ELOTRANS

ELOTRANS powder

Important notes (mandatory information)

Elotrans, powder for solution. Indications: for oral salt (electrolyte) and fluid intake (compensation of salt and water loss) in diarrheal diseases.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Elotrans, powder for oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the 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.
• If you do not feel better or if you feel worse after 36 hours, talk to your doctor.

What this leaflet contains

1. WHAT IS ELOTRANS AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELOTRANS?
3. HOW TO TAKE ELOTRANS?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ELOTRANS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ELOTRANS AND WHAT IS IT USED FOR?

Elotrans is a medicine for the oral treatment of fluid deficiency (dehydration) by compensating for salt and water loss. Elotrans contains salts (electrolytes) and glucose. Elotrans is used for oral salt (electrolyte) and fluid intake (compensation of salt and water loss) in diarrheal diseases.

Notes

Any diarrhea can be a sign of a serious illness. Therefore, if it lasts for a long time and/or affects your general well-being, you should see a doctor immediately. Especially in infants and toddlers, diarrhea, especially when accompanied by uncontrollable vomiting, can quickly lead to serious symptoms (loss of consciousness, shock). Therefore, a doctor should always be consulted when treating diarrhea in infants and toddlers.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELOTRANS?

Elotrans must not be taken:

• if you are allergic to any of the ingredients of this medicine (listed in section 6).
• if you suffer from acute and chronic impairment of kidney function (acute and chronic renal insufficiency).
• in case of uncontrollable vomiting.
• in case of loss of consciousness or shock in severe cases of fluid deficiency.
• if you suffer from an acid-base imbalance with acidosis of the blood (metabolic alkalosis).
• in case of disorders of carbohydrate absorption (monosaccharide malabsorption) from the intestine.

Treatment with Elotrans is not indicated if the absorption of the ingested fluid from the gastrointestinal tract into the blood is not or only partially possible (e.g. in acute intestinal obstruction).

Warnings and precautions

It is important to ensure an adequate intake of fluids in addition to the therapy! Since any diarrhea can be a sign of a serious illness, a doctor should be consulted immediately if it lasts for a long time and/or affects your general well-being. In patients with heart failure (cardiac insufficiency) and high blood pressure, the doctor should be consulted before starting treatment because of the amount of fluid and sodium supplied by Elotrans. Due to the high glucose content, Elotrans should only be used by diabetics after consulting the treating physician.

Infants and toddlers

A doctor should always be consulted when treating diarrhea in infants and toddlers.

Taking Elotrans with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effect of cardiac glycosides (certain medicines for the treatment of heart failure) may be reduced. In patients who are also being treated with glycosides, the doctor may regularly check the blood potassium level.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In any case, consult your doctor if you have diarrhea during pregnancy or breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been reported to date. Side effects listed in section 4 (Possible side effects) could affect your ability to react.

Elotrans contains glucose, potassium and sodium

Therefore, please only take Elotrans after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

• 1 sachet contains 4 g of glucose corresponding to approx. 0.33 bread units (BE). If you have to follow a diabetes diet, you should take this into account.
• 1 sachet contains 4.01 mmol (157 mg) of potassium. If you have impaired kidney function or have to follow a potassium-controlled diet (low-potassium diet), you should take this into account.
• 1 sachet contains 17.98 mmol (413.5 mg) of sodium. If you have to follow a low-salt diet, you should take this into account.

3. HOW TO TAKE ELOTRANS?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The dosage of Elotrans depends on the severity of your diarrhea. Elotrans is intended to replace the fluid lost with diarrhea.

Unless otherwise prescribed by your doctor, the recommended dose is:

• Infants and toddlers

  3 to 5 (possibly more) sachets in 24 hours.
• Children: 1 sachet after each bowel movement.
• Adults: 1 to 2 sachets after each bowel movement.

These are only guidelines. In individual cases, both a higher and a lower dosage may be required. Please consult your doctor if you are unsure. At the beginning of treatment, a higher dose may be given to compensate for fluid loss quickly and completely.

For information for the treating physician/pharmacist

The dosage recommendation is based on a fluid intake of 150 ml per kg body weight for infants and toddlers and 20 to 40 ml per kg body weight for older children and adults.

Method of administration

For oral administration after dissolving in drinking water. If no drinking water is available, freshly boiled and cooled water can also be used. Dissolve the contents of one sachet of Elotrans in 200 ml of liquid. The amount of liquid in which 1 sachet of Elotrans is to be dissolved must be strictly adhered to, otherwise the optimal composition of salts, sugar and liquid will not be achieved and disturbances of the salt balance in the body could be caused. Use the finished solution immediately. Do not store any leftovers of the solution. Do not boil Elotrans solution! In case of simultaneous nausea and/or vomiting, small amounts of 5 - 10 ml of drinking solution are initially given at intervals of 5-10 minutes and the amount is increased depending on the patient's state of health until the required dose is reached. In case of diarrhea, all food should be stopped before starting treatment with Elotrans. This also applies to milk with the exception of breast milk. Breast-fed infants are breast-fed on demand in parallel to the administration of Elotrans from the beginning of treatment. The required amount of Elotrans is administered before a breastfeeding. If an infant does not drink the offered portion at once, the drinking solution should be fed by spoon or in small portions until the recommended amount is reached.Non-breastfed infants initially receive only the solution with Elotrans (food break for approx. 6 hours, also no bottle milk). Afterwards, food diluted with water is given. After the symptoms have subsided (generally after 24 to 48 hours), it is usually possible to gradually return to normal food. Children receive their usual solid food again after the Elotrans treatment has ended. In individual cases, however, this can also be done earlier.

Duration of use

The duration of use of Elotrans in infants and toddlers is determined by the treating physician. It is usually 6 to 12 hours and should not exceed 24 hours. School children and adults take Elotrans, powder as directed by the doctor until the diarrhea subsides, but for a maximum of 36 hours. The doctor may then decide on the treatment again if necessary.

Please talk to your doctor if you have the impression that the effect of Elotrans is too strong or too weak.

If you have taken more Elotrans than you should

In any case of overdose, a doctor should be consulted immediately so that he can decide on the further course of action. In the treatment of an overdose, he will be guided by the clinical picture and take appropriate countermeasures. This applies in particular if you have an unbalanced water and salt balance, e.g. due to impaired kidney function, as well as in the case of existing or previously unrecognized diabetes mellitus. In the case of existing or previously unrecognized diabetes mellitus, taking electrolyte (salt)-glucose drinking solution can lead to hyperglycemia and even diabetic coma. If kidney function is intact, poisoning and overdosing generally do not occur. If the undissolved powder is accidentally ingested or if one sachet is diluted with less than 200 ml of drinking water, a disturbance of the salt balance and possibly a worsening of the diarrhea may occur.

If you forget to take Elotrans

Do not take twice the amount if you have forgotten to take the previous dose. Continue treatment as prescribed or as recommended in section 3 (How to take Elotrans?).

If you stop taking Elotrans

If treatment is interrupted, the success of the treatment is jeopardized. If you experience any unpleasant side effects, please talk to your doctor.

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

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

The following side effects have been reported. The frequency of these side effects is not known (frequency cannot be estimated from the available data)

Nausea and vomiting may occur as a result of potassium-induced gastric irritation.

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 to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELOTRANS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the sachet. The expiry date refers to the last day of the month indicated. The prepared solution should be used immediately. No special storage conditions are required for this medicine. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Elotrans contains

The active ingredients are: D-glucose, sodium chloride, sodium citrate, potassium chloride. 1 sachet of 6.03 g contains 4 g D-glucose, 0.7 g sodium chloride, 0.59 g sodium citrate 2H2O, 0.3 g potassium chloride.
Electrolyte content of the finished solution: Sodium+ 90 mmol/l, Potassium+ 20 mmol/l, Chloride- 80 mmol/l, Citrate3- 10 mmol/l.
Glucose content of the finished solution: Glucose 111 mmol/l.
Theoretical osmolarity of the finished solution: 311 mosm/l.

Note

1 sachet of Elotrans contains 4 g of glucose corresponding to 4 g of carbohydrates (= 16.4 kcal or 69 kJ).

The other ingredients are

Malic acid, saccharin sodium 2H2O, tea aroma, lemon aroma, sugar color.

What Elotrans looks like and contents of the pack

Light brown powder. Elotrans is available in packs of 10 and 20 sachets of 6.03 g powder for oral solution.

Marketing Authorisation Holder

STADA Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Phone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in September 2019.

Source: Information from the package leaflet
Status: 09/2020
Indications: for oral salt (electrolyte) and fluid intake (compensation of salt and water loss) in diarrheal diseases.