Radirex Plus

Leaflet attached to the packaging: patient information

Radirex PLUS

Fluid extract composed of: Rhei radix, Frangulae cortex, Foeniculi fructus, Carvi fructus
12.7 mg of anthranoid compounds per 15 ml, calculated as glucofrangulin A
syrup

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 1-2 weeks, a doctor should be consulted.

Table of contents of the leaflet

• 1. What is Radirex PLUS and what is it used for
• 2. Important information before using Radirex PLUS
• 3. How to use Radirex PLUS
• 4. Possible side effects
• 5. How to store Radirex PLUS
• 6. Package contents and other information

1. What is Radirex PLUS and what is it used for

Radirex PLUS syrup has a laxative effect and is used traditionally for constipation.
The 1,8 dihydroanthracene derivatives contained in the Frangula bark and Rhei root affect the motor function of the colon, accelerate intestinal passage, and reduce fluid absorption. The laxative effect occurs 6-8 hours after taking the medicine.

Indications for use

Radirex PLUS syrup is a traditionally used medicine for constipation.

2. Important information before using Radirex PLUS

When not to use Radirex PLUS

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• Do not use in case of intestinal obstruction, atony of the intestine, acute and chronic inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease), appendicitis, diarrhea, dehydration, and electrolyte disturbances, or abdominal pain of unknown etiology.

Warnings and precautions

Before starting to use Radirex PLUS, the doctor or pharmacist should be consulted.
Due to the content of 12.4 g of sucrose in one tablespoon of the syrup, patients with diabetes should not use this medicine. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
In case of use in patients with hemorrhoids, anal fissures, after surgical procedures in the anal area, and in case of prolonged immobilization, consultation with a doctor is recommended. The medicine should be used for constipation when diet and other non-pharmacological methods of treatment have failed. Do not use without consulting a doctor for more than 1-2 weeks. Prolonged use of the product may lead to weakened intestinal peristalsis and disruption of water and electrolyte balance. Use during menstruation should be avoided.
The medicinal product contains up to 3.5% m/m ethanol (alcohol), i.e., up to 700 mg of ethanol in one tablespoon, which is equivalent to 14 ml of beer or 6 ml of wine.

Children and adolescents

Use in children under 12 years of age is not recommended.

Radirex PLUS and other medicines

The doctor should be informed about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
During prolonged use of Radirex PLUS, the potentiation of the effect of cardiac glycosides and antiarrhythmic drugs may occur due to potassium deficiency. Potassium loss may increase when used concomitantly with diuretics, adrenal cortex steroids, and licorice root.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
The medicine should not be used during pregnancy and breastfeeding.
The effect on fertility is unknown.

Driving and using machines

There are no data on the effect on the ability to drive and use machines.

3. How to use Radirex PLUS

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Use orally, before bedtime. A measuring cup is attached to the packaging to facilitate dosing.
Adults: 30 ml with the measuring cup or 2 tablespoons, i.e., 25.4 mg of anthranoid compounds calculated as glucofrangulin A.
Adolescents over 12 years: 10-15 ml with the measuring cup or 2 to 3 teaspoons, i.e., from 8.5 to 12.7 mg of anthranoid compounds calculated as glucofrangulin A.

Using a higher dose of Radirex PLUS than recommended

No symptoms of overdose have been observed during the use of Radirex PLUS so far.
In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.

Missing a dose of Radirex PLUS

A double dose should not be used to make up for a missed dose.

Stopping the use of Radirex PLUS

In case of any further doubts related to the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects of the medicine are presented according to the MedDRA system organ classification and frequency of occurrence: very common (>1/10); common (1/100 to <1>During the use of Radirex PLUS, the following may occur:
Immune system disorders
Allergic reactions - rare
Gastrointestinal disorders
Abdominal pain, intestinal cramps, liquid stools (especially in patients with irritable bowel syndrome) - frequency unknown.
Prolonged use of the medicine may lead to water and electrolyte imbalance, proteinuria, and hematuria.
Prolonged use of the medicine may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually disappears after the end of treatment.
During treatment, urine may turn yellow or reddish-brown (depending on the pH) due to the presence of metabolites of the active substances, which is not clinically significant.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Radirex PLUS

Store the medicine at a temperature not exceeding 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Radirex PLUS contains

100 g of the syrup contains:
Active substance: liquid extract (1:1) composed of: Rhei radix, Frangulae cortex, Foeniculi fructus, Carvi fructus (5/4/0.5/0.5) - 10.0 g
[Extractant: ethanol 50% v/v]
Excipients: sucrose, purified water.
15 ml of the syrup (one tablespoon) contains 12.7 mg of anthranoid compounds calculated as glucofrangulin A.
The syrup contains no more than 3.5% m/m ethanol.

What Radirex PLUS looks like and what the package contains

Syrup - transparent, brown-red in color, with a characteristic odor.
The packaging is a brown glass bottle containing 125 g of the medicine, closed with an HDPE cap with a measuring cup, in a cardboard box.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie "Herbapol" S.A.
50-951 Wrocław, ul. św. Mikołaja 65/68
phone: +48 71 33 57 255
fax: +48 71 37 24 740
email: [email protected]
To obtain more detailed information, please contact the marketing authorization holder - phone: 71 321 86 04 ext. 123
Date of the last update of the leaflet: