What is ORS effervescent tablet?

ORS is a combination that consists mainly of different salts. If the body loses more fluid than it takes
in, this can result in dehydration. To enable the intestines to obtain fluid from food residues, glucose
(grape sugar) and minerals are important. ORS contributes to avoid dehydration in children and adults
which can be caused for instance by diarrhoea. The usual dosage form for ORS is in sachet, but we
were convinced that a better form was possible. The composition of the tablet is based on the
guidelines of the WHO. We succeeded to combine a lot of advantages in our product. The major
advantages of the effervescent tablets are:
o Convenience and speed
o Quick disintegration time
o Completely dissolves, no remaining residues.
o Great taste: Fresh lemon flavour. More 'lemonade' than 'medicine', easy to drink for kids.
o Premium product. A premium and unique dosage form, much more appreciated than sachet.
o The customer recognizes the advantages and is willing to pay a premium.

Packet sizes and volumes

The ORS effervescent tablets are available in
• Tubes with 24 tablets – minimum batch size 10.080 tubes
• Tubes with 12 tablets – minimum batch size 20.160 tubes.

Consumer price
The ORS effervescent tablet can not be compared to the conventional sachets. It is a
premium product with much higher convenience and a much better taste. Production costs
are significantly higher, because of the difficulty of combining the different types of salts and
still get a good effervescent effect. But the consumer price can be much higher as well. In
different European Countries the product sells easily for prices between € 6,- and € 8,- for a
tube of 24 tablets.

Package design
You are completely free in choosing your own name and package design for the product
(max. 4 colors). It is of course possible to put several languages on the package. We expect
you to deliver your own language text (and maybe other languages) texts. We can design the
package for you, but you can also decide to design it yourself.

Distribution Agreement
We can give you an exclusive Distribution Agreement or a semi-exclusive Distribution
Agreement for one country or for several countries. (the semi-exclusive agreement gives us
the right to appoint one other Distributor). The exclusivity depends on the volume you will
guarantee.

Delivery time
Delivery time for a batch of 10.000 or more is 3 months ex-factory and then you have to add
the transportation time. For the first order you have to reckon with some extra time because
of the design work for the package.

Next Stage
If we you are interested in the product we can make you a concrete proposal for a
distribution agreement (including volumes and prices). If the agreement is signed by both
parties we can start making the package design and than we are ready to produce and
deliver.
In the Annexes you will find

Annex 1 The standard English language leaflet text. This text can be the basis for your text.
Depending on local needs and (legal) demands the text can be adapted to your exact
situation.

Annex 2: information concerning the composition of the tablet,

Annex 3: some examples of artwork

Annex 4: Our commercial factsheet.

If you want more information do not hesitate to contact us.

With kind regards,

Focus Care Pharmaceuticals B.V.

Jan Erik Bruin

Business development Director

M: +31 (0)6-54364965
E: janerik.bruin@focuscare.nl

Address
Focus Care Pharmaceuticals B.V.
Lagedijk 1-3
1541 KA Koog aan de Zaan
Nederland
Annex 1: Standard English Language text ORS effervescent tablets:

O.R.S. effervescent [COMPANY]

Effervescent tablets

If you need more information or advice contact your pharmacist.

Content of this information leaflet

1. What is O.R.S. effervescent [COMPANY] and what is it used for?

2. What is the composition of O.R.S. effervescent [COMPANY]?
3. What you should know before you take O.R.S. effervescent [COMPANY].
4. What are the instructions for use of O.R.S. effervescent [COMPANY]?
5. How to store O.R.S. effervescent [COMPANY]?
6. Who markets O.R.S. effervescent [COMPANY]?
7. Further information

O.R.S. effervescent [COMPANY]

Effervescent tablets with lemon flavour

For a proper fluid balance

For infants, children and adults

1. WHAT IS O.R.S. EFFERVESCENT [COMPANY] AND WHAT IS IT USED FOR?

O.R.S. effervescent [COMPANY] is a glucose-salt combination. The effervescent tablets replenish the
water and body salts and thereby help to maintain a proper fluid balance. However, besides taking the
O.R.S. solution it is important you keep drinking sufficiently.

2. WHAT IS THE COMPOSITION OF O.R.S. EFFERVESCENT [COMPANY]?

One effervescent tablet (for 100 ml solution) contains:

glucose 1826 mg
sodium chloride 176 mg
potassium chloride 150 mg
citric acid 429 mg

Ingredients: glucose, citric acid, moisturisers: sodium bicarbonate and polyethylene glycol, sodium
chloride, potassium chloride, lemon flavour, sweetener: aspartame, colouring agent: riboflavin.

3. WHAT YOU SHOULD KNOW BEFORE YOU TAKE O.R.S. EFFERVESCENT [COMPANY]

Do not take O.R.S. effervescent [COMPANY]:

- If there is blood in the faeces.
- In people with poor kidney function.

As far as known O.R.S. effervescent [COMPANY] can be used without objection during pregnancy
and breastfeeding.
Warnings and precautions:
- Only use good quality drinking water to prepare the solution. Water of poor or questionable quality,
is to be boiled for 2 minutes and cooled down before use.
- Do not add sugar or sugar containing liquids to the solution.
- Always take the effervescent tablet in dissolved form.
- Do not exceed the recommended dosage.
- Consult your doctor in case of dehydration symptoms like excessive thirst (dry tongue and mouth)/
drowsiness or confusion/ (tendency to) faint/ very dry skin/ reduced urine production. Be
particularly alert in case of children under 2 years of age and elderly people. These age groups
can very quickly show symptoms of dehydration.
- Contact your doctor in case these symptoms occur in combination with fever and/or vomiting.
- Contact your doctor in case the symptoms persist for more than 3 days (in infants/children for
more than 1 day) or with regularly recurring symptoms.
- In case of vomiting it makes sense to continue drinking O.R.S. effervescent solution, even though
some of the solution is regurgitated.
- Besides taking the O.R.S. effervescent solution it is advised to drink additional fluids (tea, water,
light broth) as well as to keep eating (small portions). You can continue feeding (breast- or bottle
feeding) infants as you are used to. The amount of feeding does not have to be reduced.

An effervescent tablet contains 1.8 grams of glucose. Diabetics should take this into account.

People suffering from high blood pressure and/or cardiac disease should take into account that an
effervescent tablet contains sodium.

Hygienic advice
- Thoroughly clean cutlery, kitchen utensils, cups, and toys after use.
- Keep toilet and kitchen sink thoroughly cleaned.
- Thoroughly wash your hands (your child’s hands) after using the toilet.
- Thoroughly wash your hands after taking care of and/or changing diapers of a child.

4. WHAT ARE THE INSTRUCTIONS FOR USE OF O.R.S. EFFERVESCENT [COMPANY]?

Use:

Adults and children of 20 kg or more: 200 ml of solution each time the fluid level needs to be retained.

Infants and children up to 20 kg: 10 ml of solution per kg body weight each time the fluid level needs to
be retained.

Body Weight 5 kg 10 kg 15kg 20 kg

Amount of ml at a time 50 ml 100 ml 150 ml 200 ml

Preparing the solution:
Take 200 ml of drinking water. Add 2 tablets and let them dissolve completely. Drink all of the solution
slowly by taking a sip at a time. This is the best way for it to be absorbed in the body. If this is difficult
for you, slowly sip all of the solution during the day.

For infants and children up to 10 kg 1 tablet in 100 ml drinking water is sufficient. Give O.R.S.
effervescent solution to babies with small bits at a time (for example every few minutes). This way the
solution is best absorbed in the body. The solution can be given with a small spoon or (sterilised)
bottle. Attention: never dissolve effervescent tablets in baby formula. Preferably, give O.R.S.
effervescent solution before bottle- or breastfeeding, sufficient amounts will be drunk more easily.
Afterwards, feed as you are used to.

NB: Even if you need less solution, you must still take 100 ml of water per tablet. Subsequently use
the appropriate amount and throw away the remaining solution or store it according to storage advice
given below.

5. HOW DO YOU STORE O.R.S. EFFERVESCENT [COMPANY]?

Store at room temperature and out of reach of young children. Keep the tube well closed.

Use the solution directly. Do not store for more than 8 hours outside of the refrigerator. The solution
can be stored in the refrigerator for a maximum of 24 hours.

Keep this product out of reach of young children

Do not use O.R.S. effervescent [COMPANY] after the expiry date which is stated on the packaging
after “expiry date” or “EXP”. This date indicates the time after which the quality of the product is no
longer guaranteed.

6. WHO MARKETS O.R.S. EFFERVESCENT [COMPANY]?

[The name of the company]

7. FURTHER INFORMATION

This product and the accompanying information have been formulated with the utmost care. This
information leaflet is meant to provide information only and is in no way meant to replace the advice of
your doctor.

For more information you can contact our Service desk for free xxxxxxxxxxxxxxxxxxx.
Annex 2: Composition effervescent tablets

Description and Composition (O.R.S. Effervescent tablets)

Ingredient mg/tablet
Citric acid 429
Sodium hydrogen carbonate 331
Riboflavin 5 phosphate 0.3
Aspartame 14
Flavour Lemon 40
Glucose 1826
Potassium chloride 150
Sodium chloride 176
PEG 6000 33.7

The tablets are packed in PP tube with PP cap containing 24 tablets.

Weight of one tablet: 3 gram

Annex 3: Examples artwork ORS Effervescent tablets:
Annex 4: Commercial factsheet
Oral Rehydration Salts (ORS), 2011

Drug substance Oral Rehydration Salts (ORS)

Pharmaceutical form Effervescent Tablets
Free from Gluten and Lactose
Particulars
Lemon Flavour
According guidelines WHO
• Glucose
• Sodium
Contents
• Potassium
• Citrate
• Chloride
Territory To be determined
24 tabs. in plastic tube / Moistureproof / Box imprint max. 4
Packaging colours / Leaflet.
Design and branding according to your choice.
Colour: off white
Shape: round
Trade dress
Size: Ǿ 24 mm.- H 4mm
Weight: 3,000 mg
Purchase Price To be determined
• Effervescent tablet
• Quick disintegration time in glass of water
• Completely dissolves, no remaining residues
Product features • Fresh lemon flavour
• Tube package, more convenient to take with you than
sachets.
• Contents according guidelines WHO
• Much more appreciated than sachet
Commercial features • Premium consumer price compared to sachet
• Attractive price structure
Focus Care Pharmaceuticals B.V.
Mr. Jan Erik Bruin (janerik.bruin@focuscare.nl)
Additional information
Tel +31 (0)75 - 612 0511
Mob. +31 (0) 6 - 54364965