2 x 10 Radirex 513.5 mg Tablets For Intestinal Obstruction Stenosis

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2 x 10 Radirex 513.5 mg Tablets For Intestinal Obstruction Stenosis

Radirex 513.5 mg tablets for constipation, N10
Rhubarb root powder

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 as your doctor or pharmacist has told you.
- Do not throw this leaflet away as you may need to read it again.
- If you want to know more or consult, contact your pharmacist.
- If side effects occur (even if they are not listed in this leaflet), contact your doctor or pharmacist.
- If your condition has not improved or even worsened within 7-14 days, consult a doctor.

What is this leaflet about?

1. What Radirex is and what it is used for
2. What you need to know before you use Radirex
3. How to use Radirex
4. Possible side effects
5. How to store Radirex
6. Contents of the pack and other information

1. What Radirex is and what it is used for
Radirex is a herbal medicine for the short-term relief of occasional constipation. If your condition has not improved or even worsened within 7-14 days , consult a doctor.

2. What you need to know before you take Radirex
Radirex tablets should not be used:
- if you are allergic to rhubarb root or any of the excipients of this medicine (listed in section 6).
- Intestinal obstruction and stenosis, atony, appendicitis, intestinal inflammation (e.g. Crohn's disease, ulcerative colitis), unexplained abdominal pain, severe dehydration and impaired water and electrolyte balance.
- children younger than 12 years old.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Radirex. Patients taking cardiac glycosides, antiarrhythmic drugs, QT prolonging drugs, diuretics, adrenocorticosteroids or licorice preparations must consult their doctor before taking Radirex.

As with other laxatives, rhubarb preparations should not be used in patients who are unable to have a bowel movement or who have acute or persistent gastrointestinal symptoms of unknown cause, such as abdominal pain, nausea and vomiting, as these may be signs of intestinal obstruction.

If laxatives are needed daily, the causes of constipation must be investigated. Long-term use of laxatives should be avoided.

Long-term use of laxatives can disrupt bowel function and lead to the development of laxative dependence. Rhubarb preparations should be used only in cases where the therapeutic effect cannot be achieved by diet or measures that increase the volume of feces.

If rhubarb preparations are prescribed to incontinent adults, in order to avoid skin contact with feces, pads should be changed as often as possible.

When administering the drug to patients with kidney disease, a possible electrolyte imbalance should be assessed.

Children and adolescents
Radirex should not be used in children under 12 years of age.

Other medicines and Radirex
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are not sure. Hypokalemia (appearing due to long-term use of antiarrhythmic drugs) enhances the effect of fenugreek glycosides, with the simultaneous use of antiarrhythmic drugs, causes sinus rhythm reversion (eg, quinidine) and prolongation of the QT segment. Concomitant use of other drugs that cause hypokalemia (eg, diuretics, adrenocorticosteroids, and licorice) may increase electrolyte imbalance.

Pregnancy and breast-feeding
If you are pregnant, breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Pregnancy
There are no data on adverse effects on the mother or the fetus at recommended doses during pregnancy. However, due to research data on fetal toxicity of some anthracene derivatives (e.g. aloe emodin, emodin, frangulin, chrysophanol and fiscion), the use of Radirex during pregnancy is not recommended.

Breastfeeding
Radirex is not recommended for breastfeeding women, as it is not known how many metabolites pass into breast milk. After consumption of other anthracene derivatives, active metabolites such as rhein pass into breast milk in small amounts. Laxative effects have not been reported in breastfed infants.

Driving and using machines
Radirex does not affect the ability to drive and use machines.

3. How to take Radirex tablets for constipation
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist. Adults, adolescents over 12 years old, elderly patients should take 2 tablets once a day before going to bed. The maximum daily dose is 2 tablets. It is usually sufficient to use this medicine two or three times a week. If used for more than 1-2 weeks, medical supervision is necessary.

Use in children
Radirex should not be used in children under 12 years of age.

What to do if you overdose on Radirex?
The main symptoms of overdose/overuse are spasmodic abdominal pain and severe diarrhoea, causing the patient to lose a lot of fluids and electrolytes that need to be replaced. Diarrhea can cause potassium deficiency with cardiac arrhythmias and muscle weakness, especially if cardiac glycosides, diuretics, corticosteroids, or licorice root preparations are used together. It is necessary to drink plenty of fluids during treatment. The balance of electrolytes, especially potassium, in the body should be monitored. This is especially important for elderly patients. Constant use of drugs containing anthracene derivatives can cause inflammation of the liver. If you experience any of the above symptoms, contact your doctor or the nearest medical center.

If you forget to take Radirex
Do not take a double dose to make up for a missed tablet. If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects of Radirex
Like all medicines, this medicine can cause side effects, although not everybody gets them. Hypersensitivity reactions may occur. Rhubarb preparations may cause abdominal pain, cramping, and loose stools, especially in patients with irritable bowel syndrome. The frequency is not known. However, these symptoms can also occur after an overdose of the drug. In such cases, it is necessary to reduce the dose of the drug. Long-term use may cause water and electrolyte imbalance and albuminuria and hematuria. In addition, long-term use can cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually disappears after stopping the drug. During treatment, the urine may acquire a yellow or reddish-brown tint (depending on the pH), but this is clinically insignificant. If side effects occur,

5. How to store Radirex tablets for constipation
Keep this medicine out of the sight and reach of children. Store below 25 °C. Do not use this medicine after the expiration date stated on the box and blister after "Use by". The medicine is suitable for use until the last day of the specified month. Do not dispose of the medicine in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicine. These measures will help protect the environment.

6. Radirex package contents and other information
Composition of Radirex tablets
- The active substance of Radirex is rhubarb root powder. One tablet contains 513.5 mg of Rheum palmatum L. or Rheum officinale Baillon, radix (rhubarb root) powder, corresponding to at least 11.97 mg of hydroxyanthracene derivatives, calculated as rhein.
- The other ingredients are crospovidone talc.

Marketing authorization holder and manufacturer of Radirex
Wrocławskie Zakłady Zielarskie Herbapol SA
ul. St. Mikołaja 65/68
50-951 Wrocław
Poland

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