ORALPÄDON

ORALPÄDON 240 Strawberry Packets Powder

Important notes (mandatory information)

Oralpädon 240 Strawberry, powder for oral 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

Oralpädon 240 Strawberry, 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 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.
• 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 ORALPÄDON AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORALPÄDON?
3. HOW TO TAKE ORALPÄDON?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ORALPÄDON?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Oralpädon is a medicine for the oral treatment of fluid deficiency (dehydration) by compensating for salt and water loss. Oralpädon contains salts (electrolytes) and glucose. Oralpädon Stada 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 if your general condition worsens, you should see a doctor immediately. Especially in infants and toddlers, diarrhea, especially when accompanied by unquenchable 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 ORALPÄDON?

Oralpädon must not be taken:

• if you are allergic to any of the ingredients of Oralpädon listed in section 6.
• if you suffer from acute and chronic impairment of kidney function (acute and chronic renal insufficiency).
• in case of unquenchable vomiting.
• in case of loss of consciousness or shock in severe fluid deficiency conditions.
• if you suffer from a disturbance of the acid-base balance with acidosis of the blood (metabolic alkalosis).
• in case of disorders of carbohydrate absorption (sugar absorption) from the intestine (monosaccharide malabsorption).

Oralpädon treatment 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 if your general condition worsens. 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 Oralpädon. Due to the high glucose content, Oralpädon 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.

Use of Oralpädon 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 taking glycosides at the same time, the doctor may check the blood potassium level regularly.

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 in case of a diarrheal disease 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 under 4. (What are the possible side effects?) could affect the ability to react.

Oralpädon contains aspartame, glucose, potassium and sodium

Contains aspartame as a source of phenylalanine and may be harmful if you have phenylketonuria. This medicine contains glucose. Therefore, please only take Oralpädon after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

• 1 sachet contains 3.56 g glucose monohydrate corresponding to approx. 0.3 bread units (BE). If you have to follow a diabetes diet, you should take this into account.
• 1 sachet contains 4.01 mmol (157mg) 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 12.05 mmol (277 mg) sodium. If you have to follow a low-salt diet, you should take this into account.

3. HOW TO TAKE ORALPÄDON?

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 Oralpädon depends on the severity of your diarrheal disease. Oralpädon 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 (if necessary also 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 necessary. 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

1 sachet of Oralpädon is dissolved in 200 ml of drinking water and drunk. If no drinking water is available, freshly boiled and cooled water can also be used. The amount of liquid in which 1 sachet of Oralpädon 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. The solution should only be prepared immediately before taking. Do not use any unused solution after 1 hour at room temperature. If stored in the refrigerator, it can be kept for a maximum of 24 hours. Do not boil the prepared solution! In case of simultaneous nausea or vomiting, Oralpädon should be drunk in small sips until the required dose has been reached. In case of diarrhea, all food should be stopped before starting treatment with Oralpädon. 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 Oralpädon from the beginning of treatment. The required amount of Oralpädon 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 Oralpädon (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 end of Oralpädon treatment. In individual cases, however, this can also be done earlier.

Duration of use

Children and adults take Oralpädon until the diarrhea subsides, but for a maximum of 36 hours. If the diarrhea persists, a doctor should be consulted again. The duration of use of Oralpädon in infants and toddlers is determined by the treating physician. It is usually 6-12 hours and should not exceed 24 hours.

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

If you have taken more Oralpädon 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. as a result of kidney dysfunction, 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 drink solution can lead to hyperglycemia up to diabetic coma. If kidney function is intact, poisoning and overdosing generally do not occur. In case of accidental ingestion of undissolved powder or dilution of a sachet with less than 200 ml of drinking water, a disturbance of the salt balance and possibly a worsening of the diarrheal disease may occur.

If you forget to take Oralpädon

Do not take a double dose to make up for a forgotten dose. Continue treatment as prescribed or as recommended under 3. (How to take Oralpädon?).

If you stop taking Oralpädon

If treatment is interrupted, the success of the treatment is endangered. 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 ORALPÄDON?

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. Do not store above +25°C. The solution should only be prepared immediately before use. At room temperature, the finished solution can be stored for 1 hour. Do not use any unused solution after one hour. It can be stored in the refrigerator for a maximum of 24 hours. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Oralpädon contains

The active ingredients are: sodium chloride, potassium chloride, glucose monohydrate, disodium hydrogen citrate 1.5 H2O. 1 sachet of 5.13 g contains 0.47 g sodium chloride, 0.3 g potassium chloride, 3.56 g glucose monohydrate (Ph.Eur.), 0.53 g disodium hydrogen citrate 1.5 H2O. The other ingredients are aspartame, strawberry flavor, highly dispersed silicon dioxide, beetroot juice dry substance.

Electrolyte content of the finished solution:

• Sodium+ 60 mmol/l
• Potassium+ 20 mmol/l
• Chloride– 60 mmol/l
• Citrate3– 10 mmol/l
• Glucose content of the finished solution: Glucose 90 mmol/l
• Theoretical osmolarity of the finished solution: 240 mosm/l.

1 sachet of Oralpädon contains 3.56 g glucose, corresponding to 3.56 g carbohydrates = 0.3 BE.

What Oralpädon looks like and contents of the pack

Light red powder or easily shaken agglomerates. Oralpädon is available in packs of 10 sachets of 5.13 g powder for oral solution.

Pharmaceutical entrepreneur

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: 10/2020
Indications: for oral salt (electrolyte) and fluid intake (compensation of salt and water loss) in diarrheal diseases.