Rehydron Optim powder for oral solution 10.7g packages for N20

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 directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• Contact your pharmacist for more information or to ask a doctor.
• If you get side effects (even if this is not indicated in this leaflet), ask your doctor or pharmacist. See Chapter 4
• If within 2 days your well-being has not improved or even worsened, ask your doctor.

What is this leaflet about?

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 take Rehydron Optim
4. Possible side effects
5. How to store Rehydron Optim
6. Package content and other information

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

This medicine is used to:

• For the removal of light and moderate dehydration associated with acute diarrhea (to compensate for the loss of water and salts in the body);
• Prevention of dehydration.

If acute diarrhea occurs, there is a risk of dehydration (fluid and salt loss). The Rehydron Optim solution replaces the lost fluid and salts with the usual diarrhea. Sugar in the product promotes the absorption of water and salts in the intestines, and citrate corrects acid-base balance in the body.

2. What you need to know before you use Rehydron Optim

Do not use Rehydron Optim:

• If you are allergic to glucose, sodium chloride, sodium citrate, potassium chloride or any of the other ingredients of this medicine (listed in section 6);
• Severe dehydration;
• If the patient is unconscious (possible suffocation);
• If there is a shock (possible suffocation);
• If there is an intolerance to the gut;
• If you have too much vomiting.

Warnings and precautions

Check with your doctor or pharmacist before taking rehydrate Optim.

• A disease of kidney disease, which reduce the urine flow does not pass if not completely.
• There is a narrowing of the gastrointestinal tract.
• He has diabetes.
• Hepatic or renal disease.
• Controlled sodium or potassium in the diet.
• There is any other chronic disease.
• Blood contains stools.
• Diarrhea (even mild) lasts longer than 2 days.
• There is a strong abdominal pain.
• Changes in mental status (eg., Appeared irritability, lethargy or drowsiness).
• You started fever (above 39 ° C).

If dehydration is severe, rehydration may be inappropriate for oral use: intravenous rehydration may be required. If you or your child have severe dehydration due to diarrhea or vomiting, talk to your doctor. Symptoms of severe dehydration include frequent heart beat, difficulty in breathing, fever, very tiredness, muscle cramps, headache, nausea, tingling in the arms and legs, vomiting, confusion, seizures and loss of consciousness.

Acute diarrhea in infants may result in an immediate dehydration of the patient. If your baby has any diarrhea and dehydration caused by any cause, you should contact your doctor as soon as possible.

Other medicines and Rehydron Optim

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are unsure about this.

There is no data available on possible interactions with other medicines. Diarrhea may impair the absorption of many medicines.

Pregnancy and breastfeeding

During pregnancy and breast-feeding, the recommended dose of Rehydron Optim can be used.

Driving and operating machinery

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

Rehydron Optim contains potassium and glucose

It is important to consider if you have impaired kidney function or controlled potassium in your diet.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Rehydron Optim

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.

How to prepare a solution

One of the pills in the Rehydron Optim package should be dissolved in half a liter of lukewarm water. After reconstitution, the solution is ready for consumption. The reconstituted solution is opaque, colorless, with a lemon smell.

In order to optimize the elimination of fluid balance in the body, the Rehydron Optim powder must be dissolved in a suitable amount of water (0.5 liters). If the powder is dissolved in an inadequate amount of water, excessive amounts of salt can be consumed.

Rehydron Optim powder should not be dissolved in any liquid other than water.

How to use the product

Rehydron Optim is a solution for oral use. If necessary, the solution can be administered via the nosocommand of the gastric prosthesis under the supervision of a physician.

A fast dose of Rehydron Optim is safe, but vomiting may begin. If you or your child have experienced nausea or vomiting, the solution should be cooled and taken at small, repeated doses (for example, using a teaspoonful, syringe or dosing cup). Your dose may then be gradually increased depending on how tolerable you or your child are.

Taking medicine with food and drink

• Other liquids (eg, diluted juice) may be used during treatment. However, it is recommended to avoid high-carbohydrate liquids as they can complicate diarrhea.
• The Rehydron Optim solution is not intended to help thirst. Do not exceed the recommended dose unless prescribed by your doctor.
• If diarrhea is mild, you or your child can drink any fluids and eat any food: it is necessary to continue normal eating habits.
• No food can be consumed during substitution treatment (during the first 4 hours), but regular breastfeeding can be continued.

Dosage

Ease of mild to moderate dehydration, i.e. normalizing the amount of fluid after dehydration, associated with diarrhea

Substitution treatment is started if you or your child develop mild to moderate dehydration symptoms such as decreased urine output, dry skin, coldness of hands and feet, fatigue, general weakness, muscle cramps and / or weight loss.

If your or your child's body weight and / or mild to moderate dehydration have been diagnosed in a medical study, the usual dose of Rehydron Optim is ½-1 dl / kg body weight. The dose of the Rehydron Optim solution that is used to normalize the amount of fluid in the body depends on body weight.

During substitution, the solution should be used within four hours to eliminate the underlying fluid deficiency in the body. If diarrhea persists after substitution treatment, it is recommended to use Rehydron Optim solution for supportive treatment (see section "Prevention of mild diarrhea related dehydration" below).

Prevention of mild diarrhea-related dehydration

Rehydron Optim should be started immediately after diarrhea. Generally, Rehydron Optim does not need to be treated for more than 3-4 days, but discontinuation of diarrhea should be discontinued. The following doses of Rehydron Optim solution are used.

Contact your doctor

During treatment it is necessary to observe body weight and general health status. If you or your child develop the following, talk to your doctor.

• The mental state has changed (eg irritability, apathy or lethargy).
• Body temperature has risen above 39 ° C.
• Blood appeared in the stool.
• Constantly vomiting.
• Meditate longer than 2 days.
• There was a severe abdominal pain.

In some cases, Rehydron Optim therapy may not be able to eliminate or prevent diarrhea due to dehydration.

What to do with overdose of Rehydron Optim?

In case of an overdose, seek medical advice immediately.

Possible symptoms of overdose include thirst, dry mouth, swallowing difficulties, dehydration, low blood pressure, disorientation, drowsiness, neck stiffness, loss of consciousness, seizures and muscle weakness. These symptoms are more common in patients with impaired renal function.

If you have any further questions on the use of this product, ask your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rehydron Optim should not be used in combination with the recommended dose. A solution that is too fast can cause vomiting (see section 3, "How to take Rehydron Optim").

Side effects report

Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet. You can also report a side effect to the State Medicines Control Agency at the Ministry of Health of the Republic of Lithuania free of charge by calling 8 800 73568 or fill out the form on the website www.vvkt.lt and submit it to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania in one of the following ways: : In writing (at Žirmūnų St. 139A, LT-09120 Vilnius), free fax number 8 800 20131, e-mail: Mail to UnwantedR@vvkt.lt, as well as via the website of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (http://www.vvkt.lt). By reporting on side effects, you can help us get more information about the safety of this medicine.

5. How to store Rehydron Optim

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and the carton after "EXP / EXP". The medicine is suitable for use until the last day of the specified month.

Batch: Store below 25 ° C.

Ready to store: Store in a refrigerator (2 ° C - 8 ° C). The reconstituted solution should be used within 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.

6. Package content and other information

The composition of Rehydron Optim

• The active substances in one sachet are 6.75 g of anhydrous glucose, 1.30 g of sodium chloride, 1.45 g of sodium citrate and 0.75 g of potassium chloride.
• The other ingredients are acesulfame potassium salt (E950), lemon aromatic substance (maltodextrin, gum arabic (E414), D-limonene (dextrose), citral, lemon essential oil, green lemon essential oil, vanillin).

What Rehydron Optim looks like and contents of the pack

Powder for oral solution is white, crystalline, lemon scent packed in 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.

The registrant and the manufacturer

The registrant

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturers

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Or

Recipharm Parets SL

C / Ramón y Cajal 2

ES-08150 Parets del Vallès

Spain