly
• 500 mg ginger or placebo 2x/day, 30 min before each dose of antiretroviral regimen for
14 days.
The severity of nausea was assessed based on the VAS (visual analogue scale) and the number of vomiting episodes
was recorded during the study period.

A total of 46 (90.2%) and 29 (56.4%) of the patients in placebo and ginger groups experienced some
degree of nausea during the first 2 weeks of antiretroviral therapy (ART), respectively (p = 0.001).
• Frequency of mild, moderate and severe nausea were significantly lower in the ginger group vs.
placebo (p = 0. 001).
• Also, 24 (47.1%) and 5 (9.8%) of the patients in the placebo and ginger groups reported at least one
episode of vomiting during their time on ART, respectively (p = 0.01).
• Ginger was effective in reducing antiretroviral-induced nausea and vomiting. The
difference between ginger and placebo was far more significant than in any other condition that causes
NV. Patients tolerated ginger well, and no considerable adverse effects were detected.

Dabaghzadeh et al. [2014]

 EMRANI ET AL. 2016

Importance: During treatment with anti-tuberculosis (Anti-TB) drugs up to 83.5% of patients experience
Adverse Drug Reactions (ADRs). More common: Gastrointestinal (nausea, vomiting, abdominal pain, and
dyspepsia) and hepatotoxicity
Objective: potential benefits of ginger in preventing Anti-TB drug-induced gastrointestinal adverse reactions
Methodology: 60 newly diagnosed TB patients, Ginger 500mg vs. placebo
2 caps of 250mg ginger root (1.13mg 6-gingerol + 6-shogaol) vs. placebo, 30’ before Anti-TB treatment
Duration: 4 weeks
Results:
Nausea (80%), abdominal pain (41.7%), and vomiting (40%) the most common GI complaints
Frequency of mild, moderate, and severe episodes of nausea was significantly lower in ginger group vs.
placebo (p = 0.001)
Lower number of patients with vomiting episodes in ginger group (27%) vs. placebo (53%) p=0.06
Patients in the ginger group experienced less hepatotoxicity, but not statistically significant
no patients ceased ginger treatment because of its adverse reactions.
Trial supports the role of ginger in the prevention of anti-TB-induced gastrointestinal ADRs including nausea and
vomiting. The results weakly support the role of ginger in the prevention of anti-TB induced hepatotoxicity
 USING GINGER TO TREAT
ANTIDEPRESSANT-INDUCED NAUSEA
Daniel B. Block, MD, Current Psychiatry. 2003 February;2(2):78-78
Web article

• Achieving maximum efficacy with minimal side effects is never easy, but nausea and
other associated GI effects can make use of the newer antidepressants difficult.
Drug-induced nausea can compound the GI discomfort already felt in anxiety disorder.
Patients often stop taking the medication.
• Metoclopramide and prochlorperazine are used to treat nausea, but both carry a risk for
extrapyramidal symptoms and—if used for extended periods—tardive dyskinesia or
dystonia.
Over the past decade, I’ve found that use of ginger as an antiemetic has helped
improve compliance — and outcomes — among my patients.
Ginger is relatively devoid of side effects or drug interactions and can help ease
antidepressant-related GI discomfort.

I typically have patients start by using the ginger as needed during antidepressant
therapy. If nausea is persistent or pervasive—as it tends to be in the first few weeks
of treatment—I will prescribe the ginger at 1,000 mg 2-3 x / day
2 tablets Antimetil 2-3x/day
 USING GINGER TO TREAT
MEDICATIONS INDUCED NAUSEA AND VOMITING
Medications that could cause nausea and vomiting:

• Duloxetine (Cymbalta®): antidepressant, neuropathic pain

• Venlafaxine (Effexor®): antidepressant
• Bupropion (Wellbutrin®): antidepressant, stop smoking
• Varenicline (Champix®): treatment of nicotine addiction (mild nausea in 30% of patients)
• Valproic acid (Depakine ®): epilepsy, bipolar disorder, migraine headaches
• Methylphenidate (Rilatin®) : stimulant medication used to treat attention deficit hyperactivity disorder (ADHD)
• Oxycodone (OxyContin®, Tramadol®): opioid analgesic
• Carbamazepine (Tegretol®): anticonvulsant for epilepsy, neuropathic pain. schizophrenia and bipolar disorder.
• Baclofen (Lioresal®): antispasmodic agent, for spasm pain and stiffness caused by multiple sclerosis and spinal cord injuries
• Calcitonin (Miacalcic®): hormone that lowers calcium in plasma, calcium regulation for Hypercalcemia, Osteoporosis
USING GINGER TO TREAT
MEDICATIONS INDUCED NAUSEA AND VOMITING
• Antidepressants: few weeks 2 tablets 2-3x / day
• + Varenicline (Champix®), Valproic acid (Depakine®), Methylphenidate (Rilatin®),

• Chemotherapy: 2 tablets 3 days before 3 days after chemotherapy

• Antiretroviral medicines
• Anti-tuberculosis drugs
GINGER CLINICAL EVIDENCES
NAUSEA AND VOMITING

Pregnancy induced
nausea and vomiting
 FDA
“Gener
a
recogni lly
Ginger is recongnised as SAFE z e d as
s a f e”

WHO World Health Organization

RECOMANDATIONS

AAFP American Academy of Family Physicians

OFFICIAL

ACOG American Congress of Obstetricians and Gynecologists

NHS National Health Service

(=The publicly funded healthcare systems in the countries of the United Kingdom)

NIC
National Institute of health and Care Excellence
E (United Kingdom)

NHG Dutch College of General Practitioners

Nederlands Huisartsen Genootschap

FDA= Food and Drug Administration

MORNING SICKNESS
PREGNANCY INDUCED NAUSEA AND VOMITING

SYSTEMATIC REVIEW
2016 (JAMA)

Importance: Nausea and vomiting affect approximately 85 % of

pregnant women
Objective: Summary of ALL current evidences on effective
treatments for Nausea and Vomiting in Pregnancy (until June 2016)

Findings: 78 studies (67 Randomized Controlled Studies (RCT),

11 nonrandomized), 8930 participants

MacParlin et al. JAMA October 4, 2016 Volume 316, Number 13

 MacParlin et al. JAMA October 4, 2016 Volume 316,
Number 13

First-Line Treatments for Mild to Moderate Symptoms

Ginger: 10 low bias studies
 4 RCTs ginger vs. placebo, all reported an improvement in symptoms from baseline vs.
placebo, regardless of the ginger dose and preparation
 4 RCTs ginger capsules vs. vitamin B6
 2 studies reported greater improvement in nausea scores in ginger > vitamin B6
 2 studies reported no difference ginger = vitamin B6
 1 Study reported equivalent efficacy ginger = vitamin B6/ doxylamine
 1 Study reported greater improvement in symptoms with ginger > sea bands

In Summary ginger was associated with improvement in mild symptoms:

 level A, class IIa
RCT: Randomized Controlled Trial
 MORNING SICKNESS
PREGNANCY INDUCED NAUSEA AND VOMITING

First-Line Treatments for Mild to Moderate

Symptoms

Ginger:

Quality: level A (high)

Strength: class IIa (Moderate)

 The highest number of trials n=17

 The highest number of low bias trials n=10

 The highest quality and strength of evidences

ANTIMETIL
PREGNANCY INDUCED NAUSEA AND VOMITING
45th ESCP Symposium Oslo - Norway 5-7 October 2016
SAFETY OF THE GINGER EXTRACT GR10 = Antimetil
DURING PREGNANCY: A PILOT STUDY

Prospective intervention as a ‘real life’ study

45 pregnant women used Antimetil for pregnancy induced

nausea and vomiting. Average age 29.9 years

Antimetil 2 tablets / day

19 patients were satisfied to very satisfied, 15 patients had a neutral
opinion, 3 patients were dissatisfied

The majority of patients were satisfied

Antimetil was safe and effective

+ 60% of the patients will use Antimetil again in the future
Laekeman 2017
MORNING SICKNESS
PREGNANCY INDUCED NAUSEA AND VOMITING
REVIEW 2018

Stanisiere, et al. 2018 Foods.

MORNING SICKNESS
PREGNANCY INDUCED NAUSEA AND VOMITING
REVIEW 2018

15 randomised studies (vs. Placebo, Vit B6,

Metoclopramide, Dimenhydrinate, Accupression)

3 prospective studies

> 70,000 pregnant women

> 1500 women on ginger during pregnancy

Studies ran through over > 25 years

Answer: very safe … but Stanisiere, et al. 2018 Foods.

Stanisiere, et al. Foods. Avril 2018
MORNING SICKNESS
PREGNANCY INDUCED NAUSEA AND VOMITING

Ginger is very safe… but

Quality ginger plant
Quality of the extract
Quality of finished product
& Standardisation

Stanisiere, et al. 2018 Foods.

IMPORTANCE OF QUALITY
FOR GINGER
EXTRACT SELECTION AND QUALITY
 EXTRACT SELECTION AND QUALITY
The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally
Widespread Adulteration
Front Pharmacol. 2019; 10: 1227

The distribution of the DNA-tested herbal products and their overall authenticity at continental level.
The HPs’s DNA-based authenticity varies substantially among continents (authentic/adulterated %): Asia (77/23%) (light blue-green), Europe
(53/47%) (reddish-orange), Africa (73/27%) (violet), North America (67/33%) (orange), South America (33/67%) (blue), and Australia (21/79%)
(brown). Ichim 2019
 EXTRACT SELECTION AND QUALITY

The DNA-Based Authentication of Commercial Herbal Products Reveals Their

Globally Widespread Adulteration
Front Pharmacol. 2019; 10: 1227

5,957 commercial herbal products sold in 37 countries

a substantial proportion (27%) of the herbal products commercialized in the global marketplace is
adulterated when their content was tested against their labeled, claimed ingredient species
adulterated herbal products contain:
• undeclared contaminant,
• cheaper substitute and filler species,
• or none of the labeled species,
which all may be accidental or intentional, economically-motivated and fraudulent.

The globally widespread adulteration is a serious threat to consumers’ well-

being and safety…
EXTRACT SELECTION AND QUALITY
The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally
Widespread Adulteration

68% impure

Ichim 2019
EXTRACT SELECTION AND QUALITY
The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally
Widespread Adulteration

Czech Republic Romania

100 % 94 %
Adulterated = Adulterated =
impure impure Ichim 2019
EXTRACT SELECTION AND QUALITY
The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally
Widespread Adulteration

Germany
55 %
Adulterated =
impure
Ichim 2019
EXTRACT SELECTION AND QUALITY

One of these 3 products is contaminated !

but I cannot say which brand

GOOD
LUCK !
EXTRACT SELECTION AND QUALITY
EXTRACT SELECTION AND QUALITY

16 Ginger products Tested in United States

Some products contained:
• Less ginger than expected
• Low quality ginger
• Contaminated with lead

49
ZINGIBER OFFICINALE ZINGIBERACEAE;
INDIA, ASIA

Rhizome of Zingiber officinale

Important ingredient in Asian cooking
Used for 3.900 years in Ayurvedic medicine
Known active ingredients: gingerols

• 6- Gingerol

• 6- Shogaol: Degradation molecule 3 x more pungent

GINGER EXTRACT SELECTION AND QUALITY
Tilman Expertise:
Audit of extract manufacturer
Ginger plant: GACP (Good Agricultural and Collection Practice)
Ginger extract: GMP (Good Manufacturer Practice)

Quality control at every badge of

ginger extract delivered

Verification of standardisation:
% of active ingredients
6- Gingerol

6-Shogaol
GINGER EXTRACT SELECTION AND QUALITY

Tilman Expertise:

Quality control
 Identification: ginger
 Measure Concertation (%)
on active ingredients:
standardisation
 No contaminations

31. Oktober 2023 52

GINGER POWDER / GINGER EXTRACT / STANDARDISATION

Fresh Plant 2.500 mg

Dry Plant 500 mg

Dry Extract 50 mg

Coated 50 mg
Tablet

Gingerol Active 5 mg
Ingredients
GINGER POWDER / GINGER EXTRACT / STANDARDISATION

1. QUALITY plant + QUALITY extract

Fresh Plant 2.500 mg
2. Standardisation ex. 10%

Dry Plant 500 mg Drug: Row dry ginger powder

10
Drug Extract Ratio DER= 10:1
1
Dry Extract 50 mg Extract: Dry ginger extract

Coated 50 mg
Tablet
Standardisation: 10% of active
Gingerol Active 5 mg ingredients
Ingredients Guarantee of same concentration
on active ingredients: gingerols
 STANDARDISATION & HOW TO COMPARE GINGER PRODUCTS?

Guarantee of same concentration on active ingredients: gingerols

Drug: Row ginger powder

500 mg x2 250 mg x 10 50 mg

Extract: dry ginger extract 10:1 5:1 1:1

50 mg ≠ 50 mg ≠ 50 mg

Finished product: tablet

capsule

Gingerol 10% 2% ?%
Standardisation: Active x5 x…
ingredients 5 mg 1 mg ? mg
Shogaol
 A CONCENTRATED GINGER
EXTRACT

Antimetil Emetix
50 mg Ginger extract/tablet 15 mg ginger extract/tablet
3,3x more extract >
Drug Extract Ratio DER= 10:1 No DER known ?
50mg extract tablet equivalent to 500mg dried ginger Not possible to extrapolate to ginger plant
Standardized 10% gingerols Claim to be Standardized … but at what % ?
 A CONCENTRATED GINGER
EXTRACT

Antimetil Emetix
50 mg Ginger extract/tablet 15 mg ginger extract/tablet
3,3x more extract >
Drug Extract Ratio DER= 10:1 No DER known ?
50mg extract tablet equivalent to 500mg dried ginger Not possible to extrapolate to ginger plant
Standardized 10% gingerols Claim to be Standardized … but at what % ?

5 mg gingerols /tablet 0,70 mg gingerols /tablet (tested in Tilman

Laboratory)
7x more active ingredients >
No Vit B6 2mg Vit B6 / tablet
• Vit B6 only studied for Pregnancy induced nausea and
vomiting at doses of 30-100 mg /day
2mg = Ineffective dose for nausea

31. Oktober 2023 57

 A QUALITY STANDARDISED
GINGER EXTRACT
Antimetil Navatac
50 mg Ginger extract/tablet 20 mg ginger extract/tablet +
10mg Vit B6 / tablet
2,5x more extract > 150 mg artichoke (20% chlorogenic acids)
250 mg alginic acid
50 mg Calcium carbonate / 50 mg potassium bicarbonate
Drug Extract Ratio DER= 10:1 No DER known ? Not possible to extrapolate to ginger plant
50mg extract/tablet equivalent to 500mg dried ginger not possible to calculate the equivalence in dried ginger and calculate the dosage
especially for pregnant women
Standardized 10% gingerols >25% gingerols very concentrated in gingerols not sure about safety of extraction
process

5 mg gingerols /tablet ± 5 mg gingerols /tablet ?

No Vit B6 10mg Vit B6 / tablet: Ineffective dose for nausea
• Vit B6 only studied for Pregnancy induced nausea and vomiting at doses
of 30-100 mg /day
150mg Artichoke extract: not sufficient,
seems that higher dosages needed 800 - 1900 mg / day
Alginic acid is a precursor of Alginates. Alginates used typically in liquid forms or chewable tablets
for gastric acidity (ex. Gaviscon). In form of tablets it is very unusual to use alginic acid.
Alginic acid and antacids could have interactions for the absorption of many medications and
vitamins. Alginic acid is not an antiemetic, and it could create the sentiment of fullness, the
opposite of the effect of ginger (light stomach)

LESS is MORE The combination of so many ingredients has never been studied, and always alterations in
absorption and efficacy of each of the ingredients could be expected.
±10 € 16 €
Made in Belgium by the Expert in Herbal Medicine Made in Italy
31. Oktober 2023 58
 A CONCENTRATED GINGER
EXTRACT
What about Drops and Syrups ?
 A CONCENTRATED GINGER
EXTRACT
What about Drops and Syrups ?

Product Total Gingerols / 5g (in mg)

122,73mg x 1636
Lokomotiv syrup 0,075 mg
x 909
Nausolvit drops 0,135 mg
 A CONCENTRATED GINGER
EXTRACT
What about Drops and Syrups ?
In practice:

Lokomotiv syrup contains 1,5 mg of gingerols per whole 100ml bottle

Nausolvit drops contain 0,57 mg of gingerols per whole 20 ml bottle
 A CONCENTRATED GINGER
EXTRACT
What about Drops and Syrups ?
In practice:
Lokomotiv syrup contains 1,5 mg of gingerols per whole 100ml bottle
Nausolvit drops contain 0,57 mg of gingerols per whole 20 ml bottle

1 tablet Antimetil =
3,3 Boxes

8,8 Boxes
PRODUCTION OF FINISHED PRODUCT

31. Oktober 2023 65

FINISHED PRODUCT: ANTIMETIL TABLETS

1 tablet Antimetil:
• 50 mg of Zingiber officinale dry extract and
• 5mg Gingerols (standardized 10%)

• 50mg dry extract are equivalent to 500mg powdered ginger

[Drug Extract Ration (DER) 10:1)]

• Very Small Double Coated tablets

• Lactose Free & Gluten Free

31. Oktober 2023 66

FINISHED PRODUCT: ANTIMETIL TABLETS

• Antimetil = Made in Belgium

• GMP: Good Manufacturing Practices
• Production like a herbal medicine
• Excellent quality ingredients:
• Ginger plant: GACP (Good Agricultural and Collection Practice)
• Ginger extract: GMP(Good Manufacturer Practice)
• Quality control at every step of the production
• Very small tablet
• Double coating to cover the hot taste of
concentrated ginger
• Never break the tablet: very hot taste !

67
GINGER FORMULATIONS GALENIC FORMS

Oral use:
Solid forms:
 Tablets and capsules: ok + better quality and stability
 NEW: lozenges – gum : ok but lower dose vs. tablets and capsules
≈ Chewing gum: Low concentration of ginger …
✖ Lollipops: Very low concentration of ginger just taste

Liquid forms
✖ Syrups: Very low concentration of ginger just taste
✖ Drops: ?

Rectal use:
• Suppositories: NO, European Medicines Agency does not describes the rectal
use of ginger
ANTIEMETICS
DOMPERIDONE
RX ONLY !

Drugs with domperidone

Prescription only from 1st January 2014 in several EU countries

Since December 2011, the Vigilance division of the Belgian

Risk of ventricular arrhythmiasFAMHP (Federal Agency for Medicines and Health Products) has
and sudden cardiac death, received 4 Belgian cases of serious cardiac adverse reactions (2
of which led to the death of the patient) when taking domperidone.
especially in patients> 60 yearsTheORcausal link between the adverse reaction and the drug had
at doses> 30mg / day (> 3 tabs.) been assessed as possible, according to WHO criteria.
 METOCLOPRAMIDE (Dopamine D2 antagonist)

Serious side effects:

• Tardive dyskinesia
• Irregular heartbeat
• Agitation or anxiety

Less serious side effects:

•Drowsiness, Confusion

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
Agency warns against chronic use of these products to treat gastrointestinal disorders

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement
disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used
metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous
reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more
than three months.

Tardive dyskinesia: involuntary movement

These symptoms are rarely reversible and there is no known treatment.
However, in some patients, symptoms may lessen or resolve after
metoclopramide treatment is stopped
ANTIHISTAMINES

Caution: Cinnarizine crosses the brain barrier and therefore causes side
effects such as
 tachycardia (fast heart rate),
 drowsiness (sedation) and
 Discomfort

 Anticholinergic side effects:

 dryness of the mouth and eyes,
 disturbances of eye accommodation,
 urinary retention
Vit B6
Obstet Gynecol. 1991 Jul;78(1):33-6.
Vitamin B6 is effective therapy for nausea and vomiting of pregnancy: a randomized, double-blind placebo-
controlled study.
Sahakian V1, Rouse D, Sipes S, Rose N, Niebyl J
Fifty-nine women completed a randomized, double-blind placebo-controlled study of pyridoxine
hydrochloride (vitamin B6) for the treatment of nausea and vomiting of pregnancy.
• Thirty-one patients received vitamin B6, 25-mg tablets orally every 8 hours (75mg /day) for
72 hours, and 28 patients received placebo in the same regimen.
• Patients were categorized according to the presence of vomiting: severe nausea (score greater than 7)
or mild to moderate nausea (score of 7 or less). The severity of nausea (as graded on a visual
analogue scale of 1-10 cm) and the number of patients with vomiting over a 72-hour period were used
to evaluate response to therapy. Twelve of 31 patients in the vitamin B6 group had a pre-treatment
nausea score greater than 7 (severe) (mean 8.2 +/- 0.8), as did ten of 28 patients in the placebo group
(mean 8.7 +/- 0.9) (not significant).
• Following therapy, there was a significant difference in the mean "difference in nausea" score (ie,
baseline - post-therapy nausea) between patients with severe nausea receiving vitamin B6 (mean
4.3 +/- 2.1) and placebo (mean 1.8 +/- 2.2) (P less than .01).
• In patients with mild to moderate nausea and in the group as a whole, no significant difference
between treatment and placebo was observed. Fifteen of 31 vitamin B6-treated patients had vomiting
before therapy, compared with ten of 28 in the placebo group (not significant).
• At the completion of 3 days of therapy, only eight of 31 patients in the vitamin B6 group had any
vomiting, compared with 15 of 28 patients in the placebo group (P less than .05).
Vit B6
Am J Obstet Gynecol. 1995 Sep;173(3 Pt 1):881-4.
Pyridoxine for nausea and vomiting of pregnancy: a randomized, double-blind, placebo-controlled trial.
Vutyavanich T1, Wongtra-ngan S, Ruangsri R.
Abstract
OBJECTIVE:
• Our purpose was to determine the effectiveness of pyridoxine for nausea and vomiting of pregnancy.
STUDY DESIGN:
• During an 11-month period 342 women who first attended Chiang Mai University Hospital antenatal clinic at < or =
17 weeks' gestation were randomized to received either oral pyridoxine hydrochloride, 30 mg per day, or
placebo in a double-blind fashion. Patients graded the severity of their nausea by a visual analog scale and
recorded the number of vomiting episodes over the previous 24 hours before treatment and again during 5
consecutive days on treatment.
RESULTS:
• There was a significant decrease in the mean of posttherapy minus baseline nausea scores in the pyridoxine
compared with that in the placebo group (t test, p = 0.0008). There was also a greater reduction in the mean
number of vomiting episodes, but the differences did not reach statistical significance (p = 0.0552).
CONCLUSION:
• Pyridoxine is effective in relieving the severity of nausea in early pregnancy.
 Ginger vs. Vit B6
Sripramote 2003
• Randomized double-blind trial
• Patients: 64 Ginger group vs. 64 Vitamin B6 group
• Period of Gestation (week) <17
• Ginger 500 mg 3 times daily
• Vitamin B6 (10 mg; 3 times a day) (30 mg)
• Treatment duration: 3 days
• Severity of nausea (visual analogue scale), number
of vomiting episodes, and occurrence of adverse
effects
Results
• Significant reductions of nausea score and
vomiting episodes were observed in ginger and
vitamin B6 groups
Smith, 2004
• Randomized double-blind trial
• Patients: 120 Ginger group vs. 114 Vitamin B6 group
• Period of Gestation (week) >8 <16
• Ginger 350 mg 3 times daily
• Vitamin B6 (25 mg; 3 times a day) (75 mg)
• Treatment duration: 3 weeks (21 days)
• Nausea, retching, and vomiting at days 7, 14, 21
Results
• Ginger was as effective as vitamin B6 in reducing
nausea, dry retching (haut le coeur) , and vomiting
compared with baseline
CONCLUSIONS
SAY STOP
TO NAUSEA
TRUST ANTIMETIL
GINGER
ADVANTAGES

 Complete mode of action

 Gastroprokinetic: Accelerates gastric emptying
 Action on gastrointestinal tract ( Serotonin, Acetylcholine, Substance P) on Chemoreceptor
Trigger Zone (Serotonin, Acetylcholine, Substance P) and at inner ear (Acetylcholine)
 Effective in many types of nausea and vomiting:
 motion sickness, morning sickness, post-operative, chemotherapy, gastroenteritis
 + dyspepsia
 Fast onset of action (15’ – 1h)
 Significant efficacy: as effective as chemical antiemetics
 Safe: No serious adverse reactions and no sedation, no tardive dyskinesia
 From the 1st month of pregnancy
77
… However ginger quality is important
TRUST
1. QUALITY of the plant

2. QUALITY of the extract

3. QUALITY of the finished product (tablet, capsules)

 Standardised extract 50 mg (ex. 10% gingerols): 5 mg gingerols/ tablet

 Coated tablets: no taste, best stability

 Small tablets easy to swallow

 Clinical study in pregnant women with Antimetil: safe and effective

 No 1 OTC antiemetic in Belgium

78
Messages

Quick messages at the Pharmacy:

Well established = PROVEN efficacy with numerous clinical studies

Fast Action "From 15 Min Before Departure”

Optimal Safety For Children From 6 Years Old

Without Drowsiness or Other Side Effects

 Carnet de vacances
PRO-587
Voir paliers
CONDITIONS
Matériel PV été

Display DIP-ANTIME-04 Vitrine KITM-ANTIME-03 Animation pharmacie

à l’achat de 12 Antimetil cpr et à l’achat de 84 pièces KITM-ANTIME-05
6 Antimetil Gom à l’achat de 84 pièces
Ok pour 60 pièces uniquement pour les petites
pharmacies qui ne peuvent atteindre 84.
BOOK
VISUAL AID
Matériel PV été
SWOT

STRENGTHS:
− More concentrated in ginger than competitors
− Clinical trial with Antimetil in pregnant women (poster- abstract)
− Ginger is well-documented
− Ginger is safe - No negative effects
− Fast onset of action
− Can be taken by children from 3-year old, pregnant women and during the breast feeding
− Small coated tablet easy to swallow
− Leader on its market

WEAKNESSES:
− A little more expensive than competitors
− Food supplement → cannot communicate clearly on nausea
SWOT

Opportunities:
−Motilium (domperidone) put on doctor’s prescription in Europe
−Touristil (domperidone + cinnarizine) not allowed anymore in Europe
 Huge opportunity on the nausea market

Threats:
−Other competitors (mainly medical products for motion sickness) also took
advantage of the situation concerning Motilium and Touristil
STRATEGY

 Positioning: Antimetil is a food supplement and is ginger-based

coated tablet useful for nausea (in case of overeating, disruption
to usual diet habits), travel sickness and morning sickness

 Key messages: Antimetil helps you to keep a light stomach in

all occasions: in case of unusual diet, during travelling and during
pregnancy
(Cannot communicate clearly on nausea due to the status of food
complement !)
 TARGET GROUP: Every person suffering from nausea and from
travel sickness (from 3-year old), and pregnant women suffering from
morning sickness

 COMPETITIVE ADVANTAGES OR DIFFERENTIATION VS.

COMPETITORS:
 More concentrated than the main competitors, 50 mg of
standardized extract (10% gingerols) equivalent to 500 mg of
ginger powder = 10 x more concentrated than traditional ginger
powder
 Ginger is scientifically well-documented
 Small tablet easy to swallow
 No adverse effects