Radirex Max

Leaflet attached to the packaging: patient information

Radirex MAX

15 mg of hydroxyanthracene derivatives in terms of rhein,
hard capsules
Rhei radicis extractum siccum normatum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Radirex MAX is a herbal medicine intended for short-term use in sporadically occurring constipation.
The medicine has a laxative effect.
If there is no improvement after 7 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Radirex MAX

When not to take Radirex MAX

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has an obstruction, narrowing, or atony of the intestines, appendicitis, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), abdominal pain of unknown cause, severe dehydration with excessive loss of electrolytes and water.
• In children under 12 years of age.
• In pregnant or breastfeeding women.

Warnings and precautions

Before taking Radirex MAX, the patient should discuss it with their doctor or pharmacist.
Patient's taking cardiac glycosides (digoxin), anti-arrhythmic drugs (quinidine, phenytoin, propranolol, amiodarone, verapamil), drugs that prolong the QT interval (hydroxyzine, escitalopram, amitriptyline), diuretics (hydrochlorothiazide, furosemide, indapamide), corticosteroids (prednisone, prednisolone, methylprednisolone), licorice root should consult their doctor before taking the medicine.
Like other laxatives, if not recommended by a doctor, Radirex MAX should not be taken by patients with fecal impaction and acute or chronic gastrointestinal disorders of unknown cause, such as abdominal pain, nausea, vomiting, as these symptoms may be a sign of possible or existing intestinal obstruction.
If the patient is taking laxatives every day, the cause of constipation should be investigated.
Long-term use of laxatives should be avoided.
Long-term use of laxatives that stimulate intestinal peristalsis may lead to intestinal function disorders and dependence on laxatives. Medicines containing rhubarb extract should only be given when a therapeutic effect cannot be achieved through dietary changes or the use of bulking agents.
If Radirex MAX is given to patients with fecal incontinence, diapers should be changed more frequently to prevent prolonged skin contact with feces.
Patient's with renal impairment should be aware of the risk of electrolyte disturbances.

Children and adolescents

The use of Radirex MAX in children under 12 years of age is contraindicated.

Radirex MAX and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Low potassium levels in the blood (hypokalemia) resulting from long-term abuse of laxatives enhances the effect of cardiac glycosides (digoxin) and may cause interactions with anti-arrhythmic drugs (quinidine, phenytoin, propranolol, amiodarone, verapamil). Concomitant use with other drugs that cause hypokalemia, such as diuretics (hydrochlorothiazide, furosemide, indapamide), corticosteroids (prednisone, prednisolone, methylprednisolone), licorice root may exacerbate electrolyte disturbances.

Taking Radirex MAX with food and drink

The medicine should be taken after a meal, swallowing the capsule with water.

Pregnancy and breastfeeding

The use of Radirex MAX during pregnancy and breastfeeding is contraindicated.
If the patient suspects they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Radirex MAX has no significant effect on the ability to drive and use machines.
Radirex MAX contains from 3.8 mg to 178.1 mg of lactose monohydrate per capsule.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Radirex MAX

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The maximum daily dose is 30 mg of hydroxyanthracene glycosides, which corresponds to two Radirex MAX capsules per day.
The recommended single dose is the lowest dose necessary to achieve a soft stool.
The laxative effect occurs 8-12 hours after administration.
The medicine should be taken orally.
The recommended dose is:

• 1-2 Radirex MAX capsules per day, in the evening, orally.

Usually, it is sufficient to take the medicine 2-3 times a week.
Do not take for more than 7 days. See Warnings and precautions.
If symptoms persist during treatment, the patient should consult their doctor or pharmacist.

Use in children

Radirex MAX should not be taken by children under 12 years of age.

Overdose of Radirex MAX

The main symptom of overdose or abuse of the medicine is crampy abdominal pain and severe diarrhea with accompanying fluid and electrolyte loss, which should be replenished. In this case, the patient should immediately consult their doctor to initiate symptomatic treatment. The patient should be aware that diarrhea with accompanying potassium loss can be dangerous, especially for the elderly. Chronic abuse of anthranoid-containing medicines may lead to toxic liver inflammation.

Missed dose of Radirex MAX

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

Stopping Radirex MAX

In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Radirex MAX can cause side effects, although not everybody gets them.
Side effects are listed by system organ class and frequency according to MedDRA and frequency: frequency not known (cannot be estimated from the available data).
During treatment with Radirex MAX, the following side effects may occur:
Immune system disorders
Hypersensitivity reactions (itching, hives, local or generalized rash) - frequency not known.
Gastrointestinal disorders
Abdominal pain, intestinal spasms, liquid stools (especially in patients with irritable bowel syndrome) - frequency not known.
These symptoms may also occur as a consequence of individual overdose of the medicine.
In such cases, it is necessary to reduce the dose.
Long-term use of the medicine may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually disappears after the end of treatment - frequency not known.
Urinary disorders
During treatment, the 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 - frequency not known.
Long-term use of the medicine may lead to disturbances in water and electrolyte balance, proteinuria, and hematuria - frequency not known.
If other, unlisted side effects occur, the patient should consult their doctor or pharmacist.

Reporting side effects

If side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 gather more information on the safety of the medicine.

5. How to store Radirex MAX

The medicine should be stored at a temperature below 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 carton after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Radirex MAX contains

The active substance of the medicine is a standardized extract from rhubarb root (Rhei radicis extractum siccum normatum).
One capsule contains196.9 mg - 371.2 mg of dry extract from Rheum palmatumL. and/or Rheum officinaleBaillon, radix (rhubarb root), which corresponds to 15 mg of hydroxyanthracene derivatives in terms of rhein, extractant: ethanol 70% (V/V).
The excipient with a known effect is lactose monohydrate from 3.8 mg to 178.1 mg per capsule.
Other ingredients are: colloidal anhydrous silica, calcium carbonate, crospovidone type A, magnesium stearate, hard gelatin capsule with imprint (capsule: black iron oxide, titanium dioxide, yellow iron oxide, gelatin; ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide).

What Radirex MAX looks like and contents of the pack

Hard capsules of cylindrical shape, olive-colored, with imprint RADIREX MAX.
The package contains 1 or 2 blisters of PVC/ACLAR/PVC/Aluminum foil, each containing 10 capsules.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie „Herbapol” SA
ul. św. Mikołaja 65/68
50-951 Wrocław
Tel: +48 71 33 57 225
Fax: +48 71 37 24 740
e-mail: [email protected]
To obtain more detailed information on this medicine, the patient should contact the marketing authorization holder: tel. 71 321 86 04 w.123.
Date of last revision of the leaflet: