RADIREX PLUS

Package leaflet: information for the patient

Radirex PLUS
12.7 mg anthranoid compounds expressed as glucofranguline A/15 ml
syrup
Extractum fluidum compositum ex: Rhei radice, Frangulae cortice, Foeniculi fructu, Carvi fructu
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

1. What Radirex PLUS is and what it is used for
2. Important information before taking Radirex PLUS
3. How to take Radirex PLUS
4. Possible side effects
5. How to store Radirex PLUS
6. Contents of the pack and other information

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

Radirex PLUS syrup has a laxative effect and is a herbal medicinal product traditionally used for constipation. The 1,8-dihydroanthracene derivatives contained in the rhubarb root and buckthorn bark affect colonic motor activity, accelerate intestinal transit, and reduce fluid resorption. The laxative effect occurs 6–8 hours after taking the medicine.
Indications for use
Radirex PLUS syrup is a herbal medicinal product traditionally used for constipation.
The efficacy in the mentioned indications is based solely on long-standing use and experience.

2. Important information before using Radirex PLUS

When not to use Radirex PLUS

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• Do not use in cases of intestinal obstruction, intestinal atony, acute and chronic inflammatory bowel diseases (e.g. ulcerative colitis, Crohn's disease), appendicitis, diarrhoea, dehydration and electrolyte disturbances, or in cases of abdominal pain of unknown origin.
• In children under 12 years of age.

Warnings and precautions
Before starting to use Radirex PLUS, consult a doctor or pharmacist.
In patients with haemorrhoidal disease, anal fissures, after surgical procedures in the anal region, or in cases of prolonged immobilization, medical advice is recommended. This medicine should be used for constipation only when dietary and other non-pharmacological treatments have failed. Do not use for longer than 1–2 weeks without medical advice. Prolonged use of this product may lead to weakened intestinal peristalsis and disturbances in water-electrolyte balance. Avoid using the medicine during menstruation.

Warnings regarding excipients with known effects
The medicine contains in 10 ml of syrup 8.1 g of sucrose, in 15 ml of syrup 12.1 g of suc游戏副本

3. How to use Radirex PLUS

This medicine should always be used exactly as described in the patient leaflet or as recommended by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Administer orally, before bedtime. A measuring cup is provided in the packaging to assist with dosing.
Adults: 30 ml using the measuring cup or 2 tablespoons, i.e. 25.4 mg of anthranoid compounds calculated as glucofranguline A. Take once daily before bedtime.
Adolescents over 12 years of age: 10–15 ml using the measuring cup or 2 to 3 teaspoons, i.e. 8.5 to 12.7 mg of anthranoid compounds calculated as glucofranguline A. Take once daily before bedtime.
The most appropriate single dose is the lowest dose required to achieve soft stools.
Laxative effect occurs within 6–8 hours after taking the medicine.

Use of a higher than recommended dose of Radirex PLUS
To date, no symptoms of overdose have been observed during the use of Radirex PLUS.
The main symptoms of overdose or abuse may include cramping abdominal pain and severe diarrhoea accompanied by fluid and electrolyte loss, which should be replenished. In such cases, immediate consultation with a doctor is necessary to initiate symptomatic treatment. The patient should be aware that diarrhoea accompanied by loss of potassium ions may be dangerous, particularly in elderly individuals. Chronic abuse of medicines containing anthranoids may lead to toxic liver inflammation.
In case of ingestion of a higher than recommended dose, seek immediate advice from a doctor or pharmacist.

Missed dose of Radirex PLUS
Do not take a double dose to make up for a missed dose.

Discontinuation of Radirex PLUS
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Possible adverse reactions of the medicinal product are listed according to organ systems as per MedDRA classification and frequency of occurrence: very common (>1/10); common (1/100 to <1/10); uncommon (1/1000 to <1/100); rare (1/10,000 to <1/1000); very rare (<1/10,000), including single cases; frequency not known (cannot be estimated from available data).
When using Radirex PLUS, the following may occur:

Immune system disorders
Hypersensitivity reactions – frequency not known.

Gastrointestinal disorders
Abdominal pain, intestinal cramps, diarrhoea (especially in patients with irritable bowel syndrome) – frequency not known.
Long-term use of the medicinal product may lead to intestinal mucosa pigmentation (pseudomelanosis coli), which usually resolves after discontinuation of the medicine – frequency not known.

Renal and urinary disorders
Long-term use of the medicinal product may lead to disturbances in water and electrolyte balance, proteinuria and haematuria – frequency not known.
During treatment, yellow or red-brown (depending on urine pH) discoloration of urine may occur due to the presence of active substance metabolites. This is clinically insignificant – frequency not known.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Radirex PLUS

Keep this medicine below 25°C.
Keep this medicine 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Radirex PLUS contains
Active substance: liquid extract (1:1) composed of: rhubarb root (Rhei radice), buckthorn bark (Frangulae cortice), fennel fruit (Foeniculi fructu), caraway fruit (Carvi fructu) (5/4/0.5/0.5).
1 ml of syrup (corresponding to 1.29 g) contains 129 mg of liquid extract (1:1) composed of: Rheum palmatum L., radix (rhubarb root), Rhamnus frangula L., cortex (buckthorn bark), Foeniculum vulgare Mill., fructus (fruit of bitter fennel variety), Carum carvi L., fructus (caraway fruit) (5/4/0.5/0.5), equivalent to 0.85 mg of anthraquinone derivatives calculated as glucofrangulin A.
Extraction solvent: ethanol 50% (V/V).
Excipients: sucrose, purified water.
10 ml of syrup contains 8.5 mg, and 15 ml of syrup (one tablespoon) contains 12.7 mg of anthraquinone derivatives calculated as glucofrangulin A.
The syrup contains no more than 3.5% (m/m) ethanol.

What Radirex PLUS looks like and contents of the pack
Syrup – clear, reddish-brown in colour, with a characteristic odour.
Packaged in a coloured glass bottle containing 125 g of the medicinal product, closed with an HDPE screw cap and provided with a measuring device, all contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
tel. +48 71 33 57 255
fax: +48 71 37 24 740
e-mail: [email protected]

For further information about this medicinal product, please contact the Marketing Authorisation Holder – tel. 71 321 86 04 ext. 123