Package leaflet: information for the patient

Xenna Extra Comfort
20 mg hydroxyanthracene glycosides calculated as sennoside B
enteric-coated tablets
Sennae angustifoliae fructus extractum siccum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of contents

What Xenna Extra Comfort is and what it is used for
Important information before taking Xenna Extra Comfort
How to take Xenna Extra Comfort
Possible side effects
How to store Xenna Extra Comfort
Contents of the pack and other information

1. What Xenna Extra Comfort is and what it is used for

Xenna Extra Comfort is a herbal medicinal product used for the short-term treatment of constipation.
It is formulated as enteric-coated tablets containing a herbal laxative ingredient, namely dry extract of senna fruit. This contains hydroxyanthracene glycosides (sennosides) that stimulate the activity of the large intestine, facilitating the movement of faecal matter. Additionally, Xenna Extra Comfort softens the stool by increasing mucus secretion and simultaneously inhibiting the reabsorption of water from the intestinal lumen.
If there is no improvement after 7–14 days, or if you feel worse, consult your doctor.

2. Important information before using Xenna Extra Comfort

When not to use Xenna Extra Comfort
Do not use Xenna Extra Comfort if you are known to be hypersensitive (allergic)
to the active substance or to any of the other ingredients of this medicine. Also do not use in cases of intestinal obstruction, appendicitis, acute inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, or in states of dehydration with electrolyte loss. Do not administer senna-containing products to children under 12 years of age.

Warnings and precautions
Xenna Extra Comfort is not intended for long-term use. Prolonged use of laxatives beyond the recommended duration may impair intestinal function and lead to dependence on laxatives. Only a physician should decide whether treatment should continue beyond 7–14 days. If daily use of a laxative becomes necessary, consult a doctor to determine the underlying cause of constipation.
Xenna Extra Comfort should only be used when normal bowel movements cannot be achieved through dietary changes.

If any undiagnosed acute or persistent gastrointestinal symptoms occur, do not use this medicine without consulting a doctor. Do not use in patients with faecal impaction or gastrointestinal complaints such as abdominal pain, nausea, and vomiting, unless otherwise directed by a physician. These symptoms may indicate possible intestinal obstruction.

If cardiac glycosides are being used concomitantly, consult a doctor before use.

Patients with faecal incontinence who are using laxatives require enhanced hygiene of areas exposed to contact with faeces.

Xenna Extra Comfort with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.

This medicine may reduce the absorption of other orally administered medicines due to accelerated intestinal transit.

With chronic use, depletion of blood electrolytes, especially potassium, may occur. Potassium loss may enhance the effects of cardiac glycosides and antiarrhythmic drugs.

Potassium depletion is worsened by concomitant use of drugs that cause hypokalaemia (e.g. thiazide diuretics, corticosteroids, liquorice root-containing preparations).

Patients taking cardiac glycosides, antiarrhythmic drugs, medicinal products causing QT prolongation, diuretics, corticosteroids, or liquorice root should consult a doctor before starting this medicine. In case of doubt, please consult your 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 and breastfeeding
There are insufficient data on the safety of use during pregnancy; therefore, use during pregnancy is not recommended.

Use during breastfeeding is not recommended due to insufficient data on passage of drug metabolites into breast milk. Small amounts of rhein (active metabolite) have been reported to pass into breast milk; however, no laxative effect has been observed in breastfed infants.

If you are pregnant, breastfeeding, suspect you may be pregnant, or planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
No effect.

Xenna Extra Comfort contains lactose, sucrose, and dry glucose syrup.
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Xenna Extra Comfort

Adults and adolescents over 12 years of age
1 enteric-coated tablet once daily, taken one hour before bedtime; the expected laxative effect occurs
after 8–12 hours. The tablets must not be chewed, but swallowed whole with an adequate amount of fluid.
Usually, it is sufficient to take the medicine 2–3 times per week.
Duration of use
Do not use this medicine for longer than 1–2 weeks without consulting a doctor.
Use in children
Xenna Extra Comfort is not recommended for children under 12 years of age.
Use of a higher than recommended dose of Xenna Extra Comfort
Intestinal cramps and severe diarrhoea may occur, leading to loss of water and electrolytes. Diarrhoea
may cause potassium depletion, which may result in cardiac arrhythmias and muscle weakness,
particularly in patients concurrently using cardiac glycosides, diuretics, corticosteroids,
or preparations containing liquorice root.
If a dose higher than recommended has been taken, seek immediate advice from a doctor
or pharmacist.
Chronic use of excessive doses of medicinal products containing hydroxyanthracene glycosides may lead to toxic hepatitis.
Missed dose of Xenna Extra Comfort
Do not take a double dose to make up for a missed dose. Continue taking the medicine as previously directed.
Discontinuation of Xenna Extra Comfort
Xenna Extra Comfort is intended for short-term use only and may be discontinued at any time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Frequency unknown (cannot be estimated from available data):

abdominal cramps and pain, diarrhoea with watery stools, particularly in patients with irritable bowel syndrome. This reaction may result from taking too high a dose of the medicine; in such case, the dose should be reduced. Chronic use may lead to pigmentary changes in the colon (brownish discolouration of the intestinal mucosa), which resolve after discontinuation of the product;
hypersensitivity reactions: itching, urticaria, localised or generalised rash;
disturbances in water and electrolyte balance, and particularly albuminuria (presence of small-molecular-weight proteins in urine), haematuria (presence of blood in urine) in case of chronic use of the product;
change in urine colour to yellow or red-brown (this effect does not require discontinuation of the medicine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 181C, 02-222 Warsaw, phone: +48 (22) 492 13 01, fax: +48 (22) 492 13 09, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables further monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store the medicine Xenna Extra Comfort

Keep the medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use the medicine after the expiry date stated on the carton and immediate packaging (month/year). The labelling on the blister reads: EXP – expiry date, Lot – batch number.

6. Contents of the packaging and other information

What Xenna Extra Comfort contains
One enteric tablet contains 150 mg – 220 mg Sennae angustifoliae fructus extractum siccum
(4-6:1) [dry extract of senna fruit], equivalent to 20 mg of hydroxyanthracene glycosides calculated as sennoside B; extraction solvent: water.
Excipients: gelatin, methylated silicon 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, dried glucose syrup, sodium carboxymethylcellulose, titanium dioxide E171, montan wax.

What Xenna Extra Comfort looks like and contents of the pack
Aluminum and PVC/PVDC foil blisters (each containing 10 or 15 enteric tablets), with packs of 10, 15, 20, 30, or 60 enteric tablets, in a cardboard box.
PP container with PE cap containing 45 enteric tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.,
Ziębicka 40, 50-507 Wrocław, Poland

Manufacturer
roha arzneimittel GmbH
Rockwinkeler Heerstrasse 100
28355 Bremen, Germany

Representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o., Poleczki 35, 02-822 Warsaw, Poland, tel. +48 (22) 543 60 00.