Xenna Extra Comfort

Package Leaflet: Information for the Patient

Xenna extra comfort

20 mg of hydroxyanthracene glycosides calculated as sennoside B
enteric-coated tablets
Sennae angustifoliae fructus extractum siccum

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

This medicine should always be taken exactly as described in the package leaflet for the patient 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 after 14 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Xenna extra comfort and what is it used for
• 2. Important information before using Xenna extra comfort
• 3. How to use Xenna extra comfort
• 4. Possible side effects
• 5. How to store Xenna extra comfort
• 6. Contents of the pack and other information

1. What is Xenna extra comfort and what is it used for

Xenna extra comfort is a herbal medicine for the short-term treatment of constipation.
It is produced in the form of enteric-coated tablets containing a herbal laxative ingredient
namely dry extract of senna fruits. It contains hydroxyanthracene glycosides (sennosides),
which stimulate the activity of the large intestine, making it easier to move bowel masses. Additionally, Xenna extra
comfort causes softening of the stool by increasing the secretion of mucus with simultaneous
inhibition of water reabsorption from the intestinal lumen.
If there is no improvement after 7-14 days or the patient feels worse, a doctor should be consulted.

2. Important information before using Xenna extra comfort

When not to use Xenna extra comfort

Xenna extra comfort should not be used in case of known hypersensitivity (allergy)
to the active substance or to any of the other ingredients of this medicine, as well as in case of
intestinal obstruction, appendicitis, acute inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis),
abdominal pain of unknown origin, or dehydration with electrolyte imbalance. Products containing senna should not be given to children under 12 years of age.

Warnings and precautions

Xenna extra comfort is not intended for long-term use. The use of laxatives for a longer period than recommended may lead to impaired intestinal function
and dependence on laxatives. The decision to use for a period longer than 7-14 days should be made by a doctor. If there is a need for daily use of a laxative, it is recommended to consult a doctor to determine the cause of constipation.
Xenna extra comfort should only be used when it is not possible to achieve regular bowel movements through dietary changes.
In case of any undiagnosed acute or persistent abdominal symptoms, the medicine should not be used without consulting a doctor. It should not be used in patients with fecal impaction and gastrointestinal disorders, such as abdominal pain, nausea, and vomiting, unless the doctor decides otherwise. Such symptoms may indicate the possibility of intestinal obstruction.
In case of concomitant use of cardiac glycosides, it is recommended to consult a doctor before use.
The use of laxatives by patients with fecal incontinence requires increased hygiene of the areas exposed to feces.

Xenna extra comfort and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient,
as well as about medicines that the patient plans to take.
Taking the medicine may limit the absorption of other oral medicines due to accelerated intestinal passage.
In case of chronic use, it is possible to decrease the level of electrolytes in the blood, especially potassium. Potassium losses may enhance the effect of cardiac glycosides and antiarrhythmic drugs.
Potassium losses are exacerbated by concomitant use of drugs that cause hypokalemia (e.g. thiazide diuretics, corticosteroids, licorice root preparations).
Patients taking cardiac glycosides, antiarrhythmic drugs, medicinal products that prolong the QT interval, diuretics, corticosteroids, or licorice root should consult a doctor before using this medicine. In case of doubts, please consult a doctor or pharmacist.

Xenna extra comfort with food and drink

It is recommended to take Xenna extra comfort with a large amount of water.

Pregnancy, breastfeeding

There is insufficient data on the safety of use during pregnancy, so it is not recommended to use during this period.
It is not recommended to use during breastfeeding, as there is insufficient data on the passage of the medicine's metabolites into breast milk. Small amounts of rhein (an active metabolite) have been detected in breast milk, but no laxative effect has been observed in infants.
If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

No effect.

Xenna extra comfort contains lactose, sucrose, and dry glucose syrup

If the patient has previously been diagnosed with intolerance to some sugars, the patient should
consult a doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Xenna extra comfort

Adults and adolescents over 12 years of age

1 enteric-coated tablet once a day, 1 hour before bedtime; the expected laxative effect occurs after 8-12 hours. The tablets should not be chewed, but swallowed with a sufficient amount of liquid.
It is usually sufficient to use the medicine 2-3 times a week.
Duration of use
The preparation should not be used for a longer period than recommended (more than 1-2 weeks) without consulting a doctor.

Use in children

Xenna extra comfort is not recommended for use in children under 12 years of age.

Use of a higher than recommended dose of Xenna extra comfort

Intestinal cramps and severe diarrhea leading to water and electrolyte loss may occur. Diarrhea may cause potassium loss, which may lead to cardiac arrhythmias and muscle weakness, especially in patients also taking cardiac glycosides, diuretics, corticosteroids, and licorice root preparations.
In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.
Chronic use of excessive doses of medicinal products containing hydroxyanthracene glycosides may lead to toxic hepatitis.

Missed dose of Xenna extra comfort

A double dose should not be taken to make up for a missed dose. The medicine should be taken with the usual dosage.

Stopping use of Xenna extra comfort

Xenna extra comfort is intended for short-term use and can be discontinued at any time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (cannot be estimated from the available data):

• abdominal cramps and pain, diarrhea with watery stools, especially in people with irritable bowel syndrome. Such a reaction may be caused by taking too high a dose of the medicine, in which case the dose of the medicine should be reduced. Chronic use may lead to disorders of pigmentation of the colon (change in the color of the intestinal mucosa to brown), which disappear after discontinuation of the preparation;
• hypersensitivity reactions: itching, hives, rash occurring locally or on the whole body;
• water and electrolyte balance disorders, in particular albuminuria (presence of low-molecular-weight proteins in the urine), hematuria (presence of blood in the urine) in case of chronic use of the preparation;
• change in urine color to yellow or reddish-brown (this effect does not require discontinuation of the preparation).

Reporting side effects

If any side effects occur, including any possible 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 181C, 02-222 Warsaw, tel.: +48 (22) 492 13 01, fax: +48 (22) 492 13 09,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Xenna extra comfort

The medicine should be stored out of sight and reach of children. Store in a temperature not exceeding 25°C.
Do not use the medicine after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the blister is EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What Xenna extra comfort contains

One enteric-coated tablet contains 150 mg - 220 mg of Sennae angustifoliae fructus extractum siccum
(4-6:1) [dry extract of senna fruits] which corresponds to 20 mg of hydroxyanthracene glycosides
calculated as sennoside B; extractant: water.
Excipients: gelatin, methylated silica dioxide, magnesium stearate, stearic acid, talc, microcrystalline cellulose, lactose, methacrylic acid - ethyl acrylate copolymer (1:1), macrogol 6000, sucrose, arabic gum, dried dispersion, polysorbate 80, calcium carbonate E170, dry glucose syrup, sodium carboxymethyl cellulose, titanium dioxide E 171, montan wax.

What Xenna extra comfort looks like and contents of the pack

Blister packs of aluminum and PVC/PVDC (each containing 10 enteric-coated tablets) containing 10, 20, 60 enteric-coated tablets, in a cardboard box.
PP container with PE cap containing 45 enteric-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.,
ul. Ziębicka 40, 50-507 Wrocław

Manufacturer

roha arzneimittel GmbH
Rockwinkeler Heerstrasse 100
28355 Bremen, Germany
Representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.

Date of last revision of the leaflet: