REHYDRON OPTIM PULV 10.7G N20

ATC code: A07CA 

Active substances: Natrii Chl, Glucosum Anhydricum, Natrii Citras, Kalii Chl

Vendor, principal: Orion Pharma. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

REHYDRON OPTIM 10.7G N20

Package leaflet: Information for the user

Rehydron Optim, powder for oral solution

Anhydrous glucose, sodium chloride, sodium citrate and potassium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

What is in this leaflet:

1.   What Rehydron Optim is and what it is used for
2.   What you need to know before you use    Rehydron Optim
3.   How to use Rehydron Optim
4.   Possible side effects
5.   How to store Rehydron Optim
6.   Contents of the pack and other information

1.   What Rehydron Optim is and what it is used for

This product is indicated for:
-   treatment of mild to moderate dehydration associated with acute diarrhoea (to replace water and salts lost by the body)
-   prevention of dehydration.
Acute diarrhoea involves a risk of dehydration (loss of water and salts). Rehydron Optim solution replaces water and salts lost in connection with ordinary diarrhoea. Sugar contained in the product promotes the absorption of water and sodium from the intestines, and citrate corrects disturbances in the acid-base balance of the body.

2.   What you need to know before you use Rehydron Optim Do not use Rehydron Optim, if you or your child:

-   are allergic to glucose, sodium chloride, sodium citrate, potassium chloride or any of the other ingredients of this medicine (see section 6)
-   are severely dehydrated
-   are unconscious (risk of suffocation)
-   are in shock (risk of suffocation)
-   have intestinal obstruction
-   are vomiting profusely.

Warnings and precautions

Talk to your doctor before using this product if you or your child:
-   have a kidney disorder causing decreased urinary output or complete suppression of urine formation
-   have gastrointestinal strictures
-   have diabetes
-   have a liver or kidney disease
-   have a sodium or potassium restricted diet
-   have any other chronic disease
-   have blood in the stool
-   have diarrhoea that continues for more than 2 days, even if it is mild
-   have severe abdominal pain
-   have changes in mental status (e.g. irritability, apathy or lethargy)
-   develop fever over 39°C.
Oral rehydration therapy is insufficient in case of severe dehydration and intravenous rehydration therapy may be required. Contact a doctor if you or your child have diarrhoea or vomiting which has resulted in severe dehydration. Symptoms of severe dehydration are rapid pulse, breathing difficulty, fever, extreme fatigue, muscle cramps, headache, nausea, tingling of the limbs, vomiting, confusion, seizures and loss of consciousness.
In infants acute diarrhoea may cause dehydration resulting in rapid status worsening. All cases of diarrhoea and dehydration in infants should be consulted by a doctor as soon as possible.

Other medicines and Rehydron Optim

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
There is no information about possible interactions between Rehydron Optim and other medicinal products. Diarrhoea as such may influence the absorption of many medicinal products.

Pregnancy and breast-feeding

Rehydron Optim can be used during pregnancy and breast-feeding at recommended doses.

Driving and using machines

Rehydron Optim has no influence on the ability to drive and use machines.

Rehydron Optim contains potassium and glucose

This medicine contains potassium, which should be taken into consideration when administering the solution to patients with reduced kidney function or patients on a potassium restricted diet.
This medicine contains glucose. If you have been told by a doctor that you or your child have an intolerance to some sugars, contact a doctor before taking this medicinal product.

3. How to use Rehydron Optim

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How to reconstitute the solution

Mix one sachet of Rehydron Optim powder with 0.5 litres of lukewarm water. After mixing, the solution is ready to be used. The reconstituted solution is opaque and colourless and has a lemony scent.
Make sure that you mix the Rehydron Optim powder with the correct amount of water (0.5 litres) to ensure optimal efficacy of the product in the treatment of fluid imbalance. Mixing the powder with an insufficient amount of water may result in excessive salt intake.
Do not mix the Rehydron Optim powder with fluids other than water.

How to take the product

The Rehydron Optim solution is administered orally. If necessary, the solution can also be administered through a nasogastric tube under medical supervision.
Rapid administration of the solution is safe but may induce vomiting. If you or your child are nauseous or vomit, refrigerate the solution and administer it in small, repeated doses using e.g. a teaspoon, a syringe, or a dosing cup. After this, you may gradually increase the dose according to your or your child’s tolerance.
Taking the medicine with food and drink
-   Other fluids (e.g. diluted juice) can also be given during the treatment. However, fluids with a high sugar content should be avoided as they may worsen the diarrhoea.
-   Rehydron Optim solution is not intended as a thirst-quencher, and the recommended doses should not be exceeded without medical advice.
-   During mild diarrhoea, you or your child may drink other fluids freely and continue a normal, age-appropriate diet.
-   During replacement therapy (for the first 4 hours), no food should be given. However, breastfeeding can be continued normally.

Dosing

Treatment of mild to moderate dehydration, i.e. fluid replacement therapy for dehydration (associated
with acute diarrhoea)
Replacement therapy should be administered, if you or your child experience symptoms of mild or moderate dehydration, such as decreased urinary output, dry mucous membranes, cold hands and feet, tiredness, general weakness, muscle cramps and/or weight loss.
If you or your child already lost weight and/or suffer from mild to moderate dehydration based on a medical examination, the required dose of Rehydron Optim solution is usually 54- dl per kg of body weight. The dose of Rehydron Optim solution in fluid replacement therapy is based on the body weight:

Body weight (and age)	Amount of solution
Under 5 kg (under 4 months)	2-4 dl
5-7.9 kg (4-11 months)	4-6 dl
8-10.9 kg (12-23 months)	6-8 dl
11-15.9 kg (2-4 years)	8-12 dl
16-29.9 kg (5-14 years)	12-22 dl
Over 30 kg (over 15 years)	22-40 dl

In fluid replacement therapy, the solution should be administered over a period of four hours to correct the estimated fluid deficit. If diarrhoea persists after administration of the fluid replacement therapy, administration of Rehydron Optim solution should be continued as maintenance therapy, see section “Prevention of dehydration (associated with mild diarrhoea)” below.
Prevention of dehydration (associated with mild diarrhoea)
Treatment with Rehydron Optim solution should be started immediately after the onset of diarrhoea. Providing treatment beyond 3-4 days is usually not necessary and the treatment should be discontinued once the diarrhoea has ceased. Rehydron Optim solution should be administered as follows:

Body weight	Amount of solution
Under10 kg	14-1 dl after each diarrhoea stool
Over 10 kg	1-2 dl after each diarrhoea stool

Contact a doctor

Monitor the weight and general condition during the treatment and contact a doctor, if you or your child:
-   experience changes in the mental status, e.g. irritability, apathy or drowsiness
-   have fever over 39°C
-   have blood in the stool
-   experience persistent vomiting
-   have diarrhoea that continues for more than 2 days
-   have severe abdominal    pain.
In some cases, Rehydron Optim therapy is not sufficient for correcting or preventing dehydration caused by diarrhoea.

If you take more Rehydron Optim oral solution than you should

In the event of an overdose, immediately contact a doctor.
Symptoms of an overdose can be thirst, dry mouth, difficulty in swallowing, dehydration, low blood pressure, disorientation, drowsiness, stiffness of the neck, unconsciousness, convulsions and muscle weakness. This is more likely to happen in patients with decreased renal function.
If you have any further questions on the use of this medicine, ask your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rehydron Optim is not expected to cause any side effects at recommended doses. Too rapid
administration of the solution can induce vomiting (see section 3 “How to take the product”).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee , By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rehydron Optim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Sachet: Store below 25°C.
Reconstituted solution: Store in a refrigerator (2°C-8°C). The reconstituted solution must be used within 24 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rehydron Optim contains

-   The active substances in one sachet are: anhydrous glucose 6.75 g, sodium chloride 1.30 g, sodium citrate 1.45 g and potassium chloride 0.75 g.
-   The other ingredients are: acesulfame potassium (E950), lemon aroma (maltodextrin, acacia [E414], d-limonene [dextro], citral, lemon oil, lime oil, vanillin).

What Rehydron Optim looks like and contents of the pack

White crystalline powder for oral solution with lemon scent packed into sachets. One sachet contains 10.7 g of powder for oral solution.
Pack sizes: 2, 4, 6, 10 and 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Manufacturer
Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland
Recipharm Parets S.L.U.
C/ Ramon y Cajal 2 Parets del Valles ES-08150 Barcelona Spain

This leaflet was last revised in January 2018.